| NCT05060666 ↗ |
Prophylaxis of COVID-19 Disease With Ivermectin in COVID-19 Contact Persons [German: Prophylaxe Der COVID-19-Erkrankung Mit Ivermectin Bei COVID-19 Kontaktpersonen] |
Not yet recruiting |
Phase 3 |
2021-11-01 |
The Prevent-COVID study is a prospective, multicenter, randomized, two-armed,
placebo-controlled, double-blind, interventional study in which the efficacy and safety of
ivermectin in COVID-19 post-exposure prophylaxis (PEP) is examined in adult, close family
contacts living in the household of a subject suffering from COVID-19.
|
| NCT04395170 ↗ |
Convalescent Plasma (PC) and Human Intravenous Anti-COVID-19 Immunoglobulin (IV Anti COVID-19 IgG) in Patients Hospitalized for COVID-19. |
Not yet recruiting |
Phase 2/Phase 3 |
2020-09-01 |
A randomized, open-label, multicenter, three-arm clinical trial to study the efficacy and
safety of passive immunotherapy (convalescent plasma and anti-COVID-19 human immunoglobulin)
compared to the standard treatment in Colombia.
|
| NCT05173441 ↗ |
Human COVID-19 Immunoglobulin (COVID-HIG) Therapy for COVID-19 Patients |
Not yet recruiting |
Phase 2 |
2021-12-30 |
A randomized, double-blind, placebo-controlled phase II exploratory clinical trial to
evaluate the efficacy and safety of Human COVID-19 immunoglobulin (pH4) for intravenous
injection (COVID-HIG) in the treatment of patients with COVID-19.
|
| NCT04353180 ↗ |
Assessment the Activity Value of Isotretinoin (13- Cis-Retinoic Acid ) in the Treatment of COVID-19 ( Isotretinoin in Treatment of COVID-19) (Randomized) |
Not yet recruiting |
Phase 3 |
2021-08-01 |
Assessment the Activity Value of Isotretinoin (13- Cis-Retinoic Acid ) in the Treatment of
COVID-19
Mahmoud ELkazzaz(1),Tamer Haydara(2), Mohamed Abdelaal(3), Abedelaziz Elsayed(4) ,Yousry
Abo-amer(5), Hesham Attia(6), Quan Liu(7)' Tim Duong(8) and Heba Sahyon(9)
1. Department of chemistry and biochemistry, Faculty of Science, Damietta University,
Egypt.
2. Department of Internal Medicine, Faculty of Medicine, Kafrelsheikh University, Egypt
3. Department of Cardiothoracic Surgery, Faculty of Medicine, Kafrelsheikh University,
Egypt
4. Department of Pharmaceutical Biotechnology, Faculty of Pharmacy, Tanta University,
Egypt.
5. Hepatology,Gastroenterology and Infectious Diseases Department, Mahala Hepatology
Teaching Hospital, Egypt
6. Department of Immunology and Parasitology, Faculty of Science, Cairo University, Egypt.
7. School of Life Sciences and Engineering, Foshan University, Laboratory of Emerging
Infectious Disease, Institute of Translational Medicine, The First Hospital of Jilin
University, Changchun, China.
8. Montefiore Health System and Albert Einstein College of Medicine, New York, United
States of America.
9. Chemistry Department, Faculty of Science, Kafrelsheikh University, Egypt.
- This clinical study is the first clinical study in literature (submitted on 20
April, 2020) which demonstrated that Isotretinoin will provide complete protection
against COVID-19
Abstract
The COVID-19 pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
has infected over 100 million people causing over 2.4 million deaths over the world, and it
is still expanding. There is an urgent need for targeted and effective COVID-19 treatments
which has put great pressure on researchers across the world for developing effective drugs.
In this clinical study we attempt to demonstrate Isotretinoin could be an effective and
promising treatment for SARS-CoV-2 based on the intracellular mechanism of SARS-CoV-2
transmission and consequences caused. Isotretinoin could strongly inhibit both inflammation
and viral entry in severe acute respiratory syndrome coronavirus 2 infection via decreasing
the overproduction of early response proinflammatory cytokines (interleukin-6 ) which are
over expressed in COVID-19 and contributed to disease progression, poor outcomes, vascular
hyper permeability and multiorgan failure in patients infected with COVID-19. It could also
block the entry of COVID-19 by inhibiting androgenic factors that induce serine 2
transmembrane protease (TMPRSS2) expressions.. In addition to inhibiting of
Angiotensin-converting enzyme-2 (ACE2), Angiotensin T1 protein and Angiotensin II-mediated
intracellular calcium release pathway which is responsible for COVID-19 cell fusion and
entry, ACE2-expressing cells are prone to SARS-CoV-2 infection as ACE2 receptor facilitates
cellular viral entry and invasion. Moreover, isotretinoin is a potential repressor and
inhibitor of papain-like protease (PLpro), which is a lethal protein expressed by COVID-19
genes and is an enzyme of dubiquitination which facilitates virus replication in patients
with COVID-19.The genome of Middle East Respiratory Syndrome Coronavirus is recognized by
melanoma differentiation-associated protein-5 (MDA5), retinoic acid inducible gene-1 (RIG-1)
and endosomal toll-like receptor 3 (TLR3) as pathogen-associated molecular patterns. This
recognition resulted in the formation of type-1 interferon (IFN1). As an evasion mechanism,
virus synthesize proteins that hinder the production IFN1 in the pathway. 13-cis retinoic
acid induced significant upregulation of toll-like receptor 3 (TLR3), mitochondrial
antiviral-signaling protein (MAVS) and IFN regulatory factor 1 expression in a
time-dependent. Furthermore, 13 cis Retinoic Acid (13 cis RA) could be an effective and
promising treatment for SARS-CoV-2 owing to its ability to increase CD4 cells and induce
mucosal IgA antibodies that are less prone to Antibody Dependent Enhancement process (ADE)
and responsible for passive mucosal immunity in the respiratory tract. ADE is a phenomenon in
which antiviral antibodies facilitate viral infection of target immune cells and, in some
cases, make a second infection worse, such as dengue fever (dengue virus), By inducing IgA
antibodies, 13 cis retinoic acid enhances mucosal immunity and is known to be a potent IgA
isotype.13 Cis retinoic acid induced significant upregulation of toll-like receptor 3 an
immune boosting action that may result in an immune response to dsRNA intermediate leading to
the production of type I IFNs which is important to enhance the release of antiviral proteins
for the protection of uninfected cells. Isotretinoin therapy has furthermore proven
anti-platelet and fibrinolytic activities which may protect patients infected with covid-19
from widespread blood clots. From this point, we suggest that isotretinon will be the
Immunity passport" in the context of COVID-19
|
| NCT04353518 ↗ |
Clinical Trial to Evaluate Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19 |
Recruiting |
Phase 3 |
2020-06-30 |
This clinical trial is a randomized, blinded, two arms, placebo controlled, clinical trial to
evaluate the safety and efficacy of Mycobacterium w in combination with standard care as per
hospital practice to prevent COVID 19 in subjects at risk of getting infected with COVID 19.
|
| NCT04363840 ↗ |
The LEAD COVID-19 Trial: Low-risk, Early Aspirin and Vitamin D to Reduce COVID-19 Hospitalizations |
Not yet recruiting |
Phase 2 |
2020-05-01 |
Although the novel SARS-CoV-2 virus (COVD-19) is classified as an acute respiratory
infection, emerging data show that morbidity and mortality are driven by disseminated
intravascular coagulopathy. Untreated CAC leads to microangiopathic thromboses, causing
multiple systems organ failure and consuming enormous healthcare resources. Identifying
strategies to prevent CAC are therefore crucial to reducing COVID-19 hospitalization rates.
The pathogenesis of CAC is unknown, but there are major overlaps between severe COVID-19 and
vitamin D insufficiency (VDI). We hypothesize that VDI is a major underlying contributor to
CAC. Preliminary data from severe COVID-19 patients in New Orleans support this hypothesis.
The purpose of the proposed multi-center, prospective, randomized controlled trial is to test
the hypothesis that low-risk, early treatment with aspirin and vitamin D in COVID-19 can
mitigate the prothrombotic state and reduce hospitalization rates.
|
| NCT04365257 ↗ |
Prazosin to Prevent COVID-19 (PREVENT-COVID Trial) |
Recruiting |
Phase 2 |
2020-05-13 |
The purpose of this study is to assess the efficacy and safety of prazosin to prevent
cytokine storm syndrome and severe complications in hospitalized patients with Coronavirus
disease 2019 (COVID-19).
|
| NCT04373824 ↗ |
Max Ivermectin- COVID 19 Study Versus Standard of Care Treatment for COVID 19 Cases. A Pilot Study |
Recruiting |
N/A |
2020-04-25 |
At present, there are no specific treatments for COVID-19. WHO recommends four treatments for
COVID 19 with drugs i.eRemdesivir, Lopinavir/ ritonavir, Lopinavir/ ritonavir with interferon
beta -1a, and chloroquine or hydroxychloroquine. Currently, there are several ongoing
clinical trials evaluating potential treatments. Recently, LeonCaly reported that Ivermectin,
an FDA-approved anti-parasitic previously shown to have broad-spectrum anti-viral activity in
vitro, is an inhibitor of the causative virus (SARS-CoV-2), with a single addition to
Vero-hSLAM cells 2 hours post infection with SARSCoV-2 able to effect about 5000-fold
reduction in viral RNA at 48 h. Ivermectin therefore warrant further investigation for
possible benefits in humans. The study rationale is to understand the effect of the drug on
eradication of virus.
|
| NCT04392232 ↗ |
A Study of COVID 19 Convalescent Plasma in High Risk Patients With COVID 19 Infection |
Recruiting |
Phase 2 |
2020-05-05 |
Purpose of Study
• The purpose of this study to evaluate, the effectiveness of convalescent plasma in
combatting the symptoms and effects of the coronavirus disease, COVID-19. Beyond supportive
care, there are no proven treatment options for COVID-19.
|
| NCT04475120 ↗ |
Efficacy and Safety of Liposomal Lactoferrin in COVID-19 Patients With Mild-to-Moderate Disease and in COVID-19 Asymptomatic Patients |
Completed |
Phase 2/Phase 3 |
2020-04-15 |
COVID-19 is considered an ongoing international global health problem which already caused 12
million confirmed cases. No specific effective treatment has been identified so far, and
available supportive therapies are intended just to severe patients. Asymptomatic and mildly
symptomatic patients remain a transmission reservoir, with possible evolution to the most
severe disease form, without a clear treatment indication.
Lactoferrin (Lf) is a multifunctional glycoprotein, belonging to transferrin family, secreted
by exocrine glands and neutrophils and present in all human secretion. The pleiotropic
activity of Lf is mainly based on its four different functions: chelate two ferric iron per
molecule, interact with anionic molecules, enter inside nucleus and modulate iron
homeostasis. The ability to chelate two ferric ions per molecule is associated to the
inhibition of reactive oxygen species formation as well as this sequestration of iron,
pivotal for bacterial and viral replication, is at the basis of its antibacterial and
antiviral activity. Moreover, Lf exerts its antiviral activity against the majority of the
tested viruses by binding to heparan sulphate, while against few viruses by interacting with
surface components of viral particles. The capability of Lf to exert antiviral activity, by
binding to host cells or viral particles or both, strengthens the idea that this glycoprotein
is "an important brick in the mucosal wall, effective against viral attacks". Lf was able to
block the binding of the spike protein to host cells, indicating that Lf exerted its
inhibitory function at the viral attachment stage. The current accepted model suggests that
Lf could block viral entry by interacting with heparan sulfate proteoglycans (HSPGs), which
mediate the transport of extracellular virus particles from the low affinity anchoring sites
to the high affinity specific entry as ACE-2.
Investigators performed a prospective, interventional pilot study to assess the efficacy of
liposomal lactoferrin in COVID-19 patients with mild-to moderate disease and in COVID-19
asymptomatic patients.
Secondary objectives evaluated the safety and tolerability of liposomal lactoferrin for oral
and intra-nasal use.
|
| NCT04510194 ↗ |
COVID-OUT: Early Outpatient Treatment for SARS-CoV-2 Infection (COVID-19) |
Recruiting |
Phase 3 |
2021-01-01 |
The purpose of this trial is to understand whether:
1. Metformin vs fluvoxamine vs ivermectin vs metformin+fluvoxamine vs metformin+ivermectin
is superior to placebo in non-hospitalized adults with SARS-CoV-2 disease for preventing
Covid-19 disease progression.
2. To understand if the active treatment arms are superior to placebo in improving viral
load, serologic markers associated with Covid-19, and gut microbiome in non-hospitalized
adults with SARS-CoV-2 infection.
3. To understand if any of the active treatment arms prevent long-covid syndrome, PASC
(post-acute sequelae of SARS-CoV-2 infection).
|
| NCT04521322 ↗ |
Efficacy of a Nasal Spray Containing Iota-Carrageenan in the Prophylaxis of COVID-19 Disease in Health Personnel Dedicated to Patients Care With COVID-19 Disease |
Recruiting |
Phase 4 |
2020-07-24 |
Coronaviruses are enveloped viruses with an RNA genome. Carrageenans are sulfate
polysaccharides synthesized by red algae. Studies conducted in adults and children with the
common cold showed the effectiveness of the use of Carrageenan in nasal spray.
For decades, the antiviral action of Carrageenans has been described in numerous studies with
different viruses that infect humans: herpes viruses types 1 and 2, human immunodeficiency
virus, human papillomavirus, H1N1 influenza virus, dengue virus, rhinovirus, hepatitis A
virus, and enteroviruses. Studies on the dynamics of COVID-19 disease show an intense and
rapid pharyngeal multiplication in the first 3-5 days of the onset of symptoms, prior to the
onset of pulmonary disease.
Finally, this molecule has shown a viricidal effect against SARS-Cov2 in vitro. All this
underscores the potential value of a therapy that inhibits the virus in the rhinopharynx.
|
| NCT04565392 ↗ |
Remotely-conducted Trial of Famotidine vs Placebo for Patients at Home With Coronavirus (COVID) of 2019 (COVID-19) |
Not yet recruiting |
Phase 4 |
2021-05-01 |
Kit for reading vital signs (thermometer, wrist blood pressure device, finger oximeter) and
with study drug is overnighted to qualified subjects with early symptoms of COVID-19.
Subjects take a 20-milligram (mg) tab of famotidine or matching placebo twice a day, increase
to 1 tablet every 8 hours if not better the 2nd day, and continue same for 30 days. Vital
signs, symptoms, compliance etc are rechecked daily for the 30 days and once again 60 days
after starting study drug. Consent, baseline, and follow-up are handled via internet plus
calls/texts/virtual visits from study nurse or doctor as needed for clarifications and
compliance.
|
| NCT04570449 ↗ |
Fluoxetine to Reduce Hospitalization From COVID-19 Infection (FloR COVID-19) |
Withdrawn |
Early Phase 1 |
2020-11-01 |
The current research is a pilot study to determine the feasibility of recruiting and
retaining 40 participants diagnosed with COVID-19. The purpose is to observe the early use of
fluoxetine (commonly known as Prozac) to reduce the severity of the COVID-19 illness.
Fluoxetine is a drug that has been approved by the U.S. Food and Drug Administration (FDA)
since 1987 for various mental health disorders.
|
| NCT04577378 ↗ |
Efficacy and Safety of Drug Combination Therapy of Isotretinoin and Some Antifungal Drugs as A Potential Aerosol Therapy for COVID-19 : An Innovative Therapeutic Approach COVID-19 |
Not yet recruiting |
Phase 2 |
2020-10-20 |
Efficacy and safety of Drug combination therapy of Isotretinoin and some Anti fungal Drugs as
A potential Aerosol therapy for COVID-19 : An innovative therapeutic approach
The pandemic of COVID-19 which is caused by severe acute respiratory syndrome coronavirus 2
(SARS-COV-2) has infected over 2,000,000 people causing over 150,000 deaths.It hasno
currently approved treatments.. Airborne SARS-CoV-2 infections in humans initiate from the
virus entering nasal and airway epithelial cells through binding to angiotensin-converting
enzyme 2 (ACE2). TMPRSS2, a cellular protease that activates the SARS-CoV-2 spike protein,
colocalizes with ACE2 and can prime SARS-CoV-2 fusion directly at the plasma membrane. In the
lungs, SARS-CoV-2 infects type I and type II alveolar epithelial cells, as well as alveolar
macrophages that are among the first producers of pro-inflammatory cytokines. As key
components of the immediate antiviral response, type I interferons (here after referred to as
IFNs) are crucial for restricting viral replication and spread, through autocrine and
paracrine type I IFN receptor (IFNAR) signalling. However, minimal amounts of IFNs have been
detected in the peripheral blood or lungs of patients with severe COVID-19 In a mouse model
of SARS-CoV infection, local IFN responses in the lungs were delayed relative to peak viral
replication, which impeded virus clearance and was associated with the development of CRS .
SARS-CoV-2 ORF3b is a potent interferon inhebitor and antagonist Here, we review the
molecular mechanisms by which Retinoic acid (isotretinoin) and antifungal drugs can cooperate
to induce interferon in covid-19 infected patients A study reported that 13 Cis retinoic acid
induced significant upregulation of toll-like receptor 3 resulting in an immune response to
dsRNA intermediate which can be partially generated during CoV-2 replication . TLR3
sensitized by dsRNA and cascades of signaling pathways (Interferon-regulatory factor 1 (IRFs)
and Nuclear factor-κB (NFκB) activation, respectively) are activated to produce type I
interferons. The production of type I IFNs is important to enhance the release of antiviral
proteins for the protection of uninfected cells. RA can be generated in multiple forms as
all-trans, 9-cis,and 13-cis retinoic acid. A study reported that Retinoic acid induces
directly the expression of two transcription factors, Stat1 and IRF-1 which play central
roles in the IFN signal transduction. In addition, RA induces IFN-a synthesis, IFNs can serve
as the first line of immune defense against viral infections. IFNs are very powerful
cytokines, which play a key role in combatting pathogenic infections by controlling
inflammation and immune response by directly inducing antipathogen molecular countermeasures.
There are three classes of IFNs: type I, type II, and type III. Antifungal drug. Fluconazol
or itraconazol can inhibit cytochrome P450 enzymes, especially cype 26 which control retinoic
acid concentration into human cells enhance both isotretinoin effect and Concentrations in
Target Tissues This in turn lead to hyper interferon induction and synthesis in case of
COVID-19. Also a study demonstrated that isotretinoin can be given as aerosolized via
inhalation rout without any damage in lung cells. Repeated high doses of 13 cis retinoic by
inhalation resulted in moderate loss of body weight, but microscopic investigation of ten
tissues including lung and oesophagus did not detect any significant aerosol-induced damage
therefore inhaled isotretinoin might provide sufficient drug to the target cells in lung for
efficacy while avoiding systemic toxicity. In conclusion,isotretinoin therapy has furthermore
a proven anti-inflammatory, anti-platelet and fibrinolytic activities which may protect
patients infected with covid-19 from widespread blood clots. From this point, we suggest that
isotretinoin will be the immunity passport" in the context of COVID-19.
|
| NCT04627467 ↗ |
Prevention With Chloroquine in Health Personnel Exposed to Infection With Coronavirus Disease 2019 (COVID-19) (TS-COVID) |
Completed |
Phase 2 |
2020-03-28 |
The purpose of this study is to assess the efficacy and safety of chloroquine prophylaxis on
the incidence of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infections in
healthcare workers exposed to patients with confirmed Coronavirus Disease 2019 (COVID-19)
|
| NCT04668950 ↗ |
Fluvoxamine for Early Treatment of Covid-19 (Stop Covid 2) |
Active, not recruiting |
Phase 3 |
2020-12-22 |
The purpose of this research study is to determine if a drug called fluvoxamine can be used
early in the course of the COVID-19 infection to prevent more serious complications like
shortness of breath. Fluvoxamine is an anti-depressant drug approved by the FDA for the
treatment of obsessive-compulsive disorder. The use of fluvoxamine for the treatment of
COVID-19 is considered investigational, which means the US Food and Drug Administration has
not approved it for this use.
This study is fully-remote, which means that there is no face-to-face contact; study
materials including study drug will be shipped to participants' houses. People around the
United States and Canada can participate.
|
| NCT04729140 ↗ |
An Outpatient Clinical Trial Using Ivermectin and Doxycycline in COVID-19 Positive Patients at High Risk to Prevent COVID-19 Related Hospitalization |
Recruiting |
Phase 4 |
2020-12-28 |
The purpose of this Clinical trial is to explore the therapeutic benefits of Ivermectin and
Doxycycline in different combinations in high risk patients diagnosed with COVID-19.
|
| NCT04790240 ↗ |
Medical Herbs Inhibit Inflammation Directing T Cells to Kill the COVID-19 Virus (COVID) |
Recruiting |
Phase 1/Phase 2 |
2021-02-01 |
The human immune system is designed to protect individuals from external sources of infection
and internal cell mutation. It works effectively and efficiently until inflammation disturbs
its functioning. Once compromised by inflammation, the immune system loses its capacity to
recognize antigens and dependably defend the body against disease and illness.
When COVID-19 invades humans, it causes an immune-storm (cytokine-storm) that can directly
damage the organ(s), leading to death. The virus is an antigen - a trigger - but it is not
the actual reason that causes organ failure and death; instead, it is the body's over immune
reaction that is the cause. In attempting to protect the body, the immune system overreacts
to the antigen, which includes the infected cells, which causes a cytokine-storm, and the
subsequent and rapid shut down of the infected individual's organ(s)' structure, leaving the
body without sufficient strength or time to fight back. When the medical herbs join the body,
it can slow down the immune reaction. Medical herbs benefit the physical body; they protect
the cells and organism structure and mediate the immune response, allowing the T cells to
kill the virus (mutated or not) internally. Such success has been achieved by the All Natural
Medicine Clinic during pre-clinical trials.
This clinical study's goal is to demonstrate that the immune system can be rebuilt and
retrained, using natural medicine (i.e., medical herbs), to kill the virus without causing
the immune storm, and to explore the mechanism by which these medical herbs, which have been
used for thousands of years for healing, achieve results.
|
| NCT04801940 ↗ |
HElping Alleviate the Longer-term Consequences of COVID-19 (HEAL-COVID) |
Recruiting |
Phase 3 |
2021-05-19 |
HEAL-COVID is jointly Sponsored by Cambridge University Hospitals NHS Foundation Trust and
The University of Cambridge.
The acute effects of COVID-19 are now well described. Evidence is emerging of serious
longer-term complications occurring in the convalescent phase of the illness in a significant
proportion of patients; particularly cardiovascular and pulmonary complications.
The ill-defined syndrome, "Long COVID" is likely to include a constellation of different
conditions traversing post-ICU syndromes, significant cardiopulmonary complications,
post-viral syndromes and exacerbations of underlying conditions. Patients have reported a
range of longer-term symptoms associated with Long COVID that have significant impacts on
their quality of life.
To date, there has been little work evaluating treatments in the convalescent phase of
COVID-19. HEAL-COVID aims to evaluate the impact of treatments on longer-term morbidity,
mortality, re-hospitalisation, symptom burden and quality of life associated with COVID-19.
The first two treatment arms are Apixaban and Atorvastatin, with further treatment arms to be
added at the direction of the UK COVID-19 Therapeutic Advisory Panel (UKCTAP).
|
| NCT04809974 ↗ |
Clinical Trial of Niagen to Examine Recovery in People With Persistent Cognitive and Physical Symptoms After COVID-19 Illness (Long-COVID) |
Recruiting |
Phase 4 |
2021-07-22 |
The study will assess whether Niagen, a safe dietary supplement, improves recovery of
COVID-19 related symptoms in individuals who were infected at least 2 months prior to study
entry ("Long-COVID" "Long-haulers"). 60% of participants will receive Niagen and 40% will
receive PBO. Outcomes will consist of standardized cognitive, neuropsychiatric, physical,
functional and biomarker assessments.
|
| NCT04894721 ↗ |
Prophylaxis for COVID-19: Ivermectin in Close Contacts of COVID-19 Cases (IVERNEX-TUC) |
Recruiting |
Phase 2/Phase 3 |
2021-03-20 |
Randomized controlled clinical trial on using oral ivermectin in COVID-19 prophylaxis
supplying the drug to close contacts of confirmed cases.
|
| NCT04948203 ↗ |
Assessing the Efficacy of Sirolimus in Patients With COVID-19 Pneumonia for Prevention of Post-COVID Fibrosis |
Recruiting |
Phase 2/Phase 3 |
2021-07-09 |
The primary purpose of this study is to determine whether the drug sirolimus reduces the
likelihood of developing of pulmonary fibrosis in patients who are hospitalized with COVID-19
pneumonia.
|
| NCT04951323 ↗ |
Impact of the Immune System on Response to Anti-Coronavirus Disease 19 (COVID-19) Vaccine in Allogeneic Stem Cell Recipients (Covid Vaccin Allo) |
Recruiting |
Phase 3 |
2021-03-22 |
The present study is a prospective phase IV study. All participants will receive the
anti-Coronavirus Disease 2019 (COVID-19) Vaccine (messenger Ribonucleic acid-based vaccine,
BNT162b2 or Comirnaty®, commercialized by Pfizer-BioNTech) being authorized in the European
Union since December 2020. The vaccine is administered intramuscularly after dilution as a
series of two doses at least 21 days apart.
|
| NCT05258565 ↗ |
TPA in Acute Stroke With COVID Verus Non-COVID-19 Patients |
Not yet recruiting |
Phase 1 |
2022-02-25 |
The investigator will recruit consecutively all patients coming with acute ischemic stroke
either with or without COVID -19 infection and suitable for IV injection with Tissue
plasminogen activators according to guideline and inclusion criteria of tPA.
Aswan University Hospital.
|
| NCT05670444 ↗ |
Melatonin, Vitamins and Minerals Supplements for the Treatment of Covid-19 and Covid-like Illness |
Not yet recruiting |
Phase 1 |
2023-01-02 |
a multicenter, double-blind, randomized, placebo-controlled trial. Patients aged less than 60
years old with no previous medical history consulting the emergency department for covid and
covid-like illness and who were not hospitalized were included. Those who have known allergy
or severe side effect on the study drugs and those who refused to consent were excluded.
Pregnant women were not included. For all the included patients, a PCR test for the detection
of SARS COV2 was realized. Patients were assigned in a 1:1 ratio to the treatment group or
the placebo group. The treatment group received two pills in the morning containing Vit C Vit
D zinc and minerals and one pill of 2 mg of melatonin in the evening . Patients from the
placebo group received three similar pills . The pills were identical in color, taste, smell,
consistency, and container
|
| NCT05877508 ↗ |
Anti-SARS-CoV-2 Monoclonal Antibodies for Long COVID (COVID-19) |
Not yet recruiting |
Phase 2 |
2023-07-23 |
Persistent viral infection with viral reservoirs and detection of circulating spike protein
after the initial acute illness is one potential pathogenic mechanism for Long COVID. This
mechanism may be able to be targeted by SARS-CoV-2 monoclonal antibodies (mAbs). This trial
will study the safety and efficacy of AER002 to treat individuals with Long COVID in an adult
population.
|
| NCT03331445 ↗ |
Inhaled Gaseous Nitric Oxide (gNO) Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections |
Terminated |
Phase 2 |
2017-10-24 |
Non tuberculous mycobacteria (NTM), Burkholdria spp, Aspergillus in the lung are almost
impossible to eradicate with conventional antibiotics. In addition COVID-19 has know current
treatment. These patients have few options to treat their lung infection. Nitric oxide has
broad bactericidal and virucidal properties. It has been shown that nitric oxide was safe to
be inhaled for similar cystic fibrosis patients and reduced drug resistant bacteria in the
lungs. Further, research indicates that clinical isolates of NTM, Burkholderia spp,
Aspergillus spp and Corona-like viruses can be eradicated by 160ppm NO exposure in the
laboratory petri dish. This is not the first time inhaled NO treatment has been used in
patients with difficult lung infections. This study will provide more data to see if NO
therapy can reduce the bacterial load in the lungs, help the patients breath better; and in
the case of COVID-19 act as a anti-viral agent resulting in the reduction of incidence of
oxygen therapy, mechanical assistance of BIPAP, CPAP, intubation and mechanical ventilation
during the study period.
|
| NCT03376854 ↗ |
Pilot RCT of Therapeutic Hypothermia Plus Neuromuscular Blockade in COVID-19 Patients With ARDS |
Withdrawn |
Phase 2 |
2018-05-01 |
Acute Respiratory Distress Syndrome (ARDS) is a serious condition that occurs as a
complication of medical and surgical diseases, has a mortality of ~40%, and has no known
treatment other than optimization of support. Data from basic research, animal models, and
retrospective studies, case series, and small prospective studies suggest that therapeutic
hypothermia (TH) similar to that used for cardiac arrest may be lung protective in patients
with ARDS; however, shivering is a major complication of TH, often requiring paralysis with
neuromuscular blocking agents (NMBA) to control. Since the recently completed NHLBI PETAL
ROSE trial showed that NMBA had no effect (good or bad) in patients with moderate to severe
ARDS, the investigators sought to evaluate whether TH combined with NMBA is beneficial in
patients with ARDS. The investigators are scheduled to begin enrolling in a Department of
Defense-funded Phase IIb multicenter RCT of TH (core temperature 34-35°C) + NMBA for 48h vs.
usual temperature management in patients with ARDS with time on ventilator as the primary
outcome. Since COVID-19 is now the most common cause of ARDS, we are conducting a pilot study
to examine the safety and feasibility of including patients with COVID-19-associated ARDS in
our upcoming trial. In this pilot, we will randomize 20 patients with COVID-19 and ARDS to
either TH+NMBA for 48h or usual temperature management. The primary outcome is achieving and
maintaining the target temperature. Secondary outcomes include safety, physiologic measures,
mortality, hospital and ICU length of stay, and serum biomarkers collected on days 0, 1, 2,
3, 4, and 7.
|
| NCT03808922 ↗ |
Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study |
Recruiting |
Phase 3 |
2019-05-23 |
This study will seek to enroll immunocompromised patients with Lower Tract parainfluenza
infection.
It also contains a sub-study to enroll patients with severe COVID-19.
|
| NCT03891420 ↗ |
A Study to Evaluate the Safety, Pharmacokinetics and Antiviral Effects of Galidesivir in Yellow Fever or COVID-19 |
Terminated |
Phase 1 |
2020-04-09 |
This is a placebo-controlled, randomized, double-blind study to evaluate the
pharmacokinetics, safety and antiviral activity of galidesivir in subjects with yellow fever
(YF) or COVID-19.
|
| NCT04244591 ↗ |
Glucocorticoid Therapy for COVID-19 Critically Ill Patients With Severe Acute Respiratory Failure |
Completed |
Phase 2/Phase 3 |
2020-01-26 |
In this multi-center, randomized, control study, the investigators will evaluate the efficacy
and safety of glucocorticoid in combination with standard care for COVID-19 patents with
Severe acute respiratory failure.
|
| NCT04251871 ↗ |
Treatment and Prevention of Traditional Chinese Medicines (TCMs) on COVID-19 Infection |
Recruiting |
N/A |
2020-01-22 |
The aim of this study is to test whether Traditional Chinese Medicines (TCMs) are effective
and safe for treating COVID-19 infection. After the enrolment of approximately 30 subjects,
the recruitment will be paused, and planned interim analysis will be performed to
preliminarily investigate the efficacy and safety of TCMs in patients infected with COVID-19.
|
| NCT04252274 ↗ |
Efficacy and Safety of Darunavir and Cobicistat for Treatment of COVID-19 |
Recruiting |
Phase 3 |
2020-01-30 |
The study aims to evaluate the efficacy and safety of darunavir and cobistastat in the
treatment of COVID-19 pneumonia
|
| NCT04252664 ↗ |
A Trial of Remdesivir in Adults With Mild and Moderate COVID-19 |
Suspended |
Phase 3 |
2020-02-12 |
In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of
pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome
information of a novel coronavirus (SARS-CoV-2) from these pneumonia patients and developed a
real-time reverse transcription PCR (real-time RT-PCR) diagnostic assay.
Given no specific antiviral therapy for COVID-19 and the availability of remdesvir as a
potential antiviral agent based on pre-clinical studies in SARS-CoV and MERS-CoV infections,
this randomized, controlled, double blind trial will evaluate the efficacy and safety of
remdesivir in patients hospitalized with mild or moderate COVID-19.
|
| NCT04257656 ↗ |
A Trial of Remdesivir in Adults With Severe COVID-19 |
Terminated |
Phase 3 |
2020-02-06 |
In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of
pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome
information of a novel coronavirus (SARS-CoV-2) from these pneumonia patients and developed a
real-time reverse transcription PCR (real-time RT-PCR) diagnostic assay.
Given no specific antiviral therapy for COVID-19 and the ready availability of remdesvir as a
potential antiviral agent, based on pre-clinical studies in SARS-CoV and MERS-CoV infections,
this randomized, controlled, double blind trial will evaluate the efficacy and safety of
remdesivir in patients hospitalized with severe COVID-19.
|
| NCT04261517 ↗ |
Efficacy and Safety of Hydroxychloroquine for Treatment of COVID-19 |
Completed |
Phase 3 |
2020-02-06 |
The study aims to evaluate the efficacy and safety of hydroxychloroquine in the treatment of
COVID-19 pneumonia.
|
| NCT04273529 ↗ |
The Efficacy and Safety of Thalidomide in the Adjuvant Treatment of Moderate New Coronavirus (COVID-19) Pneumonia |
Not yet recruiting |
Phase 2 |
2020-02-20 |
In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of
pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome
information of a novel coronavirus (2019-nCoV) from these pneumonia patients and developed a
real-time reverse transcription PCR (real time RT-PCR) diagnostic assay.
In view of the fact that there is currently no effective antiviral therapy, the prevention or
treatment of lung injury caused by COVID-19 can be an alternative target for current
treatment. Thalidomide has anti-inflammatory, anti-fibrotic, anti-angiogenesis, and immune
regulation effects. This study is the first Prospective, Multicenter, Randomized,
Double-blind, Placebo, Parallel Controlled Clinical Study at home and abroad to use
immunomodulators to treat patients with COVID-19 infection.
|
| NCT04273581 ↗ |
The Efficacy and Safety of Thalidomide Combined With Low-dose Hormones in the Treatment of Severe COVID-19 |
Not yet recruiting |
Phase 2 |
2020-02-18 |
In view of the fact that there is currently no effective antiviral therapy, the prevention or
treatment of lung injury caused by COVID-19 can be an alternative target for current
treatment. Patients with severe COVID-19 have rapid disease progression and high mortality.
There is currently no effective treatment method, which may be related to the excessive
immune response caused by cytokine storm. This study will evaluate thalidomide combined with
low-dose hormone adjuvant therapy for severe COVID-19 Patient effectiveness and safety.
|
| NCT04275414 ↗ |
Bevacizumab in Severe or Critical Patients With COVID-19 Pneumonia |
Completed |
Phase 2 |
2020-02-15 |
The novel identified coronavirus (SARS-CoV-2) in 2019 causes an nationwide outbreak as well
as public health crisis in China, and expands globally. Pulmonary edema is one of the most
detrimental symptoms and usually presents in severe and critical coronavirus disease
(COVID-19), resulting in dyspnea, acute lung injury (ALI) ,acute respiratory distress
syndrome (ARDS), and even death. Recent evidence revealed higher levels of blood Vascular
Endothelial Growth Factor (VEGF) in COVID-19 patients compared with healthy controls. VEGF is
considered as the most potent vascular permeability inducers. Numerous studies have revealed
that VEGF was a key factor and a potential therapeutic target in ALI and ARDS. Bevacizumab,
an anti-VEGF drug, approved by the FDA on February 26, 2004 and widely used in clinical
oncotherapy, is a promising drug for ALI/ARDS in COVID-19 through suppression of pulmonary
edema.
|
| NCT04278963 ↗ |
Yinhu Qingwen Decoction for the Treatment of Mild / Common CoVID-19 |
Suspended |
Phase 2/Phase 3 |
2021-10-01 |
In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of
pneumonia caused by CoVID-19, and the number of cases of infection with CoVID-19 identified
in Wuhan increased markedly over the later part of January 2020, with cases identified in
multiple other Provinces of China and internationally.
Given no specific antiviral therapy for CoVID-19 infection and the availability of Yinhu
Qingwen Decoction as a potential antiviral Chinese medicine based on vivo antiviral studies
in CoVID-19, this randomized,three-arm controlled, single-blind trial will evaluate the
efficacy and safety of Yinhu Qingwen Decoction (Granula) in patients hospitalized with mild
or common CoVID-19 respiratory disease.
|
| NCT04279197 ↗ |
Treatment of Pulmonary Fibrosis Due to COVID-19 With Fuzheng Huayu |
Recruiting |
Phase 2 |
2020-04-23 |
According to previous studies, viral pneumonia can develop into pulmonary fibrosis, which can
affect patients'lung function and even life health.This study aims to observe the efficacy
and safety of Fuzheng Huayu Tablets in the treatment of pulmonary fibrosis after COVID-19.
|
| NCT04280705 ↗ |
Adaptive COVID-19 Treatment Trial (ACTT) |
Completed |
Phase 3 |
2020-02-21 |
This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the
safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with
COVID-19. The study is a multicenter trial that will be conducted in up to approximately 100
sites globally. The study will compare different investigational therapeutic agents to a
control arm. There will be interim monitoring to introduce new arms and allow early stopping
for futility, efficacy, or safety. If one therapy proves to be efficacious, then this
treatment may become the control arm for comparison(s) with new experimental treatment(s).
Any such change would be accompanied by an updated sample size. Because background standards
of supportive care may evolve/improve over time as more is learned about successful
management of COVID-19, comparisons of safety and efficacy will be based on data from
concurrently randomized subjects. An independent Data and Safety Monitoring Board (DSMB) will
actively monitor interim data to make recommendations about early study closure or changes to
study arms. To evaluate the clinical efficacy, as assessed by time to recovery, of different
investigational therapeutics as compared to the control arm.
|
| NCT04285190 ↗ |
The Effect of T89 on Improving Oxygen Saturation and Clinical Symptoms in Patients With COVID-19 |
Withdrawn |
N/A |
2020-02-26 |
This is an open-label, randomized, blank-controlled treatment clinical study. The objective
of this study is to investigate the effect of T89 on improving oxygen saturation and clinical
symptoms in patients with Coronavirus Disease 2019 (COVID-19). In this study, estimated total
of 120-240 male and female patients who have been diagnosed with non-critical type of
coronavirus pneumonia (COVID-19) will be enrolled and randomly assigned to one of two study
groups, the T89 treatment group and the blank control group, to T89 or nothing on the base of
a recommended standard treatment for up to 14 days . The primary efficacy parameters include
the time to oxygen saturation recovery to normal level (≥97%), the proportion of patients
with normal level of oxygen saturation after treatment, and the total duration of oxygen
inhalation, oxygen flow change by time, oxygen concentration change by time during treatment.
|
| NCT04287686 ↗ |
Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19 |
Withdrawn |
N/A |
2020-02-01 |
This is an open label, randomized, controlled, pilot clinical study in patients with
COVID-19, to obtain preliminary biologic, physiologic, and clinical data in patients with
COVID-19 treated with rhACE2 or control patients, to help determine whether a subsequent
Phase 2B trial is warranted.
|
| NCT04290871 ↗ |
Nitric Oxide Gas Inhalation for Severe Acute Respiratory Syndrome in COVID-19. |
Withdrawn |
Phase 2 |
2020-03-23 |
The investigators will enroll 102 patients with a confirmed diagnosis of COVID-19. Patients
will be randomized to receive either inhaled nitric oxide (per protocol) or placebo. ICU
Standards of care will be the institution's own protocols (such as ventilation strategies and
use and dose of antivirals and antimicrobials, steroids, inotropic and vasopressor agents).
|
| NCT04303299 ↗ |
Fight COVID-19 Trial |
Completed |
Phase 3 |
2020-08-19 |
A 6-Week Prospective, Open label, Randomized, in Multicenter Study of, Oseltamivir 300mg per
day plus Hydroxychloroquine 800 mg per day versus Combination of Lopipinavir 800mg (or 10
mg/kg ) per day and Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Oseltamivir 300 mg ( or
4-6 mg /kg ) per day versus Combination of Darunavir 400 mg every 8 hours plus ritonavir 200
mg (or 2.5 mg/kg ) per day plus Oseltamivir 300mg ( or 4-6 mg /kg ) per day plus
Hydroxychloroquine 400 mg per day in mild COVID-19 and Combination of Lopipinavir 800 mg (or
10 mg/kg ) per day and Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Oseltamivir 300 mg ( or
4-6 mg /kg ) per day versus Favipiravir 2400 mg, 2400 mg, and 1200 mg every 8 h on day 1, and
a maintenance dose of 1200 mg twice a day plus Lopipinavir 800 mg ( or 10 mg/kg ) per day and
Ritonavir 200 mg ( or 2.5 mg/kg ) per day versus Combination of Darunavir 400 mg every 8
hours plus ritonavir 200 mg (or 2.5 mg/kg ) plus Oseltamivir 300 mg (or 4-6 mg /kg ) per day
plus Hydroxychloroquine 400 mg per day versus Favipiravir 2400 mg, 2400 mg, and 1200 mg every
8 h on day 1, and a maintenance dose of 1200 mg twice a day plus Darunavir 400 mg every 8
hours Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Hydroxychloroquine 400 mg per day in
moderate to critically illness in COVID-19
|
| NCT04304053 ↗ |
Treatment of COVID-19 Cases and Chemoprophylaxis of Contacts as Prevention |
Completed |
Phase 3 |
2020-03-18 |
This study is a research project to evaluate the efficacy of hydroxychloroquine for
post-exposure prophylaxis and early treatment of Covid-19. The intervention entails
administering prophylactic hydroxychloroquine to all contacts (Study 1) and treating non
severe confirmed cases with hydroxychloroquine (Study 2).
|
| NCT04305457 ↗ |
Nitric Oxide Gas Inhalation Therapy for Mild/Moderate COVID-19 |
Active, not recruiting |
Phase 2 |
2020-03-21 |
The scientific community is in search for novel therapies that can help to face the ongoing
epidemics of novel Coronavirus (SARS-Cov-2) originated in China in December 2019. At present,
there are no proven interventions to prevent progression of the disease. Some preliminary
data on SARS pneumonia suggest that inhaled Nitric Oxide (NO) could have beneficial effects
on SARS-CoV-2 due to the genomic similarities between this two coronaviruses. In this study
we will test whether inhaled NO therapy prevents progression in patients with mild to
moderate COVID-19 disease.
|
| NCT04306393 ↗ |
Nitric Oxide Gas Inhalation in Severe Acute Respiratory Syndrome in COVID-19 |
Active, not recruiting |
Phase 2 |
2020-03-21 |
Severe acute respiratory syndrome (SARS-CoV2) due to novel Coronavirus (2019-nCoV) related
infection (COVID-19) is characterized by severe ventilation perfusion mismatch leading to
refractory hypoxemia. To date, there is no specific treatment available for 2019-nCoV. Nitric
oxide is a selective pulmonary vasodilator gas used in as a rescue therapy in refractory
hypoxemia due to acute respiratory distress syndrome (ARDS). In-vitro and clinical evidence
indicate that inhaled nitric oxide gas (iNO) has also antiviral activity against other
strains of coronavirus. The primary aim of this study is to determine whether inhaled NO
improves oxygenation in patients with hypoxic SARS-CoV2. This is a multicenter single-blinded
randomized controlled trial with 1:1 individual allocation
|
| NCT04310865 ↗ |
Yinhu Qingwen Granula for the Treatment of Severe CoVID-19 |
Suspended |
Phase 2/Phase 3 |
2021-11-01 |
In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of
pneumonia caused by CoVID-19, and the number of cases of infection with CoVID-19 identified
in Wuhan increased markedly over the later part of January 2020, with cases identified in
multiple other Provinces of China and internationally.Given no specific antiviral therapy for
CoVID-19 infection and the availability of Yinhu Qingwen Granula as a potential antiviral
Chinese medicine based on vivo antiviral studies in CoVID-19, this adaptive,
randomized,double-blind,controlled trial will evaluate the efficacy and safety of Yinhu
Qingwen Granula in patients hospitalized with severe CoVID-19.
|
| NCT04311697 ↗ |
Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure |
Completed |
Phase 2/Phase 3 |
2020-05-15 |
Novel Corona Virus (SARS-CoV-2) is known to cause Respiratory Failure, which is the hallmark
of Acute COVID-19, as defined by the new NIH/FDA classification. Approximately 50% of those
who develop Critical COVID-19 die, despite intensive care and mechanical ventilation.
Patients with Critical COVID-19 and respiratory failure, currently treated with high flow
nasal oxygen, non-invasive ventilation or mechanical ventilation will be treated with ZYESAMI
(aviptadil), a synthetic form of Human Vasoactive Intestinal Polypeptide (VIP) plus maximal
intensive care vs. placebo + maximal intensive care. Patients will be randomized to
intravenous Aviptadil will receive escalating doses from 50 -150 pmol/kg/hr over 12 hours.
|
| NCT04312243 ↗ |
NO Prevention of COVID-19 for Healthcare Providers |
Active, not recruiting |
Phase 2 |
2020-04-07 |
Thousands of healthcare workers have been infected with SARS-CoV-2 and contracted COVID-19
despite their best efforts to prevent contamination. No proven vaccine is available to
protect healthcare workers against SARS-CoV-2.
This study will enroll 470 healthcare professionals dedicated to care for patients with
proven SARS-CoV-2 infection. Subjects will be randomized either in the observational
(control) group or in the inhaled nitric oxide group. All personnel will observe measures on
strict precaution in accordance with WHO and the CDC regulations.
|
| NCT04315896 ↗ |
Hydroxychloroquine Treatment for Severe COVID-19 Pulmonary Infection (HYDRA Trial) |
Active, not recruiting |
Phase 3 |
2020-04-14 |
Double blinded randomized clinical trial designed to evaluate the security and efficacy of
hydroxychloroquine as treatment for COVID-19 severe respiratory disease. The investigators
hypothesize that a 400mg per day dose of hydroxychloroquine for 10 days will reduce all-cause
hospital mortality in patients with severe respiratory COVID-19 disease.
|
| NCT04315948 ↗ |
Trial of Treatments for COVID-19 in Hospitalized Adults |
Recruiting |
Phase 3 |
2020-03-22 |
DisCoVeRy is a randomized controlled trial among adults (≥18-year-old) hospitalized for
COVID-19. This study is an adaptive, randomized, open or blinded, depending on the drug to be
evaluated, clinical trial to evaluate the safety and efficacy of possible therapeutic agents
in hospitalized adult patients diagnosed with COVID-19. The study is a multi-centre/country
trial that will be conducted in various sites in Europe with Inserm as sponsor. The study
will compare different investigational therapeutic agents to a control group managed with the
SoC including corticosteroids and anticoagulants. There will be interim monitoring to allow
early stopping for safety and to introduce new therapies as they become available. If one
therapy proves to be superior to others in the trial, this treatment may become part of the
SoC for comparison(s) with new experimental treatment(s).
In previous versions of the DisCoVeRy protocol, remdesivir, lopinavir/ritonavir with or
without interferon ß-1a and hydroxychloroquine were evaluated as potential treatments for
COVID-19. These treatments have been discontinued based on analyses review by both DSMC/DSMB,
the Solidarity Executive Group and the DisCoVeRy steering committee.
This version of the protocol, therefore, describes a randomized blinded placebo-controlled
trial among adults (≥18-year-old) hospitalized for COVID-19 that randomly allocates them (1:1
ratio) between 2 arms: SoC + placebo versus SoC + AZD7442.
Randomization will be stratified by region (according to the administrative definition in
each country), antigenic status (positive or negative) obtained from the result of a rapid
antigen test on nasopharyngeal swab performed at enrolment and vaccination initiation (yes or
no).
The primary analyses will be conducted on patients with antigen-positive results. A positive
antigenic test is evidence of high viral shedding consistent with a recently started or
uncontrolled infection. Overall, the number of antigen-negative patients will be at most 30%
of all included subjects. The number of patients with vaccination (partly or fully) will be
limited to 20% of all participants, split evenly between antigen positive and antigen
negative patients (i.e. vaccinated patients can make up at most 20% of antigene positive
patients and 20% of antigene negative patients). Sensitivity analyses will be performed in
all patients, stratified by antigenic status and vaccination initiation.
A global independent data and safety monitoring board (DSMB) monitors interim data to make
recommendations about early study closure or changes to conduct, including adding or removing
treatment arms. However, the current version of the protocol does not allow for efficacy or
futility analysis, and the ability to add trial arms will be limited by the study being
blinded and placebo-controlled during the investigation of AZD7442.
|
| NCT04318015 ↗ |
Hydroxychloroquine Chemoprophylaxis in Healthcare Personnel in Contact With COVID-19 Patients (PHYDRA Trial) |
Recruiting |
Phase 3 |
2020-04-14 |
Triple blinded, phase III randomized controlled trial with parallel groups (200mg of
hydroxychloroquine per day vs. placebo) aiming to prove hydroxychloroquine's security and
efficacy as prophylaxis treatment for healthcare personnel exposed to COVID-19 patients.
|
| NCT04318444 ↗ |
Hydroxychloroquine Post Exposure Prophylaxis for Coronavirus Disease (COVID-19) |
Recruiting |
Phase 2/Phase 3 |
2020-03-29 |
The purpose of this study is to test the hypothesis that post-exposure prophylaxis with
hydroxychloroquine will reduce the symptomatic secondary attack rate among household contacts
of known or suspected COVID-19 patients.
|
| NCT04320277 ↗ |
Baricitinib in Symptomatic Patients Infected by COVID-19: an Open-label, Pilot Study. |
Not yet recruiting |
Phase 2/Phase 3 |
2020-05-16 |
There is no specific antiviral treatment recommended for COVID-19, and no vaccine is
currently available. Baricitinib, an anti-Janus kinase inhibitor (anti-JAK) acting against
JAK1 and JAK2. The drug was found capable to reduce or interrupt the passage of the virus
into target cells, and to inhibit the JAK1- and JAK2-mediated cytokine release. The drug was
licensed for the treatment of rheumatoid arthritis at the daily dose of 4 mg/orally, with
excellent results in terms of clinical response and a good safety profile. Since baricitinib
does not interact with antivirals due to its prevalent renal elimination, it may be used in
combination.The evidence on the advantageous action of baricitinib on viral entry and
cytokine outbreak constituted the rationale to perform a trial on patients with mild to
moderate COVID-19 infection receiving baricitinib combined with antiviral therapy.
|
| NCT04322123 ↗ |
Safety and Efficacy of Hydroxychloroquine Associated With Azithromycin in SARS-Cov-2 Virus (COVID-19) |
Active, not recruiting |
Phase 3 |
2020-04-01 |
Coronavirus (COVID-19) is a somewhat new and recognized infectious disease that is now
spreading to several countries in the world, including Brazil. Hydroxychloroquine and
azithromycin may be useful for treating those patients.
COALITION I study aims to compared standard of care, hydroxychloroquine plus azithromycin and
hydroxychloroquine monotherapy for treatment of hospitalized patients with COVID-19.
COALITION I will recruit 630 patients with infection by COVID-19 (210 per arm). Ordinal
endpoint of status at 15 days will be the primary endpoint.
|
| NCT04323592 ↗ |
Methylprednisolone for Patients With COVID-19 Severe Acute Respiratory Syndrome |
Completed |
|
2020-03-23 |
COVID-19 infection is overwhelming Italian healthcare. There is an urgent need for a solution
to the lack of ICU beds and increasing deaths day after day.
A recent retrospective Chinese paper (JAMA Intern Med, online March 13, 2020) showed
impressive positive effect of methylprednisolone (MP) on survival of SARS-CoV-2 critically
ill patients. Moreover, the Italian Infectious Disease leading institution guidelines for
COVID-19 clinical management included as an option for patients with "incipient worsening of
respiratory functions" methylprednisolone treatment at an approximate dose of 80mg.
The main objective of this multi-centre observational trial is to analyse the association of
low dose prolonged infusion of methylprednisolone (MP) for patients with severe acute
respiratory syndrome with composite primary end-point (ICU referral, need for intubation,
in-hospital death at day 28).
|
| NCT04323631 ↗ |
Hydroxychloroquine for the Treatment of Patients With Mild to Moderate COVID-19 to Prevent Progression to Severe Infection or Death |
Withdrawn |
Early Phase 1 |
2020-04-30 |
This is a multi-center, randomized controlled, superiority, open label trial. The objective
of this trial is to evaluate the efficacy of HCQ in patients with newly diagnosed COVID-19
who have mild to moderate disease or at risk for complications. We aim to demonstrate
decrease in progression to severe pneumonia and hospital related complications among patients
who are treated with HCQ compared to patients who are not.
|
| NCT04324463 ↗ |
Anti-Coronavirus Therapies to Prevent Progression of Coronavirus Disease 2019 (COVID-19) Trial |
Recruiting |
Phase 3 |
2020-04-21 |
ACT is a randomized clinical trial to assess therapies to reduce the clinical progression of
COVID-19.
|
| NCT04325061 ↗ |
Efficacy of Dexamethasone Treatment for Patients With ARDS Caused by COVID-19 |
Terminated |
Phase 4 |
2020-04-03 |
Background: There are no proven therapies specific for Covid-19. The full spectrum of
Covid-19 ranges from asymptomatic disease to mild respiratory tract illness to severe
pneumonia, acute respiratory distress syndrome (ARDS), multiorgan failure, and death. The
efficacy of corticosteroids in viral ARDS remains controversial.
Methods: This is an internationally (Spain, Canada, China, USA) designed multicenter,
randomized, controlled, open-label clinical trial testing dexamethasone in mechanically
ventilated adult patients with established moderate-to-severe ARDS caused by confirmed
Covid-19 infection, admitted in a network of Spanish ICUs. Eligible patients will be randomly
assigned to receive either dexamethasone plus standard intensive care, or standard intensive
care alone. Patients in the dexamethasone group will receive an intravenous dose of 20 mg
once daily from day 1 to day 5, followed by 10 mg once daily from day 6 to day 10. The
primary outcome is 60-day mortality. The secondary outcome is the number of ventilator-free
days at 28 days. All analyses will be done according to the intention-to-treat principle.
|
| NCT04325633 ↗ |
Efficacy of Addition of Naproxen in the Treatment of Critically Ill Patients Hospitalized for COVID-19 Infection |
Terminated |
Phase 3 |
2020-04-24 |
The symptoms of respiratory distress caused by COVID-19 may be reduced by drugs combining
anti-inflammatory and antiviral effects. This dual effect may simultaneously protect
severely-ill patients and reduce the viral load, therefore limiting virus dissemination We
want to demonstrate the superiority of naproxen (anti-inflamatory drug) treatment addition to
standard of care compared to standard of care in term of 30-day mortality.
|
| NCT04326036 ↗ |
Use of cSVF Via IV Deployment for Residual Lung Damage After Symptomatic COVID-19 Infection |
Recruiting |
Early Phase 1 |
2020-03-25 |
COVID-19 Viral Global Pandemic resulting in post-infection pulmonary damage, including
Fibrotic Lung Disease due to inflammatory and reactive protein secretions damaging pulmonary
alveolar structure and functionality. A short review includes:
- Early December, 2019 - A pneumonia of unknown cause was detected in Wuhan, China, and
was reported to the World Health Organization (WHO) Country Office.
- January 30th, 2020 - The outbreak was declared a Public Health Emergency of
International Concern.
- February 7th, 2020 - 34-year-old Ophthalmologist who first identified a SARS-like
coronavirus) dies from the same virus.
- February 11th, 2020 - WHO announces a name for the new coronavirus disease: COVID-19.
- February 19th, 2020 - The U.S. has its first outbreak in a Seattle nursing home which
were complicated with loss of lives..
- March 11th, 2020 - WHO declares the virus a pandemic and in less than three months, from
the time when this virus was first detected, the virus has spread across the entire
planet with cases identified in every country including Greenland.
- March 21st, 2020 - Emerging Infectious Disease estimates the risk for death in Wuhan
reached values as high as 12% in the epicenter of the epidemic and ≈1% in other, more
mildly affected areas. The elevated death risk estimates are probably associated with a
breakdown of the healthcare system, indicating that enhanced public health
interventions, including social distancing and movement restrictions, should be
implemented to bring the COVID-19 epidemic under control." March 21st 2020 -Much of the
United States is currently under some form of self- or mandatory quarantine as testing
abilities ramp up..
March 24th, 2020 - Hot spots are evolving and identified, particularly in the areas of New
York-New Jersey, Washington, and California.
Immediate attention is turned to testing, diagnosis, epidemiological containment, clinical
trials for drug testing started, and work on a long-term vaccine started.
The recovering patients are presenting with mild to severe lung impairment as a result of the
viral attack on the alveolar and lung tissues. Clinically significant impairment of pulmonary
function appears to be a permanent finding as a direct result of the interstitial lung damage
and inflammatory changes that accompanied.
This Phase 0, first-in-kind for humans, is use of autologous, cellular stromal vascular
fraction (cSVF) deployed intravenously to examine the anti-inflammatory and structural
potential to improve the residual, permanent damaged alveolar tissues of the lungs.
|
| NCT04326920 ↗ |
Sargramostim in Patients With Acute Hypoxic Respiratory Failure Due to COVID-19 (SARPAC) |
Completed |
Phase 4 |
2020-03-24 |
Phase IV study to evaluate the effectiveness of additional inhaled sargramostim (GM-CSF)
versus standard of care on blood oxygenation in patients with COVID-19 coronavirus infection
and acute hypoxic respiratory failure.
|
| NCT04327206 ↗ |
BCG Vaccination to Protect Healthcare Workers Against COVID-19 |
Active, not recruiting |
Phase 3 |
2020-03-30 |
Phase III, two-group multicentre, randomised controlled trial in up to 10 078 healthcare
workers to determine if BCG vaccination reduces the incidence and severity of COVID-19 during
the 2020 pandemic.
|
| NCT04327505 ↗ |
Safety and Efficacy of Hyperbaric Oxygen for ARDS in Patients With COVID-19 |
Recruiting |
Phase 2/Phase 3 |
2020-06-03 |
COVID-19 may cause severe pneumonitis that require ventilatory support in some patients, the
ICU mortality is as high as 62%. Hospitals do not have enough ICU beds to handle the demand
and to date there is no effective cure.
We explore a treatment administered in a randomized clinical trial that could prevent ICU
admission and reduce mortality.
The overall hypothesis to be evaluated is that HBO reduce mortality, increase hypoxia
tolerance and prevent organ failure in patients with COVID19 pneumonitis by attenuating the
inflammatory response.
|
| NCT04328285 ↗ |
Chemoprophylaxis of SARS-CoV-2 Infection (COVID-19) in Exposed Healthcare Workers |
Active, not recruiting |
Phase 3 |
2020-04-14 |
Since December 2019, the emergence of a new coronavirus named SARS-Cov-2 in the city of Wuhan
in China has been responsible for a major epidemic of respiratory infections, including
severe pneumonia. Within weeks, COVID-19 became a pandemic.
In the absence of specific antiviral treatment, a special attention should be given to
prevention. Personal protection equipments may be insufficiently protective, including in
healthcare workers, a significant proportion of whom (around 4%) having been infected in the
outbreaks described in China and more recently in Italy. Infection in healthcare workers
could result from the contact with COVID-19 people in community or with infected colleagues
or patients.
As it will take at least a year before vaccines against SARS-CoV-2 becomes available,
chemoprophylaxis is an option that should be considered in this setting where prevention of
SARS-CoV-2 infection in Health Care Workers.
The COVIDAXIS trial evaluates a chemoprophylaxis of SARS-CoV-2 infection in Health Care
Workers. This trial is divided into two distinct studies that could start independently each
with its own randomization process: COVIDAXIS 1 will study Hydroxychloroquine (HCQ) versus
placebo; COVIDAXIS 2 will study Lopinavir/ritonavir (LPV/r) versus placebo.
Upon randomization healthcare workers (HCWs) involved in the management of suspected or
confirmed COVID-19 cases will be assigned to one of the following 2 treatment groups:
|
| NCT04328441 ↗ |
Reducing Health Care Workers Absenteeism in Covid-19 Pandemic Through BCG Vaccine |
Active, not recruiting |
Phase 3 |
2020-03-25 |
Rationale: Covid-19 spreads rapidly throughout the world. A large epidemic in the Netherlands
would seriously challenge the available hospital capacity, and this would be augmented by
absenteeism of healthcare workers (HCW). Strategies to prevent absenteeism of HCW are,
therefore, desperately needed to safeguard continuous patient care. Bacille Calmette-Guérin
(BCG) is a vaccine against tuberculosis, with protective non-specific effects against other
respiratory tract infections in in vitro and in vivo studies, and reported significant
reductions in morbidity and mortality. The hypothesis is that BCG vaccination can reduce HCW
absenteeism during the epidemic phase of Covid-19.
Objective: Primary objective: To reduce absenteeism among HCW with direct patient contacts
during the epidemic phase of Covid-19. Secondary objective: To reduce hospital admission, ICU
admission or death in HCW with direct patient contacts during the epidemic phase of Covid-19.
Study design: A placebo-controlled adaptive multi-centre randomized controlled trial.
Study population: HCW with direct patient contacts among which nurses and physicians working
at emergency rooms and wards where Covid-19-infected patients are treated.
Intervention: Participants will be randomized between intracutaneous administration of BCG
vaccine or placebo in a 1:1 ratio.
Main study parameters/endpoints: Primary endpoint: number of days of (unplanned) absenteeism
for any reason. Secondary endpoints include the number of days of (unplanned) absenteeism
because of documented Covid-19 infection, and the cumulative incidence of hospital admission,
Intensive Care Admission, and death.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: Based on previous experience and randomized controlled trials in adult and
elderly individuals, the risks of BCG vaccination are considered low. The objective of this
trial is to evaluate the beneficial effects of BCG vaccination through a lower work
absenteeism rate of HCW and/or a mitigated clinical course of Covid-19 infection. The primary
endpoint and the adaptive design with frequent interim analyses facilitate maximum efficiency
of the trial, so that results can inform policy making during the ongoing epidemic.
|
| NCT04328480 ↗ |
The ECLA PHRI COLCOVID Trial. Effects of Colchicine on Moderate/High-risk Hospitalized COVID-19 Patients. |
Completed |
Phase 3 |
2020-04-17 |
The ECLA PHRI COLCOVID Trial is a simple, pragmatic randomized open controlled trial to test
the effects of colchicine on moderate/high-risk hospitalized COVID-19 patients with the aim
of reducing mortality and/or new requirement for mechanical ventilation.
|
| NCT04328493 ↗ |
The Vietnam Chloroquine Treatment on COVID-19 |
Completed |
Phase 2 |
2020-04-07 |
COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes
substantial morbidity and mortality. There is currently no vaccine to prevent COVID-19 or
therapeutic agent to treat COVID-19. This clinical trial is designed to evaluate potential
therapeutics for the treatment of hospitalized COVID-19.
We hypothesis that chloroquine slows viral replication in patients with COVID-19, attenuating
the infection, and resulting in more rapid declines in viral load in throat swabs. This viral
attenuation should be associated with improved patient outcomes. Given the enormous
experience of its use in malaria chemoprophylaxis, excellent safety and tolerability profile,
and its very low cost, if proved effective then chloroquine would be a readily deployable and
affordable treatment for patients with COVID-19.
The study is funded and leaded by The Ministry of Health, Vietnam.
|
| NCT04328961 ↗ |
Hydroxychloroquine for COVID-19 Post-exposure Prophylaxis (PEP) |
Completed |
Phase 2/Phase 3 |
2020-03-31 |
This is a clinical study for the prevention of SARS-CoV-2 infection in adults exposed to the
virus. This study will enroll up to 2000 asymptomatic men and women 18 to 80 years of age
(inclusive) who are close contacts of persons with laboratory confirmed SARS-CoV-2 or
clinically suspected COVID-19. Eligible participants will be enrolled and randomized to
receive the intervention or placebo at the level of the household (all eligible participants
in one household will receive the same intervention).
|
| NCT04329572 ↗ |
Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Hospitalized Patients With Moderate to Severe COVID-19 |
Suspended |
Early Phase 1 |
2020-04-23 |
This is an exploratory study to evaluate the efficacy of hydroxychloroquine (400 mg BID on D1
and 400 mg/day on D2 to D5) and azithromycin (500 mg/ 5 days) to treat moderate to severe
COVID-19 pneumonia.
|
| NCT04329611 ↗ |
ALBERTA HOPE COVID-19 for the Prevention of Severe COVID19 Disease |
Terminated |
Phase 3 |
2020-04-13 |
Albertans with COVID-19 are at risk of deteriorating and developing severe illness. Those
over age 40 or with co-morbid illness, and likely those who are immune suppressed, are at
highest risk. This study will include a focus on people with immune-suppressed states.
Individuals confirmed to have SARS-CoV-2 infection will be identified using administrative
data (positive lab result, age 18 or over, not hospitalized, and not living in SL4 level of
care). They will then be contacted by AHS staff, independent of the researchers, to obtain
their consent for the researchers to contact them about this trial. The AHS staff member who
contacts the individual will enroll consenting individuals into a study database. If they
provided an email address an email will automatically be sent to the individual with study
information. Those who decline to be contacted will also be informed of the study website so
they can choose to review the study information and self-enrol, although they will need to do
so quickly to meet study timelines. Enrolled participants will be contacted by a study
coordinator. Those without access to the internet will be informed about the study details
when they are contacted by a study coordinator. When the study coordinator contacts potential
participants the study will be reviewed, and the potential participant will have an
opportunity to ask questions. Consent for participation will be obtained by telephone.
Telephone consent will be recorded. Participants will then be screened for inclusion and
exclusion criteria by telephone interview and review of Alberta Netcare. Alberta Netcare is
the province of Alberta's public Electronic Health Record used to store patient information
so that it is easily accessible to healthcare professionals for the purpose of care.
Information like immunizations, ECG results, diagnostic images and reports, written medical
reports (e.g. surgery reports, consultations, hospital admissions), diagnostic lab testing
results (e.g. blood tests, urine tests, blood bank info), allergies and intolerances (drug
and food allergies, food intolerances), prescription history, and general patient information
(e.g. name, birthdate, personal health number, address, phone number). Those who are not
eligible for the study will be informed of the reason(s) for ineligibility (generally it will
be a safety exclusion and they should be aware of this). Those who are eligible will be
randomized to receive HCQ or placebo for a total duration of 5 days. Study drug will be
delivered to their residence by courier. Telephone follow-up will occur at day 7 (range 7-10
days) and at day 30 (range 25-35 days).
|
| NCT04330638 ↗ |
Treatment of COVID-19 Patients With Anti-interleukin Drugs |
Completed |
Phase 3 |
2020-04-03 |
The purpose of this study is to test the safety and effectiveness of individually or
simultaneously blocking IL-6 and IL-1 versus standard of care on blood oxygenation and
systemic cytokine release syndrome in patients with COVID-19 coronavirus infection and acute
hypoxic respiratory failure and systemic cytokine release syndrome
|
| NCT04330690 ↗ |
Treatments for COVID-19: Canadian Arm of the SOLIDARITY Trial |
Recruiting |
Phase 2 |
2020-03-18 |
This study is an adaptive, randomized, open-label, controlled clinical trial, in
collaboration with countries around the world through the World Health Organization.
Subjects will be randomized to receive either standard-of-care products or the study
medication plus supportive care, while being hospitalized for COVID-19.
Participants will be randomized to one of the following groups:
1. Remdesivir 200mg IV on day 1, followed by 100 mg IV daily infusion for 9 days plus
optimized supportive care, OR
2. Interferon-beta-1a, 22 or 44 micrograms subcutaneously on days 1, 3 and 6, plus
optimized supportive care OR
3. Optimized support care, all or until discharge from hospital, whichever occurs first
|
| NCT04331470 ↗ |
Evaluation of Efficacy of Levamisole and Formoterol+Budesonide in Treatment of COVID-19 |
Recruiting |
Phase 2/Phase 3 |
2020-04-04 |
New Corona virus (COVID-19) has made a horrible situation for all of the countries. This
disease is not only a health problem but also economy, culture and the whole entity of the
countries is under attack by the virus. This disease seems to affect the body in two
different pathology pathways. From one side virus can decrease activity of immune system in
the blood stream and whole body and from other side it can attack the respiratory cells.
Tissue biopsy shows that immune cells penetrate into the Lung tissue and we have accumulation
and over activity of Immune cells in the lung. This inflammation in respiratory tract
probably is the major cause of Cytokine storm and release of TNF-α and IL-6 into the blood.
It seems that by three strategy disease can be treated. 1- By using systemic immune
simulators. 2- By using topical anti-inflammatory drug in the respiratory system (Steroids or
NSAIDs) 3- By inhibition of replication of the virus in the attacked cells.
|
| NCT04331665 ↗ |
Study of the Efficacy and Safety of Ruxolitinib to Treat COVID-19 Pneumonia |
Terminated |
N/A |
2020-05-21 |
The purpose of this study is to determine the safety and efficacy of the drug ruxolitinib in
people diagnosed with COVID-19 pneumonia by determining the number of people whose conditions
worsen (requiring machines to help with breathing or needing supplemental oxygen) while
receiving the drug.
This is a sub-study of the U-DEPLOY study: UHN Umbrella Trial Defining Coordinated Approach
to Pandemic Trials of COVID-19 and Data Harmonization to Accelerate Discovery. U-DEPLOY helps
to facilitate timely conduct of studies across the University Health Network and other
centers.
|
| NCT04332107 ↗ |
Azithromycin for COVID-19 Treatment in Outpatients Nationwide |
Terminated |
Phase 3 |
2020-05-22 |
This individually randomized telemedicine-based trial aims to evaluate the efficacy of a
single dose of azithromycin for prevention of progression of COVID-19 in patients with a
recent positive SARS-CoV-2 test who are not currently hospitalized.
|
| NCT04332666 ↗ |
Angiotensin-(1,7) Treatment in COVID-19: the ATCO Trial |
Not yet recruiting |
Phase 2/Phase 3 |
2021-12-30 |
Background: A novel Coronavirus (SARS-CoV-2) described in late 2019 in Wuhan, China, has led
to a pandemic and to a specific coronavirus-related disease (COVID-19), which is mainly
characterized by a respiratory involvement. While researching for a vaccine has been started,
effective therapeutic solutions are urgently needed to face this threaten. The
renin-angiotensin system (RAS) has a relevant role in COVID-19, as the virus will enter host
's cells via the angiotensin-converting enzyme 2 (ACE2); RAS disequilibrium might also play a
key role in the modulation of the inflammatory response that characterizes the lung
involvement. Angiotensin-(1-7) is a peptide that is downregulated in COVID-19 patient and it
may potentially improve respiratory function in this setting.
Methods/Design: The Investigators describe herein the methodology of a randomized,
controlled, adaptive Phase II/Phase III trial to test the safety, efficacy and clinical
impact of the infusion of angiotensin-(1-7) in COVID-19 patients with respiratory failure
requiring mechanical ventilation. A first phase of the study, including a limited number of
patients (n=20), will serve to confirm the safety of the study drug, by observing the number
of the severe adverse events. In a second phase, the enrollment will continue to investigate
the primary endpoint of the study (i.e. number of days where the patient is alive and not on
mechanical ventilation up to day 28) to evaluate the efficacy and the clinical impact of this
drug. Secondary outcomes will include the hospital length of stay, ICU length of stay, ICU
and hospital mortality, time to weaning from mechanical ventilation, reintubation rate,
secondary infections, needs for vasopressors, PaO2/FiO2 changes, incidence of deep vein
thrombosis, changes in inflammatory markers, angiotensins plasmatic levels and changes in
radiological findings. The estimated sample size to demonstrate a reduction in the primary
outcome from a median of 14 to 11 days is 56 patients, 60 including a dropout rate of 3%
(i.e. 30 per group), but a preplanned recalculation of the study sample size is previewed
after the enrollment of 30 patients.
Expected outcomes/Discussion: This controlled trial will assess the efficacy, safety and
clinical impact of the Angiotensin-(1-7) infusion in a cohort of COVID-19 patients requiring
mechanical ventilation. The results of this trial may provide useful information for the
management of this disease.
|
| NCT04332991 ↗ |
Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease |
Completed |
Phase 3 |
2020-04-02 |
ORCHID is a multicenter, blinded, placebo-controlled, randomized clinical trial evaluating
hydroxychloroquine for the treatment of adults hospitalized with COVID-19. Patients, treating
clinicians, and study personnel will all be blinded to study group assignment.
|
| NCT04333472 ↗ |
Piclidenoson for Treatment of COVID-19 |
Recruiting |
Phase 2 |
2021-01-06 |
Patients with documented moderate COVID-19 infection will be randomized 1:1 to receive
piclidenoson 2 mg Q12H orally with standard supportive care (SSC - intervention arm) or
placebo orally with SSC (control arm) for up to 28 days.
|
| NCT04333628 ↗ |
Chloroquine for Mild Symptomatic and Asymptomatic COVID-19 |
Terminated |
Phase 2/Phase 3 |
2020-06-01 |
19 COVID (Coronavirus disease 2019 ) is a deadly viral disease that has been spreading around
the world for several months, and is caused by a CORONA family virus (COVID-19). Following
IN-VITRO evidence of the antiviral effect of CHLOROQUINE in CORONA viruses, this drug has
been used empirically for COVID-19 patients and is currently recommended in Israel for the
treatment of intermediate and severity disease.
The mechanism of action of chloroquine is in part by inhibiting the virus distribution, and
changing the intracellular acidity, the virus distribution site. The intracellular
chloroquine concentration is determined by a pump called PGP (permeability glycoprotein) that
removes the drug from the cell and is activated by the drug. In the treatment of malaria, the
benefit of low dosage of the drug has been shown to be effective due to the fact that the
intracellular concentration of the drug is probably higher, and therefore the logic to
examine this issue in COVID-19 treatment.
The purpose of this study is to test whether a low dose of Chloroquine will reduce the
duration of the viral shedding and prevent the disease from worsening.
|
| NCT04333732 ↗ |
CROWN CORONATION: COVID-19 Research Outcomes Worldwide Network for CORONAvirus prevenTION |
Active, not recruiting |
Phase 3 |
2020-09-04 |
The objective of CROWN CORONATION is the prevention of symptomatic COVID-19 by using
combinations of approved and safe repurposed interventions, with complementary mechanisms of
action.
|
| NCT04334460 ↗ |
Safety and Antiviral Activity of BLD-2660 in COVID-19 Hospitalized Subjects |
Active, not recruiting |
Phase 2 |
2020-05-04 |
BLD-2660 is a novel, synthetic, orally active, small molecule inhibitor of calpain (CAPN) 1,
2, and 9 that is selective over the cathepsins as well as other protease families, displays
good metabolic stability and permeability, oral bioavailability and low cytochrome P450 (CYP)
inhibition. It is under development for the treatment of coronavirus disease-19 (COVID-19)
resulting from infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARSCoV2),
where there is significant unmet medical need.
|
| NCT04334512 ↗ |
A Study of Quintuple Therapy to Treat COVID-19 Infection |
Recruiting |
Phase 2 |
2020-06-22 |
This is a Phase II interventional study will test the efficacy of quintuple therapy
(Hydroxychloroquine, Azithromycin, Vitamin C, Vitamin D, and Zinc) in the treatment of
patients with COVID-19 infection).
|
| NCT04334928 ↗ |
Randomized Clinical Trial for the Prevention of SARS-CoV-2 Infection (COVID-19) in Healthcare Personnel |
Completed |
Phase 3 |
2020-04-15 |
Healthcare workers are particularly at risk of SARS-CoV-2. This study aims to assess the
efficacy of a daily single dose of tenofovir disoproxil fumarate (TDF) (245 mg)/
Emtricitabine (FTC) (200 mg), a daily single dose of hydroxychloroquine (HC) (200 mg), a
daily single dose of TDF (245 mg)/FTC (200 mg) plus HC (200 mg) versus placebo, during 12
weeks in: (1) reducing the incidence of symptomatic disease and (2) reducing clinical
severity COVID-19 among hospital healthcare workers aged 18 to 70 years in public and private
hospitals in Spain.
|
| NCT04334967 ↗ |
Hydroxychloroquine in Patients With Newly Diagnosed COVID-19 Compared to Standard of Care |
Suspended |
Phase 4 |
2020-03-30 |
This study will assess the efficacy of hydroxychloroquine in reducing the severity of
symptoms in patients with COVID-19
|
| NCT04335071 ↗ |
Tocilizumab in the Treatment of Coronavirus Induced Disease (COVID-19) |
Terminated |
Phase 2 |
2020-04-26 |
The mortality rate of the disease caused by the corona virus induced disease (COVID-19) has
been estimated to be 3.7% (WHO), which is more than 10-fold higher than the mortality of
influenza. Patients with certain risk factors seem to die by an overwhelming reaction of the
immune system to the virus, causing a cytokine storm with features of Cytokine-Release
Syndrome (CRS) and Macrophage Activation Syndrome (MAS) and resulting in Acute Respiratory
Distress Syndrome (ARDS). Several pro-inflammatory cytokines are elevated in the plasma of
patients and features of MAS in COVID-19, include elevated levels of ferritin, d-dimer, and
low platelets.
There is increasing data that cytokine-targeted biological therapies can improve outcomes in
CRS or MAS and even in sepsis. Tocilizumab (TCZ), an anti-IL-6R biological therapy, has been
approved for the treatment of CRS and is used in patients with MAS. Based on these data, it
is hypothesized that TCZ can reduce mortality in patients with severe COVID-19 prone to CRS
and ARDS.
The overall purpose of this study is to evaluate whether treatment with TCZ reduces the
severity and mortality in patients with COVID-19.
|
| NCT04335084 ↗ |
A Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection |
Recruiting |
Phase 2 |
2020-06-22 |
This is a Phase II interventional study testing whether treatment with hydroxychloroquine,
Vitamin C, Vitamin D, and Zinc can prevent symptoms of COVID-19
|
| NCT04335123 ↗ |
Study of Open Label Losartan in COVID-19 |
Completed |
Phase 1 |
2020-04-04 |
This is an open label, phase 1 clinical trial to evaluate the safety of losartan in
respiratory failure due to COVID-19.
Briefly, 50 patients with COVID-19 and respiratory failure who meet eligibility criteria and
agree to participation in the study will be placed on losartan 25 mg daily on study day 0. If
parameters are met the dose of losartan will be increased to 50 mg once daily on study day 3.
Participants will continue losartan until they experience resolution of respiratory failure
(normal oxygen levels on room air), are discharged from the hospital, meet stoppage criteria
(detailed below) or complete 14 days of therapy.
Patients and/or surrogate decision maker who do not give consent to treatment will be asked
to allow collection of data from their medical record for use as a control group. We will
also collect medical information relating to safety criteria on historical controls treated
at the University of Kansas Hospital in the 30 days prior to the study start date (3/25/2020)
and during the study period.
|
| NCT04335201 ↗ |
Defibrotide in COVID-19 Pneumonia |
Recruiting |
Phase 2 |
2020-05-20 |
Phase II, prospective, interventional, single-arm, multicentric, open label trial, with a
parallel retrospective collection of data on not treated patients from IRCCS, San Raffaele
Scientific Institute included in the institutional observational study.
A sample of 50 patients with COVID-19 pneumonia will allow to detect an absolute reduction in
the rate of Respiratory-failure at day+14 after treatment of 20%, assuming that the actual
rate of failure in the corresponding not treated patients is 70% (alpha=5%, power=90%,
two-sided test). The software PASS15 was used for calculations.
The study will also include a parallel retrospective group of temporally concomitant patients
from IRCCS, San Raffaele Scientific Institute, who did not receive an experimental treatment
and who are enrolled in an already IRB approved observational study
|
| NCT04336904 ↗ |
Clinical Study To Evaluate The Performance And Safety Of Favipiravir in COVID-19 |
Active, not recruiting |
Phase 3 |
2020-03-25 |
This study evaluates treatment with Favipiravir combined with supportive care for adult
patients with COVID-19-moderate type.
|
| NCT04337918 ↗ |
Nitric Oxide Releasing Solutions to Prevent and Treat Mild/Moderate COVID-19 Infection |
Completed |
Phase 2 |
2020-05-08 |
This is a multi-center, randomized, controlled, phase II clinical efficacy study evaluating a
novel Nitric Oxide Releasing Solution (NORS) treatment for the prevention and treatment of
COVID-19 in healthcare workers at risk of infection. Participants will be enrolled into one
of two components of this study. Based on initial swabs/symptoms, volunteers who are COVID-19
negative will be enrolled in the Prevention study and randomized to receive standard
institutional precautions or standard institutional precautions + NORS. Those who are
COVID-19 positive will be enrolled in the open-label Treatment Sub-Study.
|
| NCT04338802 ↗ |
Efficacy and Safety of Nintedanib in the Treatment of Pulmonary Fibrosis in Patients With Moderate to Severe COVID -19 |
Not yet recruiting |
Phase 2 |
2020-04-02 |
This center intends to conduct a single-center, randomized, placebo-controlled study to
evaluate the effectiveness and safety of Nintedanib ethanesulfonate soft capsule in the
treatment of pulmonary fibrosis in patients with moderate to severe COVID-19.
|
| NCT04338828 ↗ |
Nitric Oxide Inhalation Therapy for COVID-19 Infections in the ED |
Active, not recruiting |
Phase 2 |
2020-04-18 |
The spread of novel Coronavirus (2019-nCoV) related infection (COVID-19) has led to many
patient presentations in the emergency department for respiratory complaints, with many of
these patients requiring ICU admission and ventilatory support. While COVID-19 patients have
an increased need for supportive care, there is currently no specific treatment directed
against 2019-nCoV. Nitric oxide inhalation has been used as a pulmonary vasodilator and has
been found to have antiviral activity against other coronavirus strains. The primary aim of
this study is to determine whether inhaled NO improves short term respiratory status,
prevents future hospitalization, and improves the clinical course in patients diagnosed with
COVID-19 specifically in the emergency department.
|
| NCT04338906 ↗ |
Combination Therapy With Camostat Mesilate + Hydroxychloroquine for COVID-19 |
Withdrawn |
Phase 4 |
2020-05-01 |
Evaluation of the efficacy and safety of hydroxychloroquine - camostat combination therapy in
hospitalized patients with moderate COVID-19 infection, CLOCC-Trial Primary Objectives: The
primary objective of this study is to demonstrate, that a combination therapy of
hydroxychloroquine and camostat (Foipan®) is superior to hydroxychloroquine + placebo in
participants with moderate COVID-19.
|
| NCT04338958 ↗ |
Ruxolitinib in Covid-19 Patients With Defined Hyperinflammation |
Completed |
Phase 2 |
2020-04-22 |
RuxCoFlam is a single arm, non-randomized open phase II trial for front line treatment of
Covid-19 patients with defined hyperinflammation.
|
| NCT04339426 ↗ |
Atovaquone and Azithromycin Combination for Confirmed COVID-19 Infection |
Recruiting |
Phase 2 |
2020-04-20 |
This study will evaluate anti-malarial/anti-infective single-agent and in combination for
patients with confirmed COVID-19 infection. The first combination to be evaluated is
atovaquone and azithromycin.
|
| NCT04339816 ↗ |
Azithromycin Added to Hydrochloroquine in Patients Admitted to Intensive Care With COVID-19: Randomised Controlled Trial |
Terminated |
Phase 3 |
2020-05-13 |
Trial design: Prospective, multi-centre, randomised, pragmatic, double blind trial
Methods:
Participants: Adult (>18 years) within 24 hours of admission to intensive care unit with
proven or suspected COVID-19 infection, whether or not mechanically ventilated. Exclusion
criteria: symptoms of febrile disease for ≥1 week, treatment limitations in place or moribund
patients, allergy or intolerance of any study treatment, incl. long QT syndromes,
participation in another outcome-based interventional trial within last 30 days, patients
taking Hydrochloroquine for other indication than COVID-19, pregnancy.
Interventions: Patients will be randomised in 1:1:1 ratio to receive Hydrochloroquine 800mg
orally in two doses followed by 400mg daily in two doses and Azithromycin 500 mg orally in
one dose followed by 250 mg in one dose for a total of 5 days (HC-A group) or
Hydrochloroquine+ placebo (HC group) or placebo + placebo (C-group) in addition to best
standard of care, which may evolve during the trial period but will not differ between
groups.
Objective: To test the hypothesis that early administration of combination therapy slows
disease progression and improves mechanical-ventilation free survival.
Outcomes:
Primary outcome: Composite percentage of patients alive and not on end-of-life pathway who
are free of mechanical ventilation at day 14.
Secondary outcomes:
Composite percentage of patients alive and not on end-of-life pathway who are free of
mechanical ventilation at day 14 in the subgroup of patients without the need of mechanical
ventilation at baseline.
ICU-LOS D28 and D 90 mortality (in hospital)
Tertiary (exploratory) outcomes:
Viral load at D7 of study enrolment (No of viral RNA copies/ml of blood), proportion of
patients alive and rtPCR negative from nasal swab at D14, Difference of FiO2 requirement and
respiratory system compliance between day 0 and 7.
Randomization: In 1:1:1 ratio and stratified according to study centre and patients age
(cut-off 70 years) Blinding (masking): Patients, treating clinicians, outcome assessors and
data analyst will be blinded to study treatment allocation. Unblinded study pharmacist or
research nurse will prepare investigational products.
|
| NCT04340232 ↗ |
Safety and Efficacy of Baricitinib for COVID-19 |
Withdrawn |
Phase 2/Phase 3 |
2021-03-01 |
This study plans to learn more about the effects of a medicine called baricitinib on the
progression of COVID-19 (coronavirus disease of 2019), the medical condition caused by the
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Baricitinib is FDA-approved for
the treatment of rheumatoid arthritis, an autoimmune condition. This study intends to define
the impact of baricitinib on the severity and progression of COVID-19. This drug might to
lower the hyperinflammation caused by the virus, which would prevent damage to the lungs and
possibly other organs.
The study will recruit patients who have been diagnosed with COVID-19.
The goal is to recruit 80 patients.
|
| NCT04340349 ↗ |
Low-dose Hydroxychloroquine and Bromhexine: a Novel Regimen for COVID-19 Prophylaxis in Healthcare Professionals |
Enrolling by invitation |
Early Phase 1 |
2021-02-01 |
This study will investigate the security and efficacy of a daily low dose of
hydroxychloroquine and Bromhexine, in preventing the development of the disease from COVID-19
in Health Care Workers at a National Institute of Health In Mexico City.
|
| NCT04340544 ↗ |
Hydroxychloroquine for the Treatment of Mild COVID-19 Disease |
Terminated |
Phase 2 |
2020-04-22 |
The current outbreak of coronavirus disease 2019 (COVID-19) caused by severe acute
respiratory syndrome corona virus 2 (SARS-CoV-2) is a global health emergency with a case
fatality rate so far approximately 4% and a growing number of confirmed cases (>57.000) in
Germany. There is no data available on the efficacy of antiviral agents for the treatment of
COVID-19. In-vitro data show that hydroxychloroquine can inhibit SARS-CoV-2 [1] replication
and anecdotal reports from Chinese COVID-19 patients [2, 3] suggest that chloroquine is a
good candidate for treatment. No data have been published and reported evidence is based on
non-controlled use of hydroxychloroquine.
The aim of this placebo-controlled trial is to assess the effect of hydroxychloroquine on
duration of symptoms in mild COVID-19 patients and time of virus shedding as an important
tool to reduce the risk of further community transmissions. This data will inform practice
for the design of larger trials on clinical efficacy of hydroxychloroquine in the treatment
and post- and preexposure prophylaxis of COVID-19 and as a tool for reduction of community
transmission.
|
| NCT04341038 ↗ |
Clinical Trial to Evaluate Methylprednisolone Pulses and Tacrolimus in Patients With COVID-19 Lung Injury |
Recruiting |
Phase 3 |
2020-04-01 |
The primary objective of the study is to evaluate the days until reaching clinical stability
after starting randomization in hospitalized patients with elevated inflammatory parameters
and severe COVID-19 lung injury.
|
| NCT04341441 ↗ |
Will Hydroxychloroquine Impede or Prevent COVID-19 |
Terminated |
Phase 3 |
2020-04-07 |
This is a prospective, multi-site study designed to evaluate whether the use of
hydroxychloroquine in healthcare workers (HCW), Nursing Home Workers (NHW), first responders
(FR), and Detroit Department of Transportation bus drivers (DDOT) in SE, Michigan, can
prevent the acquisition, symptoms and clinical COVID-19 infection
The primary objective of this study is to determine whether the use of daily or weekly oral
hydroxychloroquine (HCQ) therapy will prevent SARS-CoV-2 infection and COVID-19 viremia and
clinical COVID-19 infection healthcare workers (HCW) and first responders (FR) (EMS, Fire,
Police, bus drivers) in Southeast Michigan.
Preventing COVID-19 transmission to HCW, FR, and Detroit Department of Transportation (DDOT)
bus drivers is a critical step in preserving the health care and first responder force, the
prevention of COVID-19 transmission in health care facilities, with the potential to preserve
thousands of lives in addition to sustaining health care systems and civil services both
nationally and globally. If efficacious, further studies on the use of hydroxychloroquine to
prevent COVID-19 in the general population could be undertaken, with a potential impact on
hundreds of thousands of lives.
|
| NCT04341493 ↗ |
Hydroxychloroquine vs Nitazoxanide in Patients With COVID-19 |
Terminated |
Phase 4 |
2020-04-06 |
Coronaviruses (CoV) are positive-sense single-stranded RNA viruses that infect a wide range
of hosts producing diseases ranging from the common cold to serious / fatal events.
Nitazoxanide (NTZx) is a derivative of 5-nitrothiazole, synthesized in 1974 by Rosignol -
Cavier. NTZx has powerful antiviral effects through the phosphorylation of protein kinase
activated by double-stranded RNA, which leads to an increase in phosphorylated factor
2-alpha, an intracellular protein with antiviral effects. The purpose of this study is to
contrast the beneficial effect of NTZx vs NTZx plus hydroxychloroquine in patients
Coronavirus Disease (COVID-19) as well as against other treatments.
|
| NCT04341688 ↗ |
A Clinical Trial of Gargling Agents in Reducing Intraoral Viral Load Among COVID-19 Patients |
Not yet recruiting |
N/A |
2021-12-01 |
Pakistan is a resource restraint country, it's not possible to carry out coronavirus testing
at mass scale. Simple cost effective intervention against the present pandemic is highly
desirable.
For patients: Identifying an antiviral gargle that could substantially reduce the colonies of
COVID-19 residing in mouth and oro-naso-pharynx is likely to reduce the viral load. Such
reduction in the viral load through surface debridement could aid the effective immune
response in improving the overall symptoms of the patients.
For dentists: This study is important because the nature of the dental profession involves
aerosol production, carrying out dental work on asymptomatic patients carrying coronavirus
puts the entire dental team at a great risk of not only acquiring the infection but also
transmitting it to the others. Antiviral gargles could be used by dentist and their
auxiliaries as prophylaxis.
For physicians and nurses: The risk of morbidity and mortality is high among physicians and
nurses involved in the screening and management of Covid-19 patients. Globally, over 215
physicians and surgeons have died while taking care of Covid-19 patients. The cause of death
is attributed to high exposure of viral load. The antiviral gargles and nasal lavage can
decrease the fatalities among doctors and nurses.
Thus, patients, physicians, nurses and dentists, all could be benefited with this findings of
this study.
|
| NCT04342169 ↗ |
University of Utah COVID-19 Hydrochloroquine Trial |
Active, not recruiting |
Phase 2 |
2020-04-04 |
A novel coronavirus, SARS-CoV-2, is responsible for a rapidly spreading pandemic that has
reached 160 countries, infecting over 500,000 individuals and killing more than 24,000
people. SARS-CoV-2 causes an acute and potentially lethal respiratory illness, known as
COVID-19, that is threatening to overwhelm health care systems due to a dramatic surge in
hospitalized and critically ill patients. Patients hospitalized with COVID-19 typically have
been symptomatic for 5-7 days prior to admission, indicating that there is a window during
which an effective intervention could significantly alter the course of illness, lessen
disease spread, and alleviate the stress on hospital resources.
There is no known treatment for COVID-19, though in vitro and one poorly controlled study
have identified a potential antiviral activity for HCQ. The rationale for this clinical trial
is to measure the efficacy and safety of hydroxychloroquine for reducing viral load and
shedding in adult outpatients with confirmed COVID-19.
|
| NCT04342221 ↗ |
Hydroxychloroquine for COVID-19 |
Terminated |
Phase 3 |
2020-03-29 |
The current outbreak of COVID-19 caused by SARS-CoV-2 is a global health emergency with a
case fatality rate so far approximately 4% and a growing number of confirmed cases (>9500) in
Germany. There is no data available on the efficacy of antiviral agents for the treatment of
COVID-19. In vitro data show that hydroxychloroquine can inhibit SARS-CoV-2 replication and
anecdotal reports from COVID-19 patients in China and France suggest that chloroquine or
hydroxychloroquine is a good candidate for treatment. In the French study a favourable effect
was seen when hydroxychloroquine was used together with azithromycin in a small series of
COVID-19 patients. However, so far all published evidence is based on non-controlled use of
hydroxychloroquine.
We propose to conduct a placebo-controlled trial in COVID-19 patients with mild to moderate
disease in Germany to assess virological efficacy, tolerability and safety of
hydroxychloroquine in the treatment of COVID-19. The objective of this trial is to identify
an effect of hydroxychloroquine on viral clearance in vivo. This data will inform practice
for the design of larger trials on clinical efficacy of hydroxychloroquine in the treatment
and post-exposure prophylaxis of COVID-19.
|
| NCT04342663 ↗ |
A Double-blind, Placebo-controlled Clinical Trial of Fluvoxamine for Symptomatic Individuals With COVID-19 Infection |
Completed |
Phase 2 |
2020-04-10 |
The purpose of this research study is to determine if a drug called fluvoxamine can be used
early in the course of the COVID-19 infection to prevent more serious complications like
shortness of breath. Fluvoxamine is an anti-depressant drug approved by the FDA for the
treatment of obsessive-compulsive disorder. The use of fluvoxamine for the treatment of
COVID-19 is considered investigational, which means the US Food and Drug Administration has
not approved it for this use.
This study is fully-remote, which means that there is no face-to-face contact; study
materials including study drug will be shipped to participants' houses. Only residents of
Missouri and Illinois may participate.
|
| NCT04342689 ↗ |
The Role of Resistant Starch in COVID-19 Infection |
Recruiting |
Phase 2/Phase 3 |
2020-06-03 |
This study is a multicenter randomized trial to evaluate the efficacy of administering a
dietary supplement containing resistant starch to non-hospitalized COVID-19 positive
subjects, The intervention will begin as soon as possible after subjects test positive for
COVID-19 and continue for 14 days. Investigators hypothesize that short-term administration
of a dietary supplement containing resistant starch has the potential to reduce rates of
hospitalization and improve time to clinical recovery and symptoms in non-hospitalized
COVID-19 positive patients.
|
| NCT04343001 ↗ |
Coronavirus Response - Active Support for Hospitalised Covid-19 Patients |
Withdrawn |
Phase 3 |
2020-10-01 |
The CRASH-19 trial is a multinational, open-label, factorial, randomised trial in adults
hospitalised with suspected or confirmed acute COVID-19 infection.
|
| NCT04343248 ↗ |
Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Post-Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses in Elderly Residents of Long-Term Care Facilities (LTCF) |
Active, not recruiting |
Phase 3 |
2020-05-12 |
Trial to evaluate the efficacy and safety of NTZ for post-exposure prophylaxis of COVID-19
and other VRIs in elderly LTCF residents.
|
| NCT04343677 ↗ |
Military COVID-19 Hydroxychloroquine Pre-exposure and Post-exposure Prophylaxis Study |
Not yet recruiting |
Phase 2 |
2020-04-01 |
There is significant interest throughout the United States in performing a well-designed
study to evaluate whether there is value in using Hydroxychloroquine or Chloroquine as a
pre-exposure prophylaxis or post-exposure prophylaxis regimen for COVID-19 patients and at
risk personnel.
We have designed a prospective double blinded randomized controlled clinical trial to answer
just this question.
The study will consist of 4 arms:
1. A placebo control arm of 450 patients
2. A low dose prophylaxis arm of 450 patients treated with 200mg Hydroxychloroquine daily
3. A high dose prophylaxis arm of 450 patients treated with 400mg Hydroxychloroquine daily
4. A post-exposure arm of 100 patients treated with 400mg Hydroxychloroquine daily for 7
days.
|
| NCT04343768 ↗ |
An Investigation Into Beneficial Effects of Interferon Beta 1a, Compared to Interferon Beta 1b And The Base Therapeutic Regiment in Moderate to Severe COVID-19: A Randomized Clinical Trial |
Completed |
Phase 2 |
2020-04-09 |
The present study is a randomized clinical trial, with the approval of the ethics committee
will be conducted on patients who have a positive test confirming COVID-19 in Loghman Hakim
Medical Education Center in Tehran. Patients will be randomly assigned to the three arms of
the study and after completing the course of treatment and collecting and analyzing the
necessary information from each patient, the results of the study will be published both on
this site and in the form of an article in a reputable international journal.
|
| NCT04343989 ↗ |
A Randomized Placebo-controlled Safety and Dose-finding Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection |
Completed |
Phase 2 |
2020-03-31 |
In this study invetigators propose to administer clazakizumab to patients with
life-threatening COVID-19 infection manifest by pulmonary failure and a clinical picture
consistent with a cytokine storm syndrome. This is a double-blinded randomized multi-center
trial designed as a phase II dose-finding three arm trial with seamless adaptive transition
to a phase III efficacy trial. For phase II, patients were randomized 1:1:1 ratio to three
study arms and received clazakizumab at a dose of 12.5 mg, 25 mg or placebo.
Based on interim analysis, the low dose arm was dropped and the phase III portion of the
study continued to enroll patients randomized 1:1 to high dose clazakizumab or placebo.
Based on interim analysis, the remaining 10 subjects at NYU will be randomly assigned to a
1:1 ratio to two arms that will receive clazakizumab at a dose of 25 mg or placebo. The NYU
site will serve as the central data management site for other centers who undertake this
protocol. Other sites will enroll patients based on the two arm 1:1 randomization. 60
patients at outside sites are expected to enroll.
|
| NCT04344236 ↗ |
Gargling and Nasal Rinses to Reduce Oro- and Nasopharyngeal Viral Load in Patients With COVID-19 |
Withdrawn |
Phase 2 |
2020-04-09 |
For this study, 48 patients who have been diagnosed with COVID-19 will be randomly assigned
to four study groups: control, saline, chlorhexidine gluconate, and povidone-iodine. Each
patient will be asked to gargle with a solution of either saline, chlorhexidine gluconate, or
povidone-iodine or nothing (control group) as well as spray the same solution in their nose
four times daily. Patients will then be tested for COVID-19 once daily in the evening for 7
days and viral loads will be measured.
|
| NCT04344444 ↗ |
Treatment in Patients With Suspected or Confirmed COVID-19 With Early Moderate or Severe Disease |
Active, not recruiting |
Phase 3 |
2020-04-13 |
This study proposes to evaluate clinical outcomes and viral load in COVID-19 infected
patients with early moderate and severe disease admitted to the hospital and randomized to
one of three arms. Patients will be randomized to supportive care, OR hydroxychloroquine
alone, OR hydroxychloroquine and azithromycin.
|
| NCT04344457 ↗ |
Evaluate the Efficacy and Safety of Oral Hydroxychloroquine, Indomethacin and Zithromax in Subjects With Mild Symptoms of COVID-19 |
Recruiting |
Phase 1/Phase 2 |
2020-04-16 |
Currently there are no US Food and Drug Administration (FDA)-approved drugs specifically for
the treatment of patients with COVID-19. At present, clinical management includes infection
prevention and control measures, as well as supportive care, including supplementary oxygen
and mechanical ventilatory support when indicated. An array of drugs approved for other
indications as well as several investigational drugs are being studied in several hundred
clinical trials that are underway across the globe; however, currently there are no clinical
trials available to patients in Arizona.
This study will determine if a specific drug cocktail can improve clinical outcomes in
patients with confirmed Mild SARS-CoV-2
|
| NCT04344730 ↗ |
Dexamethasone and Oxygen Support Strategies in ICU Patients With Covid-19 Pneumonia |
Active, not recruiting |
N/A |
2020-04-10 |
The main manifestation of COVID-19 is acute hypoxemic respiratory failure (AHRF). In patients
with AHRF, the need for invasive mechanical ventilation is associated with high mortality.
Two hypotheses will be tested in this study. The first hypothesis is the benefit of
corticosteroid therapy on severe COVID-19 infection admitted in ICU in terms of survival.
The second hypothesis is that, in the subset of patients free of mechanical ventilation at
admission, either Continuous Positive Airway Pressure (CPAP) or High-Flow Nasal Oxygen (HFNO)
allows to reduce intubation rate safely during COVID-19 related acute hypoxemic respiratory
failure.
|
| NCT04345289 ↗ |
Efficacy and Safety of Novel Treatment Options for Adults With COVID-19 Pneumonia |
Not yet recruiting |
Phase 3 |
2020-04-20 |
CCAP is an investigator-initiated multicentre, randomized, double blinded,
placebo-controlled, multi-stage trial, which aims to assess the safety and efficacy of novel
treatment option of moderate-severe COVID-19.
Participants will be randomized 1:1:1:1:1:1 to parallel treatment arms: Convalescent plasma,
sarilumab, hydroxychloroquine, baricitinib, intravenous and subcutaneous placebo, or oral
placebo.
Primary outcome is a composite endpoint of all-cause mortality or need of invasive mechanical
ventilation up to 28 days.
|
| NCT04345523 ↗ |
Convalescent Plasma Therapy vs. SOC for the Treatment of COVID-19 in Hospitalized Patients |
Completed |
Phase 2 |
2020-04-03 |
A total of 278 patients are planned.
All patients will be in an early-stage of COVID-19. They must be adults and hospitalized.
In this study, all participating patients will receive the standard treatment provided
according to the current treatment protocols for coronavirus disease. In addition to this
treatment, each patient will be randomly assigned to receive additional treatment with
convalescent plasma transfusion (CP; blood plasma from patients who have been cured of
coronavirus), or continue with standard treatment but without adding transfusion.
50% of the chances of additional treatment with CP, and 50% of the chances of receiving only
the standard treatment for coronavirus.
The duration of the study shall be one month from the assignment of the treatment.
The patient and the doctor will know the treatment assigned.
|
| NCT04345653 ↗ |
Hydroxychloroquine as Chemoprevention for COVID-19 for High Risk Healthcare Workers |
Completed |
Phase 2 |
2020-04-14 |
The study proposes to conduct an open-label Phase II trial to evaluate the feasibility,
safety and early efficacy of hydroxychloroquine (HCQ) administration in reduction of
transmission of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and development
of Corona Virus Disease 2019 (COVID-19) in high-risk, healthy acute care provider
participants exposed, directly or indirectly, to COVID-19 patients. There is a more than 50
years track record of safety of HCQ for treatment and prevention of various disease states.
Early data on use of HCQ for COVID treatment suggests anti-viral activity and
immunomodulatory properties for reducing inflammation associated with COVID-19.
|
| NCT04345692 ↗ |
A Randomized Controlled Clinical Trial: Hydroxychloroquine for the Treatment of COVID-19 in Hospitalized Patients |
Terminated |
Phase 3 |
2020-03-26 |
This study is a randomized, open label clinical trial to evaluate the safety and efficacy of
hydroxychloroquine (HCQ) plus usual care compared to usual care in approximately 350
hospitalized patients diagnosed with COVID-19. The study will be a 2-arm, non-blinded
comparison between open label hydroxychloroquine and usual care. The course of treatment
(HCQ) is five days. Participants will be followed to study day 28.
|
| NCT04346147 ↗ |
Clinical Trial to Evaluate Efficacy of 3 Types of Treatment in Patients With Pneumonia by COVID-19 |
Active, not recruiting |
Phase 2 |
2020-05-07 |
In absence of vaccine and medications specifically designed to treat SARS-CoV-2 disease,
identifying treatment options is critical at this time to control the disease outbreak.
For this, we have designed a phase II trial of efficacy and safety with 3 branches of
different combinations of treatment to identify which is the best early treatment option for
patients with pneumonia due to SARS-CoV-2 (Covid-19) Identifying treatment options as early
as possible is critical to the SARS-CoV-2 outbreak response. Currently, there is no approved
vaccine for the disease and the treatments being used are not specifically designed for the
SARS-CoV-2 virus, but are different groups of drugs used for other pathologies with
mechanisms of action that justify their use because they inhibit entry of the virus into
virus cells or proteases.
The study aims to compare Imatinib 400mg, Baricitinib 4mg or supportive treatment,
administered for 7 days in the setting of SARS-CoV-2 pneumonia treatment.
Patients who meet inclusion criteria and do not have any exclusion criteria will be
randomized to receive open treatment 1:1:1
|
| NCT04347174 ↗ |
A Clinical Trial of Mycobacterium w in Critically Ill COVID 19 Patients |
Completed |
N/A |
2020-04-30 |
The trial is randomized, blinded, two arms, active comparator controlled, clinical trial to
evaluate the safety and efficacy of Mycobacterium w in combination with standard care as per
hospital practice versus standard care alone in critically ill adult patients suffering from
COVID-19 infection.
|
| NCT04347226 ↗ |
Anti-Interleukin-8 (Anti-IL-8) for Patients With COVID-19 |
Recruiting |
Phase 2 |
2020-04-16 |
This study is for patients that are hospitalized for Coronavirus Disease 2019 (COVID-19). The
purpose of this study is to see whether neutralizing interleukin-8 (IL-8) with BMS-986253 can
help improve the health condition of participants infected with COVID-19. This is the first
in-human study of this investigational product specifically in patients with severe COVID-19.
Currently there are no FDA approved medications that improve the chance of survival in
patients diagnosed with COVID-19. However there are usual treatments currently being used to
help treat COVID-19 patients and BMS-986253 will be compared to these standard of care
treatments in this study.
|
| NCT04347382 ↗ |
Honey & Nigella Sativa Trial Against COVID-19 |
Completed |
Phase 3 |
2020-04-30 |
To evaluate the effectiveness of Nigella Sativa and honey stirred in 250 ml of distilled
water 12 hourly till patient becomes asymptomatic or a maximum of 14 days with standard
hospital care versus standard hospital care alone with placebo capsule and 250 ml water, in
clearing the COVID-19 nucleic acid from throat and nasal swab, lowering disease detrimental
effects on HRCT chest/X-ray and severity of symptoms along with duration of hospital stay
till day 14th day of follow up and 30 days mortality (primary outcomes).
|
| NCT04347889 ↗ |
Preventing COVID-19 in Healthcare Workers With HCQ: A RCT |
Withdrawn |
Phase 2 |
2020-04-20 |
Healthcare workers (HCW) at risk of Covid-19 will have baseline serology for SARS-CoV-2 to
see if they are already immune to Covid-19. HCW will get baseline assessment and if meeting
inclusion criteria and no exclusion criteria they will be randomized in a 2:1 ratio to
hydroxychloroquine or Vitamin C on a weekly basis for three months. Subjects will complete
daily diary of symptoms and temperature, and will have repeat SARS-CoV-2 serology at 6 weeks
and 3 months to determine seroconversion.
|
| NCT04347980 ↗ |
Dexamethasone Treatment for Severe Acute Respiratory Distress Syndrome Induced by COVID-19 |
Terminated |
Phase 3 |
2020-04-17 |
Single blind randomized clinical trial designed to evaluate the efficacy of the combination
of hydroxychloroquine and dexamethasone as treatment for severe Acute Respiratory Distress
Syndrome (ARDS) related to coronavirus disease 19 (COVID-19). We hypothesize that
dexamethasone (20 mg for 5 days followed by 10 mg for 5 days) combined with 600 mg per day
dose of hydroxychloroquine for 10 days will reduce the 28-day mortality compared to
hydroxychloroquine alone in patients with severe ARDS related COVID-19.
|
| NCT04348071 ↗ |
Safety and Efficacy of Ruxolitinib for COVID-19 |
Withdrawn |
Phase 2/Phase 3 |
2021-07-01 |
This study plans to learn more about the effects of a medicine called ruxolitinib on the
progression of COVID-19 (coronavirus disease of 2019), the medical condition caused by the
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Ruxolitinib is FDA-approved for
the treatment of myelofibrosis, polycythemia vera, and graft-versus-host disease. This study
intends to define the impact of ruxolitinib on the severity and progression of COVID-19. This
drug might to lower the hyperinflammation caused by the virus, which would prevent damage to
the lungs and possibly other organs.
The study will recruit patients who have been diagnosed with COVID-19.
The goal is to recruit 80 patients.
|
| NCT04348305 ↗ |
Hydrocortisone for COVID-19 and Severe Hypoxia |
Completed |
Phase 3 |
2020-04-17 |
We aim to assess the benefits and harms of low-dose hydrocortisone in patients with COVID-19
and severe hypoxia.
|
| NCT04348409 ↗ |
Efficacy and Safety of Nitazoxanide for the Treatment of Hospitalized Patients With Moderate COVID-19 |
Recruiting |
N/A |
2020-05-25 |
This is a proof of concept study to evaluate the efficacy of nitazoxanide (600 mg BID) to
treat hospitalized patients with moderate COVID-19.
|
| NCT04348435 ↗ |
A Randomized, Double-Blind, Single Center, Efficacy and Safety Study of Allogeneic HB-adMSCs to Provide Immune Support Against COVID-19 |
Enrolling by invitation |
Phase 2 |
2020-04-23 |
Hope Biosciences is conducting a research study of an investigational product called
allogeneic adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) to provide
immune support against COVID-19. The study purpose is to evaluate the safety and efficacy of
five IV infusions of HB-adMSCs in subjects with no signs of COVID-19.
|
| NCT04348474 ↗ |
Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Ambulatory Patients With Mild COVID-19 |
Suspended |
Early Phase 1 |
2020-04-20 |
This is an exploratory study to evaluate the efficacy of hydroxychloroquine (400 mg BID on D1
and 400 mg/day on D2 to D7) and azithromycin (500 mg/ 5 days) to treat mild ambulatory
COVID-19 patients.
|
| NCT04349241 ↗ |
Efficacy and Safety of Favipiravir in Management of COVID-19 |
Completed |
Phase 3 |
2020-04-18 |
Randomized controlled interventional trial (Clinical Trial) phase 3 to assess the safety and
efficacy of favipiravir versus the standard care therapy in the treatment of patients with
COVID-19.
|
| NCT04349371 ↗ |
Saved From COVID-19 |
Terminated |
Phase 2 |
2020-04-21 |
The primary objective is to determine the clinical efficacy of Chloroquine (CQ) in health
care workers with moderate to high risk of exposure to COVID-19 in preventing symptomatic
COVID-19 infections. Secondary endpoints will explore the efficacy of CQ in preventing any
infection as defined by seroconversion to positive anti-COVID antibody status.
|
| NCT04349410 ↗ |
The Fleming [FMTVDM] Directed CoVid-19 Treatment Protocol |
Completed |
Phase 2/Phase 3 |
2020-04-11 |
Diagnostic determination of disease and treatment responses has been limited to qualitative
imaging, measurement of serum markers of disease, and sampling of tissue. In each of these
instances, there is a built in error either due to sensitivity and specificity issues,
clinician interpretation of results, or acceptance of the use of an indirect marker (blood
test) of what is happening elsewhere in the body - at the tissue level.
The Fleming Method for Tissue and Vascular Differentiation and Metabolism (FMTVDM) using same
state single or sequential quantification comparisons [1] provides the first and only
patented test (#9566037) - along with the associated submitted patent applications ruled to
be covered under #9566037 - that quantitatively measures changes in tissue resulting from
inter alia a disease process. This includes inter alia coronary artery disease (CAD), cancer
and infectious/inflammatory processes including CoVid-19 pneumonia (CVP) resulting from the
metabolic and regional blood flow differences (RBFDs) caused by these diseases.
The purpose of this paper is to make clinicians and researchers aware of this proposed method
for investigating the prevalence and severity of CVP - in addition to providing rapid
determination of treatment response in each patient, directing treatment decisions; thereby
reducing the loss of time, money, resources and patient lives.
|
| NCT04349592 ↗ |
Hydroxychloroquine With or Without Azithromycin for Virologic Cure of COVID-19 |
Completed |
N/A |
2020-04-14 |
Q-PROTECT is a placebo controlled randomized trial (RCT) to ascertain the efficacy of
hydroxychloroquine (HC) alone or, in combination with azithromycin (AZ), in reducing viral
load in patients with COVID 19.
|
| NCT04349631 ↗ |
A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy (HB-adMSCs) to Provide Protection Against COVID-19 |
Enrolling by invitation |
Phase 2 |
2020-04-16 |
Hope Biosciences is conducting a research study of an investigational product called
autologous adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) to provide
immune support against COVID-19. The study purpose is to evaluate the safety and efficacy of
five IV infusions of HB-adMSCs in subjects with no signs of COVID-19.
|
| NCT04350320 ↗ |
Trial to Study the Benefit of Colchicine in Patients With COVID-19 |
Completed |
Phase 3 |
2020-04-30 |
COVID-19 is associated with a cytokine storm that leads to respiratory distress, multiorgan
failure and elevated mortality. Oral colchicine exhibits high anti-inflammatory capacity
attributed to the inhibition of microtubules polymerization, inflammasome and production of
IL-1β and IL-6, which could prevent the inflammatory storm in COVID-19 patients at risk. We
present a randomized clinical trial, controlled, open-label and pragmatic, including COVID-19
patients requiring hospitalization but no intensive care yet. Colchicine will be started
within the first 48 hours and then administered for four weeks using a descending dose. The
benefit will be study in terms of clinical evolution (WHO 7-point scale) and IL-6 levels, as
well as other clinical and biochemical secondary end-points. In the case of positive results,
the clinical impact would be relevant given that this oral medication is widely accessible
which would help to prevent the inflammatory complications associated with COVID-19.
|
| NCT04350580 ↗ |
Polyvalent Immunoglobulin in COVID-19 Related ARds |
Completed |
Phase 3 |
2020-04-11 |
As of 30/03/2020, 715600 people have been infected with COVID-19 worldwide and 35500 people
died, essentially due to respiratory distress syndrome (ARDS) complicated in 25% of the with
acute renal failure. No specific pharmacological treatment is available yet. The lung lesions
are related to both the viral infection and to an intense inflammatory reaction. Because of
it's action, as an immunomodulatory agent that can attenuate the inflammatory reaction and
also strengthen the antiviral response, it is proposed to evaluate the effectiveness and
safety of intravenous immunoglobulin administration (IGIV) in patients developing ARDS
post-SARS-CoV2. IGIV modulates immunity, and this effect results in a decrease of
pro-inflammatory activity, key factor in the ARDS related to the COVID-19. It should be noted
that IGIV is part of the treatments in various diseases such as autoimmune and inflammatory
diffuse interstitial lung diseases. In addition, they have been beneficial in the
post-influenza ARDS but also have been in 3 cases of post-SARS-CoV2 ARDS. IGIV is a treatment
option because it is well tolerated, especially concerning the kidney. These elements
encourage a placebo-controlled trial testing the benefit of IGIV in ARDS post-SARS-CoV2.
|
| NCT04350593 ↗ |
Dapagliflozin in Respiratory Failure in Patients With COVID-19 |
Completed |
Phase 3 |
2020-04-22 |
This is an international, multicenter, parallel-group, randomized, double-blind, placebo
controlled, study in hospitalized adult patients with COVID-19 in the US, Brazil, Mexico,
Argentina, India, Canada, and UK. The study is evaluating the effect of dapagliflozin 10 mg
versus placebo, given once daily for 30 days in addition to background local standard of care
therapy, on reducing complications and all-cause mortality, or improving clinical recovery.
|
| NCT04350671 ↗ |
Interferon Beta 1a in Hospitalized COVID-19 Patients |
Enrolling by invitation |
Phase 4 |
2020-04-15 |
The present study is a randomized, double-blind, placebo-controlled, clinical trial, with the
approval of the ethics committee will be conducted on patients who have a positive test
confirming COVID-19 in Loghman Hakim Medical Education Center in Tehran. Patients will be
randomly assigned to the two arms of the study and after completing the course of treatment
and collecting and analyzing the necessary information from each patient, the results of the
study will be published both on this site and in the form of an article in a reputable
international journal.
|
| NCT04350684 ↗ |
Umifenovir in Hospitalized COVID-19 Patients |
Enrolling by invitation |
Phase 4 |
2020-04-15 |
The present study is a randomized, double-blind, placebo-controlled, clinical trial, with the
approval of the ethics committee will be conducted on patients who have a positive test
confirming COVID-19 in Loghman Hakim Medical Education Center in Tehran. Patients will be
randomly assigned to the two arms of the study and after completing the course of treatment
and collecting and analyzing the necessary information from each patient, the results of the
study will be published both on this site and in the form of an article in a reputable
international journal.
|
| NCT04351152 ↗ |
Phase 3 Study to Evaluate Efficacy and Safety of Lenzilumab in Patients With COVID-19 |
Active, not recruiting |
Phase 3 |
2020-05-05 |
The primary objective of this study is to assess whether the use of lenzilumab in addition to
current standard of care can alleviate the immune-mediated cytokine release syndrome (CRS)
and improve ventilator-free survival in hospitalized subjects with severe or critical
COVID-19 pneumonia.
|
| NCT04351243 ↗ |
A Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19 (BREATHE) |
Completed |
Phase 2 |
2020-04-12 |
Study KIN-1901-2001 is a multi-center, adaptive, randomized, double-blind, placebo-controlled
study to assess the efficacy and safety of gimsilumab in subjects with lung injury or acute
respiratory distress syndrome (ARDS) secondary to COVID-19.
|
| NCT04351295 ↗ |
Efficacy of Faviprevir in COVID-19 Treatment |
Completed |
Phase 2/Phase 3 |
2020-04-20 |
Faviprevir in COVID-19 treatment
|
| NCT04351347 ↗ |
The Efficacy of Ivermectin in Larger Doses in COVID-19 Treatment |
Recruiting |
Phase 2/Phase 3 |
2020-06-16 |
Efficacy of Ivermectin in larger doses in COVID-19 treatment
|
| NCT04351620 ↗ |
High-dose Hydroxychloroquine for the Treatment of Ambulatory Patients With Mild COVID-19 |
Recruiting |
Phase 1 |
2020-04-01 |
This study aims to examine the tolerability of high dose hydroxychloroquine in patients with
COVID-19 who are not yet hospitalized, but have risk factors for disease progression and
complications.
|
| NCT04352400 ↗ |
Efficacy of Nafamostat in Covid-19 Patients (RACONA Study) |
Recruiting |
Phase 2/Phase 3 |
2021-06-04 |
RACONA is a prospective trial that will test the hypothesis that nafamostat can lower lung
function deterioration and need for intensive care admission in COVID-19 patients.
Design: Adult hospitalized COVID-19 patients will be randomized in a prospective double-blind
randomized placebo-controlled study to test the clinical efficacy of nafamostat mesylate
(administered intravenously) on top of best standard of care.
Primary outcome measures: the time-to-clinical improvement, defined as the time from
randomization to an improvement of two points (from the status at randomization) on a seven
category ordinal scale or live discharge from the hospital, whichever comes first.
|
| NCT04352465 ↗ |
Efficacy and Safety of MTX-loaded Nanoparticles to Treat Severe COVID-19 Patients |
Not yet recruiting |
Phase 1/Phase 2 |
2020-05-01 |
The aim of this study is to evaluate the efficacy and safety of MTX-loaded nanoparticles in
three different doses to treat severe COVID-19 patients.
|
| NCT04352933 ↗ |
PROLIFIC ChemoprophylaxisTrial (COVID-19) |
Recruiting |
Phase 3 |
2020-05-11 |
The number of confirmed cases of COVID-19 infectious disease arising from the SARS-CoV-2
coronavirus is rising substantially and rapidly, with the potential to overwhelm the ability
of the entire National Health Service (NHS) to cope with the increased demand. The
availability of personal protective equipment is limited and reports of high risk procedures
such as aerosol generating procedures (e.g. intubation for the sickest patients) is a source
of great concern for infection transmission. Frontline NHS staff with direct patient contact
have the highest likelihood of exposure to SARS-CoV-2 and development of COVID-19 disease.
Efforts to protect these workers from development of COVID-19, using drugs to prevent the
disease, require urgent evaluation.
|
| NCT04352946 ↗ |
HEalth Care Worker pROphylaxis Against COVID-19: The HERO Trial |
Not yet recruiting |
Phase 3 |
2020-04-24 |
This is a double-blinded, randomized placebo-controlled trial to determine if pre-exposure
prophylaxis (PrEP) with 400mg hydroxychloroquine (HCQ), taken orally once daily, for health
care workers in the hospital reduces symptomatic and asymptomatic COVID-19 disease during the
pandemic. 374 health care workers will be randomized at a 1:1 allocation between the
intervention and placebo arms and followed for 90 days. The cumulative incidence of COVID-19
infection in the intervention group will be compared to the cumulative incidence of COVID-19
in the placebo group with relative (risk ratio and 95% CI) and absolute measures (risk
difference and 95% CI).
|
| NCT04353037 ↗ |
PATCH 2&3:Prevention & Treatment of COVID-19 (Severe Acute Respiratory Syndrome Coronavirus 2) With Hydroxychloroquine |
Terminated |
Phase 2 |
2020-04-07 |
The proposed hypothesis is that high doses of hydroxychloroquine (HCQ) for at least 2 weeks
can be effective antiviral medication both as a treatment in ambulatory patients and
prophylaxis/treatment in health care workers because it impairs lysosomal function and
reorganizes lipid raft (cholesterol and sphingolipid rich microdomains in the plasma
membrane) content in cells, which are both critical determinants of Emerging Viral Disease
(EVD) infection. This hypothesis is based on a growing literature linking chloroquine to
antiviral activity. It is estimated that enough information exists to launch a clinical trial
of hydroxychloroquine for COVID-19.
|
| NCT04353271 ↗ |
Trial of Hydroxychloroquine In Covid-19 Kinetics |
Terminated |
Phase 2/Phase 3 |
2020-04-17 |
To test if the medication Hydroxychloroquine will decrease the amount of virus(as measured by
PCR) , 7 days after initiation of therapy compared to control patients receiving placebo.
The study design is a randomized (5 days of medication v. 5 days of placebo) clinical trial
initiated immediately after diagnosis in ambulatory health care workers at University of
South Alabama Health, or in ambulatory USA patients. At 7 days after enrollment another
nasopharyngeal swab will be taken to measure if the virus is still present. At 10 weeks we
will measure immunity from Covid-19 using a single blood sample. It is a phase 2/3 clinical
trial.
|
| NCT04353336 ↗ |
Efficacay of Chloroquine or Hydroxychloroquine in COVID-19 Treatment |
Completed |
Phase 2/Phase 3 |
2020-03-23 |
Chloroquine or hydroxychloroquine in COVID-19 treatment
|
| NCT04353596 ↗ |
Stopping ACE-inhibitors in COVID-19 |
Completed |
Phase 4 |
2020-04-20 |
ACEI-COVID-19 is a multicenter, randomized trial testing the hypothesis that
stopping/replacing chronic treatment with ACE-inhibitors (ACEI) or angiotensin receptor
blockers (ARB) improves outcomes in symptomatic SARS-CoV2-infected patients
|
| NCT04354259 ↗ |
Interferon Lambda for Immediate Antiviral Therapy at Diagnosis in COVID-19 |
Recruiting |
Phase 2 |
2020-05-13 |
Interferon lambda is one of the main arms of the innate antiviral immune response and is
critical for controlling respiratory viral infections in mice. Interferon lambda has a better
side effect profile than other interferons because of the limited tissue distribution of its
receptor. Peginterferon lambda is a long-acting form that has been studied extensively in
human trials in viral hepatitis, confirming its safety. We propose to evaluate
peginterferon-lambda in ambulatory and hospitalized patients with mild to moderate COVID-19.
|
| NCT04354389 ↗ |
DAS181 for STOP COVID-19 |
Withdrawn |
Phase 2/Phase 3 |
2020-07-25 |
It is a multicenter, randomized, placebo-controlled, double-blind study. The study population
is defined as subjects diagnosed with lower respiratory tract COVID-19 who require
supplemental oxygen ≥2 LPM at the time of randomization.
|
| NCT04354441 ↗ |
Effect of Hydroxychloroquine in COVID-19 Positive Pregnant Women |
Withdrawn |
Phase 2 |
2020-05-01 |
COVID-19 was declared a pandemic on March 11th. Efforts to save lives are essential as we
will face increasing morbidity with rising demands on health care resources. Since pregnant
women with COVID-19 have systematically been excluded from drug trials, potential treatment
options for these high-risk individuals remain untested. The aim of our trial is to determine
whether hydroxychloroquine given to COVID-19 positive pregnant women can reduce
COVID-19-related hospital admissions, thereby allowing women to stay at home while limiting
utilization of hospital resources and resulting exposure of health care providers.
|
| NCT04354805 ↗ |
Administration of Chlorpromazine as a Treatment for COVID-19 |
Not yet recruiting |
Phase 2/Phase 3 |
2020-08-01 |
In this study, defined cases of COVID-19 confirmed with PCR, with a mild, moderate or severe
pneumonia will be treated with chlorpromazine. The improvement in clinical & laboratory
manifestations will be evaluated in treated patient compared to control group.
|
| NCT04355247 ↗ |
Prophylactic Corticosteroid to Prevent COVID-19 Cytokine Storm |
Recruiting |
Phase 2 |
2020-04-14 |
This is a Phase II pilot exploratory study designed to investigate if prophylactic treatment
with short term steroids administered to high risk Covid-19 patient might prevent cytokine
storm and progression to respiratory failure. High risk is defined based on serologic markers
of inflammation that include abnormalities of Interleukin 6 (IL-6), Ferritin , D-dimer,
Lactate Dehydrogenase (LDH), as well as lymphopenia and impaired O2 saturation prior to or on
the 7th day of first symptom of Covid-19.
|
| NCT04355429 ↗ |
Efficacy of Captopril in Covid-19 Patients With Severe Acute Respiratory Syndrome (SARS) CoV-2 Pneumonia (CAPTOCOVID) |
Not yet recruiting |
Phase 2 |
2020-05-05 |
Captopril being an effective drug available in liquid preparation, administration by
nebulization could be of interest for maximizing lung action and minimizing systemic side
effects. Such a treatment might be used for "Covid-19" patients with pneumonia in order to
avoid ARDS.
|
| NCT04355936 ↗ |
Telmisartan for Treatment of COVID-19 Patients |
Completed |
Phase 4 |
2020-05-19 |
In late 2019, a new coronavirus emerged in Wuhan Province, China, causing lung complications
similar to those produced by the SARS coronavirus in the 2002-2003 epidemic. This new disease
was named COVID-19 and the causative virus SARS-CoV-2. The SARS-CoV-2 virus, enters the
airway and binds, by means of the S protein on its surface to the membrane protein ACE2 in
type 2 alveolar cells. The S protein-ACE2 complex is internalized by endocytosis leading to a
partial decrease or total loss of the enzymatic function ACE2 in the alveolar cells and in
turn increasing the tissue concentration of pro-inflammatory angiotensin II by decreasing its
degradation and reducing the concentration of its physiological antagonist angiotensin 1-7.
High levels of angiotensin II on the lung interstitium can promote apoptosis initiating an
inflammatory process with release of proinflammatory cytokines, establishing a self-powered
cascade, leading eventually to ARDS. It has recently been proposed the tentative use of
agents such as losartan and telmisartan as alternative options for treating COVID-19 patients
prior to development of ARDS. The present study is an open-label randomized phase II clinical
trial for the evaluation of telmisartan in COVID-19 patients. Briefly, patients with
confirmed diagnosis of SARS-CoV-2, will be randomized to receive 80 mg/12h of telmisartan
plus standard care or standard care alone aand will be monitored for development of systemic
inflammation and acute respiratory distress syndrome. Other variables regarding lung function
and cardiovascular function will also be evaluated.
|
| NCT04355962 ↗ |
Sevoflurane in COVID-19 ARDS (SevCov) |
Completed |
Phase 3 |
2020-04-23 |
The purpose of this trial is to study the effect of initial temporary sevoflurane sedation on
mortality and persistent organ dysfunction (POD) in survivors at day 28 after ICU admission
in the population of patients suffering from COVID-19 ARDS.
|
| NCT04356495 ↗ |
Trial of COVID-19 Outpatient Treatment in Individuals With Risk Factors for Aggravation |
Recruiting |
Phase 2/Phase 3 |
2020-07-29 |
In adults with COVID-19 without criteria for hospitalization or oxygen therapy but with risk
factors for aggravation, early treatment may avoid hospitalization, indication for oxygen
therapy or death. No treatment is currently validated for this indication.
|
| NCT04356690 ↗ |
Etoposide in Patients With COVID-19 Infection |
Active, not recruiting |
Phase 2 |
2020-05-08 |
This is a randomized, open-label phase II study designed to evaluate the safety and efficacy
of etoposide in patients with the 2019 novel coronavirus (COVID-19) infection. Randomization
will be performed with a 3:1 allocation ratio. Treatment will be comprised of etoposide
administered intravenously at a dose of 150 mg/m2 on Days 1 and 4 in patients with COVID-19
infection meeting eligibility criteria. Subsequent doses of etoposide will be allowed if the
investigator and treating physician believe the patient had clinical benefit from etoposide
therapy but subsequently has evidence of recurrent clinical deterioration. Subjects
randomized to control will receive standard of care treatment. No placebo will be used.
|
| NCT04356833 ↗ |
Nebulised Rt-PA for ARDS Due to COVID-19 |
Recruiting |
Phase 2 |
2020-04-22 |
Some patients infected with COVID-19 require hospitalisation and develop patients a severe
form of a lung disease called respiratory distress syndrome (ARDS). In these patients, the
lungs become severely inflamed because of the virus. The inflammation causes fluid from
nearby blood vessels to leak into the tiny air sacs in the lungs, making breathing
increasingly difficult. This fluid forms small clots in the air sacs, creating a barrier
until the cells regenerate.
In some patients, this clot does not disappear in a timely fashion or interferes with the
development of the new cells. Furthermore, the small clots in the air sacs obstruct the air
and oxygen getting deep into the lungs, interfering with proper ventilation. The trial will
recruit patients with COVID-19 induced ARDS. Eligible patients (or if patients lack capacity,
their legal representative) will be provided with an information sheet and informed consent
will be sought. Eligibility will be mainly assessed via routine clinical assessments.
Patients will receive a nebulised version of a type of drug called tissue plasminogen
activator (rt-PA) that is inhaled using a nebuliser. This is normally a drug used to break
down blood clots. In this situation though, it might be useful for stopping clots forming in
the lungs, because these might lead to even more difficulties with breathing.
The study will run two cohorts sequentially. In cohort 1, 9 consented patients received
nebulised rtPA in addition to SOC. 6 patients were receiving IMV and 3 were receiving non
invasive support with NIV or CPAP or high flow oxygen or standard oxygen therapy. As an
observational arm, matched historical controls who received standard of care were also
recruited at a ratio of 2 controls to every 1 treatment arm patient, resulting in 18
historical controls. Originally, the study aimed to recruit 12 patients with 6 on each
ventilation type (IMV and non-invasive oxygen support). This would have resulted in 24
historical controls. After the first wave of COVID-19 cases decreased in August 2020 in the
UK it became difficult to continue recruitment, so recruitment closed for cohort 1.
With a second surge underway in early 2021, cohort 2 will aim to recruit more patients during
this period to provide more data on the safety of rtPA. Fewer timepoints will be collected,
which will allow for more rapid recruitment while at the same time not compromising safety
monitoring. A more flexible dosing regimen for rtPA will be utilised. 30 patients will be
recruited in total, with an aim to recruit a minimum of 10 IMV patients and 10 patients on
non-invasive oxygen support.
To evaluate efficacy, the improvement of oxygen levels over time and safety will be be
monitored throughout. Blood samples will be taken to measure markers of clotting and
inflammation in both groups.
From the end of the treatment phase both groups will be followed up in accordance with SOC
for 28 days from the day of first dose of rtPA.
|
| NCT04356937 ↗ |
Efficacy of Tocilizumab on Patients With COVID-19 |
Completed |
Phase 3 |
2020-04-20 |
This is a randomized, double blind, multi-center study to evaluate the effects of tocilizumab
compared to placebo on patient outcomes in participants with confirmed SARS-CoV-2 infection
and evidence of systemic inflammation.
The aim of this study is to test the effect of Tocilizumab on multi-organ dysfunction in a
phase 3 randomized controlled trial among hospitalized patients with COVID-19 infection.
Specifically, as compared to placebo, we will test whether tocilizumab is associated with a
reduction in multi-organ dysfunction among hospitalized COVID-19 adult patients with elevated
inflammatory measures. Multi-organ dysfunction will be measured as the incidence of the
following composite endpoint (mechanical ventilation, renal replacement therapy, mechanical
support, need for inotropes or vasopressors, liver dysfunction (increased bilirubin), and
all-cause mortality). We will also assess multiple pre-specified secondary (exploratory)
endpoints and safety endpoints.
We hypothesize that, as compared to placebo, tocilizumab will reduce transfer to the ICU,
need for mechanical ventilation, increase rates of hospital discharge in patients diagnosed
with severe COVID-19 infection and evidence of exaggerated inflammatory response.
|
| NCT04357730 ↗ |
Fibrinolytic Therapy to Treat ARDS in the Setting of COVID-19 Infection |
Active, not recruiting |
Phase 2 |
2020-05-14 |
The global pandemic COVID-19 has overwhelmed the medical capacity to accommodate a large
surge of patients with acute respiratory distress syndrome (ARDS). In the United States, the
number of cases of COVID-19 ARDS is projected to exceed the number of available ventilators.
Reports from China and Italy indicate that 22-64% of critically ill COVID-19 patients with
ARDS will die. ARDS currently has no evidence-based treatments other than low tidal
ventilation to limit mechanical stress on the lung and prone positioning. A new therapeutic
approach capable of rapidly treating and attenuating ARDS secondary to COVID-19 is urgently
needed.
The dominant pathologic feature of viral-induced ARDS is fibrin accumulation in the
microvasculature and airspaces. Substantial preclinical work suggests antifibrinolytic
therapy attenuates infection provoked ARDS. In 2001, a phase I trial 7 demonstrated the
urokinase and streptokinase were effective in patients with terminal ARDS, markedly improving
oxygen delivery and reducing an expected mortality in that specific patient cohort from 100%
to 70%. A more contemporary approach to thrombolytic therapy is tissue plasminogen activator
(tPA) due to its higher efficacy of clot lysis with comparable bleeding risk 8. We therefore
propose a phase IIa clinical trial with two intravenous (IV) tPA treatment arms and a control
arm to test the efficacy and safety of IV tPA in improving respiratory function and
oxygenation, and consequently, successful extubation, duration of mechanical ventilation and
survival.
|
| NCT04357782 ↗ |
Administration of Intravenous Vitamin C in Novel Coronavirus Infection (COVID-19) and Decreased Oxygenation |
Completed |
Phase 1/Phase 2 |
2020-04-16 |
Previous research has shown that high dose intravenous vitamin C (HDIVC) may benefit patients
with sepsis, acute lung injury (ALI), and the acute respiratory distress syndrome (ARDS).
However, it is not known if early administration of HDIVC could prevent progression to ARDS.
We hypothesize that HDIVC is safe and tolerable in Coronavirus disease 2019 (COVID-19)
subjects given early or late in the disease course and may reduce the risk of respiratory
failure requiring mechanical ventilation and development of ARDS along with reductions in
supplemental oxygen demand and inflammatory markers.
|
| NCT04357808 ↗ |
Efficacy of Subcutaneous Sarilumab in Hospitalised Patients With Moderate-severe COVID-19 Infection (SARCOVID) |
Completed |
Phase 2 |
2020-04-13 |
The global health emergency created by the rapid spread of the SARS-CoV-2 coronavirus has
pushed healthcare services to face unprecedent challenges to properly manage COVID-19 severe
and critical manifestations affecting a wide population in a short period of time. Clinicians
are committed to do their best with a great uncertainty in this evolving crisis. Off label
use of plenty of drugs has arisen the need for clinical trials to demonstrate their true role
in the therapy. Based in unpublished experiences in China, Italy and Spain, intravenous IL-6
receptor inhibitors are now being tested in several trials but no data on subcutaneous
formulations are available yet. Sarilumab is a human monoclonal antibody that binds
membrane-bound and soluble IL-6 receptors to inhibit IL-6 signalling, licensed in a
subcutaneous route administration.
|
| NCT04358068 ↗ |
Evaluating the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons With COVID-19 |
Terminated |
Phase 2 |
2020-05-13 |
The purpose of this study was to evaluate the efficacy of hydroxychloroquine (HCQ) and
azithromycin (Azithro) to prevent hospitalization or death in symptomatic adult outpatients
with COVID-19 caused by SARS-CoV-2 infection.
|
| NCT04358406 ↗ |
Rhu-pGSN for Severe Covid-19 Pneumonia |
Active, not recruiting |
Phase 2 |
2020-07-30 |
Study Objectives:
Primary
- To assess the efficacy (survival without organ failure on Day 14) of three doses of
rhu-pGSN administered intravenously (IV) plus standard of care (SOC) to hospitalized
subjects with a primary diagnosis of COVID-19 pneumonia and a severity score of 4, 5 or
6 on the World Health Organization (WHO) 9-point severity scale
- To evaluate the safety and tolerability of three IV doses of rhu-pGSN administered to
hospitalized subjects with a primary diagnosis of COVID-19 pneumonia and a severity
score of 4, 5, or 6 on the WHO 9-point severity scale
Secondary
- To further assess the efficacy of IV administered rhu-pGSN
- To assess changes in WHO 9-point severity score for SOC with or without rhu-pGSN
- To evaluate the effect of administered rhu-pGSN on survival rates
- To assess the relationship of pGSN levels (and other biomarkers) at baseline with
clinical outcomes
- [OPTIONAL] To follow the pharmacokinetics (PK) of administered rhu-pGSN
Immunogenicity
• To investigate the development of antibodies against rhu-pGSN post-treatment
|
| NCT04358549 ↗ |
Study of the Use of Favipiravir in Hospitalized Subjects With COVID-19 |
Completed |
Phase 2 |
2020-04-17 |
To determine the effect of favipiravir + SOC v. SOC on COVID-19 viral clearance.
|
| NCT04358614 ↗ |
Baricitinib Therapy in COVID-19 |
Completed |
Phase 2/Phase 3 |
2020-03-16 |
Retrospective study on the efficacy of baricitinib in 12 COVID-19 patients with moderate
pneumonia.
|
| NCT04359095 ↗ |
Effectiveness and Safety of Medical Treatment for SARS-CoV-2 (COVID-19) in Colombia |
Completed |
Phase 2/Phase 3 |
2020-08-18 |
Introduction: The COVID-19 pandemic is characterized by significant morbidity and mortality.
Treatments have been administered to patients with COVID-19 in order to control viral
infection, among them: Hydroxychloroquine (HCQ), Lopinavir/Ritonavir (Lop/r), Remdesivir,
Favipavir, Emtricitabine/ Tenofovir acting over bacterial co-infection Azithromycin
(Azithro), or modifying the inflammatory response of the host (Tocilizumab, colchicine,
dexamethasone, and by other mechanisms (rosuvastatin). Except for dexamethasone clinical
trials offer conflicting evidence regarding the effectiveness and safety of therapies.
Objective: Evaluate the effectiveness and safety of pharmacological therapies used to treat
adult patients with COVID-19.
Methods: Pragmatic randomized controlled trial. Study population: Adults aged 18 years or
over with a positive real-time polymerase chain reaction (RT-PCR) or with high suspicion of
Severe Acute Respiratory Syndrome CoV-2 (SARS CoV-2) and diagnosis of mild, severe or
critical pneumonia, requiring hospital management at six hospitals in Colombia. Exclusion
criteria: Pregnancy, known allergy to treatment, cirrhosis or hepatic abnormality
(transaminases greater than 5 reference values), glomerular filtration rate lesser than 30
ml/min/1.73m^2, history of lung fibrosis, advanced or metastatic cancer. A sample size was
calculated from a sensitivity analysis with three scenarios:
scenario 1 a total of 1,163 patients, that is, 291 per treatment arm with alpha of Alpha =
0.05; power 0.8; Prop1 = 0.2 and Prop2 = 0.1 (expected difference of 10%) and 10% of possible
losses,scenario 2. With the previous parameters and with a Prop1 = 0.15 and Prop2 = 0.05 for
a total of 814 patients (204 per arm of treatment). scenario 3. With Alpha = 0.1, Prop1 =
0.15 and Prop2 = 0.05, the other previous parameters, for a total of 686 patients (172 per
treatment). in scenario 1 the study will be carried out in two phases. The first phase will
be conducted with 400 participants and aims to identify treatments with higher or minimum
potential, discontinue treatments with higher toxicity, and have the opportunity of
introducing new treatments with potential efficacy. The second phase will be conducted with
1,163 participants to evaluate the effectiveness of the selected treatments.
Four interventions have been defined: I1 Emtricitabine/ teneofovir , I2 Colchicine plus
rosuvastatin, I3 Emtricitabine/ teneofovir plus Colchicine plus rosuvastatin and I4 standard
treatment. Within each institution, participants will be randomly assigned to one of the
treatment arms assigned to that institution. Concealment will be kept through software that
maintain the assignment concealed until the random assignment is done . Treatment
administration will be open. Variables: Sociodemographic and clinical at recruitment;
(comorbidities, need for therapeutic support , grade of invasion at admission). Primary
outcomes. Effectiveness: Mortality. Safety: Serious adverse events (AE) assessed by the NCI
Community Oncology Research Program (NCORP) Guidance for Collection of Adverse Events Related
to COVID-19 Infection. Secondary outcomes: Intensive care unit (ICU) admission, requirement
of respiratory support, time to death, number of participants cured, any adverse event
related to treatment.
Analysis: Descriptive for the presentation of summary measures of the basal conditions by
type of variable. Bivariate. Description of the basal conditions (with organic failure at
admission, without failure at admission), by type of treatment, by participating institution.
Description of crude effectiveness and safety by means of the difference of accumulated
incidences, each one with 95% confidence intervals (95% CI) Intention to treat analyisis will
be done. Adjusted analysis: The ratio and difference of cumulative incidences of mortality at
7 and 28 days and severe adverse events between treatments will be estimated, adjusting for
confounding variables using logistic regression models with mixed effects considering each
institution as a level or from equations. generalized estimation (GEE). On the other hand, as
part of the pragmatic approach, the surface under cumulative ranking curve (SUCRA) will be
calculated based on Bayesian theory to define which drug has the highest probability of being
the most useful in the management of infection.
Ethical considerations: The study has a risk beyond minimum according to the Resolution
8430/1993 of the Colombian Ministry of Health. Informed consent will be explained and signed
if the patient is in condition to do so. This protocol will undergo evaluation by the ethics
committee at each of the participating institutions and at the National University of
Colombia. The protocol follows the Helsinki Declaration and institutional protocols for
clinical investigation.
|
| NCT04359277 ↗ |
Accelerating COVID-19 Therapeutic Interventions and Vaccines 4 ACUTE |
Recruiting |
Phase 4 |
2020-09-04 |
This is a randomized, open label, adaptive platform trial to compare the effectiveness of
antithrombotic and additional strategies for prevention of adverse outcomes in COVID-19
positive inpatients
|
| NCT04359290 ↗ |
Ruxolitinib for Treatment of Covid-19 Induced Lung Injury ARDS |
Completed |
Phase 2 |
2020-07-01 |
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib in the
treatment of patients with COVID-19 severe pneumonia.
|
| NCT04359316 ↗ |
Azithromycin in Hospitalized COVID-19 Patients |
Not yet recruiting |
Phase 4 |
2020-04-20 |
The present study is a randomized, double-blind, controlled, clinical trial, with the
approval of the ethics committee will be conducted on patients who have a positive test
confirming COVID-19 in Shahid Modarres Medical Education Center and Hospital in Tehran.
Patients will be randomly assigned to the two arms of the study and after completing the
course of treatment and collecting and analyzing the necessary information from each patient,
the results of the study will be published both on this site and in the form of an article in
a reputable international journal.
|
| NCT04359511 ↗ |
Efficacy and Safety of Corticosteroids in Oxygen-dependent Patients With COVID-19 Pneumonia |
Withdrawn |
Phase 3 |
2020-07-03 |
To date, there is no efficient therapeutics to prevent or treat COVID-19 related pulmonary
failure. Corticosteroids (CS) could be a helpful therapeutic. Retrospective reports suggested
survival improvement in patients with acute respiratory distress syndrome (ARDS). CT scan for
COVID19 hospitalized patients showed sometimes unusual aspects of pneumonia, suggestive of an
organizing phase of diffuse alveolar damage (DAD).
We hypothesize that, in the context of alveolar aggression induced by COVID-19, CT scan could
help to individualize patients with a high probability of pulmonary organizing process who
could benefit from CS treatment.
|
| NCT04359537 ↗ |
Efficacy of Various Doses of Hydroxychloroquine in Pre-Exposure Prophylaxis for COVID 19 |
Recruiting |
Phase 2 |
2020-05-01 |
Hydroxychloroquine has been approved by FDA as one of the treatment options for COVID
19.Healthcare personnel are amongst those at highest risk to contract the disease. Several
health authorities are now recommending the use of hydroxychloroquine as pre-exposure
prophylaxis is in health care personnel. Several studies are on going in this context.
However there is a controversy regarding the dosage regimen. This drug has a half life of
22.4 days. In this study we will be comparing three different doses of Hydroxychloroquine and
additionally have a control group in order to determine the efficacy of hydroxychloroquine as
pre- exposure prophylaxis in healthcare personnel in various doses.
|
| NCT04359615 ↗ |
Favipiravir in Hospitalized COVID-19 Patients |
Not yet recruiting |
Phase 4 |
2020-04-20 |
The present study is a randomized, double-blind, controlled, clinical trial, with the
approval of the ethics committee will be conducted on patients who have a positive test
confirming COVID-19 in Shahid Modarres Medical Education Center and Hospital in Tehran.
Patients will be randomly assigned to the two arms of the study and after completing the
course of treatment and collecting and analyzing the necessary information from each patient,
the results of the study will be published both on this site and in the form of an article in
a reputable international journal.
|
| NCT04359654 ↗ |
Nebulised Dornase Alfa for Treatment of COVID-19 |
Completed |
Phase 2 |
2020-06-16 |
An open-label, randomised, Best-Available-Care (BAC) and historic-controlled trial of
nebulised dornase alfa [2.5 mg BID] for 7 days in participants with COVID-19 who are admitted
to hospital and are at risk of ventilatory failure (the COVASE study). Controls will include
a randomised arm to receive BAC, historic data from UCLH patients with COVID-19 and biobanked
samples will be used to demonstrate an effect of dornase alfa. CRP will be measured to assess
the effect of dornase alfa on inflammation. Clinical endpoints and biomarkers (e.g. d-dimer)
will be used to assess the clinical response. Exploratory endpoints will explore the effects
of dornase alfa on features of neutrophil extracellular traps (NETs).
|
| NCT04359680 ↗ |
Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2 Infection |
Active, not recruiting |
Phase 3 |
2020-05-13 |
Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure
Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and
Others at Increased Risk of SARS-CoV-2 Infection
|
| NCT04360096 ↗ |
Inhaled ZYESAMI™ (Aviptadil Acetate) for the Treatment of Severe COVID-19 |
Recruiting |
Phase 2/Phase 3 |
2021-02-15 |
Brief Summary:
SARS-CoV-2 virus infection is known to cause Lung Injury that begins as dyspnea and exercise
intolerance, but may rapidly progress to Critical COVID-19 with Respiratory Failure and the
need for noninvasive or mechanical ventilation. Mortality rates as high as 80% have been
reported among those who require mechanical ventilation, despite best available intensive
care.
Patients with severe COVID-19 by FDA definition who have not developed respiratory failure be
treated with nebulized ZYESAMI™ (aviptadil acetate, a synthetic version of Vasoactive
Intestinal Polypeptide (VIP)) 100 μg 3x daily plus Standard of Care vs. placebo + Standard of
Care using an FDA 501(k) cleared mesh nebulizer.
The primary outcome will be progression in severity of COVID-19 (i.e. critical OR severe
progressing to critical) over 28 days. Secondary outcomes will include blood oxygenation as
measured by pulse oximetry, dyspnea, exercise tolerance, and levels of TNFα IL-6 and other
cytokines.
|
| NCT04360122 ↗ |
Levamisole and Isoprinosine in Immune-prophylaxis of Egyptian Healthcare Workers Facing COVID-19 |
Not yet recruiting |
Phase 3 |
2020-05-20 |
This randomized open labeled clinical trial will include one hundred healthy healthcare
workers who will be randomly assigned into four groups of twenty-five each to receive either
levamisole, Isoprinosine, combined levamisole and isoprinosine or no-intervention for two
months to detect the impact of Levamisole and Isoprinosine as immune-prophylaxis on the
incidence of COVID-19 infection. Participants will be followed-up for three months clinically
and laboratory. Blood samples will be collected prior to randomization and during follow up.
|
| NCT04360759 ↗ |
Chloroquine Outpatient Treatment Evaluation for HIV-Covid-19 |
Withdrawn |
Phase 3 |
2020-05-01 |
Clinical manifestations of Covid-19 are poorly characterised in HIV co-infection, which may
predispose to more severe disease. Reducing hospitalisation and severe illness in this
population has important individual and public health benefits. The investigators propose a
pragmatic multi-centre, randomized controlled trial in South Africa to evaluate the efficacy
and safety of chloroquine or hydroxychloroquine to prevent progression of disease and
hospitalisation amongst HIV-positive people with Covid-19 not requiring hospitalisation at
initial assessment.
|
| NCT04360824 ↗ |
Covid-19 Associated Coagulopathy |
Recruiting |
Phase 4 |
2020-05-06 |
This prospective, randomized, open-label, multi-center interventional study is designed to
compare the safety and efficacy of two LMWH dosing protocols in patients admitted to the
University of Iowa Hospitals with COVID-19 who meet the modified ISTH Overt DIC criteria
score ≥3. Patients will be randomized to standard prophylactic dose LMWH (standard of care
arm) or intermediate-dose LMWH (intervention arm).
|
| NCT04360876 ↗ |
Targeted Steroids for ARDS Due to COVID-19 Pneumonia: A Pilot Randomized Clinical Trial |
Withdrawn |
Phase 2 |
2020-09-01 |
This trial will determine the safety and estimate efficacy of targeted corticosteroids in
mechanically ventilated patients with the hyper-inflammatory sub phenotype of ARDS due to
coronavirus disease 2019 (COVID-19) by implementing a Phase 2A clinical trial.
|
| NCT04360980 ↗ |
The Effects of Standard Protocol With or Without Colchicine in Covid-19 Infection |
Recruiting |
Phase 2 |
2020-03-20 |
Based on data regarding the effect of colchicine on the modulation of immune system and
decreasing cytokine release and inflammation the question arises whether colchicine,
administered in a relatively low dose, could potentially have an effect on COVID-19
Polymerase chain reaction(PCR) positive patients .
|
| NCT04361214 ↗ |
Leflunomide in Mild COVID-19 Patients |
Recruiting |
Phase 1 |
2020-05-05 |
This study aims to examine the tolerability of high dose of leflunomide in patients with
COVID-19 who are being managed in the outpatient setting.
|
| NCT04361422 ↗ |
Isotretinoin in Treatment of COVID-19 |
Not yet recruiting |
Phase 3 |
2020-12-01 |
Contributors:
Lamia Elgarhy, Sabah El-Gaeish 1, Eman Hamed 2 , Wagdy Fathy2 Department of Dermatology,
Department of Pharmacology1 , Faculty of Medicine, Tanta University, Department of Chest,
Faculty of Medicine, Suez Canal University2.
Abstract:
The COVID-19 pandemic caused by SARS-COV-2 has infected over 2,000,000 people causing over
150,000 deaths. A key host cellular protein required for the virus entry is
angiotensin-converting enzyme 2 (ACE2) whose expression has been demonstrated in many tissues
including alveolar epithelial type II cells in lungs, oral mucosa and intestine, heart,
kidney, endothelium and skin. ACE2-expressing cells can act as home cells and are prone to
SARS-CoV-2 infection as ACE2 receptor facilitates cellular viral entry and replication. (1)
Fang et al. has suggested that patients with hypertension and diabetes mellitus may be at
higher risk of SARS-CoV-2 infection, as these patients are often treated with ACE inhibitors
(ACEIs) or angiotensin II type-I receptor blockers (ARBs), which have been previously
suggested to increase ACE2 expression. (2) In another study by Sinha et al who analyzed a
publicly available Connectivity Map (CMAP) dataset of pre/post transcriptomic profiles for
drug treatment in cell lines for over 20,000 small molecules, isotretinoin was the strongest
down-regulator of ACE 2 receptors. On the other hand, they found 6 drugs in CMAP that are
currently being investigated in clinical trials for treating COVID-19 (chloroquine,
thalidomide, methylprednisolone, losartan, lopinavir and ritonavir, from clinicaltrials.gov),
none of which was found to significantly alter ACE2 expression (P>0.1) (3) Moreover, Wu et
al, demonstrated that isotretinoin is a Potential papain like protease (PLpro) inhibitors
which is a protein encoded by SARS-CoV-2 genes and considered one of the proteins that should
be targeted in COVID-19 treatment by performing target-based virtual ligand screening. (4) In
addition, isotretinoin was reported to increase CD4 counts and markedly decrease viremia in
HIV positive patients suffering from acne vulgaris. (5) Currently, a study is running to
evaluate the effect of isotretinoin on immune activation among HIV-1 infected subjects with
incomplete CD4+ T cell recovery. (6) From this point, we can suggest that patient taking
isotretinoin therapy may be immune against SARS-COV-2 and it can also have a therapeutic
effect by prevention of further progression of the virus. Several potential mechanisms of
action of Chloroquine/Hydroxychloroquine against SARS-CoV-2 have been postulated and they are
actually used in treatment regimens for COVID-19.(7) It was reported that chloroquine
increase the blood level of isotretinoin, so lower doses is required when combined. We assume
to test the efficacy of isotretinoin in treatment of COVID-19 versus combined therapy with
the standard treatment of COVID-19.
|
| NCT04361474 ↗ |
Trial Evaluating the Efficacy of Local Budesonide Therapy in the Management of Hyposmia in COVID-19 Patients Without Signs of Severity |
Completed |
Phase 3 |
2020-05-18 |
The initial symptoms described in the first cases of COVID-19 were mainly fever and
respiratory signs. Recently, there has been an increase in cases of hyposmia without
associated nasal obstruction or rhinorrhea. Although we do not yet know the long-term
consequences of COVID-19 on olfaction, there is evidence in the literature demonstrating that
post-viral hyposmias are an important source of long-term olfactory disorders, impacting
quality of life.
Usually, the treatment of viral hyposmias is based on local and/or general corticosteroid
treatment combined with saline nasal irrigation at the onset of signs. Because of the
possible development of severe forms of the SARS-Cov-2 infection, the French Society of
Otorhinolaryngology has advised against treatment by corticosteroid therapy and nasal
irrigation. However, as the virus is present in the nasal fossae on average for 20 days,
persistent hyposmia at 30 days would probably result from an inflammatory or neurological
damage to the nasal slits or olfactory bulb. Local treatment with corticosteroids could then
be instituted from 30 days after the onset of symptoms of COVID-19 without risk of
dissemination.
In persistent hyposmia other than chronic rhinosinusitis, the only treatment that has proven
its efficacy is nasal irrigation associated with budesonide and olfactory rehabilitation.
However, this drug does not have marketing authorisation in France for this indication.
|
| NCT04362085 ↗ |
Coagulopathy of COVID-19: A Pragmatic Randomized Controlled Trial of Therapeutic Anticoagulation Versus Standard Care |
Completed |
Phase 3 |
2020-05-11 |
Coagulopathy of COVID-19 afflicts approximately 20% of patients with severe COVID-19 and is
associated with need for critical care and death. COVID-19 coagulopathy is characterized by
elevated D-dimer, an indicator of fibrin formation and clot lysis, and a mildly prolonged
prothrombin time, suggestive of coagulation consumption. To date, it seems that COVID-19
coagulopathy manifests with thromboembolism, thus anticoagulation may be of benefit. We
propose to conduct a parallel pragmatic multi-centre open-label randomized controlled trial
to determine the effect of therapeutic anticoagulation compared to standard care in
hospitalized patients admitted for COVID-19 with an elevated D-dimer.
|
| NCT04362111 ↗ |
Early Treatment of Cytokine Storm Syndrome in Covid-19 |
Active, not recruiting |
Phase 3 |
2020-07-29 |
This proposal addresses the problem of preventing the very high mortality and morbidity
associated with the development of Cytokine Storm Syndrome (CSS) associated respiratory
failure in Covid-19 infection.
|
| NCT04362137 ↗ |
Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm |
Completed |
Phase 3 |
2020-05-02 |
This was a randomized, double-blind, placebo-controlled, 29-day, multicenter study to assess
the efficacy and safety of ruxolitinib + standard-of-care (SoC) therapy, compared with
placebo + SoC therapy, in patients aged ≥12 years with COVID-19 disease.
|
| NCT04362189 ↗ |
Efficacy and Safety Study of Allogeneic HB-adMSCs for the Treatment of COVID-19 |
Not yet recruiting |
Phase 2 |
2020-05-15 |
Hope Biosciences is conducting a research study of an investigational product called
allogeneic adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) as treatment for
patients hospitalized with COVID-19. The study purpose is to evaluate the safety and efficacy
of four IV infusions of either placebo or HB-adMSCs in subjects with or without
hydroxychloroquine and azithromycin treatment for patients hospitalized with COVID-19.
|
| NCT04362332 ↗ |
Chloroquine, Hydroxychloroquine or Only Supportive Care in Patients AdmItted With Moderate to Severe COVID-19 |
Terminated |
Phase 4 |
2020-04-14 |
Rationale: Currently there are no approved treatments for COVID-19. In the Dutch treatment
protocol guideline (SWAB) designated treatment is supportive care with the option to add
chloroquine base (CQ) or hydroxychloroquine (HCQ). CQ and HCQ are implemented because of
their in vitro activity, results from small animal studies, and anecdotal patient's data.
There are no published randomized studies with these medications in patients with disease
caused by any coronavirus.
Objective: To evaluate if treatment with only supportive care or addition of one of two
anti-COVID_19 agents (chloroquine or hydroxychloroquine) results in less disease progression
in patients with moderate to severe COVID-19 who require hospital admission.
Study design: Multicentre, cluster randomized cross-over, open label trial. Hospitals will be
randomly allocated to one of 3 treatment arms in sequential periods of one week: chloroquine
base versus hydroxychloroquine versus supportive care without any drug presumed active
against SARS-COV-2. Patients will be treated based on the date of inclusion.
Study population: Adults aged of 18 years and older with moderate to severe, with a NEWS-2
score ≤ 5, laboratory confirmed COVID-19, who require hospital admission in a ward outside
the Medium Care or Intensive Care.
Intervention (if applicable): Depending on the treatment arm, the study subject will receive
only supportive care or an addition with one of the two agents active against SARS-CoV-2
(chloroquine or hydroxychloroquine).
Main study parameters/endpoints: Disease progression defined as a NEWS-2 score ≥ 7 within 14
days, or admission to Medium Care or Intensive Care Unit, or death.
|
| NCT04362813 ↗ |
Study of Efficacy and Safety of Canakinumab Treatment for CRS in Participants With COVID-19-induced Pneumonia |
Completed |
Phase 3 |
2020-04-30 |
This was a multicenter, randomized, double-blind, placebo-controlled study to assess the
efficacy and safety of canakinumab plus standard-of-care (SOC) compared with placebo plus SOC
in patients with COVID-19-induced pneumonia and cytokine release syndrome (CRS).
|
| NCT04363203 ↗ |
VA Remote and Equitable Access to COVID-19 Healthcare Delivery (VA-REACH TRIAL) |
Suspended |
Phase 3 |
2020-04-30 |
We propose a 3-arm RCT to determine the efficacy of hydroxychloroquine or azithromycin in
treating mild to moderate COVID-19 among Veterans in the outpatient setting.
|
| NCT04363216 ↗ |
Pharmacologic Ascorbic Acid as an Activator of Lymphocyte Signaling for COVID-19 Treatment |
Not yet recruiting |
Phase 2 |
2020-05-01 |
There are currently no approved therapies for patients with coronavirus disease (COVID-19)
caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Infusion of ascorbic
acid (vitamin C) has been shown to increase activity of lymphocytes, which are a crucial
component of the body's defense against viral disease progression and adaptive immunity.
Ascorbic acid infusion has been shown to be a safe treatment for patients suffering from
sepsis and certain types of cancer. This study is designed to evaluate the safety and
efficacy of ascorbic acid in the form of sequential I.V. infusions (Ascor®) for patients with
suspected COVID-19 who are unlikely to require mechanical ventilation within 24 hours of
study intervention.
|
| NCT04363346 ↗ |
Study of FT516 for the Treatment of COVID-19 in Hospitalized Patients With Hypoxia |
Active, not recruiting |
Phase 1 |
2020-05-14 |
This is a Phase I study with the primary objective of identifying the maximum tolerated dose
(MTD) of FT516 using 3 dose-escalation strategies (number of doses and cell dose) for the
treatment of coronavirus disease 2019 (COVID-19). This study provides initial estimates of
safety and efficacy based on stable respiratory function, as well as, determining the
feasibility for full-scale studies designed both for efficacy and safety.
|
| NCT04363437 ↗ |
COlchicine in Moderate-severe Hospitalized Patients Before ARDS to Treat COVID-19 |
Recruiting |
Phase 2 |
2020-04-26 |
The most prevalent complication of COVID-19 infection is respiratory failure from severe
acute respiratory syndrome (SARS), the leading cause of mortality. There is increasing
indication that the decompensation in severe COVD-19 infection may be due to a cytokine storm
syndrome. This hyperinflammatory syndrome results in a fulminant and fatal hypercytokinemia
and multiorgan failure.
Approximately 15% of patients with COVID-19 infection are hospitalized and 20-30% of these
hospitalized patients require ICU care and/or mechanical ventilation. Overall mortality in
hospitalized patients is approximately 20-25%. There is significant interest in therapies
that can be given upstream to reduce the rate of mechanical ventilation and thus mortality.
We hypothesize that treatment with colchicine in COVID-19 moderate-severe patients may
decrease the risk of progression into ARDS requiring increased oxygen requirements,
mechanical ventilation, and mortality.
|
| NCT04363450 ↗ |
Hydroxychloroquine as Prophylaxis for COVID-19 in Healthcare Workers (HCQPreP) |
Recruiting |
Phase 3 |
2020-04-27 |
This a double-blind, randomized, placebo-controlled clinical trial to determine if primary
prophylaxis with hydroxychloroquine in healthcare workers reduces symptomatic COVID-19
infection. Healthcare workers will be randomized at a 1:1 allocation between intervention and
placebo arms and followed for 12 weeks. This study will enroll up to 1,700 participates in
Lafayette, Louisiana. The primary outcome will number of symptomatic COVID-19 infections.
Secondary endpoints included number of days healthcare workers are absent from work and rate
of severe infection.
|
| NCT04363502 ↗ |
Use of the Interleukin-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection |
Recruiting |
Phase 2 |
2020-05-07 |
In this study Investigators propose to administer clazakizumab to patients with
life-threatening COVID-19 infection manifest by pulmonary failure and a clinical picture
consistent with a cytokine storm syndrome. This is a single-center randomized, double-blind,
placebo-controlled trial in which 30 patients will be enrolled and randomly assigned in a 1:1
ratio to two study arms that will receive clazakizumab at a dose of 25 mg or placebo.
|
| NCT04363827 ↗ |
Protect: Study With Hydroxychloroquine for Prevention and Early Phase Treatment of Coronavirus Disease (COVID-19) |
Active, not recruiting |
Phase 2 |
2020-05-14 |
This is a Italian, superiority, open label cluster-randomised, interventional clinical trial
aimed at assessing whether the treatment with Hydroxychloroquine can reduce the percentage of
symptomatic subjects compared to observation only in household members/contacts of COVID-19
patients (Group 1) and if the treatment with Hydroxychloroquine could be introduced in early
phase COVID-19 population (Group 2).
The participants will be randomised to receive either:
Arm A) hydroxychloroquine vs Arm B) Observation (2:1 randomisation).
|
| NCT04364815 ↗ |
The University of the Philippines Hydroxychloroquine PEP Against COVID-19 Trial |
Withdrawn |
Phase 3 |
2020-12-01 |
This COVID-19 pandemic warrants urgent strategies to protect people at high risk of
infection, particularly the healthcare workers. Secondary prevention through post-exposure
prophylaxis (PEP) and early treatment of infection are needed to prevent severe cases and cut
secondary transmission. Hydroxycholoroquine (HCQ) is an inexpensive anti-malarial drug with
immunomodulatory effects that are currently used as an off-label treatment for symptomatic
COVID-19 patients. In vitro studies have shown that it can efficiently inhibit SARS-CoV-2
infection and has potential as a post-exposure prophylaxis drug.
|
| NCT04365127 ↗ |
Progesterone for the Treatment of COVID-19 in Hospitalized Men |
Completed |
Phase 1 |
2020-04-27 |
The purpose of this study is to assess safety and efficacy of progesterone for treatment of
COVID-19 in hospitalized men.
|
| NCT04365153 ↗ |
Canakinumab in Covid-19 Cardiac Injury (The Three C Study) |
Completed |
Phase 2 |
2020-04-24 |
TThe purpose of this prospective, Phase 2, single center, blinded, randomized controlled
study is to demonstrate as a proof of concept that early treatment with canakinumab prevents
progressive heart and respiratory failure in patients with COVID-19 infection. These results
will lead to and inform a Phase III randomized placebo-controlled trial.
|
| NCT04365309 ↗ |
Protective Effect of Aspirin on COVID-19 Patients |
Enrolling by invitation |
Phase 2/Phase 3 |
2020-02-10 |
COVID-19 has a high infection rate and mortality, and serious complications such as heart
injury cannot be ignored. Cardiac dysfunction occurred in COVID-19 patients, but the law and
mechanism of cardiac dysfunction remains unclear. The occurrence of progressive inflammatory
factor storm and coagulation dysfunction in severe and fatal cases of NCP points out a new
direction for reducing the incidence of severe and critically ill patients, shortening the
length of duration in severe and critically ill patients and reducing the incidence of
complications of cardiovascular diseases. Aspirin has the triple effects of inhibiting virus
replication, anticoagulant and anti-inflammatory, but it has not received attention in the
treatment and prevention of NCP. Although Aspirin is not commonly used in the guidelines for
the treatment of NCP, it was widely used in the treatment and prevention of a variety of
human diseases after its first synthesis in 1898. Subsequently, aspirin has been confirmed to
have antiviral effect on multiple levels. Moreover, one study has confirmed that aspirin can
inhibit virus replication by inhibiting prostaglandin E2 (PGE2) in macrophages and
upregulation of type I interferon production. Subsequently, pharmacological studies have
found that aspirin as an anti-inflammatory and analgesic drug by inhibiting cox-oxidase
(COX). Under certain conditions, the platelet is the main contributor of innate immune
response, studies have found that in the lung injury model in dynamic neutrophil and platelet
aggregation.
In summary, the early use of aspirin in covid-19 patients, which has the effects of
inhibiting virus replication, anti-platelet aggregation, anti-inflammatory and anti-lung
injury, is expected to reduce the incidence of severe and critical patients, shorten the
length of hospital duration and reduce the incidence of cardiovascular complications.
|
| NCT04365517 ↗ |
The Effect of Sitagliptin Treatment in COVID-19 Positive Diabetic Patients |
Not yet recruiting |
Phase 3 |
2021-12-29 |
The COVID-19 pathology is frequently associated with diabetes mellitus and metabolic
syndrome. In the epidemic outbreak that exploded at the beginning of 2020 in the Lombardy
Region, about two thirds of the patients who died from COVID-19 were affected by diabetes
mellitus. COVID-19 occurs in 70% of cases with an inflammatory pathology of the airways that
can be fed by a cytokine storm and result in severe respiratory failure (10% cases) and death
(5%). The pathophysiological molecular mechanisms are currently not clearly defined. It is
hypothesized that the transmembrane glycoprotein type II CD26, known for the enzyme activity
Dipeptilpeptidase 4 of the extracellular domain, may play a main role in this condition. It
is in fact considerably expressed at the level of parenchyma and pulmonary interstitium and
carries out both systemic and paracrine enzymatic activity, modulating the function of
various proinflammatory cytokines, growth factors and vasoactive peptides in the deep
respiratory tract. Of particular interest is the fact that Dipeptilpeptidase 4 has been
identified as a cellular receptor for S glycoprotein of MERS-COV. In the case of the SARS-COV
2 virus, the main receptor is the Angiotensin-Converting Enzyme 2 protein, but a possible
interaction with Dipeptilpeptidase 4 also cannot be excluded. The selective blockade of
Dipeptilpeptidase 4 could therefore favorably modulate the pulmonary inflammatory response in
the subject affected by COVID-19. This protein is also known for the enzymatic degradation
function of the native glucagon-like peptide 1, one of the main regulators of insulin
secretion. This is why it is a molecular target in the treatment of diabetes (drugs that
selectively inhibit Dipeptilpeptidase 4 are marketed with an indication for the treatment of
type 2 diabetes). It is believed that the use of a Dipeptilpeptidase 4 inhibitor in people
with diabetes and hospitalized for Covid-19 may be safe and of particular interest for an
evaluation of the effects on laboratory and instrumental indicators of inflammatory lung
disease. Among the drugs that selectively block Dipeptilpeptidase 4, the one with the
greatest affinity is Sitagliptin.
|
| NCT04365582 ↗ |
OUTpatient Treatment of COVID-19 in Patients With Risk Factor for Poor Outcome |
Withdrawn |
Phase 3 |
2020-05-07 |
COVID-19 is a respiratory disease due to a novel coronavirus (SARS-CoV-2) that causes
substantial morbidity and mortality. To date, no treatment has been proved to be effective in
COVID-19. Elderly patients and patients with comorbidities have the worse prognosis with a
higher risk of hospitalization, ICU admission and death. The efficacy of an early outpatient
treatment could be suggested but need to be confirmed. This confirmation is mandatory to
improve prognosis of COVID-19 but also to avoid unsuspected deleterious effect of drugs
already used in clinical practice but not based on evidence.
|
| NCT04365985 ↗ |
Study of Immunomodulation Using Naltrexone and Ketamine for COVID-19 |
Terminated |
Phase 2 |
2020-04-29 |
Ideal new treatments for Novel Coronavirus-19 (COVID-19) would help halt the progression
disease in patients with mild disease prior to the need for artificial respiration
(ventilators), and also provide a rescue treatment for patients with severe disease, while
also being affordable and available in quantities sufficient to treat large numbers of
infected people. Low doses of Naltrexone, a drug approved for treating alcoholism and opiate
addiction, as well as Ketamine, a drug approved as an anesthetic, may be able to interrupt
the inflammation that causes the worst COVID-19 symptoms and prove an effective new
treatment. This study will investigate their effectiveness in a randomized, blinded trial
versus standard treatment plus placebo.
|
| NCT04366089 ↗ |
Oxygen-Ozone as Adjuvant Treatment in Early Control of COVID-19 Progression and Modulation of the Gut Microbial Flora |
Recruiting |
Phase 2 |
2020-03-26 |
Italy was the first European country affected by a severe outbreak of the Severe Acute
Respiratory Syndrome - CoronaVirus-2 (SARS-CoV-2) epidemic emerged from Wuhan region (China),
with a high morbidity and mortality associated with the disease.
In light of its pandemic spread and the very limited therapeutic options, COronaVIrus Disease
19 (COVID-19) is considered an unprecedented global health challenge. Therefore, the
evaluation of new resources, designed in the first instance for other pathologies but
potentially active against COVID-19, represents a priority in clinical research.
This is an interventional, non-pharmacological, open, randomized, prospective, non-profit
study on the adjuvant use of oxygen ozone therapy plus probiotic supplementation in the early
control of disease progression in patients with COVID-19.
Contextually, all patients are treated with the current standard of care on the basis of the
interim guidelines of the Italian Society of Infectious and Tropical Diseases.
The main purpose of the study is to evaluate the effectiveness of an ozone therapy-based
intervention (accompanied by supplementation with probiotics) in containing the progression
of COVID-19 and in preventing the need for hospitalization in intensive care units.
|
| NCT04366115 ↗ |
Evaluating AVM0703 for Treatment of COVID-19 or Influenza-mediated ARDS |
Not yet recruiting |
Phase 1 |
2021-01-01 |
This is a randomized, double-blinded, placebo-controlled study of AVM0703 administered as a
single intravenous (IV) infusion to patients with moderate or severe immediately
life-threatening Acute Respiratory Distress Syndrome (ARDS) due to COVID-19 or influenza (A
or B). The study is designed to evaluate the safety, tolerability, and pharmacokinetics of
single dose of AVM0703 in these ARDS patients.
|
| NCT04366739 ↗ |
Repurposing of Chlorpromazine in Covid-19 Treatment |
Not yet recruiting |
Phase 3 |
2020-04-29 |
This study evaluates the effects of the addition of chlorpromazine to the standard
therapeutic protocol in COVID-19 patients hospitalized for respiratory symptom management
(score 3-5 WHO Ordinal Scale for Clinical Improvement).
|
| NCT04366960 ↗ |
Comparison of Two Doses of Enoxaparin for Thromboprophylaxis in Hospitalized COVID-19 Patients |
Completed |
Phase 3 |
2020-05-14 |
The purpose of this study is to determine whether a higher dose of low molecular weight
heparin (enoxaparin 40 mg b.i.d.) is superior than the standard prophylaxis dose (enoxaparin
40 mg o.d.) in reducing thromboembolic events in COVID-19 patients.
|
| NCT04367831 ↗ |
Intermediate or Prophylactic-Dose Anticoagulation for Venous or Arterial Thromboembolism in Severe COVID-19 |
Completed |
Phase 4 |
2020-05-02 |
This study is being conducted to assess the effectiveness of intermediate versus prophylactic
doses of anticoagulation (blood thinners) in patients critically ill with COVID-19 in the
intensive care units (ICUs) throughout the hospital. Anticoagulation is part of the patient's
usual standard of care but determining the dose of anticoagulation is based on physician
preference. The investigators are conducting this study (a randomized trial with adaptive
design employing cluster randomization) with the support of all of the ICUs to collect data
in order to determine what should be the standard of care in terms of anticoagulation in
these critically ill patients. The patients care will not be altered other than the choice of
anticoagulation (both approved and used throughout the hospital as standard of care) based on
the ICU bed they are assigned. Patient data will be collected until discharge.
|
| NCT04368377 ↗ |
Enhanced Platelet Inhibition in Critically Ill Patients With COVID-19 |
Completed |
Phase 2 |
2020-04-06 |
This is a compassionate use, proof of concept, phase IIb, prospective, interventional, pilot
study in which the investigators will evaluate the effects of compassionate-use treatment
with IV tirofiban 25 mcg/kg, associated with acetylsalicylic acid IV, clopidogrel PO and
fondaparinux 2.5 mg s/c, in patients affected by severe respiratory failure in Covid-19
associated pneumonia who underwent treatment with continuous positive airway pressure (CPAP).
|
| NCT04370262 ↗ |
Multi-site Adaptive Trials for COVID-19 |
Completed |
Phase 3 |
2020-04-07 |
The overall objective of the study is to evaluate the clinical efficacy of COVID-19
treatments consisting of standard of care (SOC), vs SOC with high dose famotidine in patients
hospitalized and meeting radiologic criteria for COVID-19 disease. SOC for the treatment for
COVID-19 has evolved since the initial conceptualization of this protocol and early
recruitment of patients. Initially SOC included hydroxychloroquine and has progressed to
include Remdesivir. This protocol is amended to allow the SOC to reflect the prevailing
treatment for COVID-19. We will compare clinical outcomes associated with SOC and the
addition of high-dose intravascular famotidine. The trial is designed to enroll at least 471
COVID-19 patients hospitalized with moderate to severe disease into each of the two treatment
arms, with a total enrollment target of at least 942 patients. This trial has been designed
and powered to support up to three interim analyses that will enable prompt assessment of
benefits and risks of the two treatment groups while maintaining the rigorous gold standard
of a randomized double blind clinical trial structure. Trial design has been guided by
practical consideration of the current clinical context involving rapidly escalating demands
on hospital staff and resources, and incorporates a minimalist approach employing existing
laboratory information management systems and a clinically relevant binary primary outcome of
30-day endpoint of death or survival.
|
| NCT04370782 ↗ |
Hydroxychloroquine and Zinc With Either Azithromycin or Doxycycline for Treatment of COVID-19 in Outpatient Setting |
Completed |
Phase 4 |
2020-04-28 |
This is a randomized, open-label trial to assess the safety and efficacy of
hydroxychloroquine, and zinc in combination with either azithromycin or doxycycline in a
higher risk COVID-19 positive outpatient population.
|
| NCT04371393 ↗ |
MSCs in COVID-19 ARDS |
Active, not recruiting |
Phase 3 |
2020-04-30 |
The mortality rate in SARS-CoV-2-related severe ARDS is high despite treatment with
antivirals, glucocorticoids, immunoglobulins, and ventilation. Preclinical and clinical
evidence indicate that MSCs migrate to the lung and respond to the pro-inflammatory lung
environment by releasing anti-inflammatory factors reducing the proliferation of
pro-inflammatory cytokines while modulating regulatory T cells and macrophages to promote
resolution of inflammation. Therefore, MSCs may have the potential to increase survival in
management of COVID-19 induced ARDS.
The primary objective of this phase 3 trial is to evaluate the efficacy and safety of the
addition of the mesenchymal stromal cell (MSC) remestemcel-L plus standard of care compared
to placebo plus standard of care in patients with acute respiratory distress syndrome (ARDS)
due to SARS-CoV-2. The secondary objective is to assess the impact of MSCs on inflammatory
biomarkers.
|
| NCT04371406 ↗ |
Efficacy of Azithromycin-associated Hydroxychloroquine Therapy Given in General Practice in Early-stage Disease in COVID-19 Patients |
Withdrawn |
Phase 3 |
2020-04-01 |
Hydroxychloroquine, a derivative of chloroquine (an antimalarial drug) with a weak
immunosuppressive effect, is prescribed by some teams alone or in combination with
azithromycin. No randomized controlled trials have demonstrated its efficacy, particularly in
primary care in the early stages of the disease. However, currently available data suggest
better efficacy if treatment is given early in the disease, before symptoms worsen. To date,
the majority of COVID-19 patients treated in outpatient care, particularly in general
practice, represent the majority of COVID-19 patients.
It is essential to evaluate, in primary care, the efficacy and safety of hydroxychloroquine
combined with azithromycin in Covid-19 patients in order to be able to implement this
therapeutic strategy as soon as the first symptoms appear. We realize a randomized,
controlled, open superiority trial, in 2 parallel groups (ratio 1:1).The main objective is to
assess the efficacy of Hydroxychloroquine combined with azithromycin in COVID-19 patients in
primary care, in add-on to standard of care, on unfavorable outcome defined by the onset of
at least one of the following between D0 and D14: hospitalization, death or percutaneous O²
saturation ≤ 92% in ambient air.
|
| NCT04371822 ↗ |
Efficacy of Sunlight Activated Synthetic Porphyrin in COVID-19 Infected Patients |
Not yet recruiting |
Phase 1 |
2020-08-01 |
Efficacy of Sunlight Activated Synthetic Porphyrin in COVID-19 Infected Patients (SnPPIX)
Mahmoud ELkazzaz(1),Rokia yousry abdelaziz sallam(2)
_____________________________________________________________________________________________
_________________________________________________________________________
Abstract :
The novel coronavirus pneumonia (COVID-19) is an infectious acute respiratory caused by the
novel coronavirus. The virus is a positive-strand RNA virus with high homology to bat
coronavirus. Depending on published study in which , conserved domain analysis, homology
modeling, and molecular docking were used to compare the biological roles of specific
proteins of the novel coronavirus. The principal investigator demonstrated according to
previous researches that some viral structural and nonstructural proteins could bind to the
porphyrin, respectively. At the same time, orf1ab, ORF10 and ORF3a proteins coordinated to
attack heme on the 1-beta chain of hemoglobin, COVID-19 binds to the porphyrin of haem and
displaces iron and a study denonestrated that Covid-19 could cause acquired acute porphyria
which is the condition in which there is excess accumulation of porphyrin intermediate
metabolites. This point can be taken advantage of X-ray induced visible luminescence of
porphyrin for producing of Reactive Oxygen Species (ROS).Many porphyrins are benign in the
dark but are transformed by sunlight into caustic, flesh-eating toxins Porphyrins have been
used for photodynamic therapy (PDT) against a wide range of targets like bacteria, viruses
and tumor cells It has been reported that ROS-based inactivation of viruses may occur due to
several reasons, such as protein oxidation, single strand breaks in the RNA genome and
protein-RNA crosslinking. Since ROS-based inactivation has a multi-targeted mechanism, it is
much less likely that a virus would be able to develop resistance against it. Recently,
porphyrins, already in use as photosensitizers for Photodynamic Therapy (PDT), were a study
target to applications in medical area, namely as possible contrast agents in MRI. could be
observed some examples of porphyrin derivatives already study as MRI contrast media. Low dark
toxicity, neoplastic tissue affinity and synthetic accessibility are some of the important
properties that contribute for its selection. In MRI studies was found that CM based on
paramagnetic metalloporphyrins showed higher affinity for neoplastic tissues, observed by
increased relaxation time of the neoplastic tissues, which is reflected on an increase in MRI
signal and consequently in a better neoplastic lesions detection. A study demonestrated that
The sulfonated tetranaphthyl porphyrin contrast agents in MRI (TNapPS), sulfonated
tetra-anthracenyl porphyrin (TAnthPS), and sulfonated 2,6-difluoro-meso-tetraphenylporphine
[TPP(2,6-F2)S] and its copper chelate [TPP(2,6-F2)S,Cu], which reduced HIV infection by 99,
96, 94, and 96%, respectively. Previous studies which showed that Covid -19 binds to the
porphyrin of haem and displaces iron in addition to Sulfonated porphyrins and
light-stimulated Sn- protoporphyrin IX have broad antiviral activity against more distinct
types of viruses, Co-protoporphyrin IX and Sn-protoporphyrin IX inactivate Zika, Chikungunya
and other arboviruses by targeting the viral envelope Porphyrins are amphipathic molecules
able to interact with membranes and absorb light, being widely used in photodynamic therapy.
Previously, we showed that heme, Co-protoporphyrin IX (CoPPIX) and Sn-protoporphyrin IX
(SnPPIX) directly inactivate DENV and YFV infectious particles. Here we demonstrate that the
antiviral activity of these porphyrins can be broadened to CHIKV, ZIKV, Mayaro virus, Sindb
is virus and Vesicular Stomatitis virus. Porphyrin treatment causes viral envelope protein
loss, affecting viral morphology, adsorption and entry into target cells , Finally, the
principal investigator expect that viral load will be declined with sunlight because In
particular, porphyrins absorb essentially all the UV/visible light wavelengths in the
emission spectrum of the sun; hence they are active at very low doses .
Keywords: COVID 2019 ,Infection, Sulfonated porphyrins and X-ray induced visible luminescence
of porphyrin
|
| NCT04371926 ↗ |
Prophylactic Benefit of Hydroxychloroquine in COVID-19 Cases With Mild to Moderate Symptoms and in Healthcare Workers With High Exposure Risk |
Withdrawn |
N/A |
2020-06-01 |
Few studies have reported the efficacy of HCQ in reducing the viral load and improving the
severity of symptoms in hospitalized COVID-19 cases with serious respiratory infection.
However, the prophylactic benefits of HCQ has not been clearly defined yet.
|
| NCT04372589 ↗ |
Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC) |
Completed |
Phase 2/Phase 3 |
2020-05-20 |
Endothelial injury as a consequence of SARS-CoV-2 infection leads to a dysregulated host
inflammatory response and activation of coagulation pathways. Macro- and micro-vascular
thrombosis may contribute to morbidity, organ failure, and death. Therapeutic anticoagulation
with heparin may improve clinical outcomes in patients with COVID-19 through anti-thrombotic,
anti-inflammatory, and anti-viral activities of heparins. This pragmatic, Bayesian adaptive
randomized controlled trial will determine whether therapeutic anticoagulation with heparin
(subcutaneous low molecular weight heparin or intravenous unfractionated heparin) versus
usual care reduces the need for intubation or death in hospitalized patients with COVID-19.
The trial uses an adaptive design which was chosen to overcome limitations in available data
to inform a priori estimation of event rates and possible effect sizes. The adaptive design
also includes response-adaptive randomization based on baseline D-dimer level, probing for
differential efficacy across subgroups defined based on initial D-dimer level. This Bayesian
adaptive randomized trial will stop at a conclusion 1) when the posterior probability that
the proportional odds ratio is greater than 1.0 reaches 99% (definition of benefit); 2) when
the posterior probability that the proportional odds ratio is greater than 1.2 is less than
10% (definition of futility) or; 3) when the posterior probability that the proportional odds
ratio is less than 1.0 is greater than 90% (definition of harm). The trial will enroll a
maximum of 3,000 patients, although in many simulations the trial may require fewer patients.
The trial is strategically aligned with the international REMAP-CAP/COVID platform trial to
accelerate evidence generation.
|
| NCT04372628 ↗ |
Trial of Early Therapies During Non-hospitalized Outpatient Window for COVID-19 |
Recruiting |
Phase 2 |
2020-06-01 |
Blinded, multicenter, placebo-controlled, randomized clinical trial evaluating
lopinavir/ritonavir vs placebo in early outpatient treatment of adults with COVID-19
|
| NCT04373044 ↗ |
Baricitinib, Placebo and Antiviral Therapy for the Treatment of Patients With Moderate and Severe COVID-19 |
Terminated |
Phase 2 |
2020-05-01 |
This phase II trial studies the effect of baricitinib in combination with antiviral therapy
for the treatment of patients with moderate or severe coronavirus disease-2019 (COVID-19).
Treatment with antiviral medications such as hydroxychloroquine, lopinavir/ritonavir, and/or
remdesivir may act against infection caused by the virus responsible for COVID-19.
Baricitinib may reduce lung inflammation. Giving baricitinib in combination with antiviral
therapy may reduce the risk of the disease from getting worse and may help prevent the need
for being placed on a ventilator should the disease worsen compared to antiviral therapy
alone.
|
| NCT04373733 ↗ |
Early Intervention in COVID-19: Favipiravir Verses Standard Care |
Active, not recruiting |
Phase 3 |
2020-05-01 |
Currently we do not know how best to treat patients infected with COVID-19. This study is
looking at whether randomising participants to either favipiravir or to usual care, can help
patients with suspected or proven COVID-19 infection.
|
| NCT04374149 ↗ |
Therapeutic Plasma Exchange Alone or in Combination With Ruxolitinib in COVID-19 Associated CRS |
Completed |
Phase 2 |
2020-04-30 |
This protocol will evaluate the efficacy of Therapeutic Plasma Exchange alone or in
combination with ruxolitinib in COVID positive patients with PENN grade 2, 3, 4 cytokine
release syndrome. It is hypothesized that dual intervention of acute apheretic depletion of
cytokines and concomitant suppression of production will produce superior amelioration of the
cytokine load and to help to prevent cytokine load rebound. This protocol is envisioned as a
pilot study (n=20) for hypothesis generation for future investigation.
|
| NCT04374487 ↗ |
Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications |
Active, not recruiting |
Phase 2 |
2020-05-09 |
The novel coronavirus disease (COVID-19), which began in Wuhan, China, in December 2019, has
been declared to be a pandemic by the World Health Organization (WHO), Caused by the severe
acute respiratory syndrome coronavirus 2 (SARS-CoV-2), COVID-19 has resulted in 1,781,127
cases and 108,994 deaths globally (till 12th April, 2020), affecting 199 countries and 2
international conveyances. US FDA has recently approved Convalescent Plasma from patients
recovered from COVID 19 for the treatment of severe or life threatening COVID-19 infections.
In a small case series, five critically ill COVID-19 patients with ARDS were treated with
convalescent plasma containing neutralizing antibodies. Infusion of plasma was followed by
improvement in clinical status in all five patients, with no deaths and the study reported
that three patients were discharged, whilst two continued to be stable on mechanical
ventilation. We designed this phase II, open label, randomized clinical trial with the
primary objective to assess the safety and efficacy of the therapy in the second stage.
|
| NCT04374552 ↗ |
Asymptomatic COVID-19 Trial |
Withdrawn |
Phase 2 |
2020-05-05 |
The coronavirus disease-2019 (COVID-19) is spreading throughout the United States. While
there are no known therapies to treat those who have become sick, there have been some
reports that a medication currently used to treat rheumatoid arthritis, lupus, and malaria
(Hydroxychloroquine sulfate, also known as Plaquenil) may help to lessen the chance or
severity of illness, especially if combined with a medicine that treats other kinds of
infections (Azithromycin, also known as Zithromax or Zmax or Zpak).
There are some people who test positive for the virus but who are otherwise not ill. Current
standard of care is to advise these people to self-monitor but no treatment is offered. It is
not known how many of these individuals will remain symptom free, and how many will become
sick or how severe those symptoms will be. This study will randomize those people who do not
have symptoms into one of three treatment plans 1) Hydroxycholoquine and Azithromycin, or 2)
no active medication (placebo). All participants will be followed for 2 months.
The study will determine if there is any benefit to those who are asymptomatic to taking
taking Hydroxychloroquine sulfate in combination with Azithromycin, or if there is no benefit
from taking these medications.
|
| NCT04374565 ↗ |
Convalescent Plasma for Treatment of COVID-19 Patients With Pneumonia |
Active, not recruiting |
Phase 2 |
2020-05-05 |
This is a single arm phase II trial to assess efficacy and confirm safety of infusions of
anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory
symptoms,with or without confirmed interstitial COVID-19 pneumonia by chest Xray or CT. A
total of 29 eligible subjects will be enrolled to receive anti-SARS-CoV-2 plasma.Outcomes
will be compared to hospitalized controls with confirmed COVID-19 disease through
retrospective chart review.
|
| NCT04375046 ↗ |
Recombinant Bacterial ACE2 Receptors -Like Enzyme of B38-CAP Could be Promising Treatment for COVID-19 Infection- and Its Inflammatory Complications Better Than Recombinant Human ACE2 |
Not yet recruiting |
Phase 1 |
2021-07-01 |
Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP could be promising treatment for
COVID-19 infection- and Its inflammatory complications better than recombinant human ACE2
Mahmoud ELkazzaz(1),Tamer Haydara(2),Yousry Abo-amer(3), Quan Liu(4)
1. Department of chemistry and biochemistry, Faculty of Science, Damietta University,
Egypt.
2. Department of Internal Medicine, Faculty of Medicine, Kafrelsheikh University, Egypt
3. Hepatology,Gastroenterology and Infectious Diseases Department, Mahala Hepatology
Teaching Hospital, Egypt
4. School of Life Sciences and Engineering, Foshan University, Foshan, Guangdong Province;
Laboratory of Emerging Infectious Disease, Institute of Translational Medicine, The
First Hospital of Jilin University, Changchun, China.
Abstract
The COVID-19 pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
has infected over 100 million people causing over 2.4 million deaths over the world, and it
is still expanding. There is an urgent need for targeted and effective COVID-19 treatments
which has put great pressure on researchers across the world for developing effective drugs.
This paper reviews the possibility of using Recombinant Bacterial ACE2 Receptors -Like Enzyme
of B38-CAP to treat SARS-CoV-2 based on the intracellular mechanism of SARS-CoV-2
transmission and consequences caused. Angiotensin-converting enzyme 2 (ACE2) plays a key role
in cardiovascular physiology and pathology, and it's being currently being investigated as a
potential covid-19 and acute lung failure treatment through several clinical trials.. The
SARS-CoV2 binding site was identified as ACE2, a part of the RAAS, which is known to protect
the lung from injuries. it has been postulated that SARS-CoV-2 binding to ACE2 may attenuate
residual ACE2 activity, skewing the ACE/ACE2 balance to a state of heightened angiotensin II
activity leading to inflammatory and oxidative organ damage, as well as pulmonary
vasoconstriction, which can lead to acute lung injury.. Therefore, treatment with recombinant
soluble ACE2 protein and drugs that up regulate ACE2 may alleviate pulmonary complication. In
animal models including heart failure, acute lung injury, and diabetic nephropathy,
recombinant human ACE2 protein (rhACE2), which is devoid of its membrane-anchored domain thus
soluble, has been shown to have beneficial effects. Despite its positive effects, rhACE2 is a
glycosylated protein, which necessitates a time- and cost-intensive protein expression system
using mammalian or insect cells, which may be inconvenient in drug production and medical
economics. Moreover, we hypothesis that treating COVID-19 patients with recombinant soluble
ACE2 protein may induce autoantibodies and T cells to cellular ACE2.Furthermore, rhACE2 may
interact with spike protein based vaccine and worsen its effect . These autoantibodies may
generated by enforced presentation of the soluble Angiotensin-converting enzyme 2 (ACE2)
protein in a complex with COVID-19 Spike protein in fragment crystallizable (FC) Receptor
positive Antigen Presenting Cells in the blood The development of autoantibodies might make
injury and damage to the host epithelial cells and hamper their ACE2 dependent function in
lungs, intestine and testes which express ACE2. In addition to inducing platelet aggregation
and thrombosis . Although it has been stated that immune response associated with the chronic
infusion of rhACE2 resulting in the degradation of rhACE226, this was not the case with
B38-CAP; no antibodies against B38-CAP were detected in the serum of mice infused with
B38-CAP for two weeks... In this case we suggest that bacterial engineering could be used to
develop better protein drugs for COVID-19 treatment... B38-CAP is an ACE2-like enzyme derived
from bacteria that reduces hypertension and cardiac dysfunction. Angiotensin-converting
enzyme 2 (ACE2) plays a key role in cardiovascular physiology and pathology, and it is
currently being studied in clinical trials to treat acute lung failure. In mice, B38-CAP
treatment prevented angiotensin II-induced hypertension, cardiac hypertrophy, and fibrosis.
B38-CAP is an ACE2-like enzyme derived from bacteria, demonstrating that evolution has shaped
a bacterial carboxypeptidase (B38-CAP) to a human ACE2-like enzyme. As a result, we think
that treating COVID-19-infected patients with Bacterial ACE2 like enzymes, rather than human
ACE2, may be preferable because it will perform the same role as human ACE2 and may not be
recognized by COVID-19 spike protein
Keywords: COVID 2019 ,Infection, B38-CAP , Bacterial ACE2 receptors -like enzyme , rhACE226.
|
| NCT04375202 ↗ |
Colchicine in COVID-19: a Pilot Study |
Recruiting |
Phase 2 |
2020-04-18 |
This is an interventional, pilot, multicenter, randomized, open-label, phase 2 study,
enrolling patients with COVID-19 disease. One-month rate of entering the critical stage
(either a. Respiratory failure occurs and requires mechanical ventilation; b. Patients
combined with other organ failure need ICU monitoring and treatment; c. Death) is the primary
endpoint.
|
| NCT04376788 ↗ |
Exchange Transfusion Versus Plasma From Convalescent Patients With Methylene Blue in Patients With COVID-19 |
Recruiting |
Phase 2 |
2020-05-20 |
The aim of this project is to introduce way for treatment of patients with severe COVID-19
disease with respiratory complications.
|
| NCT04377503 ↗ |
Tocilizumab Versus Methylprednisolone in the Cytokine Release Syndrome of Patients With COVID-19 |
Not yet recruiting |
Phase 2 |
2020-05-01 |
This study compare the efficacy and safety of tocilizumab versus methylprednisolone in the
cytokine release syndrome of patients with COVID-19
|
| NCT04377997 ↗ |
Safety and Efficacy of Therapeutic Anticoagulation on Clinical Outcomes in Hospitalized Patients With COVID-19 |
Not yet recruiting |
Phase 2 |
2020-05-15 |
The coronavirus disease 2019 (COVID-19) global pandemic caused by the severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused considerable morbidity and
mortality in over 170 countries. Increasing age and burden of cardiovascular comorbidities
are associated with a worse prognosis among patients with COVID-19. In addition, serologic
markers of more severe disease including coagulation abnormalities and thrombocytopenia, are
not uncommon among patients hospitalized with severe COVID-19 infection and are more common
in patients who died in-hospital. As the COVID-19 pandemic continues to grow, there is a
pressing need to identify safe, effective, and widely available therapies that can be scaled
and rapidly incorporated into clinical practice. Understanding the putative mechanism of
increased mortality risk associated with abnormal coagulation function and cardiac injury is
critical to guide studies of promising therapeutic interventions. Published and anecdotal
reports indicate that endothelial dysfunction and thrombosis are common in critically ill
patients with COVID-19, including reports of diffuse microvascular thrombosis in the lungs,
heart, liver, and kidneys. Patients with cardiovascular disease (CVD) and CVD risk factors
are known to have endothelial dysfunction and a heightened risk of thrombosis. A recent study
of COVID-19 inpatients from Wuhan, China observed that an elevated D-dimer level greater than
1 ug/mL was associated with an 18 times higher risk of in-hospital death, underscoring the
importance of increased coagulation activity as a potential modifiable risk marker that may
drive end-organ injury. Given the established link between endothelial dysfunction and
thrombosis in patients with cardiovascular disease, and the association between coagulopathy
and adverse outcomes in patients with sepsis, the association between increased coagulation
activity, end-organ injury, and mortality risk may represent a modifiable risk factor among
COVID-19 patients with critical illness. Therefore, we propose to conduct a randomized,
open-label trial of therapeutic anticoagulation in COVID-19 patients with an elevated D-dimer
to evaluate the efficacy and safety.
|
| NCT04378244 ↗ |
CORONA: A Study Using DeltaRex-G Gene Therapy for Symptomatic COVID-19 |
Not yet recruiting |
Phase 1/Phase 2 |
2021-12-12 |
COVID-19 is an infectious disease caused by severe acute respiratory syndrome coronavirus 2.
COVID-19 causes life threatening complications known as Cytokine Release Syndrome or Cytokine
Storm and Acute Respiratory Distress Syndrome. These complications are the main causes of
death in this global pandemic. Over 1000 clinical trials are on-going worldwide to diagnose,
treat, and improve the aggressive clinical course of COVID-19. The investigators propose the
first, and so far, only gene therapy solution that has the potential to address this urgent
unmet medical need.
Rationale
1. There are striking similarities between the damaged lung environment of COVID-19 induced
ARDS and the tumor microenvironment (exposed collagen from tissue destruction by
invading tumor or by the virus-induced immune response, and presence of activated
proliferative cells (cancer cells and tumor associated fibroblasts or activated T cells,
macrophages and pulmonary fibroblasts in COVID-19);
2. DeltaRex-G is a disease-seeking retrovector encoding a cytocidal dominant negative human
cyclin G1 as genetic payload). When injected intravenously, the DeltaRex-G nanoparticles
has a navigational system that targets exposed collagenous proteins (XC proteins) in
injured tissues (e.g. inflamed lung, kidney, etc.), thus increasing the effective drug
concentration at the sites of injury, in the vicinity of activated/proliferative T cells
evoked by COVID-19. Our hypothesis is that DeltaRex-G then enters the rapidly dividing T
cells and kills them by arresting the G1cell division cycle, hence, reducing cytokine
release and ARDS;
3. Intravenous DeltaRex-G has minimal systemic toxicity due to its navigational system
(targeting properties) that limits the biodistribution of DeltaRex-G only to areas of
injury where exposed collagenous (XC) proteins are abnormally found; and
4. DeltaRex-G is currently available in FDA approved "Right to Try" or Expanded Access
Program for Stage 4 cancers for an intermediate size population. To gain this approval,
FDA requires DeltaRex-G to have demonstrated safety and efficacy in early clinical
trials.
|
| NCT04379271 ↗ |
A Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 as Addition to Investigator's Choice of Standard of Care Therapy, in Patients With Coronavirus Disease 19 (COVID-19) |
Completed |
Phase 2/Phase 3 |
2020-06-11 |
At present there is no approved drug treatment for Covid-19. In this study we plan to
investigate if an experimental drug called IMU-838 (vidofludimus calcium) can improve your
symptoms, prevent worsening that would initiate further treatments such as ventilation, and
can lower your virus number if given in addition to your doctor's choice of standard therapy.
We will also test if IMU-838 has any side effects and measure the level of IMU 838 in your
blood.
Experimental drug means that it is not yet authorized for marketing in your country. To date
approximately 600 individuals have received IMU-838 (or a drug similar to IMU-838 that
contains the same active substance as IMU-838) in research studies.
|
| NCT04379479 ↗ |
Clinical Effect of Dialyzable Leukocyte Extract in Suspected or Confirmed Cases of COVID-19 (FUTURE-T) |
Not yet recruiting |
Phase 2 |
2020-05-01 |
Main goal: To generate information on the efficacy and safety of Dialyzable Leukocyte Extract
(DLE) as an aid in the treatment of patients with acute respiratory infection (suspected or
confirmed cases of COVID-19).
Primary goal: To generate information on the efficacy of DLE as an aid in symptomatic
treatment, by reducing the signs and symptoms of acute respiratory infection
(suspected/confirmed cases of COVID-19).
Secondary goals:
1. To evaluate clinical deterioration and respiratory alarm data.
2. To evaluate the duration of the clinical picture.
3. To explore cytokine changes associated with the therapeutic effect induced by DLE.
4. To obtain data on the safety of DLE as an aid in the symptomatic treatment of acute
respiratory infection (suspected/confirmed cases of COVID-19).
5. To generate information to validate the contingency scale to assess the severity of
acute respiratory disease (suspected/confirmed cases of COVID-19).
Justification The systemic inflammatory response has been recognized as being responsible for
COVID-19 complications. Immunomodulation strategies to control it are currently being
considered, including the use of systemic steroids to down-regulate the systemic inflammatory
response, the use of human immunoglobulin and even chloroquine given its anti-inflammatory
and antiviral qualities; however, none of these treatments has been sufficiently studied or
has shown any significant change in the clinical course of infected patients.
Due to the importance of the COVID-19 pandemic and in the absence of specific treatment, it
is important to implement new treatments that allow modulating the immune response, and one
strategy may be the addition of DLE to symptomatic and supportive treatment.
Hypotheses by goals.
1. The addition of DLE to the symptomatic treatment could decrease the severity of the
clinical outcome (signs and symptoms) in individuals with an acute respiratory infection
(cases suspected/confirmed by COVID-19).
2. The addition of DLE to the symptomatic treatment could decrease the clinical
deterioration due to the acute respiratory infectious process (suspected/confirmed cases
of COVID-19).
3. The addition of DLE to the symptomatic treatment could decrease the duration of the
clinical outcome (suspected/confirmed cases of COVID-19).
|
| NCT04379518 ↗ |
Rintatolimod and IFN Alpha-2b for the Treatment of COVID-19 in Cancer Patients |
Recruiting |
Phase 1/Phase 2 |
2020-11-17 |
This phase I/IIa trial studies the best dose and side effects of rintatolimod and interferon
(IFN) alpha-2b in treating cancer patients with COVID-19 infection. Interferon alpha is a
protein important for defense against viruses. It activates immune responses that help to
clear viral infection. Rintatolimod is double stranded ribonucleic acid (RNA) designed to
mimic viral infection by stimulating immune pathways that are normally activated during viral
infection. Giving rintatolimod and interferon alpha-2b may activate the immune system to
limit the replication and spread of the virus.
|
| NCT04380376 ↗ |
Low-doses Melphalan Inhalation in Patients With COVID-19 (CoronavIrus Disease 2019) Pneumonia |
Recruiting |
Phase 2 |
2020-04-30 |
This single-center, prospective, open-label, comparator study, blind for central accessor
evaluates the efficacy, safety of inhalations of low-doses of melphalan in patients with
pneumonia with confirmed or suspected COVID-19. All patients will receive 0,1 mg of melphalan
in 7-10 daily inhalations 1 time per day.
|
| NCT04380402 ↗ |
Atorvastatin as Adjunctive Therapy in COVID-19 |
Recruiting |
Phase 2 |
2020-06-25 |
Objective: To assess whether adjunctive therapy of COVID-19 infection with atorvastatin
reduces the deterioration in hospitalized patients and improves clinical outcome.
|
| NCT04380519 ↗ |
Study of the Efficacy and Safety of a Single Administration of Olokizumab and RPH-104 With Standard Therapy in Patients With Severe Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection (COVID-19) |
Completed |
Phase 2/Phase 3 |
2020-04-23 |
The primary objective of the study is to evaluate the efficacy and safety of a single dose of
RPH-104 (80 mg) or OKZ (64 mg) compared to placebo in addition to standard therapy in
patients with severe SARS-CoV-2 infection (COVID-19) at Day 15 of the study
|
| NCT04380961 ↗ |
A Study to Evaluate the Efficacy and Safety of Sirukumab in Confirmed Severe or Critical Confirmed Coronavirus Disease (COVID)-19 |
Completed |
Phase 2 |
2020-04-24 |
The purpose of this study is to evaluate the clinical response of sirukumab (administered as
a single intravenous dose) plus standard of care (SOC) compared to placebo plus SOC in
COVID-19.
|
| NCT04381052 ↗ |
Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection |
Completed |
Phase 2 |
2020-05-18 |
In this study, the investigators propose to administer clazakizumab to patients with
life-threatening Coronavirus Disease 2019 (COVID-19) infection manifest by pulmonary failure
and a clinical picture consistent with a cytokine storm syndrome. This is a single-center
randomized, double-blind, placebo-controlled trial in which 30 patients will be enrolled and
randomly assigned in a 1:1 ratio to two study arms and receive clazakizumab at a dose of 25
mg or placebo.
|
| NCT04381377 ↗ |
Efficacy and Safety of Polyoxidonium® in Hospitalized Patients With Coronavirus Disease COVID-19 |
Active, not recruiting |
Phase 2/Phase 3 |
2020-04-29 |
The purpose of this study is to demonstrate the superiority of Polyoxidonium®, lyophilizate
for solution for injections and topical application, 6 mg over placebo in hospitalized
patients with coronavirus disease (COVID-19). This is a multicentre prospective, randomized,
double-blind, placebo-controlled, parallel-group phase IIb\IIIa clinical trial.
|
| NCT04381858 ↗ |
Convalescent Plasma vs Human Immunoglobulin to Treat COVID-19 Pneumonia |
Completed |
Phase 3 |
2020-05-06 |
Background: On December 2019, a new human coronavirus infection (COVID-19) was detected in
China. Its infectivity and virulence characteristics caused a rapid spread, being declared
pandemic on March 2020. The mortality attributed to the infection ranges between 3 and 10%.
Main risk factors are age, male sex, and chronic degenerative comorbidities. Due to the
absence of therapeutic options, potential alternatives such as human immunoglobulin or plasma
from convalescent patients have been administered. Due to the severity of the disease and the
associated mortality, it is urgent to find therapeutic alternatives.
Objective: To assess the safety and efficacy of the administration of Convalescent plasma vs
human immunoglobulin in critically ill patients with COVID-19 infection.
Material and methods: Randomized Controlled trial of patients diagnosed with respiratory
infection by COVID-19, with severe respiratory failure without indication of mechanical
ventilation, or those who due to their severity are intubated upon admission. Randomization
will be performed 2:1 to receive plasma from convalescent patients or human immunoglobulin.
Outcomes: The primary outcome will be time to discharge from hospital for improvement. The
safety outcomes will be: Kirby index (PaO2/FiO2) evolution and dead.
|
| NCT04381884 ↗ |
Ivermectin Effect on SARS-CoV-2 Replication in Patients With COVID-19 |
Completed |
Phase 2 |
2020-05-18 |
In the context of COVID-19 pandemic, a report on ivermectin suppression of SARS-CoV-2 viral
replication in cell cultures has been published, and the use of this medication seems to be
potentially useful for the therapy. IVM safety profile and IVM wide spectrum enables to move
forward with the investigation in patients infected by SARS-CoV-2 as a proof-of-concept of
its possible use in the management of patients with COVID-19, given the current pandemic
situation.
|
| NCT04381936 ↗ |
Randomised Evaluation of COVID-19 Therapy |
Recruiting |
Phase 2/Phase 3 |
2020-03-19 |
RECOVERY is a randomised trial investigating whether treatment with Lopinavir-Ritonavir,
Hydroxychloroquine, Corticosteroids, Azithromycin, Colchicine, IV Immunoglobulin (children
only), Convalescent plasma, Synthetic neutralizing antibodies (REGN-COV2), Tocilizumab,
Aspirin, Baricitinib, Infliximab, Empagliflozin or Anakinra (children only) prevents death in
patients with COVID-19.
|
| NCT04382040 ↗ |
A Phase II, Controlled Clinical Study Designed to Evaluate the Effect of ArtemiC in Patients Diagnosed With COVID-19 |
Completed |
Phase 2 |
2020-05-08 |
Agent Name and Study Duration
ArtemiC is a medical spray comprised of Artemisinin (6 mg/ml), Curcumin (20 mg/ml),
Frankincense (=Boswellia) (15 mg/ml) and vitamin C (60 mg/ml) in micellar formulation for
spray administration.
Patients will receive up to 6 mg Artemisinin, 20 mg Curcumin, 15 mg Frankincense and 60 mg
vitamin C given daily as an add-on therapy (in addition to standard care) in two divided
doses, on Days 1 and 2.
Patients will be randomized in a manner of 2:1 for study drug (ArteminC) and Standard of Care
to Placebo and Standard of Care.
Patient follow-up will last 2 weeks. During this time, patients will be monitored for adverse
events.
Additional time will be required for follow up (until hospital discharge) in order to check
side effects and study drug efficacy.
Placebo, composed of the same solvent but without active ingredients, will be given in the
placebo group as add-on therapy, 2 times a day, on Days 1 and 2.
Overall rationale A preparation of ArtemiC, comprising Artemisinin, Curcumin, Boswellia, and
Vitamin C, is proposed as a treatment for the disease associated with the novel corona virus
SARS-CoV-2. It is readily available in light of its status as a food supplement. This
initiative is presented under the urgent circumstances of the fulminant pandemic caused by
this lethal disease, which is known as COVID-19 and has spread across the globe causing death
and disrupting the normal function of modern society. The grounds for the proposal are rooted
in existing knowledge on the components and pharmacological features of this formulation and
their relevance to the current understanding of the disease process being addressed.
Leading among these considerations are well established immuno-modulatory activities of the
active ingredients as established in vitro and in vivo and published over the years. These
activities as apparent, for example, in diminishing activity of TNF alpha and IL-6 levels are
acknowledged to be relevant to the pathophysiology processes involved in the progressive form
of COVID-19. The active agents have in addition prominent anti-oxidant, anti-inflammatory as
well as anti-aggregant and anti-microbial activities.
Based on these activities and observations in animal models, together with clinical
experience of the separate ingredients and in various combinations in other contexts it is
proposed to evaluate their effect in the context of COVID-19.
Study Purpose This study is designed to evaluate the safety and efficacy of ArtemiC on
patients diagnosed with COVID-19.
Methodology 50 adult patients who suffer from COVID-19 infection studied in parallel groups
treated with active agent or placebo as add on to standard care.
Safety will be assessed through collection and analysis of adverse events, blood and urine
laboratory assessments and vital signs.
|
| NCT04382053 ↗ |
Study of Efficacy and Safety of DV890 in Patients With COVID-19 Pneumonia |
Completed |
Phase 2 |
2020-05-27 |
The study will assess the efficacy and safety of DFV890 for the treatment of SARS-Cov-2
infected patients with COVID-19 pneumonia and impaired respiratory function.
|
| NCT04382066 ↗ |
Proof of Concept Study to Evaluate the Safety Profile of Plitidepsin in Patients With COVID-19 |
Completed |
Phase 1 |
2020-05-12 |
In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of
pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome
information of a novel coronavirus (SARS-CoV-2) from these pneumonia patients and developed a
real-time reverse transcription PCR (real-time RT-PCR) diagnostic assay.
Given no specific antiviral therapy for COVID-19 and the ready availability of plitidepsin as
a potential antiviral agent, based on pre-clinical studies, this randomized, parallel and
proof of concept trial will evaluate the safety of three doses of plitidepsin in patients
hospitalized with COVID-19.
|
| NCT04382651 ↗ |
Study of Efficacy and Safety of MAS825 in Patients With COVID-19 |
Completed |
Phase 2 |
2020-06-11 |
The study will assess the efficacy and safety of MAS825 for the treatment of SARS-CoV-2
infected patients with COVID-19 pneumonia and impaired respiratory function
|
| NCT04382924 ↗ |
Safety and Efficacy of NP-120 (Ifenprodil) for the Treatment of Hospitalized Patient With Confirmed COVID-19 Disease |
Completed |
Phase 2/Phase 3 |
2020-08-05 |
The purpose of this adaptive trial is to determine the clinical efficacy of Ifenprodil in the
treatment of patients infected with COVID-19. This Protocol is largely based on the
recommendations of the WHO R&D Blueprint Clinical Trials Expert Group COVID-19 Therapeutic
Trial Synopsis, and associated Master Protocol.
The choice of the primary outcome measure will be determined by a pilot study of the first
150 subjects. Subject clinical status (on a 7-point ordinal scale) at day 15 in treatment
versus the control group is the default primary endpoint.
|
| NCT04384380 ↗ |
Efficacy and Tolerability of Hydroxychloroquine in Adult Patients With COVID-19 |
Completed |
N/A |
2020-04-01 |
The effective medical treatment against COVID-19 infection is still unknown. Chloroquine
phosphate is a well-known antimalarial drug which has been on the market for many years.
Recently, in vitro study shown that Chloroquine is effective at both entry and at post-entry
stages of the COVID-19 infection of Vero E6 cells with promising results. Chloroquine is also
an immune-modifier and could distribute to the whole body including lung. Also, chloroquine
is cheap and safe, and could be a promising agent against COVID-19 infection. However, only
hydroxychloroquine (HCQ) with the extra hydroxyl group is available in Taiwan. Therefore,
hydroxychloroquine instead become the best choice for the treatment candidate, since it shows
higher in vitro potency (EC50) against COVID-19 with lower toxicity while retaining the
original effect which compared with chloroquine.
|
| NCT04385043 ↗ |
Hyperimmune Plasma in Patients With COVID-19 Severe Infection |
Recruiting |
Phase 2/Phase 3 |
2020-05-01 |
Passive immunotherapy through plasma infusion of convalescent subjects - convalescent plasma
- or "hyperimmune" plasma was one of the most widespread and effective anti-infective
treatments in the pre-antibiotic era and one of the founding pillars of immunology, and has
also been used during the SARS (2002-2003) and Ebola (2014-2016) viral epidemy for which
there were no alternative immunoprophylactic or therapeutic interventions.
To date, there are not proven etiological therapies for SARS-CoV-2 infection, the agent
responsible for the disease called Covid-19. Among those subjected to clinical studies during
the current epidemic in China, hyperimmune plasma appears to be one of the most rational and
promising.
The objective of this study will be to evaluate the efficacy and safety of the hyperimmune
plasma administered add-on to the anti-Covid-19 treatment (standard therapy) according to
clinical practice in patients with severe Covid-19 infection, compared to patients with
severe Covid-19 infection treated only with standard therapy.
|
| NCT04386239 ↗ |
Study on the Use of Sarilumab in Patients With COVID-19 Infection |
Recruiting |
Early Phase 1 |
2021-01-01 |
Sarilumab is an anti-interleukin-6 human monoclonal antibody, such as tocilizumab, which is
administered subcutaneously every two weeks for the treatment of moderate to severe active
rheumatoid arthritis in adult patients. Despite the effectiveness reported for tocilizumab in
the recently published experiences, the need to rapidly find alternative therapies to manage
the complications of Covid-19 infection remains extremely high. The lack of clinical
experience on the usage of sarilumab in such patients prevents the possibility of adopting
early access programs for using commercially available sarilumab (prefilled syringe) packs in
patients with severe Covid-19 pneumonia. The present study is aimed to generate a rapid,
still robustly documented, evidence on the potential clinical efficacy and tolerability of a
further IL-6R antagonist in Covid-19 pneumonia.
|
| NCT04386447 ↗ |
Phase II RCT to Assess Efficacy of Intravenous Administration of Oxytocin in Patients Affected by COVID-19 |
Withdrawn |
Phase 2 |
2020-09-01 |
Introduction There are currently no treatments with demonstrated efficacy for COVID-19
infection. Epidemiological evidence points to the existence of intrinsic protection factors
which make young persons and women more resistant to the infection, whereas older patients
with multiple illnesses, above all with heart disease, are at greatest risk. This trial
proposes treatment initiated in the early stages of the disease, when clinical worsening is
most likely, with intravenous Oxytocin (OT), an endogenous hormone currently safely used in
clinical practice. The selection of this molecule is based on numerous experimental and
clinical observations, which show its activity in modulating resistance to pathogens, in
mitigating overall cardiovascular risk, and in acting on the production of Nitric Oxide (ON)
in the lungs, which is emerging as a key therapeutic factor for the improvement of
respiratory function in patients with SARS-COVID 19. Finally, OT is physiologically produced
by the human body, especially in the female sex and in the age ranges that coincide with most
resistant patients. In routine clinical practice, OT exhibits an excellent therapeutic index,
in absence of significant adverse effects.
Primary aim To assess the effects of Oxytocin in addition to standard therapy, with respect
to Standard of Care (SoC), in reducing the number of patients who enter a critical stage
Secondary aim
To describe:
- Mortality 28 days after randomization
- Time to mechanical ventilation during the study
- Duration of dependency on oxygen supply
- Length of stay
- Temporal trend of clinical improvement (7-category ordinal scale)
- Safety analysis
|
| NCT04386850 ↗ |
Oral 25-hydroxyvitamin D3 and COVID-19 |
Recruiting |
Phase 2/Phase 3 |
2020-04-14 |
The goal of this clinical trial is to investigate the therapeutic efficacy of rapidly
correcting vitamin D deficiency in adults with the use of 25-hydroxyvitamin D3 [25(OH)D3] for
reducing the risk of acquiring the SARS-CoV-2 (COVID-19) viral infection and mitigating
morbidity and mortality associated with this infection. This evidence-based hypothesis is
related to several observations. Macrophages, activated T and B lymphocytes have a vitamin D
receptor and 1,25-dihydroxyvitamin D3 induces defensin protein synthesis, influences
immunoglobulin production and modulates T-cell cytokine production and functions.
1,25-dihydroxyvitamin D3 also reduces the angiotensin-converting enzyme 2 (ACE2) that is
believed to serve as the binding site and gateway for COVID-19 to become infectious. This is
a multicenter randomized3 doubleblinded placebo-controlled study aimed at determining the
benefits of 25(OH)D3 treatment for the prevention of COVID-19 infection and improving
clinical outcomes in infected patients. The investigators plan to recruit 1500 subjects in 3
study groups that include hospital health providers, patients with a positive test for
COVID-19 and their relatives with a negative test. Eligible subjects in each study group with
a documented serum level of 25(OH)D < 20 ng/mL will be randomized. Recruited subjects will be
given 25 mcg of 25(OH)D3 daily or an identically appearing placebo at the time of
randomization for two months. Three hospitals will participate and the sample size is
foreseen to be equally distributed between the three. Since the clinical trial is designed as
minimal risk a formal committee for data monitoring is not foreseen. However, potential
toxicity will be monitored every 4 weeks with a serum calcium, albumin and creatinine by the
PI and the study coordinators. If the corrected serum calcium increases above 10.6 mg/dl and
a repeat confirms that the calcium is above 10.6 mg/dL the subject will be dropped from the
study and referred to his or her PCP. Early signs and symptoms of vitamin D toxicity
associated with hypercalcemia are increased thirst, increase in frequency of urination,
especially at night. The subjects will be followed up weekly by phone to ask about their sign
and symptoms.
|
| NCT04387240 ↗ |
Evaluating the Efficacy of Artesunate in Adults With Mild Symptoms of COVID-19 |
Not yet recruiting |
Phase 2 |
2022-01-01 |
Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered
coronavirus.
At this time, there are no specific vaccines or treatments for COVID-19. However, there are
many ongoing clinical trials evaluating potential treatments Drugs used to treat malaria
infection has shown to be beneficial for many other diseases, including viral infections.
In this Clinical trial, Investigators will evaluate the effect of Artemisinin / Artesunate on
morbidity of COVID-19 patients in decreasing the course of the disease and viral load in
symptomatic stable positive swab COVID-19 patients. Investigators are hypothesizing that due
to the antiviral properties of this drug it will help as a treatment for the COVID -19
patients. In improving their condition and clearing the virus load,
|
| NCT04387760 ↗ |
Favipiravir vs Hydroxychloroquine vs Control in COVID -19 |
Completed |
Phase 2 |
2020-08-11 |
Hydroxychloroquine is widely used to treat autoimmune diseases. Clinical investigation has
found that a high concentration of cytokines were detected in the plasma of critically ill
patients infected with SARS-CoV-2, therefore, hydroxychloroquine as anti-inflammatory agents
may reduce this response in accord with their use in autoimmune disease where the cytokine
response can be reduced.
Favipiravir is an antiviral drug developed in Japan that the data sheet notes that it is a
pyrazinecarboxamide derivative with activity against influenza viruses, west nile virus,
yellow fever virus, foot and mouth disease virus as well as against flaviviruses,
arenaviruses, bunyaviruses and alphaviruses. In February the drug was used for COVID-19
disease in China and was declared effective in treatment, and a report published (in press)
comparing Favipiravir with Lopinavir /ritonavir suggested that Favipiravir was superior for
prevention of disease progression and viral clearance.
The objective of this pilot study is to compare three arms: hydroxychloroquine; favipiravir;
standard care (no specific SARS-CoV-2 treatment) only, in symptomatic patients infected by
SARS-CoV-2 in an open label randomized clinical trial. The difference between groups will
allow an effect size to be determined for a definitive clinical trial.
|
| NCT04388683 ↗ |
Inhaled Nitric Oxide for Preventing Progression in COVID-19 |
Terminated |
Phase 2 |
2020-05-12 |
This is a pilot randomized-controlled (2:1) open label investigation of inhaled NO to prevent
progression to more advanced disease in 42 hospitalized patients with COVID-19, at risk for
worsening, based on baseline systemic oxygenation and 2 or more of the major risk factors of
age > 60 years, type II DM, hypertension, and obesity.
|
| NCT04389359 ↗ |
PROphylaxis for paTiEnts at Risk of COVID-19 infecTion |
Withdrawn |
Phase 2/Phase 3 |
2020-09-01 |
The PROTECT open-label randomised basket trial will assess the effectiveness of
hydroxychloroquine (HCQ) as chemoprophylaxis against COVID-19 in multiple vulnerable
populations in the United Kingdom.
|
| NCT04389411 ↗ |
The COvid-19 Symptom MOntelukast Trial |
Not yet recruiting |
Phase 3 |
2020-10-01 |
Due to the rapidly developing nature and severity of the COVID-19 pandemic, clinical trials
involving a repurposed drug approach are the best option for rapidly identifying an effective
COVID-19 therapeutic. The investigators propose to evaluate the efficacy of Montelukast in
attenuating cytokine storm syndrome and ARDS via a randomized, blinded, placebo-controlled
clinical trial. Specifically, our primary objective is comparing the efficacy of low-dose
Montelukast versus placebo in reducing the risk of acute care visits and hospital admissions
among COVID-19 positive patients in the general population.
|
| NCT04389671 ↗ |
The Safety and Preliminary Tolerability of Lyophilized Lucinactant in Adults With Coronavirus Disease 2019 (COVID-19) |
Recruiting |
Phase 2 |
2020-11-02 |
This is a multicenter, single-treatment study. Subjects will consist of adults with COVID-19
associated acute lung injury who are being cared for in a critical care environment.
|
| NCT04389710 ↗ |
Convalescent Plasma for the Treatment of COVID-19 |
Completed |
Phase 2 |
2020-04-15 |
This protocol provides access to investigational convalescent plasma for patients in acute
care facilities infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who
are judged by a healthcare provider to be at high risk of progression to severe or
life-threatening disease. Following provision of informed consent, patients will be
transfused with 1-2 units of ABO compatible convalescent plasma obtained from an individual
who has recovered from documented infection with SARS-CoV-2 (as detailed in separate
protocol). Safety information collected will include serious adverse events judged to be
related to administration of convalescent plasma. Other information to be collected will
include patient demographics, acute care facility resource utilization (total length of stay,
days in ICU, days intubated), and survival to discharge from acute care facility.
|
| NCT04389840 ↗ |
Dociparstat for the Treatment of Severe COVID-19 in Adults at High Risk of Respiratory Failure |
Terminated |
Phase 2/Phase 3 |
2020-06-03 |
A randomized, double-blind, placebo-controlled Phase 2/3 study to evaluate the safety and
efficacy of DSTAT in patients with Acute Lung Injury (ALI) due to COVID-19. This study is
designed to determine if DSTAT can accelerate recovery and prevent progression to mechanical
ventilation in patients severely affected by COVID-19.
|
| NCT04390152 ↗ |
Safety and Efficacy of Intravenous Wharton's Jelly Derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome Due to COVID 19 |
Recruiting |
Phase 1/Phase 2 |
2020-01-13 |
Recent COVID 19 pandemic has overwhelmed health services all around the world, and humanity
has yet to find a cure or a vaccine for the treatment of patients, mainly the severe ones,
who pose a therapeutic challenge to healthcare professionals given the paucity of information
we have regarding SARS-CoV-2 pathogenesis.
Recently, reports mainly from China from patients treated with mesenchymal stem cells have
shown promise in accelerating recovery, even in the critically ill and the therapy has
sustained an increase in research because of it's powerful immunomodulatory effects, making
it and interesting alternative in patients with lung and systemic inflammation.
These effects could help treat a lot of patients and improve their outcomes, reason why phase
I/II studies are needed to show their safety and experimental efficacy.
|
| NCT04390217 ↗ |
LB1148 for Pulmonary Dysfunction Associated With COVID-19 Pneumonia |
Not yet recruiting |
Phase 2 |
2021-10-31 |
This is a Phase 2, proof of concept, randomized, placebo-controlled, multicenter study to
evaluate the ability of LB1148 to attenuate pulmonary dysfunction associated with COVID-19
pneumonia. The primary objective of this study is to determine if enteral administration of
LB1148 will effect disease progression in hospitalized patients with moderate to severe
COVID-19 via measurement of the proportion of subjects alive and free of respiratory failure
at Day 28.
|
| NCT04390464 ↗ |
mulTi-Arm Therapeutic Study in Pre-ICu Patients Admitted With Covid-19 - Repurposed Drugs (TACTIC-R) |
Recruiting |
Phase 4 |
2020-05-08 |
TACTIC-R is a randomised, parallel arm, open-label platform trial for investigating potential
treatment for COVID-19 disease. While SARS-CoV infection evades detection by the immune
system in the first 24 hours of infection, it ultimately produces a massive immune system
response in the subgroup of people who develop severe complications. Most tissue damage
following infection with COVID19 appears to be due to a later, exaggerated, host immune
response. This leads to lung and sometimes multi-organ damage.
Most people who develop these severe complications still have virus present in their
respiratory tract at the time-point when the disease starts to evolve. Immune modulation in
the presence of active infection has potential to cause more harm than benefit. Safety
considerations when studying immune modulation strategies are paramount. Therefore, this
study proposes to assess the efficacy of immunomodulatory agents that target dysregulated
immune response that drive the severe lung, and other organ, damage. The medications
investigated for efficacy in this trial are Baricitinib and Ravulizumab.
|
| NCT04390594 ↗ |
Efficacy and Safety Evaluation of Treatment Regimens in Adult COVID-19 Patients in Senegal |
Recruiting |
Phase 3 |
2020-08-13 |
COVID-19 is an emerging pandemic disease affecting most countries including Senegal, caused
by the new coronavirus (SARS-CoV-2) which was first detected in the city of Wuhan in China in
December 2019. A rapid spread of the disease has occurred at a global scale, associated with
a mortality rate of 3.4%. The first case in Africa was declared on February 15, 2020 in Egypt
and the first case in Senegal was declared on March 2nd, 2020.
In this context, the SEN-CoV-Fadj clinical trial aims to evaluate efficacy and safety, among
adults, of different therapeutic regimens considered optimal according to current knowledge,
as well as available and adapted to Sub-Saharan Africa. This trial is nested into a cohort of
confirmed cases of COVID-19 in Senegal aiming to understand the main clinical, biological,
virologic and immunological characteristics of the infection. The protocol of the cohort is
based and adapted from the International Severe Acute Respiratory and Emerging Infection
Consortium (ISARIC) / World Health Organization (WHO) Clinical Characterisation Protocol
(CCP).
The Nafamostat mesilate, whose antiviral, anticoagulant an anti-inflammatory activities have
been shown, has been eligible for SEN-CoV-Fadj for the treatment of moderate to severe
COVID-19 cases.
|
| NCT04391101 ↗ |
Convalescent Plasma for the Treatment of Severe SARS-CoV-2 (COVID-19) |
Not yet recruiting |
Phase 3 |
2020-06-01 |
Convalescent plasma has been used for over 100 years in the treatment of severe acute
respiratory infections of viral origin. There are not pharmacological treatments for the
actual outbreak for SARS-Cov-2 and it is necessary to evaluate the efficacy of treatment
options, including convalescent plasma transfusion. The hypothesis is that convalescent
plasma is efficacious and safe for reducing mortality in patients with COVID-19 treated in
ICU
|
| NCT04391127 ↗ |
Hydroxychloroquine and Ivermectin for the Treatment of COVID-19 Infection |
Completed |
Phase 3 |
2020-05-04 |
Background: In December 2019, patients with pneumonia secondary to a new subtype of
Coronavirus (COVID-19) were identified in China. In a few weeks the virus spread and cases
started practically all over the world. In February 2020, the WHO declared a pandemic. Severe
symptoms have been found in patients mainly with comorbidities and over 50 years of age. At
this time there is no proven therapeutic alternative. In vitro studies and observational
experiences showed that antimalarial drugs (Chloroquine and hydroxychloroquine) had antiviral
activity and increased viral clearance. Ivermectin, on the other hand, has been shown in
vitro to reduce viral replication and in an observational cohort, greater viral clearance
with promising clinical results. So far there is no standard of treatment and clinical trials
are needed to find effective treatment alternatives. Objective: To evaluate the safety and
efficacy of treatment with hydroxychloroquine and ivermectin for serious COVID-19 infections
in no critical hospitalized patients. Material and methods: Randomized controlled trial of
patients diagnosed with respiratory infection by COVID-19, who present criteria for
hospitalization. Randomization will be performed to receive hydroxychloroquine at a dose of
400 mg every 12 hours for one day and then 200 mg every 12 hours, to complete a 5-day
treatment schedule. Group 2: Ivermectin 12 mg every 24 hours for one day (less than 80 kg) or
Ivermectin 18 mg every 24 hours for one day (greater than 80 kg) + placebo until the fifth
day. Group 3: Placebo. Prior to randomization, the risk of cardiovascular complications
determined by corrected QT interval, related to hydroxychloroquine intake will be assessed.
If the patient is at high risk, the allocation will be to ivermectin only or to placebo in an
independent randomization, if the risk is low, any of the three groups could be assigned.
Outcomes: The primary outcome will be discharge from hospital for improvement. The safety
outcomes will be requirement of mechanical intubation, septic shock or death. Viral clearance
will also be evaluated by means of PCR, which will be taken on the 5th day after admission,
day 14 and 21.
|
| NCT04392128 ↗ |
Study Evaluating the Efficacy of Hydroxychloroquine and Azithromycine in Patients With COVID-19 and Hematological Malignancies (HYACINTHE) |
Withdrawn |
Phase 2 |
2020-09-02 |
The primary objective of this phase 2, multicentric, placebo-controlled double-blind,
randomized study is to evaluate the efficacy of the combination of hydroxychloroquine and
azithromycine on the viral load drop at day 5 among patients with COVID-19 and hematological
malignancies.
|
| NCT04392427 ↗ |
New Antiviral Drugs for Treatment of COVID-19 |
Not yet recruiting |
Phase 3 |
2020-10-01 |
Background: In December 2019, SARS-CoV-2 was isolated on Vero E6 and Huh7 cell lines after an
outbreak of pneumonia of unknown origin in Wuhan, Hubei Province, China. Since the basis for
pathogenesis of this virus and its proliferation is unclear, there is still no definitive
treatment or vaccine against it. Thus, medications used against SARS-CoV-2 are mainly based
on their effectiveness on in vitro studies, virtual screenings and records of their effects
on earlier strains of coronavirus, SARS and MERS. Therefore, the immediate introduction of
potential COVID-19 treatments can be essential and salvaging. Aim: to compare the rate and
time of viral clearance in subjects receiving the combination of Nitazoxanide, Ribavirin and
Ivermectin vs. those control group (without any intervention). Methods: a sequential clinical
trial in this design sample size is not fixed in advance. Instead data will be evaluated as
they are collected, and further sampling is will be stopped in accordance with a pre-defined
stopping rule as soon as significant results are observed. After "n" (10 subjects in each
group) subjects in each group are available an interim analysis will be conducted. A
statistical test will be performed to compare the two groups and if the null hypothesis is
rejected the trial is terminated; otherwise, the trial continues, another n subjects per
group will be recruited, and the statistical test is performed again, including all subjects.
If the null is rejected, the trial is terminated, and otherwise it continues with periodic
evaluations until a maximum number of interim analyses have been performed, at which point
the last statistical test is conducted and the trial is discontinued [25]. Outcome: The
combination of Nitazoxanide, Ribavirin, Ivermectin and Zinc could be effective in clearance
of COVID 19.
KEY WOARD: COVID-19; clinical trial; corona virus
|
| NCT04392713 ↗ |
Efficacy of Ivermectin in COVID-19 |
Recruiting |
N/A |
2020-04-15 |
It is a randomized controlled trial to assess the efficacy of Ivermectin in COVID-19. Patient
recruited will be assigned to two groups one group will be given ivermectin with standard
chloroquine regimen and the other group will be receiving chloroquine only. Out come will be
recorded by documenting PCR reports at 48, 96 and 144 hours.
|
| NCT04393051 ↗ |
Baricitinib Compared to Standard Therapy in Patients With COVID-19 |
Not yet recruiting |
Phase 2 |
2020-05-20 |
There is urgent need of an effective therapy for Covid-19. To date, the best treatment of
SARS-CoV-2 infection is unknown. Baricitinib has been identified as potential treatment for
2019-nCoV acute respiratory disease, because of its immunomodulating and hypothesized
antiviral activity.
This is a multicenter randomized clinical trial that aims to evaluate the efficacy and safety
of baricitinib in patients with SARS-CoV2 pneumonia. Patients will be randomized to receive
or not baricitinib as adjunctive therapy. All patients will continue to receive the ongoing
standard therapy: chloroquine/idrossichloroquine and low-molecular weight heparin (LMWH)
eventually associated with ritonavir/lopinavir or darunavir/ritonavir will be allowed for all
included patients.
The primary endpoint measure is the efficacy of baricitinib in reducing the number of
patients requiring invasive ventilation after 7 and 14 days of treatment.
Secondary endpoints will be mortality rates and toxicity of baricitinib.
|
| NCT04393246 ↗ |
mulTi-Arm Therapeutic Study in Pre-ICu Patients Admitted With Covid-19 - Experimental Drugs and Mechanisms |
Recruiting |
Phase 2/Phase 3 |
2020-07-03 |
TACTIC-E is a randomised, parallel arm, open-label platform trial for investigating potential
treatments for COVID-19 disease. While SARS-CoV infection evades detection by the immune
system in the first 24 hours of infection, it ultimately produces a massive immune system
response in the subgroup of people who develop severe complications. Most tissue damage
following infection with COVID-19 appears to be due to a later, exaggerated, host immune
response (Gralinski and Baric 2015). This leads to lung and sometimes multi-organ damage.
Most people who develop these severe complications still have virus present in their
respiratory tract at the time-point when the disease starts to evolve. Immune modulation in
the presence of active infection has potential to cause more harm than benefit. Safety
considerations when studying immune modulation strategies are paramount. This study will
assess the efficacy of a novel immunomodulatory agent and a novel combination of approved
agents which may protect the patient against end-organ damage and modulate the pulmonary
vascular response. This study will compare the novel therapeutic agent EDP1815 and a novel
combination of the approved agents dapagliflozin and ambrisentan against Standard of Care.
|
| NCT04393792 ↗ |
SINUS WASH Pilot Study in Adults Testing Positive for COVID-19 |
Recruiting |
Phase 1 |
2020-05-05 |
COVID-19 is highly infectious and transmission of the virus is thought to be similar to that
of influenza which can be transferred through droplets released when a person coughs, sneezes
or talks. Studies have shown that nasal rinsing and mouth washes may be an important way to
deliver treatments that could reduce the amount of a virus that is present in the nose and
mouth. This also could mean that there is less virus available to pass on to others. We want
to see if the use of nose rinses and mouth washes using Povidone-Iodine will reduce the the
amount of virus in the nose and throat of people who have tested positive for COVID-19
disease and also reduce the spread of infection within their household.
|
| NCT04394208 ↗ |
Silymarin in COVID-19 Pneumonia |
Recruiting |
Phase 3 |
2020-08-16 |
A randomized placebo controlled trial to assess the clinical outcome in COVID-19 Pneumonia
following administration of Silymarin owing to its role as a p38 MAPK pathway inhibitor and
its antiviral, anti-inflammatory and anti-oxidant effects
|
| NCT04394377 ↗ |
Full Anticoagulation Versus Prophylaxis in COVID-19: COALIZAO ACTION Trial |
Completed |
Phase 4 |
2020-06-21 |
Pragmatic randomized clinical trial of patients admitted to the hospital with confirmed
COVID-19 infection and elevated D-Dimer.
Randomization 1:1 - Group 1 will undergo a routine full anticoagulation (oral or parenteral
when needed) strategy; and group 2 will receive usual standard of care with prophylactic
anticoagulation
|
| NCT04394416 ↗ |
Trial of Imatinib for Hospitalized Adults With COVID-19 |
Recruiting |
Phase 3 |
2020-06-02 |
This study is a randomized Double-Blind Placebo-Controlled Trial on the Safety and Efficacy
of Imatinib for Hospitalized Adults with COVID-19
|
| NCT04395768 ↗ |
International ALLIANCE Study of Therapies to Prevent Progression of COVID-19 |
Recruiting |
Phase 2 |
2020-09-09 |
COVID-19 is a global pandemic. So far encouraging results have been shown in different parts
of the world with the utilisation of hydroxycloroquine, zinc, and azithromycin, and early
studies into some of these, plus some with Vitamin C, have also proven beneficial. Vitamin D
levels have also been shown to be an important indicator to the severity of symptoms in
COVID-19 patients.
|
| NCT04396067 ↗ |
Aerosol Combination Therapy of All-trans Retinoic Acid and Isotretinoin as A Novel Treatment for Inducing Neutralizing Antibodies in COVID -19 Infected Patients Better Than Vaccine : An Innovative Treatment |
Not yet recruiting |
Phase 2 |
2020-10-01 |
Aerosol Combination therapy of All-trans retinoic acid and Isotretinoin as A novel Treatment
for Inducing Neutralizing Antibodies in COVID -19 Infected Patients better than vaccine : An
innovative Treatment
Mahmoud ELkazzaz(1),Tamer Haydara(2), Mohamed Abdelaal(3), Ahmed M. Kabel(4), Abedelaziz
Elsayed(5) ,Yousry Abo-amer(6) ,Hesham Attia(7)
1. Department of chemistry and biochemistry, Faculty of Science, Damietta University,Egypt.
2. Department of Internal Medicine,Faculty of Medicine, Kafrelsheikh University, Egypt
3. Department of Cardiothoracic Surgery,Faculty of Medicine, Kafrelsheikh University, Egypt
4. Department of Clinical Pharmacy, Faculty of Medicine , Tanta University,Egypt.
5. Department of Pharmaceutical Biotechnology, Faculty of Pharmacy,Tanta University,Egypt.
6. Hepatology,Gastroenterology and Infectious Diseases Department, Mahala Hepatology
Teaching Hospital,Egypt
7. Department of Immunology and Parasitology, Faculty of Science, Cairo University, Egypt.
- Study Chair ((( Dr.Tamer Hydara))), Department of Internal Medicine,Faculty of
Medicine, Kafrelsheikh University, Egypt Contact: Dr.Tamer Hydara-Tel:
00201142233340 Mail: tamerhydara@yahoo.com
- Principal Investigator ((( Mahmoud Elkazzaz))), Faculty of Science, Damietta
University,GOEIC,Egypt Contact:Tel: 00201090302015 Mail:
mahmoudramadan2051@yahoo.com
- Study coordinator ((Prof/Dr Mohamed Abdelaal)), Department of Cardiothoracic
Surgery,Faculty of Medicine, Kafrelsheikh University, Egypt Contact:Tel:
00201001422577 Mail: Malaal2@hotmail.com
Abstract
The pandemic of COVID-19 which is caused by severe acute respiratory syndrome coronavirus 2
(SARS-COV-2) has infected over 20,000,000 people causing over 700,000 deaths .It has no
currently approved treatments. In this clinical study we confirm that combination of
isotretinoin and All trans retinoic acid can be used in the treatment of SARS-COV-2 better
than vaccine according to the findings of previous studies and researches. Retenoic acid can
induce neutralizing antibodies in case of corona virus (COVID-19) by restoring inhebited and
exhausted T cells via inhebiting both CD13 and Angiotensin-converting enzyme-2 (ACE2). CD13
amyloid receptor which abundantly overexpressed on cell surface of lymphocyte, Dentritic
cell, Macrophage, granulocytes and monocytes and is ubiquitous in respiratory tract
epithelial cells, smooth muscle cells, fibroblasts, epithelial cells in the kidneys and small
intestine, activated endothelial cells, and platelets In addition inhibing of
Angiotensin-converting enzyme-2 (ACE2) , Angiotensin T1 protein and Angiotensin II-mediated
intracellular calcium release pathway which is responsible for COVID-19 cell fusion and
entry.ACE2-expressing cells are prone to SARS-CoV-2 infection as ACE2 receptor facilitates
cellular viral entry and replication. A study demonestrated that patients with hypertension
and diabetes mellitus may be at higher risk of SARS-CoV-2 infection, as these patients are
often treated with ACE inhibitors (ACEIs) or angiotensin II type-I receptor blockers (ARBs),
which have been previously suggested to increase ACE2 expression.Butisotretinoin was found to
be the strongest down-regulator of ACE 2 receptors.and this will give hope for diabetic
patients or patients with hypertension infected with COVID-19.Therefore we suggest that
Retinoic Acid will help in inhabiting factors which may enhance antibody dependent
enhancement (ADE), A phenomenon caused by covid-19 which expected to lead to failure of
vaccination specially in case of corona virus (covid-19) as a hyper mutatated COVID-19
antigens can lead to (ADE) phenomenon in which IgG antibodies facilitate viral entry and
fusion with infected cell through uptake of the virus-IgG complex via the Fc receptors and
later viral fusion with antigen presenting cells like Dentric cells, macrophages and B cells
via FcR , through the neonatal FcR instead of antibodies induced viral agglutination and this
is known as antibody dependent enhancement (ADE)(2) ADE can hamper vaccine development, as a
vaccine may cause the production of antibodies which, via ADE, worsen the disease the vaccine
is designed to protect against. ADE in COVID-19 infection can be caused by high mutation rate
of the gene that encodes spike (S) protein. In this clinical study we suggest that Hyper
mutated spike protein ,lymphopenia, and impaired dentreic cells all these factors can help in
and lead to delayed antibodies response and appearing after a period of covid -19 symptoms
onset and this may be responsible for antibody dependent enhancement (ADE)
Keywords: COVID 2019 , Retinoic acid, Lymphopenia ,T Cells, Dentric cells , ADE, Vaccine
|
| NCT04397328 ↗ |
COVID-19 PEP- High-risk Individuals in Long-term and Specialized Care - Canada |
Not yet recruiting |
Phase 3 |
2020-05-19 |
Older adults are at the highest risk of complications and severe illness for 2019-nCoV
infections. Hydroxychloroquine (HCQ), an emerging chemoprophylaxis, which holds clinical and
mechanistic plausibility, will help to reduce disease incidence and mitigate disease severity
across in-patient settings. This study is designed to assess the safety and efficacy of
post-exposure prophylaxis with hydroxychloroquine (HCQ) for the prevention of Coronavirus
Infectious Disease-19 (COVID-19) in high-risk older individuals in long-term and specialized
care.
|
| NCT04397497 ↗ |
Mavrilimumab in Severe COVID-19 Pneumonia and Hyper-inflammation (COMBAT-19) |
Not yet recruiting |
Phase 2 |
2020-05-22 |
This study is a prospective, phase II, multi-center, randomized, double-blind,
placebo-controlled trial to evaluate the efficacy and safety of mavrilimumab in hospitalized
patients with acute respiratory failure requiring oxygen supplementation in COVID- 19
pneumonia and a hyper-inflammatory status. The study will randomize patients to mavrilimumab
or placebo, in addition to standard of care per local practice. The total trial duration will
be 12 weeks after single mavrilimumab or placebo dose.
|
| NCT04397510 ↗ |
Nebulized Heparin for the Treatment of COVID-19 Induced Lung Injury |
Enrolling by invitation |
Phase 4 |
2020-06-01 |
Randomized, placebo controlled study to determine if nebulized heparin may reduce the
severity of lung injury caused by the novel coronavirus, also known as COVID-19
|
| NCT04397562 ↗ |
A Clinical Trial of the Efficacy and Safety of Levilimab (BCD-089) in Patients With Severe COVID-19 |
Completed |
Phase 3 |
2020-04-29 |
The objective: to study the efficacy and safety of levilimab in subjects with severe
COVID-19.
|
| NCT04398004 ↗ |
Anti-inflammatory Clarithromycin for Improving COVID-19 Infection Early |
Completed |
Phase 2 |
2020-05-06 |
Recent information appearing from different countries suggest that treatment of Coronavirus
disease 2019 (COVID-19) with hydroxychloroquine or with a combination of hydroxychloroquine
and azithromycin has either an indifferent effect on viral replication or substantial
cardiotoxicity. This is a clinical trial aiming to prove that addition of oral clarithromycin
to treatment regimen of COVID-19 is associated with early clinical improvement and
attenuation of the high inflammatory burden of the host. The study will not comprise a
placebo-comparator group since this is considered inappropriate in an era of a pandemic with
substantial global mortality.
|
| NCT04399356 ↗ |
Niclosamide for Mild to Moderate COVID-19 |
Completed |
Phase 2 |
2020-10-01 |
This study will evaluate the antihelmintic drug, Niclosamide, as a potential treatment for
mild to moderate coronavirus disease 2019 (COVID-19).
|
| NCT04399746 ↗ |
Ivermectin-Azithromycin-Cholecalciferol (IvAzCol) Combination Therapy for COVID-19 |
Recruiting |
N/A |
2020-03-15 |
As the world faces COVID-19, the search for effective treatments against the disease and its
complications has turned its gaze to drugs that are classically used in other infectious
diseases. Some drugs are being examined for the recent evidence on its effects on viral
replication and inflammation, one is Azithromycin, used to treat a wide variety of bacterial
infections, Ivermectin, an anti-parasitic drug and the other is Cholecalciferol to increase
serum concentration of 25-hydroxyvitamin D.
|
| NCT04399980 ↗ |
Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflammation |
Completed |
Phase 2 |
2020-05-20 |
The purpose of this prospective, Phase 2, multicenter, blinded, randomized placebo controlled
study is to demonstrate that early treatment with mavrilimumab prevents progression of
respiratory failure in patients with severe COVID-19 pneumonia and clinical and biological
features of hyper-inflammation.
|
| NCT04400799 ↗ |
Enoxaparin for Primary Thromboprophylaxis in Ambulatory Patients With COVID-19 |
Recruiting |
Phase 3 |
2020-06-15 |
The OVID study will show whether prophylactic-dose enoxaparin improves survival and reduces
unplanned hospitalizations in ambulatory patients aged 50 or older diagnosed with COVID-19, a
novel viral disease characterized by severe systemic, pulmonary, and vessel inflammation and
coagulation activation.
|
| NCT04400890 ↗ |
Randomized Proof-of-Concept Trial to Evaluate the Safety and Explore the Effectiveness of Resveratrol, a Plant Polyphenol, for COVID-19 |
Terminated |
Phase 2 |
2020-09-12 |
Resveratrol is a plant polyphenol (that is sold commercially as a supplement) that might help
fight coronavirus as well as help protect the body from the effects of disease (COVID-19)
caused by the infection. In this proof-of-concept pilot study we will compare the effects of
resveratrol to placebo to assess the safety of the resveratrol and explore effectiveness.
|
| NCT04400929 ↗ |
Using GM-CSF as a Host Directed Therapeutic Against COVID-19 |
Recruiting |
Phase 2 |
2020-06-02 |
The coronavirus disease 2019 (COVID-19) has rapidly become a pandemic. COVID-19 poses a
mortality risk of 3-7%, rising to 20% in older patients with co-morbidities. Of all infected
patients, 15-20% will develop severe respiratory symptoms necessitating hospital admission.
Around 5% of patients will require invasive mechanical ventilation, and up to 50% will die.
Evidence in severe COVID-19 suggests that these patients experience cytokine storm and
progressed rapidly with acute respiratory distress syndrome and eventual multi-organ failure.
Early identification and immediate treatment of hyperinflammation is thus recommended to
reduce mortality. Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) has been shown to
be a myelopoietic growth factor that has pleiotropic effects in promoting the differentiation
of immature precursors into polymorphonuclear neutrophils, monocytes/ macrophages and
dendritic cells, and also in controlling the function of fully mature myeloid cells. It plays
an important role in priming monocytes for production of proinflammatory cytokines under TLR
and NLR stimulation. It has a broad impact on the processes driving DC differentiation and
affects DC effector function at the mature state. Importantly, GM-CSF plays a critical role
in host defense and stimulating antiviral immunity. Detailed studies have also shown that
GM-CSF is necessary for the maturation of alveolar macrophages from foetal monocytes and the
maintenance of these cells in adulthood. The known toxicology, pharmacologic and safety data
also support the use of Leukine® in hypoxic respiratory failure and ARDS due to COVID-19.
This study aims to recruit patients with evidence of pneumonia and hypoxia who have increased
risk for severe disease and need for mechanical ventilation. The overall hypothesis is that
GM-CSF has antiviral immunity, can provide the stimulus to restore immune homeostasis in the
lung with acute lung injury from COVID-19, and can promote lung repair mechanisms, which
would lead to improvement in lung oxygenation parameters.
|
| NCT04401150 ↗ |
Lessening Organ Dysfunction With VITamin C - COVID-19 |
Recruiting |
Phase 3 |
2020-08-14 |
LOVIT-COVID is a multicentre concealed-allocation parallel-group blinded randomized
controlled trial to ascertain the effect of high-dose intravenous vitamin C compared to
placebo on mortality or persistent organ dysfunction at 28 days in hospitalized COVID-19
patients.
|
| NCT04401293 ↗ |
Full Dose Heparin Vs. Prophylactic Or Intermediate Dose Heparin in High Risk COVID-19 Patients |
Completed |
Phase 3 |
2020-04-26 |
The aim of this study is to test the hypothesis that prophylaxis of severe COVID-19 patients
with treatment dose LMWH leads to better thromboembolic-free outcomes and associated
complications during hospitalization than prophylaxis with institutional standard of care
with prophylactic to intermediate-doses of UFH or LMWH
|
| NCT04401423 ↗ |
TXA127 for the Treatment of Severe COVID-19 |
Completed |
Phase 2 |
2021-02-10 |
The purpose of this study is to determine if administration of angiotensin-(1-7) (TXA127)
prevents acute kidney injury and deterioration into multi-organ failure in patients with
severe COVID-19. Participants will undergo a 10-day treatment with either placebo or study
drug. The drug will be administered intravenously for 3 hours once each day for 10 days
consecutively.
|
| NCT04401527 ↗ |
Treatment of Lung Injury From COVID-19 Infection With Intravenous Sodium Nitrite |
Withdrawn |
Phase 2 |
2020-07-22 |
This multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate
the efficacy and safety of intravenous Sodium Nitrite Injection for treatment of patients
infected with COVID-19 who develop lung injury and require mechanical ventilation.
|
| NCT04402203 ↗ |
Study on Safety and Efficacy of Favipiravir (Favipira) for COVID-19 Patient in Selected Hospitals of Bangladesh |
Recruiting |
Phase 2/Phase 3 |
2020-05-01 |
A recent outbreak of coronavirus disease 2019 (COVID-19) caused by the novel coronavirus
designated as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) started in Wuhan,
China, at the end of 2019. The clinical characteristics of COVID-19 include respiratory
symptoms, fever, cough, dyspnea, and pneumonia. As of 25 February 2020, at least 77 785 cases
and 2666 deaths had been identified across China and in other countries; in particular, 977
and 861 cases were identified in South Korea and Japan, respectively. The outbreak has
already caused global alarm. On 30 January 2020, the World Health Organization (WHO) declared
that the outbreak of SARS-CoV-2 constituted a Public Health Emergency of International
Concern (PHEIC), and issued advice in the form of temporary recommendations under the
International Health Regulations (IHR).It has been revealed that SARS-CoV-2 has a genome
sequence that is 75%-80% identical to that of SARS-CoV, and has more similarities to several
bat coronaviruses. SARS-CoV-2 is the seventh reported human-infecting member of the family
Coronaviridae, which also includes SARS-CoV and the Middle East respiratory syndrome
(MERS)-CoV. It has been identified as the causative agent of COVID-19. Both the clinical and
the epidemiological features of COVID-19 patients demonstrate that SARS-CoV-2 infection can
lead to intensive care unit (ICU) admission and high mortality. About 16%-21% of people with
the virus in China have become severely ill, with a 2%-3% mortality rate. However, there is
no specific treatment against the new virus.
Therefore, it is urgently necessary to identify effective antiviral agents to combat the
disease and explore the clinical effect of antiviral drugs. One efficient approach to
discover effective drugs is to test whether the existing antiviral drugs are effective in
treating other related viral infections. Several drugs, such as ribavirin, interferon (IFN),
Favipiravir (FPV), and Lopinavir (LPV)/ritonavir (RTV), have been used in patients with SARS
or MERS, although the efficacy of some drugs remains controversial. It has recently been
demonstrated that, as a prodrug, Favipiravir (half maximal effective concentration (EC50) =
61.88 μmol·L-1, half-maximal cytotoxic concentration (CC50) > 400 μmol·L-1, selectivity index
(SI) > 6.46) effectively inhibits the SARS-CoV-2 infection in Vero E6 cells (ATCC-1586).
Furthermore, other reports show that FPV is effective in protecting mice against Ebola virus
challenge, although its EC50 value in Vero E6 cells was as high as 67 μmol·L-1. Therefore,
clinical studies are urgently needed to evaluate the efficacy and safety of this antiviral
nucleoside for COVID-19 treatment. After enrollment of the patients (day 1) depending on
inclusion and exclusion criteria and laboratory findings confirming the presence of the
COVID-19 virus, 25 patients will receive Favipiravir plus standard treatment and the second
group of 25 patients will receive standard treatment only. The comparison of the findings of
the follow up studies on days 4, 7, and 10 in terms of clinical manifestations, chest X-ray
and laboratory findings, such as Real Time Polymerase Chain Reaction (RT-PCR) results for
viral presence will determine whether Favipiravir has safety and efficacy against COVID-19
infections.
All ethical issues related to this trial including right of the participants to withdraw from
the study should be maintained according to of guidelines of International Conference on
Harmonisation (ICH)-Good Clinical Practice (GCP).
|
| NCT04403100 ↗ |
Hydroxychloroquine and Lopinavir/ Ritonavir to Improve the Health of People With COVID-19: "The Hope Coalition - 1" |
Recruiting |
Phase 3 |
2020-06-03 |
The COVID-19 pandemic has been characterized by high morbidity and mortality, especially in
certain subgroups of patients. To date, no treatment has been shown to be effective in
controlling this disease in hospitalized patients with moderate and / or severe cases of this
disease. Hydroxychloroquine and lopinavir / ritonavir have been shown to inhibit SARS-CoV
viral replication in experimental severe acute respiratory symptoms models and have similar
activity against SARS-CoV2. Although widely used in studies of critically ill patients, to
date, no study has demonstrated its role on the treatment of high-risk, newly diagnosed
patients with COVID-19 and mild symptoms.
|
| NCT04403555 ↗ |
Ivermectin as a Novel Therapy in COVID-19 Treatment |
Completed |
Phase 2/Phase 3 |
2020-06-01 |
Efficacy of Ivermectin in COVID-19 treatment
|
| NCT04403685 ↗ |
Safety and Efficacy of Tocilizumab in Moderate to Severe COVID-19 With Inflammatory Markers |
Terminated |
Phase 3 |
2020-05-08 |
The trial evaluates the efficacy and safety of Tocilizumab, which rapidly reduces the
inflammation process through inhibition of IL-6 in patients with moderate to severe COVID-19
with increased inflammatory markers. There will be two arms in the trial, one receiving the
best supportive care, and the other receiving it plus tocilizumab. Patients will be followed
until Day 29 after randomization.
|
| NCT04404361 ↗ |
PRE-VENT Study in Hospitalized Patients With Severe COVID-19 With or Without Cancer |
Terminated |
Phase 3 |
2020-05-22 |
This is a Phase 3 randomized, double-blind, placebo-controlled, multicenter study to evaluate
the efficacy and safety of pacritinib in hospitalized patients with severe COVID-19 with or
without cancer.
|
| NCT04405271 ↗ |
TAF/FTC for Pre-exposure Prophylaxis of COVID-19 in Healthcare Workers (CoviPrep Study) |
Not yet recruiting |
Phase 3 |
2020-07-31 |
A randomized parallel double-blinded placebo-controlled clinical trial to evaluate the effect
of Emtricitabine/Tenofovir alafenamide (FTC/TAF) compared with placebo on the risk of
developing SARS-CoV-2 disease (COVID-19) in healthcare workers with high transmission risk in
addition to currently recommended control measures.
|
| NCT04405570 ↗ |
A Safety, Tolerability and Efficacy of Molnupiravir (EIDD-2801) to Eliminate Infectious Virus Detection in Persons With COVID-19 |
Completed |
Phase 2 |
2020-06-16 |
This is a phase IIa, double-blind, placebo-controlled, randomized trial, designed to compare
the safety, tolerability, and antiviral activity of EIDD-2801 versus placebo as measured by
infectious virus detection in symptomatic adult outpatients with COVID-19
|
| NCT04405739 ↗ |
The Safety of Molnupiravir (EIDD-2801) and Its Effect on Viral Shedding of SARS-CoV-2 (END-COVID) |
Recruiting |
Phase 2 |
2020-06-16 |
Designed as a multi-center, randomized, double-blind, placebo-controlled study to assess the
efficacy and safety of EIDD-2801 on SARS-CoV-2 Virus Shedding in Newly Hospitalized Adults
with polymerase chain reaction (PCR)-Confirmed COVID-19.
|
| NCT04405921 ↗ |
Hydroxychloroquine, Azithromycin in the Treatment of Covid-19 |
Not yet recruiting |
Phase 3 |
2020-07-01 |
This study investigates the efficay and tolerance of 5-days course of hydroxychloroquine or
hydroxychloroquine and azithromycin of patients with COVID-19 infection. The investigators
will undertake a randomized, double-blind, controlled Trial in the region of Sousse Tunisia
|
| NCT04405999 ↗ |
Prevention of Infection and Incidence of COVID-19 in Medical Personnel Assisting Patients With New Coronavirus Disease |
Completed |
Phase 4 |
2020-05-14 |
This is a randomized controlled trial of the efficacy and safety evaluation of oral
administration of Bromhexine hydrochloride for the prevention of SARS-CoV-2 infection and
COVID-19 disease in medical personnel assisting patients with a new coronavirus disease
|
| NCT04406246 ↗ |
Prevention of Coronavirus Disease (COVID-19) Outbreaks With Nitazoxanide |
Completed |
Phase 4 |
2020-05-21 |
The new coronavirus outbreak has led to a public health emergency of international concern,
putting all health organizations on high alert. As part of the hygienic measures, isolation
and reinforcement cleaning strategies have been followed. It is known that special attention
and efforts should be applied to protect or reduce transmission in susceptible populations,
including the elderly or those with comorbidities.It has also been proposed a semaforization
to classify patients with respiratory symptoms based on: Fever (38ºC or more), dry cough,
headache, dyspnea, joint pain, muscle pain, sore throat, nose discharge, conjunctivitis,
chest pain, diarrhea, anosmia, ageusia.
Nitazoxanide has shown to be effective against several viruses, of both types RNA and DNA,
including other coronavirus that produced the Severe Acute Respiratory Syndrome (SARS) and
the Middle East Respiratory Syndrome (MERS).
Facing the lack of options against COVID-19 outbreaks for example in health workers,
nitazoxanide could contribute to decrease the contagious dissemination of SARS-CoV-2, thus
reducing at the same time the Hospital saturation of patients positive to this virus.
|
| NCT04407130 ↗ |
Efficacy and Safety of Ivermectin and Doxycycline in Combination or IVE Alone in Patients With COVID-19 Infection. |
Completed |
Phase 2 |
2020-06-16 |
Burden:
Initial outbreak of corona virus disease 2019 (COVID-19) was reported from Wuhan, China in
early December 2019.Presently known to be caused by a novel beta-corona virus, named as
Severe acute respiratory syndrome corona virus 2 ( SARS-CoV-2).
World Health Organization (WHO) declared a pandemic on March.
The clinical characteristics of COVID-19 include respiratory symptoms, fever, cough, dyspnoea
and pneumonia
Infected individuals exhibit:
1. Mostly mild illness (80% +) recover without any treatment (~80%)
2. Moderate illness that needs hospitalization and recovers after standard
3. supportive treatment (~14%)
4. Critical illness (~5%) needs ICU support
5. Death (1-2% )
COVID-19 has now spread >210 countries and territories globally. SARS-CoV-2 is a respiratory
virus which spreads primarily through droplets generalized when an infected person coughs or
sneezes or through droplets of saliva or discharge from the nose.
Symptomatic management remains the mainstay of treatment strategy. Mortality appears to be
more common in older individuals and those with co-morbidities, such as chronic lung disease,
cardiovascular disease and diabetes. Young people with no comorbidities also appear to be at
risk for critical illness including multi-organ failure and death. Seen more in Bangladesh
between 21-40 yrs of age.
Knowledge Gap:
There is no specific treatment against this new virus that WHO has officially declared until
now.There are many pharmacologic therapies that are being used or considered for treatment of
COVID-19. National Guidelines on Clinical Management of Corona virus Disease 2019 (Covid-19):
V 5.0 date 9th April 2020) CDC, DGHS, GoB
Thus an RCT is urgently needed in Bangladesh: Based on recent literatures on Rx studies in
COVID-19 patients from other countries as well as its availability & affordability of those
repurposed medicines
|
| NCT04408456 ↗ |
Efficacy of Hydroxychloroquine (HCQ) as Post Exposure Prophylaxis (PEP) for Prevention of COVID-19 |
Completed |
Phase 3 |
2020-03-01 |
Novel corona virus (SARS-CoV-2) epidemic which stared from Wuhan in China is now a well
established pandemic worldwide. After Italy, Spain, Germany, United Kingdom and USA, India is
at the edge of becoming the next epicentre of this Pandemic. If adequate preventive and
therapeutic measures are not taken, India has very high risk of affecting million of people
with high mortality because of the large population along with very high population density.
At present there are no definitive therapeutic drugs or vaccine are available for the
treatment and prevention of SARS-CoV-2 infection. Symptomatic and supportive care are being
given to COVID-19 cases along with isolation and quarantine measure are being taken for the
suspected individual at risk for COVID-19 to limit the spread of the SARS-CoV-2 infection .
Among the all the drugs being used for the treatment of COVID-19, hydroxychloroquine (HCQ),
has given some rays of hope to battle against this deadly pandemic. HCQ has some anti viral
effect against SARS-CoV in vitro. HCQ is quite safe and being used in rheumatology patients
for lifelong without much side effect, so it allow for higher dose without any significant
side effects and drug-drug interaction. Recently published clinical trial suggested HCQ can
be used for the therapeutic purpose of the SARS-CoV-2 infection. Indian council of medical
research (ICMR) has advised for HCQ prophylaxis for all asymptomatic health care workers
involved in taking care of suspected or confirmed COVID-19 cases and all asymptomatic
household contacts of labarotory confirmed COVID-19 cases. But there is still lack of
significant scientific data to prove or disprove the efficacy of HCQ for the treatment and
post exposure chemo-prophylaxis for SARS-CoV-2 infection. Being a tertiary care centre we are
catering many states which include Punjab, hariyana, himachal Pradesh, Uttara khand, Uttar
Pradesh. Among this Punjab have highest population of non residential Indian (NRI) and most
of them have returned home. This put our institute to handle highest burden of suspected
cases of SARS-CoV-2 in northern India. So we have planned this open level control clinical
trial to evaluate the efficacy of post exposure prophylaxis (PEP) with HCQ for the prevention
of COVID-19 in asymptomatic individuals who are at risk for SARS-CoV-2 infection. All
asymptomatic individuals who have undertaken international travel in last 2 weeks and all
asymptomatic individual with direct contact with laboratory confirmed cases will be advised
for home quarantine for 2 weeks along with social distancing and personal hygiene. They will
be given the option for taking HCQ prophylaxis. These quarantined asymptomatic individuals
will be assigned into one post exposure prophylaxis (PEP) group and one control group as per
inclusion and exclusion criteria. Individual who will not give consent for HCQ prophylaxis
and those with contraindication for HCQ therapy like, hypersensitivity to HCQ or
4-aminoquinolone derivatives, patients with known retionopathy, cardiac arrhythmia, G6PD
deficiency, psoriasis and pregnancy will be directly included in the control group. All
symptomatic individual, and all health care workers related to suspected or proven COVID-19
will be excluded from the study. The PEP group will receive tablet HCQ 400 mg q 12 hourly on
day one followed by 400 mg once weekly for 3 weeks (total cumulative dose of 2000 mg). The
control group will not receive HCQ. Both the groups will receive standard care of therapy in
the form of home quarantine for 2 weeks along with social distancing and personal hygiene.
They will be followed up for 4 weeks telephonically or physically as and when required and
will be enquired regarding development of any COVID-19 symptoms like fever, cough, sore
throat, shortness of breath, diarrhoea, myalgia.During follow up nasopharyngeal and or throat
swab of the participants will be taken for processing reverse transcription polymerase chain
reaction (RTPCR) for the detection SARS-Cov-2 RNA to confirm CoVID-19. Samples for RTPCR will
be taken when any asymptomatic participants become symptomatic and by the 5-14 days of
contact in asymptomatic participants through in-hospital visit at the institute's
communicable disease ward isolation. The participant with RTPCR positive and with or without
symptoms will be defined as definite COVID-19 case and the RTPCR negative symptomatic
participant will be defined as probable COVID-19 case. Asymptomatic participants with
negative RTPCR will be defined as non-COVID case. Incidence of COVID-19 or probable COVID-19
or non-COVID case in previously asymptomatic participants will be compared between the PEP
and control groups.
|
| NCT04409327 ↗ |
Phase 2 Study to Determine if RTB101 Reduces the Severity of COVID-19 in Older Adults Residing in Nursing Homes |
Terminated |
Phase 2 |
2020-07-11 |
The purpose of this study is to determine if prophylaxis with RTB101 decreases the severity
of laboratory-confirmed COVID-19 among adults ≥ 65 years who reside in a nursing homes in
which one or more residents or staff have laboratory-confirmed COVID-19
|
| NCT04409873 ↗ |
Antiseptic Mouthwash / Pre-Procedural Rinse on SARS-CoV-2 Load (COVID-19) |
Recruiting |
Phase 2 |
2021-03-31 |
In this pilot trial, 150 confirmed COVID-19 individuals will be randomly assigned to 1 of 5
groups: distilled water, CloSYS Ultra Sensitive Rinse (Rowpar Pharmaceutical Inc., USA),
Oral-B Mouth Sore (Oral-B, USA), Crest Pro-Health Multi-Protection (Crest, USA), or Listerine
Zero (Johnson and Johnson, USA).
Study participants will be asked to rinse/gargle with 10-20ml (according to the rinse
instructions) of the assigned solutions 4 times per day, for 30-60 seconds, for 4 weeks.
|
| NCT04409925 ↗ |
DISmantling COvid iNduced Neutrophil ExtraCellular Traps (DISCONNECT-1) |
Recruiting |
Phase 1 |
2020-12-25 |
This is a pilot study to investigate the safety and feasibility of rhDNase1 and its impact on
neutrophil extracellular traps (NETs) in COVID-19 infected patients.
|
| NCT04410328 ↗ |
Aggrenox To Treat Acute Covid-19 |
Recruiting |
Phase 3 |
2020-10-21 |
The purpose of this study is to explore the efficacy of Aggrenox in patients with SARS-CoV-2
infection with symptoms consistent with COVID-19. An anticipated total of 132 participants
will be randomly divided almost equally into 2 groups: one group will receive Dipyridamole ER
200mg/ Aspirin 25mg orally/enterally along with the standard of care and the other group with
receive the standard of care only but no Dipyridamole ER 200mg/ Aspirin 25mg. Participants
will be screened, enrolled, receive treatment, and followed for 28 days. The clinical and
laboratory outcomes of all the participants enrolled in the study will be evaluated at the
end of the study to explore if there is any difference in the outcomes between 2 groups.
|
| NCT04410354 ↗ |
Study of Merimepodib in Combination With Remdesivir in Adult Patients With Advanced COVID-19 |
Terminated |
Phase 2 |
2020-06-16 |
The purpose of this study is to assess the safety and efficacy of merimepodib (MMPD) oral
solution when administered in combination with remdesivir in adult patients with advanced
COVID-19.
|
| NCT04410510 ↗ |
P2Et Extract in the Symptomatic Treatment of Subjects With COVID-19 |
Recruiting |
Phase 2/Phase 3 |
2020-09-30 |
Antioxidants, and particularly polyphenols, have shown protection in respiratory pathologies,
which is related to the decrease in the severity of the clinical picture and suppression of
inflammation. This suppression of inflammation may be related to the inhibition of NF-kB
polyphenols, where its activation is related to the stimulation of 150 stimuli including
cytokines (IL-1β, IL-6, THF-α, GM-CSF, MCP-1), TLRs, among others. There may be other
additional mechanisms that can help control virus-induced respiratory pathologies, among
which are the regulation of reactive oxygen species (ROS) associated with tissue destruction
caused by the virus and a selective antiviral action can be reported. direct.
The standardized P2Et extract obtained from C. spinosa, by the Immunobiology Group of the
Pontificia Universidad Javeriana, is highly antioxidant, decreases lipid peroxidation and
tissue damage and induces complete autophagy in stressed or tumor cells. The induction of a
full autophagic flow could inhibit the replication of beta-coronaviruses like SARS-CoV-2.
Furthermore, P2Et can decrease the factors involved in tissue damage by reducing IL-6 and
decrease ILC2 cells of the lung in animals with lung metastases (unpublished data).
These antecedents suggest that the supplementation of patients with COVID-19 with the extract
P2Et, could improve their general condition and decrease the inflammatory mediators and the
viral load.
|
| NCT04411433 ↗ |
Efficacy and Safety of Hydroxychloroquine and Favipiravir in the Treatment of Mild to Moderate COVID-19 |
Active, not recruiting |
Phase 3 |
2020-05-08 |
This is an open-label, multicenter, parallel-group, randomized, phase III trial that
evaluates the efficacy and safety of hydroxychloroquine and favipiravir in the treatment of
patients with possible or confirmed COVID-19 observed within the last 5 days. 1000 patients
will be randomized in 2:1:2:2:2:1 ratio and divided into six groups.
|
| NCT04411602 ↗ |
Intermediate IND Severe Illness COVID-19 CP |
Withdrawn |
Phase 1 |
2020-04-07 |
Beyond supportive care, there are currently no proven therapeutic options for pneumonia due
to coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome
Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19
and will be available when sufficient numbers of people have recovered. Such persons should
have high titer neutralizing immunoglobulin-containing plasma.
|
| NCT04411667 ↗ |
Study of SOC Plus IVIG Compared to SOC Alone in the Treatment of COVID-19 |
Completed |
Phase 4 |
2020-04-28 |
The purpose of this research is to see if Intravenous Immunoglobulin (IVIG) can help reduce
respiratory complications (respiratory failure and need for a ventilator) caused by
coronavirus disease 2019 (COVID-19). The principal investigator has successfully utilized
IVIG for patients infected with the influenza virus. The investigator wants to find out if
IVIG is equally effective in COVID-19 infection patients, and if IVIG will give the immune
system some help to clear the infection naturally.
|
| NCT04411680 ↗ |
Study of Sargramostim in Patients With COVID-19 |
Completed |
Phase 2 |
2020-08-18 |
The purpose of this research is to find out if a drug (sargramostim) also known as Leukine®
could help patient recover faster from COVID-19. Sargramostim may help the lungs recover from
the effects of COVID-19, and this research study will help to find this out.
|
| NCT04412395 ↗ |
Clinical Assessment of Oral Lactoferrin as a Safe Antiviral and Immunoregulatory in Treating COVID-19 Disease |
Not yet recruiting |
Phase 2 |
2021-10-01 |
The aim of the study is to clinically use bovine Lf as a safe antiviral adjuvant for
treatment and to assess the potential in reducing mortality and morbidity rates in COVID-19
patients. The study was approved by the ethical committee of the Egyptian Center for Research
and Regenerative Medicine in 11-5-2020.
|
| NCT04414098 ↗ |
Ruxolitinib in the Treatment of Covid-19 |
Not yet recruiting |
Phase 2 |
2020-06-01 |
The treatment of COVID-19 severe acute respiratory syndrome with ruxolitinib 5 mg orally
every 12 hours during 14 days would stop the disproportionate inflammatory response, causing
a reduction in the proportion of patients who show a progression and worsening of the severe
acute respiratory syndrome.
|
| NCT04415060 ↗ |
SedAting With Volatile Anesthetics Critically Ill COVID-19 Patients in ICU: Effects On Ventilatory Parameters And Survival |
Recruiting |
Phase 3 |
2020-06-15 |
Patients suffering lung failure, possibly from COVID-19 or hypoxic lung failure, will need
life-saving support from a breathing machine. Any patient needing this support requires drugs
to keep them sleepy, or "sedated" to be comfortable on this machine. Sedation is made
possible by using drugs given through a vein. Unfortunately, these drugs are in short supply
worldwide due to the high number of COVID-19 patients needing these machines.
Another way to provide sleep is by using gases that are breathed in. These are used every day
in operating rooms to perform surgery. These gases, also called "inhaled agents" can also be
used in intensive care units and may have several important benefits for patients and the
hospital. Research shows they may reduce swelling in the lung and increase oxygen levels,
which allows patients to recover faster and reduce the time spent on a breathing machine. In
turn, this allows the breathing machine to be used again for the next sick patient. These
drugs may also increase the number of patients who live through their illness. Inhaled agents
are widely available and their use could dramatically lesson the pressure on limited drug
supplies.
This research is a study being carried out in a number of hospitals that will compare how
well patients recover from these illnesses depending on which type of sedation drug they
receive. The plan is to evaluate the number who survive, their time spent on a breathing
machine and time in the hospital. This study may show immediate benefits and may provide a
cost effective and practical solution to the current challenges caring for patients and the
hospital space, equipment and drugs to the greatest benefit. Finally, this trial will be a
team of experts in sedation drugs who care for patients with proven or suspected COVID-19 who
need lifesaving treatments.
|
| NCT04415073 ↗ |
A Phase 2 Study to Evaluate Axatilimab for Hospitalized Patients With Respiratory Involvement Secondary to COVID-19 |
Suspended |
Phase 2 |
2020-05-30 |
This is a randomized, double-blind, placebo-controlled, 29-day study to assess the efficacy
and safety of axatilimab plus standard of care, compared with placebo plus standard of care,
in patients with respiratory signs and symptoms secondary to novel coronavirus disease
(COVID-19).
|
| NCT04417257 ↗ |
Study of LAU-7b for the Treatment of COVID-19 Disease in Adults |
Completed |
Phase 2 |
2020-06-29 |
A randomized, double-blind, placebo-controlled Phase 2 Study of LAU-7b against confirmed
COVID-19 Disease in hospitalized patients at a higher risk of complications.
|
| NCT04418128 ↗ |
Clinical Efficacy of Nafamostat Mesylate for COVID-19 Pneumonia |
Not yet recruiting |
Phase 2/Phase 3 |
2020-06-10 |
In-vitro studies revealed that nafamostat mesylate has antiviral activity against Severe
acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and anti-inflammatory and
anti-coagulation effect. However, there is no clinical studies on the efficacy of nafamostat
in patients with COVID-19.
This study is conducted to evaluate the clinical efficacy of nafamostate mesylate in adult
patients hospitalized with COVID-19 pneumonia.
|
| NCT04420741 ↗ |
Infusion of Prostacyclin (Iloprost) vs Placebo for 72-hours in COVID-19 Patients With Respiratory Failure |
Completed |
Phase 2 |
2020-06-15 |
The purpose of this trial is to investigate the efficacy and safety of continuous intravenous
administration of low dose iloprost versus placebo for 72-hours, in 80 patients with COVID-19
suffering from respiratory failure. The study hypothesis is that iloprost may be beneficial
as an endothelial rescue treatment as it is anticipated to deactivate the endothelium and
restore vascular integrity in COVID-19 patients suffering from respiratory failure caused by
endothelial breakdown, ultimately improving survival. Given that the pulmonary system, apart
from the brain, is the most highly vascularized vital organ in the body, extensive
endothelial damage is a central feature of acute respiratory distress syndrome (ARDS) with
respiratory failure being the rationale for the current study COMBAT-COVID-19.
|
| NCT04421534 ↗ |
Utility of Lactoferrin as an Adjunct Therapeutic Agent for COVID-19 |
Not yet recruiting |
Phase 2/Phase 3 |
2020-06-01 |
There is currently no clinically proven specific antiviral agent available for SARS-CoV-2
infection. Supportive treatment, including oxygen therapy, remains the most important
management strategy.
Since its discovery, lactoferrin and its related peptides are mainly considered to be
important non-specific host defense molecules against a broad range of viruses including
SARS-CoV, which is closely related to SARS-CoV-2 that causes COVID-19. Lactoferrin has been
found to experimentally inhibit viral entry in murine coronavirus, and human coronaviruses
hCOV-NL63 and pseudotyped SARS-CoV. Besides reducing viral entry, lactoferrin can also
suppress virus replication after the viral entry.
Another major aspect of lactoferrin bioactivity relates to its immunomodulatory and
anti-inflammatory functions. Current thinking suggests that mortality from COVID-19 is not
simply due to viral infection but is a result of a cytokine storm associated with
hyper-inflammation leading to acute respiratory distress and subsequent mortality. A cytokine
profile in severe COVID-19 cases is characterized by increases in cytokines and acute phase
reactants and ferritin. In this regard, lactoferrin was demonstrated to reduce IL-6, TNF a,
and downregulate ferritin in experimental settings simulating sepsis.
In this study, we aim to study the potential application of lactoferrin against SARS-CoV-2
and propose the possibility of using different doses of supplemental lactoferrin as a
potential adjunct treatment for COVID-19.
|
| NCT04421664 ↗ |
Preemptive Therapy for SARS-Coronavirus-2 (COVID-19 PEP Canada) |
Terminated |
Phase 3 |
2020-03-25 |
Study Objective:
To test if early preemptive hydroxychloroquine therapy can prevent disease progression in
persons with known symptomatic COVID-19 disease, decreasing hospitalizations and symptom
severity.
|
| NCT04423861 ↗ |
Efficacy and Safety of Nitazoxanide 600 mg BID Versus Placebo for the Treatment of Hospitalized Patients With COVID-19 |
Not yet recruiting |
Phase 3 |
2020-12-01 |
This is a pivotal phase III study to evaluate the efficacy of nitazoxanide 600 mg BID
compared to placebo to treat hospitalized patients with non-critical COVID-19.
|
| NCT04425031 ↗ |
Handling Oxygenation Targets in COVID-19 |
Recruiting |
Phase 4 |
2020-08-25 |
Patients with COVID-19 and hypoxaemic respiratory failure and admitted to the intensive care
unit (ICU) are treated with supplementary oxygen as a standard. However, quality of quantity
evidence regarding this practise is low. The aim of the HOT-COVID trial is to evaluate the
benefits and harms of two targets of partial pressure of oxygen in arterial blood (PaO2) in
guiding the oxygen therapy in acutely ill adult COVID-19 patients with hypoxaemic respiratory
failure at ICU admission.
|
| NCT04425538 ↗ |
A Phase 2 Trial of Infliximab in Coronavirus Disease 2019 (COVID-19). |
Completed |
Phase 2 |
2020-06-01 |
The investigators hypothesize that early institution of TNFα inhibitor therapy in patients
with severe COVID-19 infections will prevent further clinical deterioration and reduce the
need for advanced cardiorespiratory support and early mortality. To address this hypothesis,
a prospective, single center, phase 2 trial is proposed to assess the efficacy of infliximab
or infliximab-abda in hospitalized adult patients with severe or critical COVID-19.
Observations from this study will inform the conduct of prospective randomized controlled
studies to follow.
|
| NCT04425707 ↗ |
Ivermectin In Treatment of COVID 19 Patients |
Recruiting |
N/A |
2020-06-09 |
as Egypt suffered a lot during the pandemic of COVID 19 with limited drug choices, many of
the patients could not acheive viral clearence with the standard module of care teh idea of
introduction of new medications in the treatment protocol of COVID 19 managment. Ivermectin
had shown a promising results in vitro studies and in limited in vivo studies. this clinical
trial may open a new hope for COVID 19 patients as a new and cheap line of treatment
|
| NCT04427098 ↗ |
Enoxaparin in COVID-19 Moderate to Severe Hospitalized Patients |
Recruiting |
Phase 2 |
2020-05-22 |
General objective of the study To assess the efficacy and safety of enoxaparin in
hospitalized patients with moderate to severe COVID-19 (Coronavirus Disease 2019) infection.
Study Design
The study consists of two parts:
- a phase II single-arm interventional prospective study including all patients treated
with the study drug;
- an observational prospective cohort study including all patients screened for receiving
the study drug but not included in the phase II study.
Patients will be enrolled from "date of study approval" for 1 month. Each patient will be
followed-up for a minimum of 90 days after COVID19 diagnosis.
|
| NCT04427865 ↗ |
Utility of Lactoferrin as a Preventive Agent for Healthcare Workers Exposed to COVID-19 |
Not yet recruiting |
Phase 2/Phase 3 |
2020-07-01 |
COVID 19, which probably started from zoonotic transmission related to crowded markets in
China was announced as a pandemic by the WHO on 11 March 2020.
There is currently no clinically proven specific antiviral agents available for SARS-CoV-2
infection. Supportive treatment, including oxygen therapy, fluid management, and
broad-spectrum antibiotics to cover secondary bacterial infection, remains the most important
management strategy.
Since its discovery, lactoferrin and its related peptides are considered non-specific host
defense molecules against a broad range of viruses including SARS-CoV, which is closely
related to SARS-CoV-2 that causes COVID-19. Besides reducing viral entry, lactoferrin can
also suppress virus replication after the viral entry and has an immunomodulatory effect that
can prevent the cytokine storm associated with COVID-19.
The aim of our study is to assess the safety and efficacy of lactoferrin within the context
of SARS-CoV-2 and propose the possibility of supplemental lactoferrin as a potential
preventive drug for healthcare workers exposed to SARS-CoV-2.
|
| NCT04428008 ↗ |
Thymosin Alpha 1 to Prevent COVID-19 Infection in Renal Dialysis Patients |
Recruiting |
Phase 2 |
2021-01-12 |
Thymalfasin (thymosin alpha 1 or Ta1), the active pharmaceutical ingredient in ZADAXIN®
injection, is a 28-amino acid synthetic peptide, identical to natural Ta1 produced by the
thymus gland. Ta1 is a biological response modifier which activates various cells of the
immune system, and is therefore expected to have clinical benefits in disorders where immune
responses are impaired or ineffective, including acute and chronic viral and bacterial
infections, cancers, and vaccine non-responsiveness. Patients with end-stage renal disease
(ESRD) on hemodialysis, in addition to their intrinsic kidney disease and frequent burden of
comorbidities, also have increased risk of exposure to communicable diseases as they are
treated several times each week at hemodialysis centers with several other patients and
clinic staff in attendance. The majority of patients are over 60 years of age and many are
receiving immunosuppressive medications. Accordingly, ESRD patients are particularly
susceptible to COVID-19 infection. Ta1 has been shown to be safely administered to
hemodialysis patients. It is our hypothesis that a course of Ta1 administered to individuals
with ESRD will reduce the rate and severity of infection with COVID-19.
|
| NCT04428021 ↗ |
Standard or Convalescent Plasma in Patients With Recent Onset of COVID-19 Respiratory Failure |
Active, not recruiting |
Phase 2 |
2020-06-15 |
To date no specific treatment has been proven to be effective for Severe Acute Respiratory
Syndrome Coronavirus 2 (SARS-Cov-2) infection. It is possible that convalescent plasma that
contains antibodies to SARS-Cov-2 might be effective against the progression of infection.
Promising results have been shown by preliminary data from China cases. The investigators
planned to compare effectiveness of adding COVID-19 convalescent plasma to standard therapy
protocol (STP) versus adding plasma donated in pre-COVID era versus STP alone in patient with
COVID-19 within 5 days from the onset of respiratory distress. STP at enrolment is the best
evidence based therapy approved for treatment of COVID patients by regional Health system
emergency committee.
|
| NCT04429555 ↗ |
Efficacy, Safety, Tolerability, and Biomarkers of MN-166 (Ibudilast) in Patients Hospitalized With COVID-19 and at Risk for ARDS |
Recruiting |
Phase 2 |
2021-01-11 |
The study aims to evaluate MN-166 (ibudilast) in patients with COVID-19 who are at risk of
developing acute respiratory distress syndrome. Subjects will be screened, randomly assigned
to MN-166 or placebo groups, receive study drug on Days 1-7, and followed up on Day 14 and
Day 28.
|
| NCT04429867 ↗ |
Hydroxychloroquine Use in Hospitalized Patients With COVID-19: Impact on Progression to Severe or Critical Disease |
Active, not recruiting |
Phase 4 |
2020-05-07 |
The primary objective is to assess the impact of hydroxychloroquine in hospitalized patients
with COVID-19 and risk factors for severe/critical disease.
|
| NCT04432298 ↗ |
Study of the Efficacy and Safety of Intravenous Pamrevlumab, in Hospitalized Participants With Acute COVID-19 Disease |
Terminated |
Phase 2 |
2020-06-20 |
This study evaluates the efficacy and safety of intravenous (IV) infusions of pamrevlumab
when compared with placebo in participants who are hospitalized with acute COVID-19 disease.
|
| NCT04432987 ↗ |
Dornase Alpha for the Treatment of COVID-19 |
Recruiting |
Phase 2 |
2020-05-25 |
In this study, the effectiveness of the Dornase Alpha treatment, which is known to reduce the
viscosity of respiratory secretions, will be investigated in new diagnosed and severe
COVID-19 patients separately.
|
| NCT04433546 ↗ |
Pemziviptadil (PB1046), a Long-acting, Sustained Release Human VIP Analogue, Intended to Provide Clinical Improvement to Hospitalized COVID-19 Patients at High Risk for Rapid Clinical Deterioration and Acute Respiratory Distress Syndrome (ARDS). |
Terminated |
Phase 2 |
2020-07-15 |
This is a multicenter, randomized, double-blind, parallel group study to investigate the
efficacy of pemziviptadil (PB1046) by improving the clinical outcomes in hospitalized
COVID-19 patients at high risk for rapid clinical deterioration, acute respiratory distress
syndrome (ARDS) and death.
The study will enroll approximately 210 hospitalized COVID-19 patients who require urgent
decision-making and treatment at approximately 20 centers in the United States.
|
| NCT04433910 ↗ |
A Clinical Trial of Convalescent Plasma Compared to Best Supportive Care for Treatment of Patients With Severe COVID-19 |
Completed |
Phase 2 |
2020-08-30 |
This is a randomized, prospective, multicenter, open label clinical trial of convalescent
plasma compared to best supportive care for treatment of patients with severe COVID-19.
The aim of the study is to explore the therapeutic effect of convalescent plasma transfusions
on the survival and course of disease of patients with severe COVID-19. Convalescent plasma
will be collected from recovered COVID-19 patients.
Patients with severe COVID-19 will be randomly assigned to two groups. Patients in the
treatment group will receive covalescent plasma (250 - 325 ml) on days 1, 3 and 5. Patients
in the control group will receive best supportive care. Clinical condition in all patients
will be evaluated on day 14. In case of progressive COVID-19 on day 14 compared to baseline,
patients in the control group may be switched to treatment with convalescent plasma on days
15, 17 and 19.
Fifty-three patients will be included in each group. Data of each patient will be collected
until discharge but nor longer than day 60.
|
| NCT04434131 ↗ |
Treatment With Investigational Convalescent Plasma and Measure Antibody Levels in Patients Hospitalized With COVID-19 |
Recruiting |
Phase 2 |
2020-04-28 |
This is an open label pilot study designed to provide access to treatment with
investigational convalescent plasma and assess the relationship between NAb titers in the
investigational convalescent plasma compared to changes in NAb levels in the recipient in
hospitalized patients with COVID-19.
|
| NCT04434248 ↗ |
An Adaptive Study of Favipiravir Compared to Standard of Care in Hospitalized Patients With COVID-19 |
Active, not recruiting |
Phase 2/Phase 3 |
2020-04-23 |
The study is Phase II/III and consists of pilot and pivotal stages. The objective of the
pilot stage is to conduct a preliminary assessment of the efficacy and safety of Favipiravir,
and to select the optimal dosing regimen to study during the pivotal stage. The objective of
the pivotal stage is to assess the efficacy and safety of Favipiravir compared with the
Standard of care (SOC) in hospitalized patients with moderate to severe COVID-19 pneumonia.
|
| NCT04435184 ↗ |
Crizanlizumab for Treating COVID-19 Vasculopathy |
Completed |
Phase 2 |
2020-07-09 |
The purpose of this trial is to test the efficacy and safety of crizanlizumab in patients
hospitalized with COVID-19.
|
| NCT04435314 ↗ |
Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19 |
Not yet recruiting |
Phase 2 |
2020-06-01 |
The primary objective of this study is to evaluate the efficacy of the drug nitazoxanide 600
mg, administered three times a day, in relation to placebo in preventing the development of
COVID-19 in subjects from vulnerable communities that had direct contact with patients
diagnosed with the disease.
|
| NCT04435717 ↗ |
Efficacy of Tocilizumab in Modifying the Inflammatory Parameters of Patients With COVID-19 (COVITOZ-01) |
Terminated |
Phase 2 |
2020-05-04 |
unicenter, randomized, open-label clinical trial on the efficacy of tocilizumab in modifying
the inflammatory parameters of patients with COVID-19.
|
| NCT04437693 ↗ |
Post Exposure Prophylaxis in Healthcare Workers Exposed to COVID-19 Patients |
Not yet recruiting |
Phase 2/Phase 3 |
2020-08-31 |
More cases of COVID-19 pandemic are being reported daily around the world. It is highly
infectious and, over 7 million people have been infected and more than 400,000 people have
died globally till this date. Countries around the world are struggling to avoid the spread
of this pandemic.
Center for Disease Control and Prevention (CDC) confirmed that there are no approved drugs
for COVID-19 treatment. Researchers around the globe, however, are researching different
medications for COVID-19 patients, including the drug Hydroxychloroquine (HCQ), which is
mainly used for Rheumatoid Arthritis and Malaria. Not enough data was obtained yet to know
how well all of these medications are functioning. Therefore, aim to perform a randomized
placebo-controlled trial to assess the impact of these medications on COVID -19 healthcare
workers exposed while treating COVID 19 patients in Qatar to avoid causality and
comorbidities in healthcare workers.
It is considered as a weak base. Many viruses enter the host cells via endocytosis, as a
result of which they are initially taken up into an intracellular compartment that is
"typically fairly acidic" whereas; Hydroxychloroquine would alter the acidity of this
compartment, which can interfere with the ability of viruses to escape into the host cell and
start replicating. Another hypothesis on the rationale of the Antiviral activity of HCQ, is
that HCQ may also alter the ability of the virus to bind to the outside of a host cell in the
first place.
An interventional, double-blind, placebo-controlled randomized trial that will include
participants who will be healthcare workers at risks of exposure to COVID-19 while managing
patients with confirmed infection.
Study will compare the safety, efficacy and effectiveness of Post Exposure Prophylaxis (PEP)
use of HCQ in healthcare workers at risk of exposure to COVID-19 patients, in comparison to
Placebo in Qatar.
|
| NCT04438837 ↗ |
Hydroxychloroquine Post-Exposure Prophylaxis for Coronavirus Disease (COVID-19) Among Health-Care Workers |
Not yet recruiting |
N/A |
2020-07-01 |
Background: The rapid spread and high infectivity of severe acute respiratory syndrome
coronavirus 2 (SARS-CoV2) makes identifying an effective prophylaxis agent highly important.
One of the important target populations for such intervention who are at high risk of
exposure are health care workers (HCWs) who may develop disease and/or expose patients and
other HCWs. Hydroxychloroquine (HCQ), currently in usage for treatment of severe Coronavirus
Disease 2019 (COVID-19), has in addition to in-vitro activities of inhibition of virus
replication and immunomodulation, an important role in the inhibition of pre-entry step of
the virus to host cells. Such activity in the early stage of infection may play a role in
prevention of disease progression.
Objectives: To evaluate the effect of HCQ in prevention of clinical disease and reduction of
viral shedding among HCWs following exposure to confirmed COVID-19 patients.
Study design: Multi-center, randomized controlled, superiority, open label trial Setting: The
study will be conducted at Rambam Health Care Campus. Eligibility: Participants eligible for
inclusion will include non-pregnant adult (>18 years old) HCWs who were exposed to a
confirmed case of COVID-19 without full adherence to droplet precautions. Participants will
be eligible in a period no longer than 72 hours after exposure.
Intervention: HCQ will be given in the intervention group in a dosage regimen of 400mg BID in
the first day followed by 200mg BID for overall 10 days. Participants in the control group
will receive no treatment. Treatment will be started no longer than 72 hours following
exposure.
Outcomes: The primary outcome will be the number of participants who develop clinical signs
compatible with COVID 19 (defined in full protocol) within 14 days of exposure. Secondary
outcomes will include virologically-confirmed COVID 19, disease severity (need for
hospitalization, mechanical ventilation and 30-day mortality) and viral shedding duration
(time between first positive PCR to last of two consecutive negative tests) for confirmed
COVID 19 cases.
Sample size: The trial will test for HCQ's superiority assuming a primary outcome incidence
of 20% in the control group and a reduction of 50% with HCQ. The sample size required for a
power of 80% (alpha 0.05) is 291 participants per each group.
|
| NCT04439006 ↗ |
Ibrutinib for the Treatment of COVID-19 in Patients Requiring Hospitalization |
Recruiting |
Phase 2 |
2020-10-23 |
This phase Ib/II trial studies the side effects and best dose of ibrutinib and how well it
works in treating patients with COVID-19 requiring hospitalization. Ibrutinib may help
improve COVID-19 symptoms by lessening the inflammatory response in the lungs, while
preserving overall immune function. This may reduce the need to be on a ventilator to help
with breathing.
|
| NCT04440007 ↗ |
Study of the Efficacy and Safety of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized With COVID-19 |
Completed |
Phase 2 |
2020-10-09 |
Study to assess the safety and efficacy of STI-5656 (Abivertinib Maleate) plus SOC versus SOC
in subjects hospitalized with COVID-19
|
| NCT04441385 ↗ |
Study to Evaluate the Efficacy and Safety of Maraviroc in SARS-CoV-2 Infection (COVID-19). |
Recruiting |
Phase 2 |
2020-06-26 |
This is a bicentric, phase 2, randomized, open-label study to evaluate the efficacy and
safety of maraviroc associated with standard treatment in hospitalized patients with
pulmonary SARS-CoV-2 infection (COVID-19).
|
| NCT04441398 ↗ |
Efficacy and Safety of Nitazoxanide 600 mg to Treat Mild Ambulatory COVID-19 Patients |
Not yet recruiting |
Phase 2/Phase 3 |
2020-07-01 |
The aim is to demonstrate a decrease in complications among ambulatory patients who are
diagnosed with mild COVID-19 by treating them with nitazoxanide for 7 to 14 days on top of
standard care compared to patients who receive standard care and placebo only.
|
| NCT04441424 ↗ |
Convalescent Plasma Therapy on Critically-ill Novel Coronavirus (COVID-19) Patients |
Completed |
N/A |
2020-04-03 |
Out of 49 early-stage critically-ill COVID-19 patients, 21 patients are the experimental
group who take convalescent plasma compared to 28 patients receive only conventional therapy
without taking Convalescent plasma. Recovery or death, length of stay in hospital, and
improvement in the clinical course of the disease are monitored in relation to monitoring
through severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) RNA detection via poly
chain reaction (PCR), and SARS-CoV-2 immunoglobulin G (IgG) and immunoglobulin M (IgM)
serological monitoring.
|
| NCT04443270 ↗ |
Chloroquine Phosphate Prophylactic Use in Health Personnel Exposed to COVID-19 Patients |
Not yet recruiting |
Phase 1 |
2020-07-27 |
The primary objective of this study is to evaluate the efficacy and security of chloroquine
phosphate prophylactic use for reducing the risk of infection by severe acute respiratory
syndrome coronavirus-2 in Health Care Workers exposed to COVID-19 patients.
|
| NCT04443725 ↗ |
Efficacy and Safety of Anti HCV Drugs in the Treatment of COVID-19 |
Not yet recruiting |
Phase 2/Phase 3 |
2020-07-01 |
COVID 19 which started from a zoonotic transmission related to crowded markets was confirmed
to have a high potential for transmission to close contacts on 20 January 2020 by the
National Health Commission of China and it was announced as a pandemic by the WHO on 11 March
2020.
There is currently no clinically proven specific antiviral agent available for SARS-CoV-2
infection. Supportive treatment, including oxygen therapy, conservation fluid management, and
broad-spectrum antibiotics to cover secondary bacterial infection, remains the most important
management strategy.
Interestingly, sofosbuvir has recently been proposed as an antiviral for the SARS-CoV-2 based
on the similarity between the replication mechanisms of the HCV and the coronaviruses.
Aim of the study is to assess the safety and efficacy of of the addition of HCV treatment to
the standard regimen for the treatment of patients who are candidates to receive Hydroxy
Chloroquine according to Egyptian MOHP protocol
|
| NCT04444700 ↗ |
A Pragmatic Randomized Controlled Trial of Therapeutic Anticoagulation Versus Standard Care as a Rapid Response to (SARS-CoV-2) COVID-19 Pandemic |
Completed |
Phase 3 |
2020-07-04 |
Coagulopathy of COVID-19 afflicts approximately 20% of patients with severe COVID-19 and is
associated with need for critical care and death. COVID-19 coagulopathy is characterized by
elevated D-dimer, an indicator of fibrin formation and clot lysis, and a mildly prolonged
prothrombin time, suggestive of coagulation consumption. To date, it seems that COVID-19
coagulopathy manifests with thromboembolism, thus anticoagulation may be of benefit. We
propose to conduct a parallel pragmatic multi-centre open-label randomized controlled trial
to determine the effect of therapeutic anticoagulation compared to standard care in
hospitalized patients admitted for COVID-19 with an elevated D-dimer.
|
| NCT04445246 ↗ |
Inhaled Iloprost for Suspected COVID-19 Respiratory Failure |
Recruiting |
Phase 2 |
2020-05-23 |
Acute respiratory distress syndrome (ARDS) is a type of respiratory failure characterized by
the rapid onset of widespread inflammation in the lungs. ARDS is thought to be the main cause
of respiratory failure in COVID-19 patients. Research is still ongoing to further elucidate
the different ARDS subtypes that may exist in COVID-19. It is crucial to find new targets for
treatment and support of COVID-19 patients with respiratory failure.
|
| NCT04445272 ↗ |
Clinical Trial to Evaluate the Effectiveness and Safety of Tocilizumab for Treating Patients With COVID-19 Pneumonia |
Completed |
Phase 2 |
2020-05-22 |
At present, no treatment has been approved for COVID-19. However, in light of the increased
interest on using the anti-cytokine therapy targeting IL-6 tocilizumab in COVID-19 infected
patients due to its potential benefit, the Spanish Agency for Medicine and Health Products
(Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) have initiated the
controlled distribution of the drug. Tocilizumab is indeed proposed as a potential treatment
for severe COVID-19 in Spain. Based on the positive results of tocilizumab in the treatment
of COVID-19 patients and the experience of tocilizumab in inducing rapid reversal of CSS in
other pathologies several clinical trials and observational studies are being conducted to
assess the effectiveness and safety of tocilizumab in COVID-19 patients. Further studies with
a large sample size are required to confirm the effectiveness of tocilizumab in patients with
COVID-19 pneumonia.
The need for the management of severe COVID-19 disease is imperative, and every effort should
be made to collect relevant clinical outcomes. The aim of the present study is to evaluate
the effectiveness of IV tocilizumab in treating patients with COVID-19 pneumonia who are
currently hospitalized or admitted to ICU by describing improvement of respiratory function
and mortality rate. This large real-world cohort therefore provides a unique opportunity to
study this potential medicine during the current emergency situation, and support the
findings from other ongoing clinical trials and observational studies, such as the
Roche-sponsored Phase III study that is planned to start early April.
|
| NCT04445389 ↗ |
Safety and Immunogenicity Study of GX-19, a COVID-19 Preventive DNA Vaccine in Healthy Adults |
Recruiting |
Phase 1/Phase 2 |
2020-06-17 |
The objective of our study is to evaluate safety, tolerability, and immunogenicity of
COVID-19 preventive DNA vaccine in healthy volunteers.
|
| NCT04445623 ↗ |
Prasugrel in Severe COVID-19 Pneumonia |
Not yet recruiting |
Phase 3 |
2020-07-01 |
Inflammatory diseases favour the onset of venous thromboembolic events in hospitalized
patients. Thromboprophylaxis with a fixed dose of heparin/low molecular weight heparin (LMWH)
is recommended if concomitant inflammatory disease. In severe acute respiratory syndrome
coronavirus 2 (SARS-CoV2) pneumonia an inflammation-dependent thrombotic process occurs and
platelet activation may promote thrombosis and amplify inflammation, as indicated by previous
experimental evidence , and the similarities with atherothrombosis and thrombotic
microangiopathies. Antiplatelet agents represent the cornerstone in the prevention and
treatment of atherosclerotic arterial thromboembolism, with limited efficacy in the context
of venous thromboembolism. The use of purinergic receptor P2Y12 inhibitors in pneumococcal
pneumonia may improve inflammation and respiratory function in humans. There are no validated
protocols for thrombosis prevention in Covid-19. There is scientific rationale to consider a
P2Y12 inhibitor for the prevention of thrombosis in the pulmonary circulation and attenuation
of inflammation. This is supported by numerous demonstrations of the anti-inflammatory
activity of P2Y12 inhibitors and the evidence of improvement in respiratory function both in
human and experimental pathology. Prasugrel could be considered as an ideal candidate drug
for Covid-19 patients because of higher efficacy and limited Interactions with drugs used in
the treatment of Sars-CoV2. The hypothesis underlying the present study project is that in
Covid-19 platelet activation occurs through an inflammation-dependent mechanism and that
early antithrombotic prophylaxis in non-critical patients could reduce the incidence of
pulmonary thrombosis and respiratory and multi-organ failure improving clinical outcome in
patients with SARS-CoV2 pneumonia. The prevention of thrombogenic platelet activity with a
P2Y12 inhibitor could be superior to fixed dose enoxaparin alone. The proposed treatment is
feasible in all coronavirus disease 2019 (COVID-19) patients, regardless of the treatment
regimen (antivirals, anti-inflammatory drugs, antibiotics), except for specific
contraindications.
|
| NCT04445935 ↗ |
Anticoagulation in Patients Suffering From COVID-19 Disease The ANTI-CO Trial |
Recruiting |
Phase 4 |
2020-06-28 |
Patients with COVID-19 associated ARDS and mechanical ventilation have a high mortality. Part
of the disease is an activation of the coagulation system which seems to contribute to
clotformation in the pulmonary bloodstream. Recently we implemented an algorithm applying
higher doses of heparins (LMWH). However, this approach could not inhibit clotformation
enough. Bivalirudin could prevent clotformation better and support dissolving existing clots.
Therefore, we want to compare 50 patients with the standard treatment with 50 patients under
bivalirudin treatment which we normally apply in patients with a HIT-syndrome.
Our primary outcome measure is oxygenation reflected as P/F ratio.
|
| NCT04446065 ↗ |
Previfenon® as Chemoprophylaxis of COVID-19 in Health Workers |
Not yet recruiting |
Phase 2/Phase 3 |
2020-09-30 |
The purpose of this clinical trial is to determine the efficacy of Previfenon® (EGCG) to
prevent COVID-19, enhance systemic immunity, and decrease the frequency and intensity of
selected symptoms when used as pre-exposure chemoprophylaxis to SARS-CoV-2.
|
| NCT04447235 ↗ |
Early Treatment With Ivermectin and LosarTAN for Cancer Patients With COVID-19 Infection |
Recruiting |
Phase 2 |
2020-07-23 |
Ivermectin plus losartan as prophilaxy to severe events in patients with cancer with recent
diagnosis of COVID-19
|
| NCT04447534 ↗ |
Zinc With Chloroquine/Hydroxychloroquine in Treatment of COVID-19 |
Recruiting |
Phase 3 |
2020-06-23 |
we want to investigate if zinc supplementation enhance the clinical efficacy of chloroquine
in treatment of COVID-19.
|
| NCT04448119 ↗ |
Control of COVID-19 Outbreaks in Long Term Care |
Active, not recruiting |
Phase 2 |
2020-10-16 |
To address the need to intervene to prevent the spread of COVID-19 in long-term care homes,
we propose a randomized clinical trial of chemoprophylaxis in long-term care homes
experiencing COVID-19 outbreaks. LTCH units experiencing an outbreak of COVID-19 will be
randomized to chemoprophylaxis with favipiravir or placebo in a 1:1 ratio.
Chemoprophylaxis in this setting refers to the use of favipiravir for pre-exposure
prophylaxis, post-exposure prophylaxis, pre-emptive therapy, or treatment for established
COVID-19. This design mimics the approach to influenza outbreaks, which has proven efficacy
for outbreak control. The primary outcome will be control of the outbreak, defined as no new
microbiologically confirmed case of COVID-19 for 24 consecutive days up to day 40.
|
| NCT04449965 ↗ |
Povidone-Iodine Rinses in the Management of COVID-19 |
Not yet recruiting |
Early Phase 1 |
2020-07-01 |
The aim of this study is to determine if Povidone iodine (PVP-I) rinses and throat gargles or
a PVP-I gel forming nasal spray compared to a placebo (a treatment that has no physical
effect to a person) is an effective treatment for patients diagnosed with COVID-19. These
patients have been diagnosed with mild/moderate COVID-19 symptoms and sent home for
self-isolation. Patients will be instructed to take either of the two treatments or placebo
twice daily for two weeks and have follow up visits 2 and 4 weeks after. The participants
will also complete study related procedures such as saliva sample collection, and two
questionnaires throughout the study period. The investigators hypothesize that COVID 19
positive participants who use either of the Povidone - Iodine treatment will have a reduction
in their viral load, develop a negative oral mucosa sample and improve their clinical
symptoms.
|
| NCT04451239 ↗ |
Topical Steroids and Cyclosporin-A for COVID-19 Keratoconjunctivitis |
Not yet recruiting |
N/A |
2020-06-30 |
To explore the feasibility of combined topical corticosteroid and topical cyclosporine-A in
COVID-19 patients with acute keratoconjunctivitis.
|
| NCT04452474 ↗ |
Study of the Efficacy and Safety of a Single Administration of Olokizumab vs. Placebo in Addition to Standard Treatment in Patients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection (COVID-19). |
Withdrawn |
Phase 2/Phase 3 |
2020-06-30 |
The primary objective of the study is to evaluate the efficacy of a single dose of OKZ (64
mg) vs placebo in addition to standard therapy in patients with severe SARS-CoV-2 infection
(COVID-19) at Day 29.
|
| NCT04452669 ↗ |
VentaProst in Subjects With COVID-19 Requiring Mechanical Ventilation |
Completed |
Phase 2 |
2020-09-15 |
The purpose of this study is to investigate whether inhaled epoprostenol given via a breath
actuated delivery system will help improve oxygen levels and treatment outcomes in patients
with COVID-19 who are on mechanical ventilation.
|
| NCT04452799 ↗ |
Hesperidin and Diosmin for Treatment of COVID-19 |
Not yet recruiting |
Early Phase 1 |
2020-07-01 |
SARS-CoV-2 or COVID-19 is representing the major global burden that implicated more than 10
million infected cases and 500 thousand deaths worldwide. The prevalence of this pandemic
disease is expected to rise every day. The challenge is to control its rapid spread meanwhile
looking for a specific treatment to improve patient outcomes. Hesperidin is a classical
herbal medicine used worldwide for a long time with an excellent safety profile. Hesperidin
is a well-known herbal medication used as an antioxidant and anti-inflammatory agent.
Available shreds of evidence support the promising use of hesperidin in prophylaxis and
treatment of COVID 19. Herein, we discuss the possible prophylactic and treatment mechanisms
of hesperidin based on previous and recent findings. Hesperidin can block coronavirus from
entering host cells through ACE2 receptors which can prevent the infection. Anti-viral
activity of hesperidin might constitute a treatment option for COVID-19 through improving
host cellular immunity against infection and its good anti-inflammatory activity may help in
controlling cytokine storm. Hesperidin mixture with diosmin co-administrated with heparin
protect against venous thromboembolism which may prevent disease progression. Based on that,
hesperidin might be used as a meaningful prophylactic agent and a promising adjuvant
treatment option against SARS-CoV-2 infection.
|
| NCT04453371 ↗ |
Impact of Tissue Plasminogen Activator (tPA) Treatment for an Atypical Acute Respiratory Distress Syndrome (COVID-19) |
Withdrawn |
Phase 3 |
2020-10-15 |
At the beginning COVID-associated lung injury was considered as typical ARDS, hence
respiratory and nonrespiratory treatments were delivered according to general principles for
this kind of illness. There is hypothesis that in predisposed individuals, alveolar viral
damage is followed by an inflammatory reaction and by microvascular pulmonary thrombosis. The
investigators suggest that thrombolytic therapy may be beneficial when compared to standard
care in patients with SARS-CoV-2 and severe respiratory failure.
|
| NCT04454307 ↗ |
Safety and Efficacy of Tramadol in COVID-19 Egyptian Patients |
Not yet recruiting |
Phase 1/Phase 2 |
2020-07-01 |
The rationale of the use of tramadol for COVID-19 patients is attributed to its
anti-inflammatory, hypocagulatory, antioxidant, cardio-protective, analgesic, antitussive,
bactericidal and antidepressant effect.
|
| NCT04454398 ↗ |
Study to Evaluate STI-1499 (COVI-GUARD) in Patients With Moderate COVID-19 |
Withdrawn |
Phase 1 |
2020-09-01 |
Randomized, placebo-controlled study to evaluate the safety, pharmacokinetics and efficacy of
a single dose of STI-1499 (COVI-GUARD™) in hospitalized patients with moderate COVID-19
|
| NCT04455815 ↗ |
A Trial Looking at the Use of Camostat to Reduce Progression of Symptoms of Coronavirus (COVID-19) in People Who Have Tested Positive. |
Active, not recruiting |
Phase 2 |
2020-09-25 |
This is a phase II randomised, multicentre, prospective, open label clinical trial. The trial
aims to recruit patients who test positive for COVID-19 who have mild symptoms and therefore
can treat their symptoms in the community. Patients who test positive for COVID-19 at
hospital may also be able to participate.
|
| NCT04456153 ↗ |
Atovaquone for Treatment of COVID-19 |
Completed |
Phase 2 |
2020-07-22 |
The purpose of the current study is to accelerate the use of a clinically available
therapeutic already FDA-approved for other indications in the setting of pandemic COVID-19
addressing a serious and emergent unmet medical need.
This is a randomized, double-blind study of atovaquone therapy in adult participants
hospitalized with COVID-19. Approximately 60 participants who meet all eligibility criteria
may be randomized in a 2:1 atovaquone/placebo ratio into one of the following treatment
groups:
Treatment Group 1: continued standard of care therapy together with an oral dose of 1500 mg
atovaquone twice daily (administered with a meal or snack) for up to 10 days
Treatment Group 2: continued standard of care therapy together with matching placebo
|
| NCT04457609 ↗ |
Administration of Allogenic UC-MSCs as Adjuvant Therapy for Critically-Ill COVID-19 Patients |
Recruiting |
Phase 1 |
2020-07-01 |
Novel Coronavirus (2019nCoV) or Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2)
that causes Coronavirus Disease 2019, or known as Covid-19 has recently become a global
health emergency since it was first detected in Wuhan, the People Republic of China in
December 2019. Since then, the prevalence has rapidly increased worldwide. In Indonesia, by
the end of April 2020, around 10,000 patients have been tested positive for Covid-19
infection, with a case fatality rate of around 8%.
The pathogenesis of Covid-19 is still under investigation and to our understanding, ACE2
receptors in the alveoli serve as the binding site of the S-protein of envelope spike virus
of SARS-CoV-2. TMPRSS2 enzyme aids the fusion between cell membrane and capsid of the virus,
allowing penetration of virus into the cell. Vesicles containing virion fuse with cell
membrane and released as new virions. Cytopathic effect of the virus and its ability to
overcome immune response determines the degree of infection.
Differences in immunological profile among degrees of severity of Covid-19 may vary
especially for the number of pro-inflammatory cytokines such as tumor necrosis factor alpha
(TNF-α), interleukin (IL)-1, IL-6, IL-8, leukemia-inhibiting factors (LIF), immunological
markers such as CXCR3+CD4+, CXCR3+CD8+ T cell and CXCR3+ NK cells, implying the ongoing
cytokine storm. The previous studies also found increasing number for infection markers such
as procalcitonin, ferritin, and C-reactive protein. The decreasing number of
anti-inflammatory cytokines in such as IL-10 also supports this finding.
Previous studies have shown immunomodulating and anti-inflammatory capacity of the
mesenchymal stem cells (MSCs). MSCs contributed to the shifting of pro-inflammatory Th2 into
anti-inflammatory Th2. One of the most recent study on the usage of MSCs on Covid-19 patients
showed increased expression of leukemia inhibitory factor (LIF), which give rise to
inhibitory effect of T lymphocyte and natural killer (NK) cell population. Vascular
epithelial growth factor (VEGF) is found increasing following MSCs administration, which
indicates the ability to improve the disrupted capillaries due to SARS-Cov-2 infection. The
ability of MSCs in differentiating to alveolar cells is proven by the presence of SPM and
SPC2, surfactant proteins produced by type II alveolar cells. MSCs are unable to be infected
by SARS-CoV-2 since they don't have ACE2 receptors and TMPRSS2 enzyme.
|
| NCT04458363 ↗ |
Convalescent Plasma in Pediatric COVID-19 |
Completed |
Early Phase 1 |
2020-07-04 |
COVID-19 is increasingly affecting children but convalescent plasma (CP) has not been
adequately studied in children to date. The study will determine safety of convalescent
plasma for pediatric patients with severe, or at high risk for severe, COVID-19 disease.
|
| NCT04459247 ↗ |
Short Term, High Dose Vitamin D Supplementation for COVID-19 |
Completed |
N/A |
2020-06-15 |
Coronavirus-2019 (COVID-19) caused by severe acute respiratory syndrome-associated
coronavirus-2 (SARS-CoV-2) has affected the lives of millions of individuals globally and
severely strained the medical community. Pre-symptomatic and asymptomatic SARS-CoV-2 positive
individuals far outnumber the symptomatic ones or those with severe disease. The transmission
potential of SARS CoV-2 is potentially greator than earlier viral outbreaks of SARS-CoV and
MERS-CoV. Identification of asymptomatic carriers of SARS-CoV-2 infection is paramount to
contain viral infection because of high transmission potential Routine measures of social
distancing, personal hand hygiene and limited outdoor contact activities have shown benefits
to limit corona virus infection. However, the role of vitamin D in SARS-CoV-2 infection is
not explored despite the knowledge of an immunomodulatory role and protective effect of
vitamin D against viral infections. It has been found that mortality from COVID-19 is more in
countries with vitamin D deficiency.
The role of therapeutic vitamin D supplementation in asymptomatic individuals with vitamin-D
deficiency and COVID-19 is not known. Immune-modulatory effect of vitamin D is likely to be
observed at 25(OH)D levels which are considered higher than that required for normal bone
metabolism.An earlier SARS-CoV-2 negativity may have significant public health benefits in
limiting the spread of the disease. Therefore, we hypothesise that high dose vitamin D
supplementation in patients with COVID-19 and vitamin D deficiency may lead to SARS-CoV-2
negativity in greater proportions of patients associated with decrease in serological markers
of inflammation.
|
| NCT04459286 ↗ |
The Nitazoxanide Plus Atazanavir for COVID-19 Study |
Completed |
Phase 2 |
2020-10-09 |
Since the outbreak of the novel coronavirus disease in 2019 (COVID-19), an unprecedented
global search for potential therapeutics and vaccines is ongoing. In this study, a
combination of two drugs that have been shown to be effective against the germ that causes
COVID-19 in the laboratory will be tested in patients diagnosed with moderate to severe
COVID-19. One of the drugs is called nitazoxanide and the second is atazanavir/ritonavir.
Nitazoxanide has been used for the treatment of diarrhea since 2004 while
atazanavir/ritonavir was approved for HIV treatment in 2003. They are known to be safe in
humans.
In this pilot study, 98 COVID-19 patients will be recruited into two groups. The 49 patients
in group 1 will receive the standard of care determined by their primary care providers while
the 49 patients in group 2 will receive both the standard of care combined with the two study
drugs. Patients in group 2 will receive the study drugs for 14 days and all patients will be
monitored for a total of 28 days.
The time it takes for the germ that causes COVID-19 to be completely removed from the body
(in nasal secretions) and the time to clinical improvement will be monitored in all patients
and compared between the two groups.
|
| NCT04460183 ↗ |
A Study to Assess Efficacy and Safety of RESP301 Plus Standard of Care (SOC) Compared to SOC Alone in Hospitalized Participants With COVID-19 |
Recruiting |
Phase 2/Phase 3 |
2020-07-29 |
The effect of RESP301 as an add on treatment to SOC will be evaluated for its efficacy in
reducing rate of progression to a more severe level of COVID-19 and for safety, by comparison
with SOC alone in hospitalized COVID-19 patients.
|
| NCT04460443 ↗ |
Sofosbuvir in Treatment of COVID 19 |
Recruiting |
Phase 2/Phase 3 |
2020-08-01 |
Sofosbuvir containing treatment in treatment of COVID 19 Egyptian patients
|
| NCT04461340 ↗ |
Efficacy and Safety of Sirolimus in COVID-19 Infection |
Recruiting |
Phase 2 |
2020-08-15 |
This research is planned to illustrate the efficacy and safety of sirolimus as an adjuvant
agent to the standard treatment protocol against COVID-19 infection
|
| NCT04461925 ↗ |
Treatment of Coronavirus COVID-19 Pneumonia (Pathogen SARS-CoV-2) With Cryopreserved Allogeneic P_MMSCs and UC-MMSCs |
Recruiting |
Phase 1/Phase 2 |
2020-05-02 |
Assessment of the clinical effects of infusions of cryopreserved allogeneic multipotent
mesenchymal stem cells of the placenta and umbilical cord for COVID-19 patients with acute
respiratory distress syndrome.
|
| NCT04462757 ↗ |
SCIL-1Ra in COVID-19 Feasibility & PK/PD |
Terminated |
Phase 2 |
2020-05-28 |
The current COVID-19 pandemic is a worldwide healthcare crisis. Of concern is the large
number of patients that are/will require mechanical ventilation, and the associated strain
that this will place on healthcare resources. At present, there are no specific therapeutic
interventions directed at COVID-19 infection. However, observational data suggest that there
is a subgroup of patients that demonstrate a hyperinflammatory response in response to
COVID-19 and have a higher requirement for Critical Care and higher mortality.
There is a strong case for the use of the naturally occurring anti-inflammatory cytokine
interleukin-1 receptor antagonist (IL-1Ra) in these patients. Anakinra is a recombinant form
of IL-1Ra that is licensed for clinical use. Success of use of anakinra in COVID-19 trials
will be greatly enhanced by robust scientific evidence and established pharmacokinetics which
inform the most effective dosing regimens. The latter is especially important when, as in the
case of anakinra, drug supplies are limited, the drug has short half-life and clinical ease
of application is critical.
|
| NCT04463004 ↗ |
Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflammation |
Completed |
Phase 2 |
2020-09-02 |
The purpose of this prospective, Phase 2, multicenter, blinded, randomized placebo controlled
study is to demonstrate that early treatment with mavrilimumab prevents progression of
respiratory failure in patients with severe COVID-19 pneumonia and clinical and biological
features of hyper-inflammation.
|
| NCT04463264 ↗ |
Efficacy and Safety Study of Nitazoxanide (NTX) in the Treatment of Patients With SARS-CoV-2 Virus Infection (COVID-19) |
Recruiting |
Phase 2/Phase 3 |
2020-06-26 |
Evaluation of the efficacy and safety of NTX in adult patients (≥18 years and <60 years),
with SARS-CoV-2 infection with mild symptoms of COVID-19, compared to a placebo control arm.
135 patients will be randomized to either Nitazoxanide (n=90) or placebo (n=45) (2:1). Simple
blind design. Primary endpoint: eradication of virus from patients' respiratory tract
secretions by the 7th day of treatment.
|
| NCT04463602 ↗ |
Desidustat in the Management of COVID-19 Patients |
Completed |
Phase 2 |
2020-07-25 |
This study is a Phase 2b, Multicenter, Open-label, Randomized, Comparator- Controlled Study
to Evaluate the Efficacy and Safety of Desidustat Tablet for the Management of mild, moderate
and severe COVID-19 patients. 100 mg of Desidustat will be administered for a period of 14
days along with recommended standard care during the trial.
|
| NCT04466540 ↗ |
Randomized Placebo-controlled Trial of Hydroxychloroquine in Outpatient Cases With Coronavirus Disease 2019 (COVID-19) |
Active, not recruiting |
Phase 4 |
2020-05-12 |
In December 2019, a group of patients with pneumonia of unknown cause was identified in
Wuhan, in the Hubei province, China. Despite the need of target specific therapeutic options
for COVID-19, until now there is no proof of effectiveness of any specific intervention. Some
limited observational trials and also evidence from randomized trials have shown no benefit
of hydroxychloroquine in inpatient context. Thus, studies evaluating interventions in an
outpatient setting in non-severe patients can provide important information related to
prognosis and safety. In this way, the present study will evaluate the effectiveness and
safety of the use of hydroxychloroquine in COVID-19 outpatients by means of a Randomized,
double-blind, placebo-controlled trial
|
| NCT04467151 ↗ |
Administration of Anti-SARS-CoV-2 Convalescent Plasma in Hospitalized, Non-ICU Patients With COVID-19 |
Withdrawn |
Phase 2 |
2020-10-01 |
The purpose of this study is to assess the efficacy and safety of the administration of
anti-SARS-CoV-2 convalescent plasma in COVID-19 patients who are sick enough to warrant
hospitalization, but not yet admitted to the ICU (prior to the onset of overwhelming disease
including a systemic inflammatory response, sepsis, and/or ARDS).
|
| NCT04468009 ↗ |
This Study Aims to Use Convalescent Plasma as Experimental Treatment in Critically Ill Patients With Covid-19 |
Recruiting |
Phase 2 |
2020-06-25 |
This study aims to collect convalescent plasma and use it as experimental treatment in
critically ill Covid-19 patients in order to reduce mortality and length of stay in intensive
care unit.
|
| NCT04468087 ↗ |
Antiviral Agents Against COVID-19 Infection |
Recruiting |
Phase 2/Phase 3 |
2021-02-15 |
A key strategy in the treatment of COVID-19 would be to find an effective antiviral agent
that would decrease the peak viral load and, consequently, the associated degree of
immunopathological damage that follows this phase. The clinically approved substances
considered for this study are used for treatment of other virus diseases, like HIV
(atazanavir) and HCV (sofosbuvir and daclatasvir). Severe progression of COVID-19 among
patients under treatment for these aforementioned viruses is empirical less common. Besides,
the clinical rationale, there are pre-clinical evidence pointing out that patients with
COVID-19 could benefit from treatments with atazanavir, sofosbuvir and daclatasvir.
|
| NCT04468646 ↗ |
To Determine the Efficacy of Neurokinin 1 Receptor Antagonist as a Therapeutic Tool Against Cytokine Storm and Respiratory Failure in Covid-19 Patients |
Recruiting |
Phase 3 |
2020-06-15 |
This is a randomized, randomized controlled trial to investigate the efficacy and safety of
Neurokinin-1 Receptor (NK-1R) 80 mg orally given daily to treat cytokine storm causing
inflammatory lung injury and respiratory failure associated with severe or critical COVID-19
infection. NK-1R is the receptor of Substance P (SP) and responsible for its functionality.
Here, we propose that SP via its tachykinin receptor, NK-1R may cause inflammation in
Covid-19 infection. It may initiate the cytokine storming via binding to its receptor NK-1
and many inflammatory mediators are released. If SP release is reduced by NK-1R antagonist,
it may control the cytokine storming and hence the hyper-responsiveness of the respiratory
tract through reduction in cytokine storming It may serve as the treatment strategy for
Covid-19 infected patients.
Patients fulfilling the inclusion criteria will be enrolled after giving consent. They wll be
randomized to treatment with either NK-1R antagonist or placebo in addition to Dexamethasone
as a standard treatment given to both groups for Covid-19 infection as per the protocol at
the treating hospital. Inflammatory lab markers as detailed should be collected once per day
in the morning, preferably at the same time every morning. All enrolled participants will
have whole blood collected for whole genome sequencing.
|
| NCT04469114 ↗ |
Tofacitinib in Hospitalized Patients With COVID-19 Pneumonia |
Completed |
Phase 3 |
2020-09-16 |
Tofacitinib suppresses pro-inflammatory signaling that may be important pathogenetically to
progression to more severe lung disease and acute respiratory distress syndrome (ARDS) in
patients with COVID-19. The purpose of the study is to assess the safety and efficacy of
tofacitinib plus standard pharmacologic and supportive measures in treating hospitalized
participants with COVID-19 pneumonia.
|
| NCT04470297 ↗ |
Melatonin Agonist on Hospitalized Patients With Confirmed or Suspected COVID-19 |
Not yet recruiting |
Phase 2 |
2020-09-01 |
COVID-19 is impacting on health systems in Brazil and worldwide. Reducing the risk of
clinical deterioration and prolonged disease duration in hospitalized patients with COVID-19
may alleviate the burden caused by the pandemic. Melatonin (N-acetyl-5-methoxytryptamine) has
demonstrated antiapoptotic, antioxidative, and anti-inflammatory roles and has been suggested
as a potential protector against organ injuries and even mediate lower mortality rates after
polymicrobial sepsis in animal models. Melatonin agonists may modulate protective effects
against acute lung injury and play a clinical role in individuals with SARS-CoV-2 infection.
The investigators proposed a clinical trial testing the effects of ramelteon 8mg in
hospitalized patients with COVID-19.
|
| NCT04470531 ↗ |
Role of Co-trimoxazole in Severe COVID-19 Patients |
Recruiting |
Phase 2 |
2020-07-12 |
Coronavirus Disease 19 (COVID-19) is a global pandemic caused by Severe Acute Respiratory
Syndrome Coronavirus 2 (SARS-CoV-2). Severe disease occurs in 15% of the cases with COVID-19
and may progress to critical disease in only 5% of the cases with a high risk of mortality.
Critical disease may present as acute respiratory failure secondary to Acute Respiratory
Distress Syndrome (ARDS) and is caused by the body's hyper-immune response to the virus in
the form of a cytokine storm syndrome (CSS). There is currently no effective anti-viral
treatment against SARS-CoV-2 and the mainstay of treatment is supportive. Co-trimoxazole
(combination of trimethoprim and sulphamethoxazole in a 1:5) ratio is a Sulphur containing
anti-folate bactericidal antibiotic indicated for the treatment of respiratory tract
infections. It has been around for over 60 years and is inexpensive and readily available
with a good safety profile. It has a rapid onset of action with excellent bioavailability and
lung penetration. In addition to having antimicrobial properties co-trimoxazole have
immunomodulatory and anti-inflammatory properties and may be a potential treatment option for
cytokine storm syndrome mediated severe COVID-19.
This open-label randomized controlled trial will be conducted in the department of medicine
at Bangabandhu Sheikh Mujib Medical University (BSMMU), Anwar Khan Modern Medical college and
Mughda Medical College Hospital (DMCH), Dhaka for a duration of 6 months following approval
of this protocol. It will recruit at least 94 consecutive adults (18 years or older) patients
with clinically suspected COVID-19 and severe illness as per WHO criteria. After taking
informed written consent patients will be randomly assigned in a 1:1 ratio to either oral
co-trimoxazole in addition to standard therapy or standard therapy alone. Baseline
characteristics, changes in the physiological and biochemical parameters like (SpO2/FiO2
ratio, respiratory rate, body temperature and C - reactive protein), length of hospital stay,
side effects of drugs, requirement for ventilatory support (non-invasive and invasive
ventilation) and in-patient mortality between the two groups will be compared.
Conclusion If the results from this clinical trial demonstrate the beneficial effects of
co-trimoxazole in severe COVID-19 patients it could be used widely, thereby reducing the need
for respiratory support and potentially saving thousands of lives in developing nations with
limited resources where healthcare may be easily overwhelmed.
|
| NCT04472585 ↗ |
Efficacy of Subcutaneous Ivermectin With or Without Zinc in COVID-19 Patients |
Recruiting |
Phase 1/Phase 2 |
2020-11-14 |
To measure the effect of Ivermectin (sub-cutaneous) with or without zinc in treating the
COVID-19 patients to clear viral load of SARS-CoV-2 along with reduction in severity of
symptoms and length of hospitalization of patients with COVID-19.
|
| NCT04473053 ↗ |
DEFINE - Evaluating Therapies for COVID-19 |
Active, not recruiting |
Phase 1/Phase 2 |
2020-07-03 |
COVID-19 is a community acquired pneumonia caused by infection with a novel coronavirus, SARS
CoV2 and is a serious condition with high mortality in hospitalised patients, for which there
is no currently approved treatment other than supportive care. Urgent investigation of
potential treatments for this condition is required.
This protocol describes an overarching and adaptive trial designed to provide safety,
pharmacokinetic (PK)/ pharmacodynamic (PD) information and exploratory biological surrogates
of efficacy which may support further development and deployment of candidate therapies in
larger scale trials of COVID-19 positive patients receiving normal standard of care.
Given the spectrum of clinical disease, community based infected patients or hospitalised
patients can be included. Products requiring parenteral administration will only be
investigated in hospitalised patients. Patients will be divided into cohorts, a) community b)
hospitalised patients with new changes on a chest x-ray (CXR) or a computed tomography (CT)
scan or requiring supplemental oxygen and c) hospitalised requiring assisted ventilation.
Participants may be recruited from all three of these cohorts, depending on the experimental
therapy, its route of administration and mechanism of action. The relevant cohort(s) for any
given therapy will be detailed in the therapy-specific appendix.
Candidate therapies can be added to the protocol and previous candidates removed from further
investigation as evidence emerges. The trial will be monitored by an independent Data
Monitoring Committee (DMC) to ensure patient safety.
Each candidate cohort will include a small cohort of patients randomised to candidate therapy
or existing standard of care management dependent on disease stage at entry. Cohort numbers
will be defined in the protocol appendices.
This is a Phase IIa experimental medicine trial and as such formal sample size calculations
are not appropriate.
|
| NCT04473170 ↗ |
Study Evaluating the Safety and Efficacy of Autologous Non-Hematopoietic Peripheral Blood Stem Cells in COVID-19 |
Completed |
Phase 1/Phase 2 |
2020-04-04 |
SENTAD-COVID Study is an adaptive, prospective, multicentric, open-label, and randomized
controlled clinical trial involving hospitalized adult patients with confirmed coronavirus
disease 2019 (COVID-19) infection during the outbreak in Abu Dhabi, 2020. The patients were
randomly allocated in a parallel assignment involving two groups of participants: Group A
(Experimental arm): autologous non-hematopoietic peripheral blood stem cells (NHPBSC) therapy
as add-on COVID-19 standard care, or Group B (No investigational intervention arm): COVID-19
standard care. Standard care is defined as per the "UAE National Guidelines for Clinical
Management and Treatment of COVID-19". SENTAD-COVID Study was conducted in the Sheikh Khalifa
Medical City (SKMC) of Abu Dhabi, as Primary Care Clinical Trial Unit, while the cell
processing and investigational product formulation were completed by Abu Dhabi Stem Cells
Center (ADSCC), according to Good Laboratory Practices (GLPs) and Good Manufacturing
Practices (GMPs).
|
| NCT04474483 ↗ |
Safety and Efficacy of Melatonin in Outpatients Infected With COVID-19 |
Recruiting |
Phase 2 |
2020-11-06 |
This study is a pilot randomized, double-blind, placebo-controlled clinical trial to evaluate
the safety and efficacy of melatonin in adult outpatients suspected to be afflicted with
COVID-19.
|
| NCT04475991 ↗ |
Safety and Efficacy of Maraviroc and/or Favipiravir With Standard Therapy in Severe COVID-19 Adults |
Recruiting |
Phase 2 |
2021-07-13 |
Phase 2, randomized, open-label study to evaluate the safety and efficacy of maraviroc,
favipiravir, and both drugs administered along with currently used therapy in hospitalized
patients with pulmonary SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2)
infection (COVID-19)
|
| NCT04476992 ↗ |
Nitric Oxide Therapy for COVID-19 Patients With Oxygen Requirement |
Active, not recruiting |
Phase 1/Phase 2 |
2020-07-24 |
Preliminary data support the effect of Nitric Oxide (NO) on improving the oxygenation in
mechanically ventilated patients and spontaneously breathing patients with COVID-19. In vitro
studies showed an antiviral effect of NO against SARS-coronavirus. The optimal therapeutic
regimen of NO gas in spontaneously breathing hypoxemic patients with COVID-19 is not known.
We hypothesize that high concentration inhaled NO with an adjunct of continuous low dose
administration between the high concentration treatments can be safely administered in
hypoxemic COVID-19 patients compared to the high dose treatment alone. Prolonged
administration of NO gas may benefit the patients in terms of the severity of the clinical
course and time to recovery. Together with a clinical effect on ventilation-perfusion
matching, a prolonged regimen would allow also an increase in antiviral activity (dose and
time-dependent).
|
| NCT04477642 ↗ |
Abatacept for Patients With COVID-19 and Respiratory Distress |
Withdrawn |
Phase 1/Phase 2 |
2020-08-01 |
This is a single-arm open label trial for hospitalized patients with COVID-19 (Coronavirus).
The primary endpoint of the study is to assess the requirement for mechanical ventilation in
patients who are admitted to the hospital with COVID-19 infection and a Pulse Oxygen Level
|
| NCT04479202 ↗ |
The Effect of Berberine on Intestinal Function and Inflammatory Mediators in Severe Patients With Covid-19 |
Completed |
Phase 4 |
2020-02-08 |
Coronavirus disease 2019 (COVID-19) rapidly spread across China and throughout the world,
causing hundreds of thousands died. Studies had shown that "cytokine storms" and subsequent
multiple organ dysfunction (MODS) are important causes for disease progression and death in
patients with COVID-19. Similar to SARS-CoV infection, SARS-CoV-2 would infect humans via
binding of S-protein to angiotensin-converting enzyme 2 (ACE2), a host cell receptor, and the
S protein is activated and cleaved by cellular transmembrane serine proteases, allowing the
virus to release fusion peptides for membrane fusion. In addition to the lungs, ACE2 is also
highly expressed in the esophagus, small intestine and colon, suggesting that the gut might
also be an important target organ for SARS-CoV-2. About 8-16% of severe pneumonia cases
confirmed with SARS-CoV-2 infection developed gastrointestinal symptoms such as abdominal
pain, vomiting, and diarrhea. Moreover, the stool of patient with COVID-19 also positive by
real-time reverse-transcriptase-polymerase-chain-reaction (rRT-PCR) assay. Furthermore,
elevated faecal calprotectin was observed in patients with COVID-19 suggested an inflammatory
response in the gut, which was significantly correlated with IL-6. For severe and critical
cases, control "cytokine storms" and maintain intestinal microenvironment balance have been
included into the Diagnosis and Treatment Guideline of patients with COVID-19 (Edition 7).
Berberine is a quaternary ammonium alkaloid isolated from rhizoma coptidis. It is often used
in treatment of infectious diarrhea by bacteriostasis and inhibition of intestinal gland
secretion. Berberine has also been found to have a role in intestinal immune regulation,
inhibiting both AP-1 and NF- B, the key factors in cell signal transduction, and reducing the
inflammatory response. Investigators conducted a prospective randomized controlled clinical
trial to investigate the effects of berberine on intestinal function, serum concentrations of
the inflammatory biomarkers, and organ function in severe patients with SARS-CoV-2 infection.
|
| NCT04480138 ↗ |
Pegylated Interferon - α2b With SARSCoV- 2 (COVID-19) |
Active, not recruiting |
Phase 2 |
2020-08-11 |
This is a phase II, multicenter, open-label, randomized, comparator-controlled study to
evaluate the efficacy and safety of Pegylated Interferon -α2b in the treatment of adult
patients diagnosed with SARS-CoV2 (COVID-19).Initial 1 mcg/kg of Pegylated Interferon-α2b
will be administered on day 1. After safety evaluation of first dose, next dose (second dose)
1 mcg/kg on day 8 will be administered with recommended standard care during the trial.
|
| NCT04482621 ↗ |
Decitabine for Coronavirus (COVID-19) Pneumonia- Acute Respiratory Distress Syndrome (ARDS) Treatment: DART Trial |
Recruiting |
Phase 2 |
2020-09-14 |
This is a a randomized double blind placebo controlled Phase 2 trial with a 12 patient
lead-in to evaluate safety, prior to full enrollment to an additional 28 patients (for a
total of 40 patients) to assess efficacy of decitabine in the treatment of critically ill
patients with COVID-ARDS. The patients will be randomized in a 1:1 ratio to receive standard
of care plus Decitabine or standard of care plus saline based placebo. The primary objective
is to determine safety and efficacy of decitabine for COVID-19 ARDS based on clinical
improvement on a 6-point clinical scale.
|
| NCT04482673 ↗ |
Vitamin D Supplementation in the Prevention and Mitigation of COVID-19 Infection |
Recruiting |
Phase 4 |
2020-07-31 |
The purpose of this study is to evaluate how useful vitamin D supplementation is in reducing
the severity of COVID-19 symptoms and the body's inflammatory and infection-fighting response
to COVID-19. Individuals ≥50 years of age and older who are tested for COVID-19 and negative
will be randomized (like flipping a coin) to either daily high dose vitamin D supplementation
(6000 IU vitamin D3/day) vs. standard of care. Those individuals ≥50 years of age or older
who test positive for COVID-19 at baseline will be randomized to bolus vitamin D (20,000
IU/day for 3 days) followed by high dose (6000 IU vitamin D/day) vs. standard of care for 12
months. All participants will receive a multivitamin containing vitamin D.
|
| NCT04482712 ↗ |
Effects of mTOR Inhibition With Sirolimus (RAPA) in Patients With COVID-19 to Moderate the Progression of ARDS |
Withdrawn |
Phase 1/Phase 2 |
2021-04-01 |
This study assesses the clinical effectiveness of mammalian target of rapamycin (mTOR)
inhibition with rapamycin in minimizing or decreasing the severity of acute lung injury/acute
respiratory distress syndrome (ALI/ARDS) in participants infected with mild to moderate
COVID-19 virus.
|
| NCT04483830 ↗ |
Suloexide in the Treatment of Early Stages of COVID-19 |
Completed |
Phase 2/Phase 3 |
2020-06-05 |
Problem:
The COVID- 19 pandemic has not only affected our healthcare system, but the impact on the
worldwide financial systems and our "normal" way of life is still to be determined.
Although the percentage of patients infected with COVID-19 that need hospital care is low,
Its high rate of contagiousness makes the total number of patients in need of hospital care
cripple any healthcare system, limiting the space available for other patients in need of
critical care, who cannot be admitted or even prefer not to attend the hospital in fear of
infection.
Early investigations report an Increase risk of thromboembolic complications, and a systemic
inflammatory response not clearly understood. There is a possible vascular endothelial
dysfunction due to chronic comorbidities (Hypertension, diabetes, obesity, chronic kidney
disease, lung disease) as a risk factor for a more severe presentation.
Justification:
Sulodexide is a two-compound drug, each of them with different endothelial action that can be
beneficial in COVID-19 patients.
Glycosaminoglycans: Can help restore venous and arterial endothelial glycocalyx which can
downregulate or limit the response to inflammatory molecules, by maintaining the integrity
lost in certain chronic diseases (high blood pressure, diabetes).
Heparin compound: It has an antithrombotic effect that could help reduce the incidence of
thromboembolic complications, and also add to the anti-inflammatory response due to it
anti-thrombin action (similar or a bit less to that of low molecular weight heparin) with
less risk of major bleeding.
It's a medication that can be used orally with minimal adverse effects and is less expensive
than low molecular weight heparin.
Hypothesis:
We hypothesize that sulodexide instituted early in populations at significant risk and
symptomatic patients affected with COVID-19 (shortness of breath, fever, weakness, diarrhoea)
and risk factors of diabetes, hypertension, COPD, atherosclerosis, chronic kidney disease,
will provide improvement in endothelial integrity, decrease inflammatory responses, and
improved clinical outcomes with decreased hospital admission, decrease VTE and arterial
complications, morbidity, and mortality.
Objective:
To use sulodexide in patients that have early onset of COVID-19 symptoms to mitigate the
progression of the disease process that can allow them to recover at home, and limit the need
of hospital care and a more severe clinical manifestation
|
| NCT04483960 ↗ |
Australasian COVID-19 Trial (ASCOT) ADAptive Platform Trial |
Recruiting |
Phase 3 |
2020-07-28 |
An International Multi-Centre Randomised Adaptive Platform Clinical Trial to Assess the
Clinical, Virological and Immunological Outcomes in Patients with SARS-CoV-2 Infection
(COVID-19).
|
| NCT04484493 ↗ |
Corticosteroid Nasal Spray in COVID-19 Anosmia |
Completed |
Phase 3 |
2020-08-08 |
The aim of this study is to evaluate the role of the topical corticosteroids nasal spray
(mometasone furoate nasal spray) in improving anosmia in patients recovered from COVID-19
infection.
|
| NCT04485130 ↗ |
DISulfiram for COvid-19 (DISCO) Trial |
Recruiting |
Phase 2 |
2021-05-01 |
Disulfiram (DSF) a safe, easily dosed, FDA-approved drug for the treatment of alcohol
dependence has been identified to be a potential therapeutic target for SARS-CoV-2 infection.
Disulfiram may have both antiviral (inhibiting viral replication via blocking the Mpro
protease and zinc ejection) and anti-inflammatory effects (via inhibition of NF-kB-induced
and NLRP inflammasome-induced cytokine release) on SARS-CoV-2. We will study oral disulfiram
given for 5 consecutive days (1000 mg/day in cohort 1; 2000 mg/day in cohort 2) in 60
symptomatic COVID+ individuals in a randomized (2:1) randomized, double blind
placebo-controlled trial evaluating disulfiram's effect on COVID-19 symptom severity,
SARS-CoV-2 viral load, and biomarkers of inflammation and pyroptosis (aberrant
pro-inflammatory cell death) over 31 days.
|
| NCT04486313 ↗ |
Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19 |
Completed |
Phase 3 |
2020-08-13 |
Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate
COVID-19
|
| NCT04486508 ↗ |
Intermediate-dose vs Standard Prophylactic Anticoagulation and Statin vs Placebo in ICU Patients With COVID-19 |
Completed |
Phase 3 |
2020-07-30 |
In a 2x2 factorial design randomized controlled trial, the investigators aim to elaborate the
safety and efficacy of two pharmacological regimens on outcomes of critically-ill patients
with COVID-19. The first randomization entails open-label assignment to intermediate versus
standard dose prophylactic anticoagulation. The investigators hypothesize that intermediate
dose compared with standard prophylactic dose anticoagulation will have a superior efficacy
with respect to a composite of venous thromboembolism (VTE), requirement for extracorporeal
membrane oxygenation (ECMO), or all-cause mortality. The second randomization will be
double-blind assignment of the included patients to atorvastatin 20mg daily versus matching
placebo. The hypothesis is that statin therapy, compared with placebo, will reduce the
composite of VTE, need for ECMO, or all-cause mortality.
|
| NCT04487444 ↗ |
Thymalfasin (Thymosin Alpha 1) to Treat COVID-19 Infection |
Recruiting |
Phase 2 |
2020-09-10 |
It is our hypothesis that a course of Ta1 administered to hospitalized individuals with
COVID-19 infection and lymphocytopenia will improve the time to recovery (primary objective)
and severity of infection (secondary objectives) compared to untreated individuals in the
same hospital with comparable lymphocytopenia.
After screening, hospitalized patients with COVID-19 and lymphocytopenia who meet the
inclusion criteria will receive Ta1 (1.6 mg) administered subcutaneously (SC) daily for 1
week. Individuals in the control arm will be followed on the identical protocol but will not
receive daily Ta1.
|
| NCT04487574 ↗ |
A Study to Assess the Efficacy and Safety of XC221 in Patients With COVID-19 |
Completed |
Phase 3 |
2020-07-25 |
The innovative drug XC221 100 mg tablet is designed for the treatment of COVID-19 (SARS-CoV-2
infection). A multicenter, adaptive, randomized, double-blind, placebo-controlled Phase III
clinical study is aimed to assess the efficacy and safety of XC221 100 mg tablet, in COVID-19
patients during a 14-day treatment.
The primary objective of the study is to demonstrate the efficacy of XC221 100 mg tablet (200
mg daily dose) in achieving clinical improvement of COVID-19 symptoms.
The secondary objective of the study is to evaluate the safety of XC221 100 mg tablet (200 mg
daily dose) in COVID-19 patients.
|
| NCT04487886 ↗ |
Duvelisib Ameliorates Manifestations of Pneumonia in Established Novel Coronavirus Infection (COVID-19) |
Recruiting |
Phase 2 |
2020-11-18 |
In this study, a total of 80 patients with severe coronavirus disease 2019 (COVID-19)
infection will be randomized to receive Duvelisib or a placebo. Participants will be enrolled
at Emory University Hospital and at the University of Pennsylvania and will be identified and
recruited by their treating physician and research team.
|
| NCT04488081 ↗ |
I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients |
Recruiting |
Phase 2 |
2020-07-31 |
The goal of this project is to rapidly screen promising agents, in the setting of an adaptive
platform trial, for treatment of critically ill COVID-19 patients. In this phase 2 platform
design, agents will be identified with a signal suggesting a big impact on reducing mortality
and the need for, as well as duration, of mechanical ventilation.
|
| NCT04491994 ↗ |
Clearing the Fog: Is Hydroxychloroquine Effective in Reducing COVID-19 Progression |
Completed |
Phase 3 |
2020-04-10 |
Brief Summary: Purpose of this study is to evaluate efficacy of hydroxychloroquine (HCQ) in
reducing progression of Corona Virus Disease 2019 (COVID - 19) and achieving viral clearance.
Condition or disease :I COVID-19 ntervention/treatment :Drug: Hydroxychloroquine Sulfate
Phase: Phase III
|
| NCT04492254 ↗ |
Early Prophylactic Low-molecular-weight Heparin (LMWH) in Symptomatic COVID-19 Positive Patients |
Recruiting |
Phase 3 |
2020-09-15 |
Evidence has shown that COVID-19 infections can lead to an increased risk of blood clots.
These blood clots can lead to individuals being admitted to hospital, or, unfortunately in
severe cases, death. Enoxaparin is a blood-thinning drug which has been used by doctors and
nurses in hospitals for many years to prevent the thickening of blood which may lead to a
clot. It is easier for doctors to prevent new blood clots from forming than treating existing
blood clots.
Currently, there are no treatments for COVID-19. There is an urgent need to find a safe and
effective treatment to prevent worsening of the disease that may lead to hospital admission
and/or death. The ETHIC (Early Thromboprophylaxis in COVID-19) study aims to find out if
giving enoxaparin in an early stage of the COVID-19 disease can prevent individuals being
admitted to hospital and/or death. The study will take place in approximately 8 to 10
countries, in approximately 30 to 50 centres.
Patients will be allowed to take part if they have had a confirmed COVID-19 infection, are ≥
55 years of age and have at least two of the following additional risk factors; age ≥ 70
years, body mass index > 25 kg/m2, chronic obstructive pulmonary disease, diabetes,
cardiovascular disease, or corticosteroid use.
Half the patients in the study will receive the blood-thinning drug enoxaparin for three
weeks, and half will receive no treatment. Individuals will be randomly allocated to one of
these groups. After 21 days, the number of patients in each group who were either admitted to
hospital, or died, will be compared. The number of patients in each group who developed a
blood clot (venous thromboembolism) will also be compared. Further comparisons will be made
at both 50 and 90 days after the beginning of the study.
|
| NCT04492501 ↗ |
Investigational Treatments for COVID-19 in Tertiary Care Hospital of Pakistan |
Completed |
N/A |
2020-04-01 |
Beyond supportive care, there are currently no proven treatment options for coronavirus
disease (COVID-19) and related pneumonia, caused by Severe Acute Respiratory Syndrome
Coronavirus 2 (SARS-CoV-2).Investigators have seen recently from experience in Western
countries with best health care systems that pandemics cannot be managed in hospitals.
Investigators have seen ICUs crowded to capacity, healthcare workers being exposed and going
to quarantine or dying after exposure to large doses of viral inoculums. Investigators
recommend that institutions should register for Clinical trials and consider emergency use of
TPE. In Pandemics, time is of essence to avoid mortality by intervening early with available
evidence, preferably as part of clinical trial.Since the outbreak of corona virus disease
(COVID-19), main treatment modalities have been antivirals, interferons, glucocorticoids,
anti-coagulants and supportive treatment in addition to traditional Chinese medicine. There
are also clinical trials exploring hydroxyquinoline / chloroquine sulphate, azithromycin,
immunoglobulins, Vitamin-C, washed microbiota, nebulized interferon, teicoplanin as well as
Mesenchymal stem cells. However, most of these trials were small and remain in the
experimental phase with currently no effective / specific antiviral with robust scientific
evidence as regards the mortality reduction in COVID-19.In an attempt to treat COVID-19,
investigator will use different investigational treatment either alone or in combination to
see mortality and morbidity benefit on the basis of limitted evidence available so far. These
investigational modalities include Therapeutic plasma exchange (TPE), Convalescent Plasma
(CP), Remdesivir, Tocilizumab and Mesenchymal stem cell (MSC) therapy in addition to standard
supportive treatment.
|
| NCT04492514 ↗ |
Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflation |
Recruiting |
Phase 2 |
2020-05-20 |
The purpose of this prospective, Phase 2, multicenter, blinded, randomized placebo controlled
study is to demonstrate that early treatment with mavrilimumab prevents progression of
respiratory failure in patients with severe COVID-19 pneumonia and clinical and biological
features of hyper-inflammation.
|
| NCT04492891 ↗ |
Cyclosporine For The Treatment Of COVID-19(+) |
Recruiting |
Phase 2 |
2020-11-23 |
Phase IIa clinical trial in which 75 non-ICU hospital inpatients will be randomized 2:1 to 7
days of an oral formulation of cyclosporine, Neoral (2.5mg/kg PO BID) + standard of care
(SOC) or no Neoral + SOC. The primary endpoint is disease severity based on the World Health
Organization (WHO) COVID Ordinal Outcomes Scale, on day 14. Secondary endpoints include
safety and changes in serum inflammatory markers.
|
| NCT04494399 ↗ |
IFN Beta-1b and Ribavirin for Covid-19 |
Recruiting |
Phase 2 |
2020-07-29 |
As of 1 July 2020, more than 10 million people been confirmed to have infected by SARS-CoV-2,
resulting in more than 500,000 deaths. No specific antiviral treatment for the SARS-CoV-2 is
currently available, but existing medication could be repurposed.
The investigators therefore propose to conduct an open-label randomized controlled trial on a
short course of interferon β-1b and ribavirin combination treatment for patients hospitalized
for COVID-19 infection.
|
| NCT04494724 ↗ |
Clazakizumab vs. Placebo - COVID-19 Infection |
Recruiting |
Phase 2 |
2020-07-13 |
The purpose of this study is to investigate the effectiveness and safety of treatment with
clazakizumab compared to a placebo (inactive substance). We are proposing to try this drug to
treat coronavirus disease 2019 (COVID-19) infection. Patients with COVID-19 infection have
been shown to have increases in certain inflammatory processes. Clazakizumab is an antibody
(immune system protein) that blocks certain inflammatory processes. The treatment plan is to
attempt to inhibit or block these inflammatory processes in order to try to limit the damage
COVID-19 causes to the lungs.
|
| NCT04495816 ↗ |
COVID-19 Anosmia Study |
Active, not recruiting |
Phase 2 |
2020-07-15 |
To capture the natural history of COVID-19 associated olfactory dysfunction as measured by
two patient reported outcome measures (SNOT-22, QOD-NS) and a 6-week BSIT with a comparison
to an intervention arm receiving daily omega-3 supplements.
|
| NCT04497649 ↗ |
Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients |
Recruiting |
Phase 2/Phase 3 |
2020-07-01 |
efficacy and safety of Sofosbuvir containing regimens in treatment of COVID-19 Egyptian
patients,
|
| NCT04497948 ↗ |
Acalabrutinib Study With Best Supportive Care in Participants Hospitalized With COVID-19 |
Terminated |
Phase 1 |
2020-09-21 |
Study D822FC00005 will investigate the Phamacokinetics, Safety and tolerability of
Acalabrutinib suspension when delivered via a nasogastric tube and co-administered with a
Proton Pump Inhibitor, in the treatment of COVID-19.
|
| NCT04498273 ↗ |
COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80 |
Active, not recruiting |
Phase 3 |
2020-09-07 |
A multi-center adaptive randomized placebo-controlled platform trial evaluating the efficacy
and safety of anti-thrombotic strategies in COVID-19 adults not requiring hospitalization at
time of diagnosis
|
| NCT04498936 ↗ |
Sofosbuvir/Ledipasvir and Nitazoxanide for Treatment of COVID-19 |
Completed |
Phase 4 |
2020-07-15 |
The efficacy of treating COVID-19 infection by using Sofosbuvir/Ledipasvir and Nitazoxanide
will be examined. Included patients will be into 3 groups. The 1st group will receive
Sofosbuvir/Ledipasvir plus the standard care treatment (SCT). The 2nd group will take
Nitazoxanide and SCT, while the 3rd group will receive only SCT. Then the clinical
improvement and the rate of PCR change from positive to negative will be evaluated in each
group.
|
| NCT04500067 ↗ |
Intravenous Immunoglobulin (IVIG, Bioven) Efficacy Assess for COVID-19 / SARS-CoV-2 Severe Pneumonia Complex Treatment |
Completed |
Phase 3 |
2020-05-07 |
Pneumonia caused by coronavirus infection COVID-19 is characterized by a combination of
several dangerous factors that consistently worsen the patient's condition: viral lung damage
early in the disease; a sharp increase in inflammation on the background of an unbalanced
immune response ("cytokine storm"); joining a bacterial infection.
The condition of patients deteriorates significantly mostly at cytokine storm development.
The damaging of a large volume of lung tissue leads to develops of respiratory failure,
respiratory distress syndrome, or shock. Ventilatory support becomes ineffective and patients
die.
There are reports of the effectiveness of Human Normal Immunoglobulin for Intravenous
Administration (IVIG) high doses when used as part of complex therapy in patients with
pneumonia caused by coronavirus COVID-19. In particular, IVIG has a positive effect on
survival rates, overall disease course, duration of stay in the intensive care unit, and
ventilatory support duration.
The probable mechanism of action of high-dose IVIG therapy is considered to be a regulatory
effect on the immune system. Similar is the known and confirmed effectiveness of IVIG for
autoimmune diseases (Kavasaky disease, Guillain Barre syndrome, Chronic inflammatory
demyelinating polyradiculoneuropathy, Multifocal motor neuropathy).
This trial to assesses the Efficacy of IVIG (medication trade name - Bioven, manufactured by
Biopharma Plasma LLC) in the High Immunomodulatory Dose in Complex Treatment of Severe
Pneumonia Caused by COVID-19 / SARS-CoV-2
|
| NCT04501783 ↗ |
Study of Efficacy and Safety of TL-FVP-t vs. SOC in Patients With Mild to Moderate COVID-19 |
Active, not recruiting |
Phase 3 |
2020-05-20 |
Randomized open-label multicenter parallel-group study of efficacy and safety of TL-FVP-t vs.
standard of care therapy in patients with mild to moderate coronavirus disease
(SARS-CoV-2/COVID-19)
|
| NCT04501796 ↗ |
A Trial of NT-I7 in COVID-19 (SPESELPIS) |
Recruiting |
Phase 1 |
2020-11-27 |
The main purposes of this study is to determine the following in participants with mild
coronavirus disease 2019 (COVID-19):
- Safety of a single dose of NT-I7
- The immunological effects of NT-I7 on peripheral lymphocyte counts in COVID-19 patients.
|
| NCT04502069 ↗ |
Treatment of COVID-19 With Opaganib in Patients With Pneumonia Requiring Oxygen |
Withdrawn |
Phase 1/Phase 2 |
2020-08-01 |
Patients diagnosed with COVID-19 infection will be offered treatment with Opaganib, 500 mg
Q12 hours. Opaganib will be continuously administered for up to 2 weeks, until discharged on
room air (if earlier than 2 weeks).
|
| NCT04502667 ↗ |
Efficacy of Vitamin D Treatment in Pediatric Patients Hospitalized by COVID-19 |
Recruiting |
Phase 3 |
2020-07-15 |
Open controlled clinical trial. Hospitalized pediatric patients with COVID-19 will be
included. Upon admission to hospital serum determination of vitamin D, interleukins, ferritin
and Dimer D will be performed. Subsequently, randomization will be performed to identify
which group the patient belongs. Adverse effects will be evaluated on a daily basis. Serum
levels of interleukin (IL) -2, 6, 7,10, ferritin and dimer-D will be taken at the beginning
of hospitalization and on the 7th day after admission. It will be recorded if the patient
presents deterioration of the respiratory function that requires endotracheal intubation and
/ or admission to intensive care and / or if he dies, and at what time of hospitalization
does this outcome occur. The study will culminate when the patient is discharged from
hospitalization.
|
| NCT04504734 ↗ |
Bucillamine in Treatment of Patients With COVID-19 |
Enrolling by invitation |
Phase 3 |
2020-11-27 |
This is a Phase 3, multi-center, randomized, double blind, placebo controlled, clinical study
of bucillamine (2 dosage levels) in patients with mild-moderate COVID-19. Patients will be
randomized 1:1:1 to receive bucillamine 100 mg 3 times a day (TID), bucillamine 200 mg TID or
placebo TID for up to 14 days. After the first interim analysis when a single dose is
selected, patients will then be randomized 2:1 to the selected bucillamine dose or placebo
The study will be overseen by an independent Data and Safety Monitoring Board (DSMB). Up to
10 centers in the United States will conduct this study. Up to 1000 patients will be enrolled
in this study. Patients will participate in the study approximately 45 days.
|
| NCT04504877 ↗ |
Burnout and Distress preventiOn With caNnabidiol in Front-line Health Care workerS deAling wIth COVID-19 |
Completed |
Phase 2/Phase 3 |
2020-06-16 |
The objective of this work is to monitor the level of stress and overload of a group of
front-line health workers (physicians, nurses and physiotherapists) who will participate in
the care of patients with COVID-19 at Hospital das Clínicas in Ribeirão Preto and its
Emergency Unit (HCRP), for four weeks, and evaluate the cannabidiol - CBD's effectiveness in
reducing stress for those who wish to use it.
|
| NCT04505592 ↗ |
Tenecteplase in Patients With COVID-19 |
Enrolling by invitation |
Phase 2 |
2020-09-25 |
This is a placebo-controlled, double blind, randomized, Phase II dose escalation study
intended to evaluate the potential safety and efficacy of tenecteplase for the treatment of
COVID-19 associated respiratory failure. The hypothesis is that administration of the drug,
in conjunction with heparin anticoagulation, will improve patients' clinical outcomes.
|
| NCT04505774 ↗ |
Accelerating COVID-19 Therapeutic Interventions and Vaccines 4 ACUTE |
Recruiting |
Phase 4 |
2020-09-04 |
This is a randomized, open label, adaptive platform trial to compare the effectiveness of
antithrombotic and additional strategies for prevention of adverse outcomes in COVID-19
positive inpatients
|
| NCT04508439 ↗ |
Effect of the Use of Anticoagulant Therapy During Hospitalization and Discharge in Patients With COVID-19 Infection |
Recruiting |
N/A |
2020-06-20 |
Viral infections provoke the systemic inflammatory response and cause an imbalance between
the procoagulant and anticoagulant homeostatic mechanisms. Multiple pathogenic mechanisms are
involved, including endothelial dysfunction, increased von Willebrand factor, Toll receptor
activation, and tissue factor pathway activation. D-dimer levels greater than 1000 ng / mL
are associated with an 18-fold increased risk of mortality. In this context, many patients
may require prophylaxis or antithrombotic treatment with low molecular weight heparins.
Currently, there is no validated scheme on the dose and timing of the use of antithrombotic
drugs.
The study aims to identify the effect of two anticoagulant strategies (prophylactic and
therapeutic) on the progression to ventilatory support or death in patients with COVID-19
infection who require hospital care.
|
| NCT04509973 ↗ |
Higher vs. Lower Doses of Dexamethasone for COVID-19 and Severe Hypoxia |
Active, not recruiting |
Phase 3 |
2020-08-27 |
We aim to assess the benefits and harms of higher (12 mg) vs lower doses (6 mg) of
dexamethasone on patient-centered outcomes in patients with COVID-19 and severe hypoxia.
|
| NCT04510038 ↗ |
Colchicine vs Current Standard of Care in Hospitalized Patients With COVID-19 and Cardiac Injury |
Suspended |
Phase 2/Phase 3 |
2020-01-01 |
Open-label randomized study comparing the current standard of care treatment of Covid-19 in
hospitalized patients with evidence of cardiac injury vs. a group of the same type of
patients treated with colchicine plus current standard of care.
|
| NCT04510402 ↗ |
Phase I/II Trial of Povidone-iodine (PVP-I) Nasal Swab For Preventing COVID-19 Spread in Healthy Subjects |
Not yet recruiting |
Phase 1/Phase 2 |
2020-08-01 |
Title: Phase I/II Trial (Safety and Dosing) of Povidone-iodine (PVP-I) Nasal Swab For
Preventing COVID-19 Spread in Healthy Subjects:
Summary: This study will evaluate in a PH I/II trial in healthy volunteers the safety and
tolerability of PVP-I nasal swabs daily application. The intent is to follow with a PH III
randomized controlled clinical trial to assess the capacity for PVP-I nasal swabs to mitigate
the transmission of respiratory viruses specifically COVID 19.
|
| NCT04511819 ↗ |
Losmapimod Safety and Efficacy in COVID-19 |
Terminated |
Phase 3 |
2020-08-28 |
The therapeutic hypothesis for the use of losmapimod in COVID-19 disease is that increased
mortality and severe disease is caused by p38 mitogen-activated protein kinase
(MAPK)-mediated exaggerated acute inflammatory response resulting from SARS-CoV-2 infection.
The study Sponsor hypothesize's that the early initiation of p38α/β inhibitor therapy in
patients hospitalized with moderate COVID-19 who are at increased risk of a poor prognosis
based on older age and elevated systemic inflammation will reduce clinical deterioration
including progression to respiratory failure and death.
To address this hypothesis, Fulcrum Therapeutics is conducting a Phase 3, multicenter,
randomized, double-blind, placebo-controlled study that will evaluate the safety and efficacy
of losmapimod versus placebo in subjects 50 and older who are hospitalized with moderate
COVID-19 disease.
|
| NCT04512079 ↗ |
FREEDOM COVID-19 Anticoagulation Strategy |
Recruiting |
Phase 4 |
2020-09-08 |
Coronavirus Disease (COVID-19), caused by severe acute respiratory syndrome coronavirus-2
(SARS-CoV-2), has led to unprecedented morbidity and mortality in the modern era. To date,
nearly 13 million people have contracted COVID-19, leading to more than 550,000 deaths
worldwide. As the number of affected individuals continues to climb, effective strategies for
treatment and prevention of the disease are of paramount importance. SARS-CoV-2 is understood
to directly invade cells via the human angiotensin-converting enzyme 2 (ACE2) receptor, which
is expressed predominantly in the lungs but also throughout the cardiovascular system. Thus,
while acute respiratory distress syndrome remains a feared complication, new thromboembolic
disease has emerged as a common and potentially catastrophic manifestation of COVID-19.
|
| NCT04513314 ↗ |
Valproate Alone or in Combination With Quetiapine for Severe COVID-19 Pneumonia With Agitated Delirium |
Not yet recruiting |
Phase 4 |
2022-11-01 |
The primary purpose of this research is to determine whether Valproate alone, and in
combination with Quetiapine, lowers confusion and agitation in persons with severe Corona
Virus Disease (COVID)19 pneumonia during weaning from the breathing machine (ventilator).
Though Valproate and Quetiapine are often given to persons with severe confusion with
agitation, the purpose of this small research study is specifically for: a) persons infected
with COVID 2019 on a ventilator whose agitation is not responding to the usual medications
(like dexmedetomidine), and b) to reduce the time persons are treated with dexmedetomidine,
which requires continuous close monitoring in an ICU.
|
| NCT04516759 ↗ |
AZD1656 in Diabetic Patients Hospitalised With Suspected or Confirmed COVID-19 |
Completed |
Phase 2 |
2020-08-12 |
The ARCADIA Trial is a randomised, double-blind, placebo-controlled clinical trial to assess
the safety and efficacy of AZD1656 in patients with either Type 1 or Type 2 diabetes,
hospitalised with COVID-19.
|
| NCT04516837 ↗ |
Eltrombopag Plus rhTPO Versus Eltrombopag for ITP During the COVID-19 Pandemic (ELABORATE-19) |
Recruiting |
Phase 2 |
2020-08-31 |
This is a prospective, multicenter, randomized, open-label study to investigate the efficacy
and safety of eltrombopag plus recombinant human thrombopoietin (rhTPO) versus eltrombopag as
treatment for corticosteroid-resistant or relapsed immune thrombocytopenia (ITP) during the
COVID-19 pandemic.
|
| NCT04516915 ↗ |
IMU-838 and Oseltamivir in the Treatment of COVID-19 |
Recruiting |
Phase 2 |
2020-06-15 |
To evaluate whether time-to-improvement is significantly better in IMU-838 plus Oseltamivir
(IONIC Intervention) and standard care vs. Oseltamivir and standard care in adult subjects
with coronavirus disease (COVID-19)
|
| NCT04517162 ↗ |
Intramuscular Effect of Polymerized Type I Collagen on the Cytokine Storm in COVID-19 Patients |
Recruiting |
Phase 1/Phase 2 |
2020-08-19 |
SARS-CoV-2 infection induces a hyperinflammatory syndrome, causing the acute respiratory
distress syndrome, massive lung cell destruction and, as a plausible sequelae, pulmonary
fibrosis in COVID-19 patients.
Current focus has been on the development of novel immunosuppressant therapies, in order to
control the cytokine storm in COVID-19 patients. Thus, the effect of steroids, intravenous
immunoglobulin, non-steroidal immunosuppressants, selective cytokine blockade, JAK/STAT
pathway inbhibition, and mesenchymal precursor cells have been evaluated. Based on the above
information, we propose COLLAGEN-POLYVINYLPYRROLIDONE (Distinctive name: FibroquelMR, active
substance: Collagen-polyvinylpyrrolidone, pharmaceutical form: intramuscular injectable
solution, with sanitary registration No. 201M95 SSA IV and SSA code: 010 000 3999) as a
potential drug for the downregulation of the cytokine storm. Polymerized type I collagen
reduces the expression of IL-1β, IL-8, TNF-alpha, TGF-β1, IL-17, Cox-1, leukocyte adhesion
molecules (ELAM-1, VCAM- 1 and ICAM-1), some other mediators of inflammation and increases
the levels of IL-10 and the number of regulatory T cells. In addition, it promotes the
mechanisms of inhibition of tissue fibrosis, without adverse effects in rheumatoid arthritis
and osteoarthritis.
|
| NCT04519125 ↗ |
Daily Regimen of Tenofovir/Emtricitabine as Prevention for COVID-19 in Health Care Personnel in Colombia |
Not yet recruiting |
Phase 2/Phase 3 |
2020-08-30 |
Effectiveness of the use of Tenofovir/Emtricitabine in addition to personal protective
equipment for the prevention of the transmission of SARS-COV-2 to health care personnel. A
Randomized Clinical Trial.
This is an experimental study whose aim is to evaluate the effectiveness of a drug to prevent
infection with the virus that causes COVID-19 (SARS-CoV-2), in health care workers.
The drug under study is Tenofovir /Emtricitabine, a well-known antiretroviral, which is safe
and is used as prophylaxis and treatment for HIV and other viral infections such as
Hepatitis.
Several laboratory-based studies indicate that this drug has the potential to inhibit
SARS-CoV-2 replication. In addition, one study in HIV infected persons found that those
taking Tenofovir /Emtricitabine tended to have a lower occurrence of COVID-19.
In this study, we will compare the occurrence of infection with SARS-CoV-2/ COVID19 in health
care workers between those assigned to an intervention group and those assigned to a control
group. The intervention group will receive Tenofovir /Emtricitabine during 60 days in
addition to the use of personal protective equipment (PPE), and the control group will
receive a placebo during 60 days in addition to the use of personal protective equipment
(PPE).
The study will recruit 950 health professionals above 18 and less than 70 years, working in
the emergency room, COVID wards and intensive care units of seven hospitals in Colombia.
To make the comparison groups very similar, the participants will be assigned through a
random mechanism to either the intervention (475), or the control (475) groups. In order to
prevent biases in the evaluation of the results, neither the participants nor the clinical
investigators, data managers, analysts and support personnel will know which intervention the
participants are receiving.
To determine the occurrence of infection with the virus the study will use both molecular
tests that detect the presence of viral genes in respiratory secretions, and serological
tests that detect the response of the immune system to the virus. The study will evaluate
also the safety of this drug determining the occurrence of adverse events.
|
| NCT04519385 ↗ |
Toclizumam Versus Dexamethasone in Severe Covid-19 Cases |
Completed |
N/A |
2020-03-01 |
randomized controlled trial comparing survival benefit of Tocilizumab therapy with
dexamethasone in patients with severe COVID 19
|
| NCT04521400 ↗ |
the Investigation Into Beneficial Effects of High-dose Interferon Beta 1-a, Compared to Low-dose Interferon Beta 1-a in Moderate to Severe Covid-19 |
Not yet recruiting |
Phase 2 |
2020-08-20 |
The present study is a randomized clinical trial, with the approval of the ethics committee
will be conducted on patients who have a positive test confirming COVID-19 in Loghman Hakim
Medical Education Center in Tehran. Patients will be randomly assigned to the two arms of the
study and after completing the course of treatment and collecting and analyzing the necessary
information from each patient, the results of the study will be published both on this site
and in the form of an article in a reputable international journal.
|
| NCT04523090 ↗ |
Catalysing the Containment of COVID-19 |
Recruiting |
Phase 2/Phase 3 |
2020-08-27 |
COVID-19 due to SARS-CoV-2 infection is a rapidly escalating global pandemic for which there
is no proven effective treatment. COVID-19 is multi-dimensional disease caused by viral
cytopathic effects and host-mediated immunopathology. Therapeutic approaches should logically
be based on interventions that have direct anti-viral effects and favourably modulate the
host immune response. Thus, an optimal drug regimen in ambulatory patients should
collectively (i) target and reduce viral replication, (ii) upregulate host innate immune
anti-viral responses, (iii) have favourable immunomodulatory properties, and (iv) minimise
disease progression to hospitalisation thus circumventing the 'cytokine storm' that likely
underpins ARDS and multi-organ failure.
Nitazoxanide (NTZ) is an antiprotozoal drug that is FDA-approved for treating Cryptosporidium
and Giardia and has an excellent safety record for a variety of indications, but primarily as
an anti-parasitic agent. It has proven broad anti-viral activity as it amplifies cytoplasmic
RNA sensing, potently augments type I interferon and autophagy-mediated anti-viral responses,
has immunomodulatory properties e.g inhibits macrophage IL-6 production, and interferes with
SARS-CoV-2 glycosylation. It has been shown to have anti-viral activity against several
viruses including Ebola, influenza, hepatitis B and C, rotavirus and norovirus.
With regard to respiratory viral infections, NTZ was evaluated in uncomplicated influenza and
demonstrated a reduction in the median time to symptom recovery. By contrast, NTZ failed to
show benefit in hospitalised patients with severe influenza suggesting that, as with
oseltamivir (Tamiflu), it likely needs to be administered early in the course of the disease.
NTZ has proven in vitro activity against SARS-CoV-2. NTZ inhibited the SARS-CoV-2 at a
low-micromolar concentrations and in vivo evaluation in patients with COVID-19 has been
strongly recommended. NTZ has an excellent drug-drug interaction profile. No clinically
significant interactions are expected with commonly used antihypertensive agents,
anti-diabetics drugs, antiretroviral agents, steroids or commonly prescribed
analgesics/anti-inflammatory agents.
The investigators propose NTZ for the treatment of mild COVID-19 in non-hospitalised patients
with HIV co-infection and/or enhanced risk for progression to severe disease (age >35 years
and/or with comorbidity). The investigators will perform a randomised controlled trial
enrolling 440 patients with mild disease. The primary outcome measure will be the proportion
progressing to severe disease (hospitalisation) based on the WHO clinical progression scale
(stage 4 and beyond). Secondary outcome measures will include disease rates in contacts and
effect on viral load, productive infectiousness using viral cultures, and ability to abrogate
the generation of infectious aerosols using novel cough aerosol sampling technology.
Recruitment is stratified and thus the study is powered to detect progression to severe
disease in HIV-infected persons.
|
| NCT04523181 ↗ |
Double-blind Study to Evaluate the Safety and Efficacy of Antroquinonol in Mild-Moderate COVID-19 Hospitalized Patients |
Recruiting |
Phase 2 |
2020-10-08 |
To evaluate the safety andefficacy of antroquinonol treatment of mild to moderate pneumonia
due to COVID-19, as measured by the proportion of patients alive and free of respiratory
failure.
|
| NCT04523246 ↗ |
Training the Innate Immune System Against SARS-CoV-2 (COVID-19) Using the Shingrix Vaccine in Nursing Home Residents |
Recruiting |
Early Phase 1 |
2020-09-01 |
The purpose of this study is to measure the effect of the Shingrix vaccine on your immune
system and whether that has any effect on the body's ability to fight off other infections
such as COVID-19. We hypothesize that:
H1: Shingrix vaccination will elevate acute and trained immunity
H2: For 6 months following the first injection, increased levels of acute and trained
immunity is associated with less disease, including fewer hospitalizations and deaths
associated with flu, pneumonia, and COVID-19.
|
| NCT04523831 ↗ |
Clinical Trial of Ivermectin Plus Doxycycline for the Treatment of Confirmed Covid-19 Infection |
Completed |
Phase 3 |
2020-06-01 |
On 31 December 2019, the World Health Organization (WHO) was formally notified about a
cluster of cases of pneumonia in Wuhan City, China. On 7 January the responsible virus was
isolated and its genome sequence was shared on 12 January. It was named as COVID-19, a novel
Coronavirus, SARS-CoV-2. It is a member of the Corona virus family which is RNA enveloped
viruses.
Very rapidly the virus emerged as pandemic. Now it is dominating the lives of every people of
this universe. Management of the COVID-19 relies on mainly supportive care and oxygen
supplementation via non-invasive or mechanical ventilation in critical cases. Patients who
are critically ill may also require vasopressor support and antibiotics for secondary
bacterial infections.
There is no vaccine or highly effective antiviral drugs for COVID-19. Currently there is a
tremendous effort around the world to develop effective preventive and therapeutic treatment
for this disease.
World Health Organization has launched a non-blinded clinical trial (SOLIDARITY) to evaluate
four candidate treatments (remdesivir, lopinavir/ritonavir, lopinavir/ritonavir/ interferon
beta-1a, and chloroquine or hydroxychloroquine) versus standard of care in 18 countries
worldwide. RECOVERY trial one of the largest trials to see the efficacy and safety of
hydroxychloroquine revealed that they are no clear cut clinical benefit for COVID-19. Other
drugs in the SOLIDARTY trial are quite expansive for resource limited countries like
Bangladesh.
Study Published in the American Journal of Tropical Medicine advocates further research into
Ivermectin for COVID-19 Treatment. The spotlight on Ivermectin was brought by Australian
researchers from Monash University who demonstrated its efficacy against the SARS-CoV-2
coronavirus in vitro studies.
In different study Doxycycline also showed promising results in treatment of COVID 19
infection. It is highly lipophilic antibiotics that are known to chelate zinc component of
matrix metalloprotienases (MMP). Corona viruses are known to rely heavily of MMPs for
survival, cell infiltration and replication. It also has an anti-inflammatory effect which
might be effective in combating cytokine storm of Covid-19 infection.
So it have been planned to conduct an experimental clinical trial using combination of
ivermectin and doxycycline for treatment of COVID 19 along with the other standard care.
|
| NCT04525820 ↗ |
High Dose Vitamin-D Substitution in Patients With COVID-19: a Randomized Controlled, Multi Center Study |
Active, not recruiting |
N/A |
2020-12-15 |
The world is currently facing a pandemic with the coronavirus (SARS-CoV-2) which leads to the
disease of COVID-19. Risk factors for a poor outcome of COVID-19 have so far been identified
as older age and co-morbidity including chronic respiratory conditions such as chronic
obstructive pulmonary disease (COPD) and current smoking status. Previous studies found, that
vitamin D deficiency is more prevalent among patients with these risk factors. There are
observational studies reporting independent associations between low serum concentrations of
25-hydroxyvitamin D (the major circulating vitamin D metabolite) and susceptibility to acute
respiratory tract infection.
Vitamin D substitution in patients with COVID-19 who show a vitamin D deficiency should
therefore be investigated for efficacy and safety.
The study is designed as a randomized, placebo-controlled, double blind study. The objective
of the study is to test the hypothesis that patients with vitamin D deficiency suffering from
COVID-19 treated under standardized conditions in hospital will recover faster when
additionally treated with a single high dose of vitamin D compared to standard treatment
only.
|
| NCT04526821 ↗ |
Lactoferrin for Prevention of COVID-19 in Health Care Workers |
Terminated |
Phase 2 |
2020-10-17 |
Clinical trial in health care personnel (physicians, nurses or nurse assistants) to determine
the effect of orally-administered bovine lactoferrin to prevent SARS-CoV-2 infection.
Participants will be randomized to receive daily bovine lactoferrin plus standard measures
during 12 weeks or placebo (maltodextrine) for the prevention of SARS-CoV-2. The target
enrollment is 336 participants. Each study participant will be monitored twice a week for
symptoms of COVID-19 and if symptoms occur, a RT-PCR will be performed. Additionally, we will
evaluate asymptomatic infections, by measuring SARS-CoV-2 serology every 4 weeks.
|
| NCT04527211 ↗ |
Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel |
Not yet recruiting |
Phase 3 |
2020-09-07 |
It will be performed a randomized, multicenter, triple-masked, placebo-controlled clinical
experiment to determine the effectiveness and safety of the administration to of ivermectin
at a dose of 200 mcg/kg once a week for 7 weeks in a prophylactic treatment against SARS
COV-2 infection in 550 Colombian health workers during the COVID-19 pandemic.
|
| NCT04527354 ↗ |
Pilot Study to Assess Efficacy and Safety of Treamid in the Rehabilitation of Patients After COVID-19 Pneumonia |
Completed |
Phase 2 |
2020-09-01 |
The innovative drug Treamid is planned for use in the rehabilitation of patients after
COVID-19 pneumonia in a pilot, multicenter, randomized, double-blind, placebo-controlled
Phase II clinical study to assess the efficacy and safety of Treamid, tablets, 50 mg in
patients with fibrotic changes in the lungs after COVID-19 pneumonia during a 28-day
treatment.
The primary objective of the study is to demonstrate the efficacy of Treamid tablet, 50 mg in
change in forced vital capacity (FVC) and/or diffusing capacity of lung for carbon monoxide
(DLCO) at Week 4.
The secondary objective of the study is to evaluate the safety of Treamid tablet, 50 mg and
pharmacokinetics (PK).
|
| NCT04528667 ↗ |
Study of the Safety and Efficacy of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized Due to COVID-19 |
Completed |
Phase 2 |
2021-01-06 |
A phase 2, placebo-controlled study of the safety and efficacy of STI-5656 (Abivertinib
Maleate) in subjects hospitalized due to COVID-19
|
| NCT04528888 ↗ |
Steroids and Unfractionated Heparin in Critically Ill Patients With Pneumonia From COVID-19 Infection |
Recruiting |
Phase 3 |
2020-11-25 |
SARS-CoV-2 infection seems to induce in most critical cases an excessive and aberrant
hyper-inflammatory host immune response that is associated with a so-called "cytokine storm",
moreover pro-thrombotic derangements of haemostatic system is another common finding in most
severe forms of COVID19 infections, which may be explained by the activation of coagulative
cascade primed by inflammatory stimuli, in line with what is observed in many other forms of
sepsis. Targeting inflammatory responses exploiting steroids' anti-inflammatory activity
along with thrombosis prevention may be a promising therapeutic option to improve patients'
outcome. Despite the biological plausibility, no good evidence is available on the efficacy
and safety of heparin on sepsis patients, and many issues have to be addressed, regarding the
proper timing, dosages and administration schedules of anticoagulant drugs. The primary
objective is to assess the hypothesis that an adjunctive therapy with steroids and
unfractionated heparin (UFH) or with steroids and low molecular weight heparin (LMWH) are
more effective in reducing any-cause mortality in critically-ill patients with pneumonia from
COVID- 19 infection compared to low molecular weight heparin (LMWH) alone. Mortality will be
measured at 28 days. The study is designed as a multicenter, national, interventional,
randomized, investigator sponsored, three arms study. Patients, who satisfy all inclusion
criteria and no exclusion criteria, will be randomly assigned in a ratio 1:1:1 to one of the
three treatment groups: LMWH group, LMWH+steroids or UFH+steroid group. A possible result
showing the efficacy of the composite treatment in reducing the mortality rate among
critically ill patients with pneumonia from COVID-19 infection will lead to a revision of the
current clinical approach to this disease.
|
| NCT04529499 ↗ |
Clinical Trial Evaluating the Efficacy and Safety of Favipiravir in Moderate to Severe COVID-19 Patients |
Active, not recruiting |
Phase 3 |
2020-08-20 |
This is a prospective, interventional, multi-centre, phase III, randomized, double blind,
placebo-controlled, parallel design trial to evaluate the efficacy, safety and tolerability
of favipiravir as adjunct ('add on') to supportive care, in comparison to placebo with
supportive care, in the acute treatment of patients who have tested positive for SARS-CoV-2
and presenting with moderate to severe COVID-19.
This study will be conducted in two parts; Stage I - Main study and Stage II - Extended
Follow up.
|
| NCT04530578 ↗ |
Nebulized Heparin in Severe Acute Respiratory Syndrome COVID-19 |
Recruiting |
Phase 4 |
2020-06-01 |
To evaluate the safety and efficacy of the use of inhalational heparin in patients with
pulmonary compromise / pneumonia / SARS associated with COVID-19, laboratory with marked
inflammation parameters, and prothrombotic state secondary to it (Fibrinogen, Ferritin and /
or elevated D-Dimer) , from admission to hospitalization.
The combination of inhalation heparin combined with prophylactic doses of LMWH could reduce
the progression to severe forms of the disease, and consequently the need for intensive care
units and mechanical ventilation.
|
| NCT04530617 ↗ |
Camostat and Artemisia Annua vs Placebo in COVID-19 Outpatients |
Terminated |
Phase 2 |
2020-10-05 |
This is a randomized, double-blind, placebo-controlled, multi-arm, multicenter, phase II
trial design to allow a rapid efficacy and toxicity assessment of potential therapies
(camostat mesilate and artemisia annua) immediately after COVID-19 positive testing in mild
to moderate disease and high-risk factors such as diabetes, hypertension, and obesity among
others.
|
| NCT04531748 ↗ |
Selective Estrogen Modulation and Melatonin in Early COVID-19 |
Withdrawn |
Phase 2 |
2021-12-01 |
This study is a randomized, double-blind, controlled clinical trial to evaluate the effects
of toremifene and/or melatonin in adults with mild COVID-19.
|
| NCT04532372 ↗ |
Leflunomide for the Treatment of Severe COVID-19 in Patients With a Concurrent Malignancy |
Recruiting |
Phase 1/Phase 2 |
2020-10-23 |
This phase I/II trial investigates the best dose and side effects of leflunomide and how well
it works in treating patients with COVID-19 and a past or present cancer. Leflunomide has
been used since the 1990s as a treatment for rheumatoid arthritis. Experiments done with
human cells that were given severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the
virus causing COVID-19, showed that leflunomide was able to reduce the ability of the virus
to make copies of itself. The coronavirus uses ribonucleic acid (RNA), a very long molecule
that contains genetic information that is like a blueprint for making more copies of itself.
Leflunomide inhibits the formation of RNA. The information gained from this study may help
researchers to learn whether leflunomide is safe for use in treating patients with COVID-19,
and whether it is potentially effective against the disease.
|
| NCT04532554 ↗ |
Growth Hormone in Obese Cases With Covid-19 |
Withdrawn |
Phase 4 |
2020-10-26 |
The use of growth hormone in obese cases with COVID-19 may help them to recover earlier.
|
| NCT04533347 ↗ |
Tafenoquine in Patients With Mild to Moderate COVID-19 |
Active, not recruiting |
Phase 2 |
2021-02-19 |
A clinical study to assess the efficacy and safety of oral tafenoquine compared to placebo in
patients with mild to moderate COVID 19 disease.
|
| NCT04534478 ↗ |
Oral Prednisone Regimens to Optimize the Therapeutic Strategy in Patients With Organizing Pneumonia Post-COVID-19 |
Not yet recruiting |
Phase 4 |
2020-09-07 |
Background: Based on data from the 2003 SARS-COVID pandemic, other serious lung infections,
and patients with respiratory distress, it is estimated that 10-30% of patients with severe
SARS-COVID-2 pneumonia may present as a sequel an organized pneumonia. The treatment of this
complication is not well defined. The use of oral corticosteroids is mandatory to avoid a
possible evolution to pulmonary fibrosis, however, the doses to be administered and the
duration of treatment are unknown as there is no study specifically aimed at solving this
doubt. Many authors advocate high-dose treatment regimens for a minimum of six months, as
proposed for cryptogenic organized pneumonia. However, there is a question whether in
non-idiopathic cases of organized pneumonia, less intense treatment could resolve the
disease. Hypothesis: The use of a less intensive prednisone regimen may be sufficient for
therapeutic control in patients with post-COVID-19 organizing pneumonia, in relation to the
established standard regimen Simplicity of the procedures: The objective of the NORCOVID
study is to identify the optimal treatment regimen with corticosteroids in post-COVID19
patients diagnosed with NO. Specifically, the primary objective of this multicenter
randomized trial is to evaluate whether treatment with a less intensive regimen of
corticosteroids produces a non-inferior therapeutic effect than the established control
regimen. Secondary objectives are to evaluate the effect of treatment on secondary efficacy
variables and on safety. DLCO, respiratory function tests, 6MWT test, need for rescue,
radiological tests, complications, mortality and the WHO ordinal scale will be evaluated.
|
| NCT04534673 ↗ |
Pegylated Interferon Lambda for Treatment of COVID-19 Infection |
Recruiting |
Phase 2 |
2020-08-05 |
A randomized, open-label, 2 arm, pilot trial of Lambda 180 mcg administered subcutaneously
once weekly, for up to two weeks (2 injections at most), in addition to standard supportive
care, compared to standard supportive care alone, in a population of COVID-19 infected
patients.
patients will be randomized according to 1:1 ratio to one of the 2 trial arms: Lambda 180 mcg
S.C + standard care (intervention arm) or standard care only (control arm).
|
| NCT04534803 ↗ |
BCG Against Covid-19 for Prevention and Amelioration of Severity Trial (BAC to the PAST) |
Withdrawn |
Phase 3 |
2021-09-01 |
The purpose of this study is to assess the efficacy of Bacille Calmette-Guérin (BCG)
vaccination compared to placebo in reducing severe Covid-19 disease among elderly residents
of skilled nursing facilities. The investigators hypothesize that BCG vaccination can reduce
severity of Covid-19 disease. Patients who are residents of participating long-term care
facilities (LTCFs), with the ability to understand and cooperate with study procedures, who
agree to participate in the study will be randomly assigned to receive BCG vaccination or a
placebo. Participants will be followed for up to twelve months to assess severity of Covid-19
outcomes.
|
| NCT04535700 ↗ |
Clinical Trial of Pioglitazone Treatment in Patients With Type 2 Diabetes Mellitus and Covid-19 |
Recruiting |
Phase 4 |
2020-09-18 |
The treatment with pioglitazone added to the standard treatment of patients with DM2
hospitalized for COVID-19 may produce a decrease in the number of patients who progress to a
second phase of severe systemic inflammation.
|
| NCT04535791 ↗ |
Efficacy of Vitamin D Supplementation to Prevent the Risk of Acquiring COVID-19 in Healthcare Workers |
Recruiting |
Phase 3 |
2020-07-15 |
In a blinded randomized clinical trial, which will include health workers (doctors,
residents, nurses, stretcher-bearers, technicians, hygiene and cleaning) who are members of
the health teams that care for patients with COVID-19. Two groups will be formed: the Vitamin
D group taking 4,000 IU orally daily for 30 days, the control group being given a placebo
during the same time period.
Participants will be adults, who have not had COVID-19 disease, and who sign the informed
consent. At the beginning of the study anthropometric variables (weight, height, BMI) will be
taken, the short medical history can be identified to identify comorbidities, and a fasting
blood sample will be taken to determine changes in Vitamin D (25 (OH) Vitamin D), in addition
to RT-PCR saliva samples, as well as detection of serum antibodies to determine whether or
not they have SARS-CoV-2 disease. Participants will follow each other 45 days. Those with
COVID-19 disease will be monitored frequently to determine the course of the disease. At the
end of 45 days, new samples will be taken to determine levels of vitamin D and antibodies
against SARS-Cov-2.
|
| NCT04535856 ↗ |
Therapeutic Study to Evaluate the Safety and Efficacy of DW-MSC in COVID-19 Patients |
Completed |
Phase 1 |
2020-11-14 |
This is a phase 1 clinical trial to verify the safety and efficacy of DW-MSC in COVID-19
patients. A total of 9 subjects are randomly allocated. Subjects who meet the final inclusion
and exclusion criteria are randomized to the test groups (low-dose group and high-dose group)
or control group (placebo group) in a ratio of 1:1:1. Subjects assigned to the test groups
were administered intravenously once with 5 x 10^7cells of DW-MSC for the low-dose group or 1
x 10^8cells for the high-dose group after registration. Subjects assigned to the control
group were administered with placebo in the same manner as the test drug (DW-MSC). At this
time, all of the existing standard co-treatment are allowed. DW-MSC is adjunct therapy to
standard therapy.
This clinical trial is a double-blind trial, in which a randomized method will be used. To
maintain the double-blindness of the study, statistician who do not participate in this study
independently generate randomization code. Subjects will be randomized to the test groups
(low-dose group and high-dose group) or the control group (placebo group) in a 1:1:1 ratio.
After the completion of the trial, the randomization code will be disclosed after unlocking
the database and unblinding procedures. Follow Up period: observed for 28 days after a single
administration
|
| NCT04535869 ↗ |
Efficacy and Safety of Direct Anti HCV Drugs in the Treatment of SARS-COV-2 (COVID-19) |
Recruiting |
Phase 3 |
2020-12-28 |
COVID 19 which started from a zoonotic transmission related to crowded markets was confirmed
to have a high potential for transmission to close contacts on 20 January 2020 by the
National Health Commission of China and it was announced as a pandemic by the WHO on 11 March
2020.
There is currently no clinically proven specific antiviral agent available for SARS-CoV-2
infection. Supportive treatment, including oxygen therapy, conservation fluid management, and
broad-spectrum antibiotics to cover secondary bacterial infection, remains the most important
management strategy.
Interestingly, sofosbuvir has recently been proposed as an antiviral for the SARS-CoV-2 based
on the similarity between the replication mechanisms of the HCV and the coronaviruses.
Aim of our study is to assess the safety and efficacy of of the addition of HCV treatment to
the standard regimen for the treatment of patients according to MOHP protocol.
|
| NCT04536090 ↗ |
Study of Isoquercetin (IQC-950AN) Plus Standard of Care Versus Standard of Care Only for the Treatment of COVID-19 |
Not yet recruiting |
Phase 2 |
2022-01-01 |
This is an open-label, randomized, multi-centre study where hospitalized subjects will be
randomized in a 2:1 ratio to receive Isoquercetin (IQC-950AN) in addition to standard of care
or standard of care only for 28 days following confirmation of a COVID-19 infection.
|
| NCT04536350 ↗ |
Inhaled Aviptadil for the Treatment of COVID-19 in Patients at High Risk for ARDS |
Recruiting |
Phase 2 |
2021-05-18 |
The world is currently experiencing a coronavirus (CoV-2) pandemic. A new (SARS)-CoV
infection epidemic began in Wuhan, Hubei, China, in late 2019; originally called 2019- nCoV
the virus is now known as SARSCoV- 2 and the disease it causes COVID-19. Previous CoV
epidemics included severe acute respiratory syndrome (SARS)-CoV, which started in China in
2003 and Middle East respiratory syndrome (MERS)-CoV in the Middle East, which started in
2012. The mortality rates were >10% for SARS and >35% for MERS. The direct cause of death is
generally due to ensuing severe atypical pneumonia and ensuing acute respiratory distress
syndrome (ARDS). Pneumonia also is generally the cause of death for people who develop
influenza, although the mortality rate is lower (1%-3% for the influenza A H5N1 pandemic of
1918-1919 in the United States). Risk factors for a poor outcome of SARS-CoV-2 infection have
so far been found to include older age and co-morbidities including chronic cardiovascular
and respiratory conditions and current smoking status. In May 2020, the FDA authorized the
emergency use of remdesivir for treatment of COVID-19 disease based on topline date of two
clinical trials, even though an underpowered clinical trial did not find significant
improvement in COVID- 19 patients treated with remdesivir. Nevertheless, remdesivir is the
first and so far, only approved treatment for COVID-19. Additionally further trials and
clinical observations have not found a significant benefit of other antiviral drugs. Although
the results of several studies are still pending, there is still a desperate need for an
effective, safe treatment for COVID-19. Aviptadil, which is a synthetic form of Human
Vasoactive Intestinal Polypeptide (VIP), might be beneficial in patients at risk of
developing ARDS. Nonclinical studies demonstrate that VIP is highly concentrated in the lung,
where it reduces inflammation.
|
| NCT04536363 ↗ |
Cri Analog PG1 Effectiveness and Safety in Covid-19 |
Not yet recruiting |
Phase 2 |
2020-10-01 |
The Clinical trial aim to evaluate the effectiveness and safety of the administration of the
intravenous prostaglandin E1 analog in the reduction of mortality and complications of
patients with COVID-19 diagnosis. Therefore the investigators propose an open randomized
clinical trial in the Fundación Santa Fe de Bogota
|
| NCT04537585 ↗ |
COVID-19: Collecting Measurements of Renin-angiotensin-system Markers, Such as Angiotensin-2 and Angiotensin 1-7 |
Not yet recruiting |
N/A |
2020-11-01 |
Investigators study meet the World Health Organization definition of a clinical trial because
it is a prospective study in which participants will be assigned to intervention groups to
investigate the effects on health outcomes. Investigators highlighted clearly the real
problem that indigeneous patients are facing now in the Democratic Republic of the Congo:
Poverty meaning the lack of money to buy goods and drugs. From the news report, investigators
learned that "In the Democratic Republic of the Congo, indigenous communities in Kananga,
Tshikapa and in the Kasai region are increasing their consumption of "Vernonia amygdalina," a
traditional plant believed to cure several diseases, including alleviating COVID-19." Based
on an unpublished work, quite a few extract molecules of Vernonia amygdalina are excellent
antiviral candidates which are the family members of Remdesivir in terms of their antiviral
mechanisms. Furthermore, the antiviral capabilities of these molecules are significantly
stronger than or at least equivalent to Remdesivir. The target zones of these molecules in
the human body cover a set of important organs and tissues. For example, Vernolide (C19H22O7)
is able to reside firmly at bronchi, the upper respiratory tract, and blood vessels.
From the news report, investigators learned also that Herbs used in Tanzania include lemon,
ginger, neem tree leaves, mango tree leaves, orange tree leaves. These traditional medicines
contain, more or less, antiviral molecules whose capacities range from good to outstanding
levels. Those herbs have been used worldwide to fight COVID-19.
In conclusion traditional medicines have been playing important roles not only in Africa but
also in Asia, in South America, etc. Herbs prove themselves with effective efficacies in many
therapeutic practices.
So maybe after careful considerations, the World Health Organization may support the use of
herbs for poor patients who cannot afford modern drugs and used traditional medicines after a
positive COVID-19 test in the Democratic Republic of the Congo. Investigators are talking
about a randomisation's nuance process to follow participants who decide by themselves if
diagnosed positive to COVID-19 to begin to take herbs not waiting for a physician
prescription.
|
| NCT04539275 ↗ |
COVID-19 (VA CURES-1) |
Completed |
Phase 3 |
2020-11-16 |
The purpose of this study is to determine if treatment with convalescent plasma improves the
clinical outcomes of Veterans who are hospitalized and require supplemental oxygen due to
COVID-19.
|
| NCT04539626 ↗ |
Estrogen Therapy in Non-severe COVID-19 Patients |
Recruiting |
N/A |
2020-10-01 |
The primary objective of this study is to evaluate the effect of additional estradiol
estrogen therapy on clinical response and mortality in non-severe COVID-19 patients
|
| NCT04539873 ↗ |
Impact of Colchicine in Hospitalized Colombian Patients With COVID-19 |
Not yet recruiting |
Phase 3 |
2021-04-30 |
This is a phase IIIa, prospective, open-label, randomized, parallel-group study designed to
evaluate the efficacy and safety of oral colchicine plus standard therapy versus standard
therapy in the clinical course of SARS-CoV-2 infection, in a population group with moderate
COVID-19 compromise and requiring hospitalization.Aproximately 120 subjects meeting all
inclusion and not inclusion criteria will be randomized to receive either Colchicine plus
standard treatment or only standard treatment for 15 days
|
| NCT04540120 ↗ |
Safety and Efficacy of Dapansutrile for Treatment of Moderate COVID-19 Symptoms and Evidence of Early Cytokine Release Syndrome |
Recruiting |
Phase 2 |
2020-09-25 |
The purpose of this study is to assess the safety and efficacy of orally administered NLRP3
inhibitor, dapansutrile, for the treatment of moderate COVID-19 symptoms and early cytokine
release syndrome (CRS) in patients with confirmed SARS-CoV-2 infection and moderate symptoms.
Coronavirus disease 2019 (COVID-19) is caused by infection from a new strain of severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2). COVID-19 is characterized by fever, cough
and shortness of breath, which in certain patients can lead to systemic organ failure and
mortality.
The data show that SARS-CoV-2 activates the innate immune signaling sensor NLRP3. Activation
of NLRP3 initiates the cytokine release syndrome (CRS), which includes the production of
primary cytokine, IL-1, triggering an intense inflammatory response that is prevalent in
symptomatic COVID-19 patients. When CRS advances further to a fulminant 'cytokine storm', the
data show that respiratory distress syndrome and multiple-organ failure take place.
A specific inhibitor of NLRP3, dapansutrile may reduce or prevent the hyperinflammation
associated with CRS by inhibiting the production of IL-1β early to arrest the progression to
a severe 'cytokine storm.' The end result would be a reduction in the need for COVID-19
patients to receive intensive medical treatment, allowing for fewer hospitalizations,
administration of mechanical ventilation and deaths.
|
| NCT04541979 ↗ |
Aerosoliserat DNase for Treatment of Respiratory Failure in Severe COVID-19 |
Recruiting |
Phase 2 |
2020-06-04 |
Recent observations have suggested a role of neutrophil extracellular traps (NETs) in the
pathophysiology of severe COVID-19. The aim of the study is to assess efficacy and safety of
aerosolized DNase I to remove NETs and decrease respiratory distress in patients with
COVID-19.
|
| NCT04542408 ↗ |
Hamburg Edoxaban for Anticoagulation in COVID-19 Study |
Recruiting |
Phase 3 |
2020-11-12 |
Hero-19 aims to evaluate if an intensive anticoagulation strategy using Edoxaban on top of
standard of care (SOC) of COVID-19 therapy is superior to SOC (in-hospital moderate
anticoagulation strategy = low-dose low-molecular weight heparin [LMWH], ambulatory no
anticoagulation, i.e. placebo within this trial) in reduction of morbidity and mortality
endpoints in patients with COVID-19.
|
| NCT04542694 ↗ |
Study of Favipiravir Compared to Standard of Care in Hospitalized Patients With COVID-19 |
Completed |
Phase 3 |
2020-05-21 |
This is open-labe randomized multicenter comparative Phase III study conducted in 5 medical
facilities. The objective of the study is to assess the efficacy and safety of Favipiravir
compared with the Standard of care (SOC) in hospitalized patients with moderate COVID-19
pneumonia.
|
| NCT04546581 ↗ |
Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC) |
Completed |
Phase 3 |
2020-10-08 |
This protocol will serve as a platform for assessing treatments for adult patients
hospitalized for medical management of COVID-19 without related serious end-organ failure.
Trials will involve sites around the world strategically chosen to ensure rapid enrollment.
This trial will compare hyperimmune intravenous immunoglobulin (hIVIG) with matched placebo,
when added to standard of care (SOC), for preventing further disease progression and
mortality related to COVID-19. SOC will include remdesivir unless it is contraindicated for
an individual patient.
|
| NCT04549376 ↗ |
Virucidal Effect of Povidone Iodine on COVID-19 In-Vivo |
Recruiting |
Phase 2 |
2020-07-01 |
It is an established fact that, corona virus spread through the respiratory droplets.
Colonization of the virus in oropharynx and/or nasopharynx is considered to be major factor
for transmissibility of the virus through respiratory secretions. Preventing colonization of
the virus by administrating povidone iodine in the nasal passage therefore, a rational
thought which is supported by recent evidence of in-vitro virucidal action of povidone iodine
in Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS CoV-2). Therefore, the study is
designed to assess the virucidal effect of povidone iodine on COVID-19 virus in-vivo.This
open label randomized clinical trial will be conducted at Department of Otorhinolaryngology
and Head Neck Surgery, in collaboration with Department of Virology and Department of
Medicine in Dhaka Medical College (DMC) Hospital. The study will be conducted from September
2020 to October 2020. Total 175 confirmed cases of COVID-19 disease, proven by Reverse
transcription polymerase chain reaction (RT-PCR) testing will be enrolled in this study.
Written informed consent will be ensured before participation. In case of no literacy, finger
print will be considered for written permission.Consent will be sought from the legal
guardian in case of minor or underaged.Formal ethical clearance will be taken from Ethical
Review Committee (ERC) of Dhaka Medical College. All of the Participants will be divided into
seven groups: Group A will receive Povidone iodine (PVP-I) nasal irrigation at concentration
of 0.4%, Group B and Group C will received 0.5% and 0.6%; Group D will receive PVP-I nasal
spray at concentration of 0.5% and Group E will received at 0.6% concentration. Group F
(Placebo comparator group) will receive nasal irrigation by distilled water (DW) and Group G
(Placebo comparator group) will received nasal spray by distilled water. The contact time
will be minimum 30 seconds. After the individual application of PVP-I and distilled water in
respective participant, they will be tested again for RT-PCR for COVID-19 from nasopharyngeal
and oropharyngeal sample. All patients will be subjected to detail history, physical
examination and adverse events. Block Randomization will be followed for randomization. Data
will be recorded in a semi-structured questionnaire and will be analyzed by 'R-4.0.2' data
analysis software
|
| NCT04549922 ↗ |
Antisense Therapy to Block the Kallikrein-kinin Pathway in COVID-19 |
Active, not recruiting |
Phase 2 |
2020-10-22 |
Up to 1/3 of all patients infected with COVID-19 can develop complications that require
hospitalization. Severe pneumonia associated with acute respiratory distress syndrome (ARDS)
is the most threatening and feared complication of COVID-19 infection, with mortality rates
close to 50% in some groups.
Autopsies between these severe cases reveal severe capillary involvement, with signs of
intense inflammatory changes, microvascular thrombosis, endothelial injury and abnormal
tissue repair. The available evidence suggests that abnormal activation or imbalance in the
counter-regulation of the kallikrein-kinin system may play a central role in a positive
feedback cycle, leading to consequent diffuse microangiopathy. Blockade of the
kallikrein-kinin system can therefore prevent deterioration of lung function by reducing
inflammation, edema and microthrombosis.
The objective of this phase IIb study is to assess the preliminary effects on the oxygenation
parameters of an antisense oligonucleotide that inhibits pre-kallikrein synthesis in patients
with moderate to severe COVID-19.
|
| NCT04550338 ↗ |
Antiviral Effects of TXA as a Preventative Treatment Following COVID-19 Exposure |
Withdrawn |
Phase 3 |
2021-08-01 |
A recent report in Physiolological Reviews proposed that the endogenous protease plasmin acts
on SARS-CoV-2 by cleaving a newly inserted furin site in the S protein portion of the virus
resulting in increased infectivity and virulence. A logical treatment that might blunt this
process would be the inhibition of the conversion of plasminogen to plasmin. Fortunately,
there is an inexpensive, commonly used drug, tranexamic acid, TXA, which suppresses this
conversion and could be re-purposed for the treatment of COVID-19. TXA is a synthetic analog
of the amino acid lysine which reversibly binds four to five lysine receptor sites on
plasminogen. This reduces conversion of plasminogen to plasmin, and is normally used to
prevent fibrin degradation. TXA is FDA approved for the outpatient treatment of heavy
menstrual bleeding (typical dose 1300 mg p.o. TID x 5 days) and off-label use for many other
indications. TXA is used perioperatively as a standard-of-care at UAB for orthopedic and
cardiac bypass surgeries. It has a long track record of safety such that it is used
over-the-counter in other countries as an antiviral and for the treatment of cosmetic
dermatological disorders. Given the potential benefit and limited toxicity of TXA it would
appear warranted to perform randomized, double-blind placebo controlled exploratory trial at
UAB as a prophylactic antiviral treatment following exposure to COVID-19 in order to
determine whether it reduces infectivity and virulence of the SARS-CoV-2 virus as
hypothesized. Involvement of each patient is only for 7 days before primary endpoints and 30
days for final data collection.
|
| NCT04551755 ↗ |
Safety and Efficacy of Ivermectin and Doxycycline in Treatment of Covid-19 |
Not yet recruiting |
Phase 2 |
2020-09-01 |
A randomized double blind control trial will be done. Total 188 Covid-19 patients will be
enrolled in this trial who are RT-PCR confirmed case of mild cases. Before enrollment, base
line investigations will be done and as per eligibility criteria 188 (one hundred eighty
eight) patients of mild symptoms will be selected by random sampling. Ninety four diagnosed
patients (Group-A) of Covid-19 will be in the experimental group and 94 Covid-19 diagnosed
patients (Group-B) will be in the control group.
Group -A will be given combination treatment of Tab Ivermectin and Cap Doxycycline along with
standard therapy and Group -B will be treated by standard therapy with placebo.
Follow up will be done every day in both group with all the parameters as stated above and
will be documented.
On 5th day of treatment, if fever subsides final outcome will be measured by result of RT-PCR
test preferably from one designated lab with sample of nasal swab for all. Subject to RT-PCR
test negative result again on 6th day another RT-PCR test will be done at 24 hours apart. But
if RT-PCR test result remain positive on 5th day, again on 10th day same test is to be done
and also on 11th day subject to test result as negative on 10th day.
Death of the patients will be documented as well. Regarding safety issues of the drugs we
shall monitor for any SAE and would report to the DSMB for proper management guideline
|
| NCT04552483 ↗ |
Effects of Early Use of Nitazoxanide in Patients With COVID-19 |
Completed |
Phase 2 |
2020-06-08 |
Multicenter, randomized, placebo-controlled, parallel, blinded, interventional, treatment
clinical trial with two arms.
Population: 392 Patients with COVID-19 (Coronavirus Disease-19), confirmed by RT-PCR (Real
Time polymerase chain reaction), symptomatic in the early phase of the disease.
Experimental group: 196 patients, nitazoxanide 500mg 8 / 8 hours for 5 days. Control group:
196 patients, placebo 8/8 hours for 5 days.
|
| NCT04558021 ↗ |
A Study To Evaluate The Efficacy And Safety Of a Novel Niclosamide Suspension Formulation For COVID-19 |
Recruiting |
Phase 3 |
2020-10-08 |
This study aims to investigate the potential antiviral efficacy and safety of a novel
formulation of Niclosamide; a well-known antihelmintic agent, together with an established
COVID-19 treatment regimen in patients.
The aim of this study is to evaluate the safety and efficacy profile of niclosamide from the
test product (Niclosamide 200 mg/10 mL Suspension) in patients treated for the novel
coronavirus infectious disease (COVID-19) in a placebo controlled phase III trial. Both
treatment groups will receive an established treatment regimen against COVID-19 together with
either niclosamide or placebo.
The efficacy and safety of the molecule is well-known and the properties of novel formulation
is well-established. The promising in vitro results of niclosamide as an antiviral compound
is well documented and make it an ideal candidate as a therapy against SARS-CoV 2 infection.
A good safety profile is expected with solid antiviral activity.
|
| NCT04558125 ↗ |
Low-Dose Tenecteplase in Covid-19 Diagnosed With Pulmonary Embolism |
Terminated |
Phase 4 |
2020-09-08 |
- There is a knowledge gap associated with the management of patients with COVID-19 lung
injury and a laboratory picture compatible with disseminated intravascular coagulation
(DIC). Clinical data to date support that COVID-19 is associated with a prothrombotic
state that is not simply explained by an influx of more critically ill individuals.
- These patients suffer from severe respiratory failure; hypoxemia and ventilator
dependence are the primary concerns; ARDS with respiratory failure is frequently the
cause of death. Macroscopic and probable microvascular thromboembolic events are a major
concern in this population.
- When DIC is associated with COVID-19, it predicts a very poor prognosis.
- This study will evaluate the clinical efficacy and safety of low-dose IV bolus
tenecteplase (TNK) together with anticoagulation compared with control patients on
therapeutic anticoagulation alone in hospitalized adults diagnosed with COVID-19 and
acute intermediate-risk PE.
- Prospective, multicenter, randomized two-arm trial enrolling consecutive patients who
meet enrollment criteria.
- The study will generate evidence that low-dose TNK together with anticoagulation is
beneficial in these patients
|
| NCT04558463 ↗ |
The Effectivity and Safety of Favipiravir Compared to Oseltamivir as Adjuvant Therapy for COVID-19 |
Recruiting |
Phase 3 |
2020-04-16 |
This study aims to analyze the effectiveness and safety of Avigan® (favipiravir) compared to
Oseltamivir as an adjuvant therapy among adult COVID-19 patients. This study will be
conducted in a hospital setting, recruiting adult COVID-19 patients with mild, moderate, and
severe symptoms. Subjects will be randomly given Favipiravir or Oseltamivir as an adjuvant
therapy to standard COVID-19 treatment. Patients will be followed up for 21 days after the
first dose of intervention given. The primary outcomes of this study are the improvement of
radiology results and RT PCR negative conversion during follow up. The secondary outcomes are
adverse events, hospital length of stay (LOS), and Case fatality rate (CFR)
|
| NCT04559074 ↗ |
Personalised Electronic Record Supported Optimisation When Alone for Patients With Hypertension- Pilot Study for Remote Medical Management of Hypertension During the COVID-19 Pandemic |
Recruiting |
Phase 4 |
2020-10-23 |
This trial is focusing on blood pressure control for patients with high blood pressure
(hypertension) during the COVID-19 pandemic when seeing a doctor for advice may be difficult.
The study utilises remote consultations by telephone or video conferencing. Patients record
blood pressure and data into an electronic diary on their phone which is reviewed in
consultations every 2 weeks by a clinician. Medication for this trial is amlodipine as an
oral solution which is uptitrated accordingly for patients receiving medication (anticipated
200). 800 patients will be in an observational group recording the same readings and will not
receive any medication.
|
| NCT04559113 ↗ |
Methylprednisolone in COVID-19 Patients (Methyl19LGH) |
Recruiting |
N/A |
2020-05-01 |
In COVID-19 deep airway and alveolar destruction occurred due to inflammatory reaction
resulting into severe pneumonia. In COVID-19, lung injury is not only due to viral damage to
tissue, but it is also due to immune response that leads to activation of inflammatory cells
and release of cytokines. In COVID-19 acute respiratory distress syndrome ARDS is produced
due to mucinous or cellular fibromyxoid exudates, desquamation of pneumocytes and alveolar
damage and hyaline membrane development and within 5-7 days disease become more aggressive
due to pneumonia and respiratory failure. It is important to start the prompt and strengthen
treatment for suppression of inflammatory response and cytokine storm. Methylprednisolone are
the traditional immunosuppressive drugs. They are important and effective to delay the
pneumonia progression and treating the ARDS.
Corticosteroids are broadly used as treatment for ARDS and there was an evidence for its
efficacy for treating SARS and decreasing mortality of SARS in the past. However for COVID-19
corticosteroids efficacy and safety usage is still under clinical trials
|
| NCT04560205 ↗ |
Tocilizumab in COVID-19 Lahore General Hospital |
Recruiting |
Phase 1 |
2020-05-01 |
The most accepted description of severe COVID-19 disease is development and over production
of pro-inflammatory cytokines. Autopsy studies have been done on COVID-19 patients proved
that severe disease is resulted due to deviant host-immune response and cytokine storm.
Elevated inflammatory biomarkers like C-Reactive protein (CRP) and pro-inflammatory cytokines
shown to be higher in severe disease of COVID-19. Several studies on severe COVID-19 have
revealed raised levels of plasma cytokines like IL-6, IL-2, IL-10, Gamma interferon (INF),
Tumor necrosis factor Alpha TNF. The Cytokines release syndrome (CRS) is a hyperinflammatory
deadly syndrome characterized by release of uncontrolled immune system activation which is
responsible for multi-organ failure. It has the main role in ARDS due to SARS-CoV-2 virus
which binds to alveolar epithelium and resulting in IL-6 release that is responsible for
increase alveolar-epithelium permeability. In many studies it has been observed that IL-6
have played a main role in CRS induction. Previous experiences from hyperinflammatory and
cytokine storm syndromes recommends that early involvement of inhibiting CRS is essential to
prevent lethal tissue damage and poor clinical outcome. In this scenario the judgement of
clinical specialist who are suggesting that evidence of CRS can be cured with
glucocorticoids, I/V immunoglobulin and anti-cytokine therapy cannot be ignored.
|
| NCT04561063 ↗ |
COVID-19 Prophylaxis South Africa (COVER HCW) |
Recruiting |
Phase 2 |
2020-12-08 |
This is a randomised, multi-center, open label, adaptive, exploratory trial to assess the
efficacy of two different drug regimens in terms of preventing symptomatic COVID-19 disease
in healthcare workers at high risk of exposure to SARS-CoV-2. The trial will compare two
different experimental medication arms to the control arm comprising the use of standard
personal protective equipment (PPE) with no additional pharmacological intervention.
|
| NCT04561219 ↗ |
Nitazoxanide Therapy for Patients With COVID-19 Pneumonia |
Completed |
Phase 2 |
2020-04-19 |
Multicenter, randomized, placebo-controlled, parallel, blinded, interventional, treatment
clinical trial with two arms.
Population: 500 Hospitalized patients with pneumonia derived from COVID-19 (Coronavirus
Disease-19), either confirmed by RT-PCR (Real Time polymerase chain reaction), or suggested
by typical findings on the computed tomography scan symptomatic.
Experimental group: nitazoxanide 500mg 8 / 8 hours for 5 days. Control group: placebo 8/8
hours for 5 days.
|
| NCT04563208 ↗ |
Study of Oral Administration of Ribavirin and Nitazoxamide Versus Placebo in COVID-19 |
Recruiting |
Phase 2 |
2020-12-09 |
This is a single center, randomized, double-blind, 2-arm, parallel-group study of DuACT in
participants with clinical symptoms of COVID-19 that have begun within the past 72 hours
prior to testing.
|
| NCT04567173 ↗ |
Convalescent Plasma as Adjunctive Therapy for Hospitalized Patients With COVID-19 |
Recruiting |
Phase 2/Phase 3 |
2020-09-21 |
This protocol provides access to investigational convalescent plasma for hospitalized
patients with COVID-19. Following provision of informed consent, patients will be
administered around 500 mL of convalescent plasma obtained from an individual who has
recovered from a documented SARS-CoV-2 infection. The study aims to evaluate the efficacy and
safety of anti-SARS-CoV-2 convalescent plasma as adjunctive therapy in preventing disease
progression (prevention of ICU admission) among hospitalized patients with COVID-19. Safety
outcomes include serious adverse events judged to be related to convalescent plasma. Other
information which will be collected includes patient demographics and clinical data which
includes quick SOFA scores, ventilator-free days, ICU-free days, dialysis-free days and
28-day mortality.
|
| NCT04568863 ↗ |
Efficacy of Intravenous Melatonin on Mortality in Adult Patients Admitted to the Intensive Care Unit With COVID-19 |
Completed |
Phase 2 |
2020-06-20 |
There is an urgent need to evaluate effective treatments for COVID-19 patients. Melatonin has
significant anti-inflammatory and antioxidant properties and it lacks of side-effects. This
randomized controlled trial seeks to evaluate the efficacy of intravenous melatonin in
reducing mortality in Covid-19 patients in the ICUs.
|
| NCT04569825 ↗ |
Effect of Nasal Steroid in the Treatment of Anosmia Due to COVID-19 Disease |
Recruiting |
Early Phase 1 |
2020-08-01 |
Background: Anosmia is a debilitating common symptom of COVID-19. The therapeutic effect of
systemic steroid for the treatment of anosmia has been studied with various findings of its
efficacy. However, the effect of local steroid was not assessed before.
Objective: To estimate the efficacy of local steroid in the treatment of anosmia in COVID-19
patients.
|
| NCT04569877 ↗ |
GM-CSF Inhalation to Prevent ARDS in COVID-19 Pneumonia |
Recruiting |
Phase 2 |
2020-09-24 |
To assess the safety and tolerability of inhaled molgramostim nebuliser solution in patients
with COVID-19 pneumonia.
|
| NCT04570384 ↗ |
Intravenous L-Citrulline to Delay and Potentially Prevent the Need for Invasive Mechanical Ventilation for Acute Hypoxemic Respiratory Failure in Patients With COVID-19 (SARS-CoV-2) Illness |
Recruiting |
Phase 2 |
2020-10-15 |
Prospective, Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Intravenous
L-Citrulline (Turnobi) to Delay and Potentially Prevent the Need for Invasive Mechanical
Ventilation for Acute Hypoxemic Respiratory Failure in Patients with COVID-19 (SARS-CoV2)
Illness. To evaluate safety and efficacy of a bolus loading dose and continuous intravenous
infusion of L-Citrulline compared to placebo in patients hospitalized with COVID-19 infection
(SARS-CoV-2).
|
| NCT04570397 ↗ |
Ravulizumab and COVID-19 |
Recruiting |
Phase 3 |
2020-12-18 |
Ultomiris (Ravulizumab), is a monoclonal antibody that specifically targets terminal
complement products and is proposed for the treatment of COVID-19 induced microvasculature
injury and endothelial damage leading to thrombotic microangiopathy (TMA) causing acute
kidney injury (AKI). Ravulizumab is to be used for participants with a confirmed diagnosis of
COVID-19 who clinically or diagnostically present with deteriorating renal function.
Ravulizumab causes immediate and sustained inhibition of the terminal complement cascade. The
use of ravulizumab could ameliorate COVID-19 induced kidney injury due to TMA, shorten
hospital stay, and improve the overall survival.
|
| NCT04573153 ↗ |
Metabolic Cofactor Supplementation and Hydroxychloroquine Combination in Covid-19 Patients |
Recruiting |
Phase 2/Phase 3 |
2020-09-21 |
This open label, randomized, controlled, investigator-initiated, multi-centre trial aims to
establish metabolic improvements in COVID-19 subjects by dietary supplementation with
cofactors N-acetylcysteine, L-carnitine tartrate, nicotinamide riboside and serine plus
standard therapy. The primary objective is to assess the clinical efficacy of the combination
of metabolic cofactors supplementation and hydroxychloroquine in COVID-19 patients.
|
| NCT04575038 ↗ |
CRISIS2: A Phase 2 Study of the Safety and Antiviral Activity of Brequinar in Non-hospitalized Pts With COVID-19 |
Completed |
Phase 2 |
2020-11-19 |
This study will assess the efficacy and safety of DHODHi (brequinar) as an antiviral via 5
days of treatment of participants with positive COVID-19 and at least one symptom of COVI019
in an out-patient setting. The study is multi-center, randomized, and placebo-controlled.
|
| NCT04575558 ↗ |
HOPE: A Trial of Hydroxichloroquine Plus Azithromycin in High Risk COVID-19 |
Withdrawn |
Phase 2 |
2020-06-30 |
Multicenter, double blind, randomized clinical trial for high-risk patients over 18 years of
age, symptomatic for COVID-19 infection, without any severity criteria
|
| NCT04575610 ↗ |
IRAK4 Inhibition in Treatment of COVID-19 With ARDS (I-RAMIC) |
Terminated |
Phase 2 |
2020-11-27 |
The purpose of this study is to assess the efficacy of PF-06650833 in addition to
standard-of-care compared to standard-of-care treatment alone in improving outcomes in
patients with COVID-19.
|
| NCT04576728 ↗ |
Efficacy and Safety of Trimodulin in Subjects With Severe COVID-19 |
Active, not recruiting |
Phase 2 |
2020-10-06 |
The objectives of the trial are to evaluate the efficacy and safety of trimodulin as add-on
therapy to standard of care (SoC) compared to placebo treatment in adult hospitalized
subjects with severe COVID-19.
Additionally, pharmacodynamic (PD) and pharmacokinetic (PK) properties of trimodulin will be
evaluated in all subjects.
|
| NCT04578158 ↗ |
Trial to Study the Adjuvant Benefits of Quercetin Phytosome in Patients With COVID-19 |
Completed |
Phase 3 |
2020-09-29 |
The purpose of this study is to investigate if Quercetin Phytosome is beneficial for the
treatment of COVID-19.
|
| NCT04578236 ↗ |
Efficacy of Aerosol Combination Therapy of 13 Cis Retinoic Acid and Captopril for Treating Covid-19 Patients Via Indirect Inhibition of Transmembrane Protease, Serine 2 (TMPRSS2) |
Not yet recruiting |
Phase 2 |
2020-11-01 |
Efficacy of Aerosol Combination Therapy of 13 Cis Retinoic Acid and Captopril for Treating
Covid-19 Patients Via Indirect Inhibition of Transmembrane Protease, Serine 2 (TMPRSS2)
Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) has infected over 20,000,000
people causing over 700,000 deaths. It has no currently approved treatments.Airborne
SARS-CoV-2 infections in humans initiate from the virus entering nasal and airway epithelial
cells through binding to angiotensin-converting enzyme 2 (ACE2). Transmembrane protease,
serine 2 (TMPRSS2), a cellular protease that activates the SARS-CoV-2 spike protein,
colocalizes with ACE2 and can prime SARS-CoV-2 fusion directly at the plasma membrane.
Transmembrane protease, serine 2 (TMPRSS2) is an androgen receptor signaling target gene and
an androgen-regulated cell-surface serine protease expressed predominantly in prostate and
lung epithelial cell. TMPRSS2 is normally expressed several folds higher in the prostate
relative to any other human tissue, though the normal physiological function(s) remains
unknown. A study found that dihydrotestosterone (DHT) s a potent activator of TMPRSS2.On the
other hand, Feily et al noted that low-dose isotretinoin (0.5 mg/kg/day for 15-20 weeks) in
PCO patients with moderate to severe nodulocystic acne resulted in significant decreases in
levels of serum total testosterone, prolactin, and dihydrotestosterone A study demonstrated
that 13- cis -Retinoic acid competitively and reversibly inhibits dihydrotestosterone.
Therefore, we suggest that 13- cis -Retinoic acid will downregulate TMPRSS2 expression
thorough temporary preventing the effect of dihydrotestosterone (DHT) on the activation of
TMPRSS2 gene expression. ACE inhibitors and ARBs are commonly taken by heart patients to
reduce blood pressure and to treat heart failure.Earlier studies had cautioned that this
class of drugs could possibly increase the risk for the novel coronavirus, SARS-CoV-2,
infection and elevate COVID-19 severity. There is conflicting observational evidence about
the potential clinical impact of ACE inhibitors and ARBs on patients with COVID-19. Select
preclinical investigations have raised concerns about their safety in patients with COVID-19.
On the other hand, Preliminary data hypothesise that angiotensin-converting enzyme (ACE)
inhibitors and renin-angiotensin- aldosterone system (RAAS) inhibitors could benefit patients
with COVID-19 by decreasing acute lung damage and preventing angiotensin-II-mediated
pulmonary inflammation. Here in our review, we use established and emerging evidence based on
the findings of previous studies and researches to propose that ACE inhibitors may benefit
patients with COVID-19 via attenuating and abolishing the effect of androgenic hormones on
inducing the expression of Transmembrane protease, serine 2 (TMPRSS2), even though, at the
same time, ACE inhibitors cause an increase in the human cell surface receptor protein ACE2
which the novel coronavirus uses to enter and infect cells. A study on hypertensive rats
demonstrated that using ACE inhibitors(captopril) abolished and attenuated the effect of
dihydrotestosterone (DHT). In this study RAS inhibition exhibited beneficial effects on
androgen-induced obesity and abolished the androgen-mediated increase in blood pressure (BP)
observed in this model of PCOS. (83 ± 1 vs 115 ± 3 mmHg, p<0.0001). A another study found
that the angiotensin converting enzyme inhibitor captopril abolished testosterone effect and
attenuates testosterone-induced benign prostatic hyperplasia in rats; a mechanistic approach.
Captopril is a potent inhibitor of the angiotensin converting enzyme. These effects of
testosterone were almost prevented by captopril (100 mg/kg). In conclusion, generally
treatment with ACE inhibitors is associated with reduced androgen levels. Therefore,we think
that Transmembrane protease, serine 2 (TMPRSS2) is an indirect target of ACE inhibitors and
13 cis retinoic acid As aresult, we hypothesize that any drug which downregulates TMPRSS2
expression through targeting AR, AR co-regulatory factors, or AR downstream transcription
factors might be potentially effective against COVID-19 and is worth investigating under a
clinical trial..
Keywords: COVID -19, Transmembrane protease, serine 2 (TMPRSS2), ACE inhibitors, ACE2.
|
| NCT04579393 ↗ |
Fostamatinib for Hospitalized Adults With COVID-19 |
Completed |
Phase 2 |
2020-10-08 |
Background:
COVID-19 is a new disease caused by SARS-CoV-2 that was identified in 2019. Some people who
get sick with COVID-19 become ill requiring hospitalization. There are some medicines that
may help with recovery. Researchers want to see if a drug called fostamatinib may help people
who are hospitalized with COVID-19.
Objective:
To learn if fostamatinib is safe in patients who are hospitalized with COVID-19 and gain
earlier insight into whether it improves outcomes.
Eligibility:
Adults age 18 and older who are hospitalized with COVID-19.
Design:
Participants will be screened with a physical exam, including vital signs and weight. They
will have a blood test and chest x-ray. They will have a COVID-19 test as a swab of either
the back of the throat or the back of the nose. They will take a pregnancy test if needed.
Participants will be randomly assigned, to take either fostamatinib pills or a placebo twice
daily for up to 14 days in addition to standard of care for COVID-19. If they can swallow,
they will take the pills by mouth with water. If they cannot swallow or are on mechanical
ventilation, the pills will be crushed, mixed with water, and given through a tube placed
through the nostril, or placed in the mouth, down the esophagus, and into the stomach. Blood
samples will be taken daily. Participants will return to the Clinical Center for safety
follow-up visits. At these visits, they will have a physical exam and blood tests. If they
cannot visit the Clinical Center, they will be contacted by phone or have a telehealth visit.
Participation will last for about two months
|
| NCT04581954 ↗ |
Inflammatory Signal Inhibitors for COVID-19 (MATIS) |
Recruiting |
Phase 1/Phase 2 |
2020-10-02 |
The Multi-arm trial of Inflammatory Signal Inhibitors for COVID-19 (MATIS) study is a
two-stage, open-label, randomised controlled trial assessing the efficacy of ruxolitinib
(RUX) and fostamatinib (FOS) individually, compared to standard of care in the treatment of
COVID-19 pneumonia. The primary outcome is the proportion of hospitalised patients
progressing from mild or moderate to severe COVID-19 pneumonia. Patients are treated for 14
days and will receive follow-up assessment at 7, 14 and 28 days after the first study dose.
Patients with mild or moderate COVID-19 pneumonia will be recruited. Initially, n=171 (57 per
arm) patients will be recruited in Stage 1. Following interim analysis to assess the efficacy
and safety of the treatments, approximately n=285 (95 per arm) will be recruited during Stage
2.
|
| NCT04582201 ↗ |
An Experiment to Evaluate the Safety of agenT-797 in COVID-19 Patients With Severe Difficulty Breathing. |
Recruiting |
Phase 1 |
2020-09-21 |
A Phase 1 Study of AGENT-797 to treat moderate to severe acute respiratory syndrome in
COVID-19 patients.
|
| NCT04583956 ↗ |
ACTIV-5 / Big Effect Trial (BET-A) for the Treatment of COVID-19 |
Active, not recruiting |
Phase 2 |
2020-10-14 |
This is a platform trial to conduct a series of randomized, double-blind, placebo-controlled
trials using common assessments and endpoints in hospitalized adults diagnosed with
Coronavirus Disease 2019 (COVID-19). Big Effect Trial (BET) is a proof-of-concept study with
the intent of identifying promising treatments to enter a more definitive study. The study
will be conducted in up to 70 domestic sites and 5 international sites. The study will
compare different investigational therapeutic agents to a common control arm and determine
which have relatively large effects. In order to maintain the double blind, each intervention
will have a matched placebo. However, the control arm will be shared between interventions
and may include participants receiving the matched placebo for a different intervention.
The goal is not to determine clear statistical significance for an intervention, but rather
to determine which products have clinical data suggestive of efficacy and should be moved
quickly into larger studies. Estimates produced from BET will provide an improved basis for
designing the larger trial, in terms of sample size and endpoint selection. Products with
little indication of efficacy will be dropped on the basis of interim evaluations. In
addition, some interventions may be discontinued on the basis of interim futility or efficacy
analyses.
One or more interventions may be started at any time. The number of interventions enrolling
are programmatic decisions and will be based on the number of sites and the pace of
enrollment. At the time of enrollment, subjects will be randomized to receive any one of the
active arms they are eligible for or placebo. Approximately 200 (100 treatment and 100 shared
placebo) subjects will be assigned to each arm entering the platform and a given site will
generally have no more than 3 interventions at once.
The BET-A stage will evaluate the combination of remdesivir with risankizumab vs remdesivir
with a risankizumab placebo. The primary objective is to evaluate the clinical efficacy of
different investigational therapeutics relative to the control arm in adults hospitalized
with COVID-19 according to clinical status (8-point ordinal scale) at Day 8.
|
| NCT04583969 ↗ |
ACTIV-5 / Big Effect Trial (BET-B) for the Treatment of COVID-19 |
Recruiting |
Phase 2 |
2020-10-19 |
This is a platform trial to conduct a series of randomized, double-blind, placebo-controlled
trials using common assessments and endpoints in hospitalized adults diagnosed with
Coronavirus Disease 2019 (COVID-19). Big Effect Trial (BET) is a proof-of-concept study with
the intent of identifying promising treatments to enter a more definitive study. The study
will be conducted in up to 70 domestic sites and 5 international sites. The study will
compare different investigational therapeutic agents to a common control arm and determine
which have relatively large effects. In order to maintain the double blind, each intervention
will have a matched placebo. However, the control arm will be shared between interventions
and may include participants receiving the matched placebo for a different intervention.
The goal is not to determine clear statistical significance for an intervention, but rather
to determine which products have clinical data suggestive of efficacy and should be moved
quickly into larger studies. Estimates produced from BET will provide an improved basis for
designing the larger trial, in terms of sample size and endpoint selection. Products with
little indication of efficacy will be dropped on the basis of interim evaluations. In
addition, some interventions may be discontinued on the basis of interim futility or efficacy
analyses.
One or more interventions may be started at any time. The number of interventions enrolling
are programmatic decisions and will be based on the number of sites and the pace of
enrollment. At the time of enrollment, subjects will be randomized to receive any one of the
active arms they are eligible for or placebo. Approximately 200 (100 treatment and 100 shared
placebo) subjects will be assigned to each arm entering the platform and a given site will
generally have no more than 3 interventions at once.
The BET-B stage will evaluate the combination of remdesivir with lenzilumab vs remdesivir
with a lenzilumab placebo. The primary objective is to evaluate the clinical efficacy of
different investigational therapeutics relative to the control arm in adults hospitalized
with COVID-19 according to clinical status (8-point ordinal scale) at Day 8.
|
| NCT04584684 ↗ |
Mouth Rinses for Inactivation of COVID-19 |
Recruiting |
Phase 2 |
2020-12-18 |
Randomized, double-blind prospective trial to test the efficacy and acceptability of
therapeutic, antiseptic mouth rinses to inactivate severe acute respiratory syndrome
coronavirus (SARS-CoV-2) in saliva of COVID-19 positive patients aged 18-65 years old. All
mouthrinses are commercially available and will be used according to on-label instructions.
Patients will be randomized to a mouthrinse and will be asked to give a saliva sample
immediately before and after a one minute mouthwash. Saliva samples will be collected from
patients at 15 minute intervals thereafter up to an hour (15, 30, 45 and 60 minutes). The
samples will be stored and used for real-time reverse transcription polymerase chain reaction
(RT-PCR) detection of viral SARS-CoV-2 RNA and viral infectivity assays. Patients will also
complete a short-survey on the taste and experience of using the mouthwash. This study
involves 480 subject participants and one, 75-90 minute visit.
|
| NCT04584697 ↗ |
Study to Evaluate the Safety, Pharmacokinetics and Efficacy of STI-2020 (COVI-AMG™) in Outpatients With COVID-19 |
Withdrawn |
Phase 1/Phase 2 |
2020-12-01 |
This is a randomized, placebo-controlled study to assess the safety, PK profile, and efficacy
of COVI-AMG in subjects with COVID-19.
|
| NCT04584710 ↗ |
A Phase 2 Study of RTB101 as COVID-19 Post-Exposure Prophylaxis in Older Adults |
Active, not recruiting |
Phase 2 |
2020-10-13 |
The proposed trial will obtain preliminary data on the feasibility of studying RTB101 as
compared to placebo for COVID-19 post-exposure prophylaxis in adults age ≥ 65 years to inform
the design of a subsequent pivotal trial.
|
| NCT04586153 ↗ |
Study to Assess the Effect of Meplazumab on COVID-19 |
Recruiting |
Phase 2/Phase 3 |
2021-02-15 |
This phase2/3 study will be conducted to evaluate the safety and efficacy of Meplazumab in
addition to Standard of Care for the treatment of Corona Virus Disease(COVID) 19 in
hospitalized adults
|
| NCT04588792 ↗ |
Furosemide as Supportive Therapy for COVID-19 Respiratory Failure |
Recruiting |
Phase 2/Phase 3 |
2021-04-16 |
This double-blind, placebo-controlled, randomized, parallel-group phase 2/3 study will study
the utility of nebulized furosemide for pulmonary inflammation in Intubated, mechanically
ventilated Patients with COVID-19.
|
| NCT04591600 ↗ |
Effectiveness of Ivermectin and Doxycycline on COVID-19 Patients |
Completed |
Phase 1/Phase 2 |
2020-07-01 |
A randomized controlled trial on using Ivermectin and doxycycline to treat mild-moderate
outpatients, severe, and critical inpatients of Coronavirus disease 19 (COVID-19) along with
standard of care. Seventy Iraqi COVID-19 patients received Ivermectin and Doxycycline plus
standard of care versus seventy Iraqi COVID-19 patients received standard of care only. .
|
| NCT04593940 ↗ |
Immune Modulators for Treating COVID-19 |
Recruiting |
Phase 3 |
2020-10-15 |
ACTIV-1 IM is a master protocol designed to evaluate multiple investigational agents for the
treatment of moderately or severely ill patients infected with severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2). The research objectives are to evaluate each agent with
respect to speed of recovery, mortality, illness severity, and hospital resource utilization.
Each agent will be evaluated as add-on therapy to the standard of care (SoC) in use at the
local clinics, including remdesivir (provided). The SoC may change during the course of the
study based on other research findings. Comparisons of the agents among themselves is not a
research objective.
The study population corresponds to moderately and severely ill patients infected with the
coronavirus disease 2019 (COVID-19) virus. Recruitment will target patients already
hospitalized for treatment of COVID-19 infection as well as patients being treated for
COVID-19 infection in Emergency Departments while waiting to be admitted to the hospital.
Patients both in and out of the ICU are included in the study population.
|
| NCT04594330 ↗ |
Virgin Coconut Oil (VCO) as a Potential Adjuvant Therapy in COVID-19 Patients |
Recruiting |
Phase 2 |
2020-06-01 |
Virgin Coconut Oil (VCO) contains multiple compounds which have antibacterial, antiviral, and
immunomodulatory properties. The role of VCO as an antivirus to treat COVID-19 requires
further studies. A previous study has investigated the used of 30 ml of VCO to healthy
volunteers for a month and reported no side effect. Here the investigators conduct a pilot
trial to investigate the effect of VCO towards the clinical outcomes of COVID-19 patients in
Indonesia.
|
| NCT04594343 ↗ |
Clinical Study to Evaluate the Effects of Disulfiram in Patients With Moderate COVID-19 |
Completed |
Phase 2 |
2020-11-20 |
This clinical trial evaluates the safety, efficacy, and biomarker levels of FDA-approved drug
disulfiram in the treatment of adult subjects hospitalized with moderate COVID-19. Disulfiram
may limit the hyperinflammatory response associated with COVID-19 and reduce the risk of
progression to severe illness.
Subjects will be screened and randomized to receive either daily administration of oral
disulfiram or placebo for 14 days. Subjects will be followed up on Day 28.
|
| NCT04597775 ↗ |
Chemoprevention Clinical Trial of COVID-19: Hydroxychloroquine Post Exposure Prophylaxis |
Not yet recruiting |
Phase 2/Phase 3 |
2020-10-27 |
Protocol summary
Title
A Prospective, randomized, adaptive phase II/III clinical trial, controlled, open-label,
chemoprevention, 3-arms, parallel, multi-centred, to A Prospective, randomized, clinical
trial, controlled, open-label, 3-arms, parallel, multi-centred, chemoprevention of COVID-19:
Hydroxychloroquine Post Exposure Prophylaxis For COVID-19
Study Periods & Duration of Treatment
Study Duration: 6 months
Approval (IRB and regulatory bodies) 1 month
Recruitment and follow-up: 3 months
Analysis, report writing and submission of publications 1 month This study is a parallel
study of one period with an expected duration of treatment (for each subject) of 28 days,
Objectives
- To evaluate if hydroxychloroquine with the proposed dose can provide potent
chemoprophylaxis against the development of COVID-19 positive patients in subjects who
had primary exposure to COVID-19 positive patients.
- To measure the incidence of potential adverse drug reaction rates for giving
hydroxychloroquine for prevention of COVID-19 amongst close contacts
- To provide early analysis of results and redefine sample size accordingly.
- identifying subjects most likely to benefit during the phase II and focusing recruitment
efforts on them during phase III
- stopping one arm or the whole trial at an early stage for success or lack of efficacy
based on phase II study results
Design
Prospective, Randomized, open-label, three-arm, parallel, adaptive phase II/III controlled
study in which subjects will be randomly assigned in a 1:1:1 ratio as per the following:
Arm-1: hydroxychloroquine 800mg (400mg twice daily) given orally on day 1, (loading dose)
hydroxychloroquine. Then 400mg (200mg 2 tablets) on day 2,3, 4 and 5.
Arm-2: hydroxychloroquine 400mg (200mg twice daily) Given orally first day (loading dose),
then 200mg once daily on day 2,3, 4 and 5.
Arm-3: No Intervention- SARS-CoV-2 surveillance Standard control measures in the country of
interest such as self isolation, good personal hygiene and good nutrition.
|
| NCT04602442 ↗ |
Safety and Efficiency of Method of Exosome Inhalation in COVID-19 Associated Pneumonia |
Enrolling by invitation |
Phase 2 |
2020-10-01 |
Coronavirus is an acute viral disease with prevailing upper respiratory tract infections
caused by the RNA-containing virus of the genus Betacoronavirus of the Coronaviridae family.
Most patients with severe COVID-19 develop pneumonia in the first week of the disease. As the
infection progresses, the infiltration increases, and the affected areas increases. Excessive
and uncontrolled immune system response with rapidly developing fatal cytokine storm plays
the main role in the pathogenesis of acute respiratory distress syndrome (ARDS) due to
SARS-CoV-2 infection.
According to available data, exosomes can regulate inflammation and regenerative processes
due to the change in the concentration of anti-inflammatory cytokines and switch the immune
cell to regenerative secretome. Inhalation of exosomes may reduce inflammation and damage to
the lung tissue and stimulate the regenerative processes.
This protocol has been developed based on the literature, information about the ongoing tests
NCT04276987 (A Pilot Clinical Study on Inhalation of Mesenchymal Stem Cells Exosomes Treating
Severe Novel Coronavirus Pneumonia) and NCT04384445 (Organicell Flow for Patients With
COVID-19), Patent No 271036826 of 2019. "A method for obtaining and concentrating
microRNA-containing exosomal multi-potent mesenchymal-stromal cells for use in cosmetic and
pharmaceutical products to stimulate regenerative processes and slow down aging.
|
| NCT04603690 ↗ |
Study to Investigate the Benefits of Colchicine in Patients With COVID-19 |
Withdrawn |
Phase 3 |
2020-12-15 |
COVID-19 is associated with a cytokine storm that leads to respiratory distress, multiorgan
failure and elevated mortality. Oral Colchicine exhibits high anti-inflammatory capacity
attributed to the inhibition of microtubules polymerization, inflammasome and production of
IL-1β and IL-6, which could prevent the inflammatory storm in COVID-19 patients at risk. The
investigators present a randomized, controlled, open-labeled, and pragmatic clinical trial to
study the treatment effect of Colchicine in COVID-19 patients requiring hospitalization, but
no intensive care yet. Colchicine will be started within the first 48 hours and continue for
14 days using a descending dose. The benefits will be studied in terms of clinical evolution
(WHO 7-point scale) and IL-6 levels, as well as other clinical and biochemical secondary
end-points. In the case of positive results, the clinical impact would be relevant given that
this oral medication is affordable and widely accessible which would help to prevent the
inflammatory complications associated with COVID-19.
|
| NCT04603729 ↗ |
Comparison of Efficacy of Dexamethasone and Methylprednisolone in Moderate to Severe Covid 19 Disease |
Completed |
Phase 3 |
2020-05-30 |
The investigator will select participants with moderate to severe covid 19 disease admitted
in Fatima memorial hospital. The investigator will divide them in two groups according to
convenience sampling. Group 1 will be given dexamethasone 8mg/day and group 2 will be given
methylprednisolone 1mg/kg/day IV for 5 days. The investigator will compare the improvement in
temperature, oxygen requirement and CRP level at day zero and day 5 in both the groups.
|
| NCT04603794 ↗ |
Efficacy of Mouthwash in Reducing Salivary Carriage of COVID-19 |
Recruiting |
Phase 4 |
2020-10-01 |
Researchers know that the virus that causes COVID-19 has been found in the saliva (spit) of
individuals who exhibit signs of the disease. Investigators would like to test the ability of
three mouthwashes to reduce the levels of this virus in participants' mouths. Investigators
will ask participants to use a liquid to swish around in the mouth for 30 seconds and spit it
into a collection cup. Investigators will also collect spit from participants before and
after participants use the mouthwash. Although participants will have no direct benefits from
the study, investigators will gain a wealth of information that would benefit patients who
are at risk for COVID-19.
|
| NCT04603924 ↗ |
Study of Niclosamide in Moderate and Severe Hospitalized Coronavirus-19 (COVID-19) Patients |
Recruiting |
Phase 2/Phase 3 |
2020-10-07 |
Study of ANA001 in Moderate and Severe COVID-19 Patients
|
| NCT04604223 ↗ |
Effect of Pioglitazone on T2DM Patients With COVID-19 |
Recruiting |
Phase 4 |
2021-01-18 |
Approximately 10-15% of patients infected with COVID-19 develop severe illness characterized
by respiratory distress, increased risk of clotting disease, myocardial damage, stroke and
mortality. Subjects with Type 2 diabetes (T2DM) are at increased risk for severe COVID-19
disease. Exuberant inflammatory and immune responses were suggested as the etiology
responsible for the development of severe COVID-19 disease. The increased chronic
inflammatory state characteristic of T2DM could contribute to the increased risk of severe
COVID-19 disease in T2DM patients. Therefore, its possible that anti-inflammatory therapy
will reduce the risk of severe COVID-19 disease. Consistent with this assumption, a recent
study has reported that steroid therapy improves the outcome in patients with severe COVID-19
disease.
The medication pioglitazone is a strong insulin sensitizer that reduces plasma glucose
concentrations in T2DM patients. In addition to improving insulin sensitivity, several
studies have demonstrated that pioglitazone reduces chronic inflammation in T2DM patients,
which is manifested in a decrease in TNF-alpha, interleukin, hs CRP, leptin and other
inflammatory markers in T2DM treated with pioglitazone. Further, pioglitazone enhances the
plasma level of anti-inflammatory agents. For example, the plasma level of 15-epi-lipoxin A,
a lipid mediator with strong anti-inflammatory and inflammation-resolving effects that has
been reported to neutralize RNA coated viruses, is significantly elevated by pioglitazone
treatment in T2DM patients. Therefore, we hypothesize that administering pioglitazone to T2DM
patients who have moderate-to-severe COVID-19 will improve the clinical outcome of their
COVID-19 disease.
|
| NCT04604678 ↗ |
Pilot Study Into the Use of Metformin and LDN for Patients With COVID-19 |
Not yet recruiting |
Phase 2 |
2021-02-01 |
Study into the effects of daily use of metformin and low-dose naltrexone (LDN) for 4 weeks to
reduce symptoms, disease severity, and recovery time from COVID-19.
|
| NCT04604704 ↗ |
Pilot Study Into LDN and NAD+ for Treatment of Patients With Post-COVID-19 Syndrome |
Recruiting |
Phase 2 |
2021-01-28 |
Pilot study into low dose naltrexone (LDN) and NAD+ for treatment of patients with
post-COVID-19 syndrome.
|
| NCT04605887 ↗ |
Angiotensin 1-7 as a Therapy in the Treatment of COVID-19 |
Recruiting |
Phase 2 |
2021-01-18 |
Phase 2 ,double blind, randomized study of therapy with Angiotensin 1-7 in COVID-19 patients.
120 confirmed SARS-CoV-2 infected patients who exhibit moderate- clinical symptoms including
dyspnea, cough and fever, hospitalized in the KETER department in several hospitals in
Israel, will be enrolled. 60 patients will receive Ang 1-7 subcutaneously 500 mcg/kg /day. 60
patients will receive placebo : NaCl 0.9% 2 ml -control arm .
Treatment duration: 14 days or until clinical improvement that enables discharge from
hospital.
(the shortest time will be the limiting factor in treatment duration). Follow-up-30 days.
14-30 days after discharge from hospital: we will contact the patient via phone to ask
questions related to any possible adverse reaction to the drug and general health.
|
| NCT04606069 ↗ |
Treat COVID-19 Patients With Regadenoson |
Recruiting |
Phase 1/Phase 2 |
2021-05-06 |
More than 17 million people have been infected and more than 677K lives have been lost since
the COVID-19 pandemic. Unfortunately, there is neither an effective treatment nor is there a
vaccination for this deadly virus. The moderate to severe COVID-19 patients suffer acute lung
injury and need oxygen therapy, and even ventilators, to help them breathe. When a person
gets a viral infection, certain body cells (inflammatory/immune cells) get activated and
release a wide range of small molecules, also known as cytokines, to help combat the virus.
But it is possible for the body to overreact to the virus and release an overabundance of
cytokines, forming what is known as a "cytokine storm". When a cytokine storm is formed,
these cytokines cause more damage to their own cells than to the invading COVID-19 that
they're trying to fight. Recently, doctors and research scientists are becoming increasingly
convinced that, in some cases, this is likely what is happening in the moderate to severe
COVID-19 patients. The cytokine storm may be contributing to respiratory failure, which is
the leading cause of mortality for severe COVID-19 patients. Therefore, being able to control
the formation of cytokine storms will also help alleviate the symptoms and aid in the
recovery of severe COVID-19 patients.
|
| NCT04606563 ↗ |
Host Response Mediators in Coronavirus (COVID-19) Infection - Is There a Protective Effect of Losartan on Outcomes of Coronavirus Infection? |
Recruiting |
Phase 3 |
2020-10-09 |
SARS-CoV-2 is a member of a class of viruses: angiotensin converting enzyme 2 (ACE2)-binding
viruses that we call "ABVs". The World Health Organization (WHO) and others are performing
randomized controlled trials (RCTs) of vaccines and novel antivirals to address SARS-CoV-2
directly. However, the critical illness complications of COVID-19 are caused in part by
SARS-CoV-2's binding and inhibiting ACE2 and the consequent host response.
ACE 2 is the receptor for H1N1, H5N1, and SARS-CoV-2. After binding ACE2, SARS-CoV-2 is
endocytosed, and surface ACE2 is down-regulated, increasing angiotensin II (ATII a potent
vasoconstrictor) in COVID-19. The original ARB, losartan, limits lung injury in murine
influenza H7N9 and decreases viral titre and RNA.
We have a unique opportunity to complement vaccine and anti-viral RCTs with an RCT modulating
the host response using an angiotensin II type 1 receptor blocker (ARB, losartan) to decrease
the mortality of hospitalized COVID-19 patient.
|
| NCT04610138 ↗ |
Study of ZnAg Liquid Solution to Treat COVID-19 Symptomatic Participants |
Not yet recruiting |
Phase 2 |
2021-02-01 |
This is a multi-site, randomized, double-blind, placebo-controlled study assessing the
efficacy and safety of ZnAg liquid solution in symptomatic participants with acute COVID-19
that are not hospitalized at the time of enrollment.
|
| NCT04610567 ↗ |
Treatment of Patients With Mild Coronavirus-19 (COVID-19) Disease With Methotrexate Associated to LDL Like Nanoparticles (Nano-COVID19) |
Recruiting |
Phase 1/Phase 2 |
2020-10-27 |
The investigators propose a prospective, randomized, double-blind, placebo-controlled study,
conducted in two phases. The purpose of the study is to evaluate the safety and efficacy of
methotrexate in a cholesterol-rich non-protein nanoparticle (MTX -LDE) in adults diagnosed
with mild Coronavirus-19(COVID-19) disease.
A total of 100 patients will be randomized to receive MTX-LDE or placebo each 7 days, up to 3
times, during in hospital treatment.
|
| NCT04611256 ↗ |
Mesenchymal Stem Cells in Patients Diagnosed With COVID-19 |
Recruiting |
Phase 1 |
2020-08-01 |
The propose of this study is implement adjuvant therapy with adipose tissue
derived-mesenchymal stem cells (MSCs) for critical COVID-19 patients admitted to the
intensive care unit of the Regional Hospital Lic. Adolfo López Mateos of the Institute for
Social Security and Services for State Workers to reduce cytokine storm and contribute to the
favorable resolution of respiratory insufficiency and multiple organic failure.
|
| NCT04611425 ↗ |
REmimazolam Infusion in the Context of Hypnotic Shortage in the Critical Care Unit During the Pandemic of COVID-19: REHSCU Study |
Completed |
Phase 2 |
2020-11-30 |
The worldwide COVID-19 pandemic has led to a dramatic increase in the number of patients
hospitalized in intensive care units for an acute respiratory failure in all countries. This
situation has quickly led to massive shortage in masks, mechanical ventilation machines and
common medications such as hypnotics. All countries over the world are currently experiencing
a major shortage in basic hypnotic medications (propofol, midazolam) in the intensive care as
well as in the operating theatre. The Principal Investigator proposes to perform a pilot
study assessing the benefit-risk ratio of Remimazolam (a novel benzodiazepine with a short
half-life) in the critical care units of Nantes University Hospital during the COVID-19
pandemic.
|
| NCT04615871 ↗ |
Semaglutide to Reduce Myocardial Injury in PATIents With COVID-19 |
Not yet recruiting |
Phase 2 |
2020-11-30 |
With the results of this study the investigators aim to identify an effective treatment that
will reduce morbidity and mortality of patients with symptomatic COVID-19 infection, which
would in turn reduce the burden on the healthcare system by decreasing the need for intensive
care.
Objectives: The main objective of this research is to determine if once weekly treatment with
the GLP-1 agonist semaglutide for 4 doses will reduce cardiac as well as non-cardiac
complications of COVID-19 infection.
Study Plan: The study design is prospective randomized open-label blinded-evaluation (PROBE).
Eligible patients with symptomatic COVID-19 infection and an enhanced risk profile as
described above, who have been admitted to hospital due to symptoms of COVID-19 infection but
do not as yet require critical care will be approached to participate in this study. Provided
there are no exclusion criteria and the participants agree by means of documented written
informed consent, The participants the participantswill be randomized to receive s.c.
semaglutide 0.25 mg s.c. or control immediately after randomization and then 0.5 mg s.c. at
Day 7, Day 14 and Day 21. Blood will be drawn at Day 7±2 and Day 14±2 for the cardiac
troponin biomarker and safety parameters. ECG will be obtained at Day 7±2 and Day 14±2.
Primary outcome will be assessed on Day 28.
Primary outcome measure: A composite of (1) death from any cause or (2) mechanical
ventilation (invasive or non-invasive) at 28 days.
Major secondary outcome measure:
(1) an elevation to >99th percentile URL upper reference limit (URL) in those with a baseline
cardiac troponin level ≤99th percentile URL; or 3x elevation from baseline in those with a
baseline cardiac troponin >99th percentile URL; measured at Day 7±2 days and Day 14±2 days
post randomization.
Other major secondary outcome measure:
A composite of
1. Death from any cause, mechanical ventilation or vasopressor or ECLS support at 28 days
2. an elevation to >99th percentile URL in those with a normal baseline troponin level; or
3x elevation from baseline in those with a baseline troponin; measured at 1 and 2 weeks
(7±2 and 14±2 days) post randomization.
|
| NCT04615949 ↗ |
Cannabidiol in Patients With COVID-19 and Cardiovascular Disease or Risk Factors |
Recruiting |
Phase 2/Phase 3 |
2021-04-30 |
Non-critical patients, hospitalized within the previous 24 hours who tested positive for
COVID-19 and have a prior history of cardiovascular disease (CVD) and/or significant risk
factors for CVD will be treated for 28 days.
|
| NCT04619680 ↗ |
The Study of the Use of Nintedanib in Slowing Lung Disease in Patients With Fibrotic or Non-Fibrotic Interstitial Lung Disease Related to COVID-19 |
Recruiting |
Phase 4 |
2020-11-18 |
This is a collaborative study between Icahn School of Medicine at Mount Sinai, Boehringer
Ingelheim Pharmaceuticals and up to 9 other clinical centers across the US to determine the
effect of Nintedanib on slowing the rate of lung disease in patients who have been diagnosed
with COVID-19, and have ongoing lung injury more than 4 weeks out from their diagnosis.
|
| NCT04621149 ↗ |
An Outpatient Study Investigating Non-prescription Treatments for COVID-19 |
Recruiting |
Phase 2 |
2020-11-15 |
This is a platform study to investigate the effectiveness of a variety of non-prescription
approaches for the treatment of non-hospitalized adults recently tested positive for
COVID-19.
|
| NCT04621461 ↗ |
Placebo Controlled Trial to Evaluate Zinc for the Treatment of COVID-19 in the Outpatient Setting |
Completed |
Phase 4 |
2020-12-20 |
This is a randomized, double-blind, placebo-controlled trial to assess the efficacy of zinc
in a higher risk COVID-19 positive outpatient population.
|
| NCT04622865 ↗ |
Masitinib Combined With Isoquercetin and Best Supportive Care in Hospitalized Patients With Moderate and Severe COVID-19 |
Recruiting |
Phase 2 |
2020-06-01 |
Study objective is to evaluate the efficacy of the combination of masitinib and isoquercetin
in adult hospitalized patients with moderate and severe COVID-19.
|
| NCT04622891 ↗ |
Clarithromycin Versus Azithromycin in Treatment of Mild COVID-19 Infection |
Completed |
N/A |
2020-04-01 |
The current study was conducted at Qena Governorate, Egypt, during the period from May 2020,
to July 2020. The study included 305 COVID-19 cases diagnosed by PCR, patients were randomly
assigned to one of three study limps, Azithromycin 500 mg/24 h for 7 days, Clarithromycin 500
/12 h for 7 days, or a control group with no antibiotics, All three groups received only
symptomatic treatment for control of fever and cough
|
| NCT04623385 ↗ |
Clinical Role of Testosterone and Dihydrotestosterone and Which of Them Should be Inhibited in COVID-19 Patients - A Double-edged Sword? |
Not yet recruiting |
Phase 4 |
2020-11-01 |
Clinical Role of Testosterone and Dihydrotestosterone and which of them should be inhibited
in COVID-19 patients - A double-edged sword?
COVID-19 attacks and affects Males significantly more than females [1], [2]. Males with
COVID-19 are reported to die at twice the rate of females when they come infected with the
virus [3]. The upregulation of TMPRSS2 by androgens could explain the increased
susceptibility to COVID-19 in men.Contrary to expected, as a study demonstrated that The
expression level of TMPRSS2 increased 6-fold in androgen stimulated LNCaP cells, relative to
androgen-deprived cells[4]. But, surprisingly, low levels of testosterone led to the over
expression and upregulation of ACE2 and TMPRSS2 receptors, facilitating SARS-CoV-1 entry into
the alveolar cells, and deregulating a lung-protective pathway [5].According to literature
Dihydrotestosterone is many times more potent than testosterone, and many of the effects that
testosterone has in the body only happen after it is converted to dihydrotestosterone [6].
Therefore, we hypothesis that testosterone has better effect than dihydrotestosterone in case
of COVID-19, because a study found that DHT significantly induced the expression of TMPRSS2
[7]. And at the same time , decreased testosterone levels in critically diseased males
harmfully affect pulmonary endothelial cell functioning, impair the ability to clear the
virus , promote systemic . Obesity among males, promote defective immune response, , and also
generates more pro-inflammatory cytokines important in cell signaling, emanating in
increased, severe disease, worst outcome and vulnerability. Insufficient serum testosterone
level is a poor prognostic indicator for patients infected with COVID-19 by downregulation
pulmonary protective pathways [5], [8]. On the contrary, high testosterone levels can lead to
complication of thrombosis which is also one of the serious manifestations in COVID-19
patients[9]. Thereby we hypothesize that decreased testosterone levels in men have a direct
relation with the severity of infection and a worse outcome in COVID-19. In this case we
should found an appropriate treatment that induces testosterone level to introduce its
protective effect and up regulate pulmonary protective pathways and at the same time protect
against thrombosis and works to reduce the impact of dihydrotestosterone on lung cells
preventing up regulation of TMPRSS2, Her we shed new light on the appropriate treatment can
overcome the challenges that face testosterone therapy in the era of COVID-19 After searching
MEDLINE , PubMed, , Google Scholar, preprints and Controlled Trials until September , 2020 we
found that the appropriate treatment in this case is aerosolized 13 cis retinoic acid in
combination with testosterone therapy, as more than one study found that 13 cis retinoic acid
reversibly and potentially inhibit the effect of dihydrotestosterone on different targeted
cells. In addition its impact on thrombin.
|
| NCT04625114 ↗ |
The Potential of Oral Camostat in Early COVID-19 Disease in an Ambulatory Setting to Reduce Viral Load and Disease Burden |
Recruiting |
Phase 2 |
2020-11-04 |
The investigators are conducting a pilot trial where they will study safety, efficacy and
compliance in a cohort of ambulatory patients in the Ghent region with confirmed COVID-19
infection, in both an early stage of disease, defined as less than 5 days of symptoms and who
at presentation do not meet any criteria for hospitalisation as well as asymptomatic
individuals with a PCR CT value below 30.
The primary endpoint is to assess the efficacy of the drug in terms of change from day 0 to
day 5 in respiratory (oropharyngeal swab RT-PCR) log10 viral load.
The aim of the study is to assess whether Camostat, a serine protease inhibitor available in
an oral formulation has the potential to be studied as an antiviral drug in a large scale
ambulatory setting to prevent transmission by decreasing viral load, to prevent symptoms
after exposure (PEP) in asymptomatic individuals or to prevent disease progression in the
occurrence of early symptomatology.
|
| NCT04625725 ↗ |
Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult. |
Active, not recruiting |
Phase 3 |
2020-11-21 |
This study will assess the safety and efficacy of a single dose of AZD7442(× 2 IM injections)
compared to placebo for the prevention of COVID-19.
|
| NCT04625972 ↗ |
Phase III Double-blind, Placebo-controlled Study of AZD7442 for Post- Exposure Prophylaxis of COVID-19 in Adults |
Active, not recruiting |
Phase 3 |
2020-12-02 |
This study will assess the efficacy of AZD7442 for the post-exposure prophylaxis of COVID-19
in Adults.
|
| NCT04628143 ↗ |
A Study Evaluating the Efficacy and Safety of CKD-314 in Hospitalized Adult Patients Diagnosed With COVID-19 Pneumonia |
Completed |
Phase 2 |
2020-12-21 |
The primary objective of this study is to evaluate the efficacy of CKD-314 (Nafabelltan)
compared to standard of care (SOC), with respect to clinical status assessed by a 7-point
ordinal scale in hospitalized adult patients diagnosed with COVID-19 pneumonia
|
| NCT04629703 ↗ |
Double-Blind, Randomized, Placebo-Controlled, Adaptive Design, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 Subjects |
Recruiting |
Phase 3 |
2021-02-22 |
The study is a double-blind, randomized, placebo-controlled, adaptive design, multi-center,
Phase 3 study to evaluate the efficacy and safety of fostamatinib in COVID-19 subjects.
|
| NCT04631536 ↗ |
Managing Endothelial Dysfunction in COVID-19 : A Randomized Controlled Trial at LAUMC |
Recruiting |
Phase 3 |
2021-01-10 |
COVID-19 infection was shown to cause endothelial dysfunction .
At the level of the endothelium the pathophysiological mechanisms have been hypothesized and
were divided into pro-coagulant, pro-inflammatory, anti-fibrinolytics, impaired barrier
function, vasoconstrictor and pro-oxidant. So far, the pro-coagulant and pro-inflammatory
pathways have been studied and as a result dexamethasone and anticoagulation became part of
the standard therapies for the disease. However, so far, no RCT has been evaluated on
targeting the vasoconstrictive and antioxidant pathways with an aim of revealing clinical
benefit.
So, with this trial we intend to provide a regiment composed of several medications we
hypothesize will act on several downstream pathways that would improve endothelial function
primarily via the increase in NO production and release.
At the time of this proposal there has been no randomized trials evaluating or testing the
use of cardiovascular drugs targeting endothelial dysfunction in COVID-19 patients. As
previously noted there has been a call to study these drugs and their effect after a strong
research regarding their theorized effectiveness. For evidence, there was a recently
published meta-analysis evaluating the role of statins in COVID-19 with preliminary findings
suggested a reduction in fatal or severe disease by 30% and discredited the suggestion of
harm, that emphasized on the need of well-designed randomized controlled trial to confirm the
role of statins in COVID-19 patients.
Our study would help determine the potential therapeutic effect of the endothelial protocol
as adjunct to mainstream management. This study seeks to further our knowledge in treating
COVID-19 to ultimately improve clinical outcomes and reduce complications.
|
| NCT04632381 ↗ |
Intravenous Zotatifin in Adults With Mild or Moderate COVID-19 |
Recruiting |
Phase 1 |
2021-07-01 |
To evaluate the safety and tolerability, the antiviral activity, and plasma pharmacokinetics
(PK) of zotatifin administered intravenously (IV) to adults with mild or moderate COVID-19.
|
| NCT04632537 ↗ |
BCG Vaccination to Prevent COVID-19 |
Withdrawn |
Phase 3 |
2020-12-07 |
The current COVID-19 epidemic threatens to overwhelm the capacity of many countries to meet
their populations' health care needs. Although several vaccines specific for SARS-CoV-2 have
been or are being developed, these require testing in animal and human safety studies and
they are unlikely to be available during the expected peak periods of the growing epidemic.
Two groups at especially high risk of infection and disease are front line health care
workers working directly with COVID-19 patients and elderly residents of group homes or
facilities that provide skilled nursing care to this frail population. Interim measures to
protect these groups while we await a high efficacy vaccine are desperately needed.
Based on the capacity of BCG to (1) reduce the incidence of respiratory tract infections in
children and adults; (2) exert antiviral effects in experimental models; and (3) reduce
viremia in an experimental human model of viral infection, we hypothesize that BCG
vaccination may induce (partial) protection against susceptibility to and/or severity of
SARS-CoV-2 infection.
This study will evaluate the efficacy of BCG to reduce risk of infection by SARS-CoV-2 and
mitigate COVID-19 disease severity in at risk health care providers.
A phase III randomized controlled trial provides the highest validity to answer this research
question. Given the immediate threat of the SARS-CoV-2 epidemic the trial has been designed
as a pragmatic study with a highly feasible primary endpoint, which can be continuously
measured. This allows for the most rapid identification of a beneficial outcome that would
allow other at-risk individuals, including the control population, to also benefit from the
intervention if and as soon as it has demonstrated efficacy and safety.
|
| NCT04633772 ↗ |
Use of Angiotensin-(1-7) in COVID-19 |
Completed |
Phase 1/Phase 2 |
2020-08-05 |
The renin-angiotensin system (RAS) has a relevant role in COVID-19, as the virus will enter
host's cells via the angiotensin-converting enzyme 2 (ACE2); RAS disequilibrium might also
play a key role in the modulation of the inflammatory response that characterizes the lung
involvement. Angiotensin-(1-7) is a peptide that could be altered in COVID-19 patient and its
supplementation may potentially helpful in this setting.
|
| NCT04634799 ↗ |
Study To antagOnize Plasminogen Activator Inhibitor-1 in Severe COVID-19 |
Recruiting |
Phase 1/Phase 2 |
2021-01-08 |
This is a single-center, randomized double blind placebo controlled trial to evaluate the
efficacy and safety of novel PAI-1 inhibitor (TM5614) for high-risk patients hospitalized
with severe COVID-19 at Northwestern Memorial Hospital. The patients will be randomized in a
1:1 ratio to receive standard of care plus TM5614 or standard of care plus placebo.
|
| NCT04636086 ↗ |
Effect of Vitamin D on Hospitalized Adults With COVID-19 Infection |
Recruiting |
Phase 4 |
2020-11-12 |
The objective of the study is to evaluate the clinical efficacy and safety of vitamin D
supplementation in hospitalized patients with COVID-19.
|
| NCT04639466 ↗ |
A Synthetic MVA-based SARS-CoV-2 Vaccine, COH04S1, for the Prevention of COVID-19 |
Recruiting |
Phase 1 |
2020-12-11 |
This phase I trial evaluates the side effects and best dose of COH04S1, a synthetic modified
vaccinia Ankara (MVA)-based SARS-CoV-2 vaccine, for the prevention of COVID-19. COVID-19 is
caused by the SARS-CoV-2 virus. SARS-CoV-2 has demonstrated the capability to spread rapidly,
leading to significant impacts on healthcare systems and causing societal disruption. COH04S1
was created by placing small pieces of SARS-CoV-2 DNA (the chemical form of genes) into
synthetic MVA, which may be able to induce immunity (the ability to recognize and fight
against an infection) to SARS-CoV-2. The purpose of this study is to determine the safety and
the optimal dose of the COH04S1 vaccine.
|
| NCT04640038 ↗ |
Contrast Enhanced Ultrasound in COVID-19 |
Recruiting |
Phase 3 |
2020-12-18 |
Initial data from COVID-19 patients suggests that one of the primary causes of death is
significant endothelial injury leading to blood clotting and impaired multiorgan
microvascular perfusion. The current study uses a safe, convenient bedside imaging tool
called contrast-enhanced ultrasound (CEUS) to estimate the extent of microvascular perfusion
impairment in the heart, kidneys and/or brain of COVID-19 pediatric patients in vivo and
assess the significance of imaging findings by correlating to clinical outcomes.
This pilot study will be conducted at one site, The Children's Hospital of Philadelphia. We
will enroll and evaluate 30 patients.
|
| NCT04640181 ↗ |
Factor Xa Inhibitor Versus Standard of Care Heparin in Hospitalized Patients With COVID-19 (XACT) |
Completed |
Phase 2 |
2020-12-01 |
This study is a multicenter, randomized trial to study the potential benefit of treatments
with a direct FXa inhibitor (rivaroxaban) versus standard of care dose subcutaneous low
molecular weight heparin (LMWH) (Lovenox) in hospitalized subjects with COVID-19.
|
| NCT04643691 ↗ |
Losartan and Spironolactone Treatment for ICU Patients With COVID-19 Suffering From ARDS |
Recruiting |
Phase 2 |
2020-09-11 |
Coronavirus disease (COVID-19) is a current pandemic infection caused by an RNA virus called
Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). Severe forms of COVID-19 are
most often responsible for isolated respiratory failure in the form of acute respiratory
distress syndrome (ARDS), which accounts for most of the mortality. Angiotensin converting
enzyme 2 (ACE2) has been shown to be a co-receptor for the entry of SARS-CoV-2 into cells and
is likely to play a prolonged role in the pathogenesis of COVID-19. ACE2 and angiotensin
(1-7) have been shown to be protective in a number of different lung lesion models. In a
mouse model of acidic lung injury, negative regulation of ACE2 by COVID, the SARS virus
responsible for the 2003 SARS outbreak, worsened the lung injury which was improved by
treatment with ARBs.
We believe that blocking the first RAS pathway at the end of the chain on the AT1r
angiotensin 2 receptor may prevent the initiation of this chain reaction and limit
decompensation secondary to the disruption of the equilibrium of the renin-angiotensin
system. We have several molecules that block the AT1r angiotensin-2 receptor (ARBs) as well
as a molecule that blocks the secretion of aldosterone (spironolactone). The main objective
is to demonstrate the value of losartan and spironolactone therapy in the regulation of the
renin-angiotensin system in improving the prognosis of patients infected with COVID-19 and
suffering from acute respiratory distress syndrome.
This is a prospective, multicenter, randomized, open-label, controlled, therapeutic trial
studying two parallel groups. The population included in this study is any major patient in
acute respiratory distress hospitalized in intensive care requiring oxygen support of at
least 6L/min and suffering from a PCR-confirmed SARS-cov2 infection. The control group will
benefit from the usual resuscitation management of COVID19 , and the experimental group will
benefit from losartan and spironolactone treatment in addition to the usual management,
according to the study protocol. The number of subjects required has been calculated and 45
patients for each group, for a total of 90 patients.
The SOFA score at D7 will be compared between the "experimental" versus "control" groups
using a mean comparison method. The comparison of this criterion and all secondary criteria
of judgments between the 2 groups will be performed using a Student or Mann-Whitney test
based on the normality of the distribution. The significance threshold will be set at 0.05.
No intermediate analysis is scheduled. The analysis will be blinded.
The main expected outcome is an improved prognosis with a decrease in the SOFA severity score
at 7 days in resuscitation patients, resulting in an improvement in organ failure. The
expected secondary results will be to show the interest of ARA2/Spironolactone treatment on
oxygenation based on the PaO2/FiO2 ratio, mechanical ventilation duration and mortality.
|
| NCT04646109 ↗ |
Ivermectin for Severe COVID-19 Management |
Completed |
Phase 3 |
2020-05-11 |
In this multicenter study; it was aimed to investigate the effectiveness and safety of
ivermectin use in the treatment of patients with severe COVID-19 pneumonia that have no
mutations which alter ivermectin metabolism and cause side effects.
|
| NCT04646655 ↗ |
Enoxaparin at Prophylactic or Therapeutic Doses in COVID-19 |
Recruiting |
Phase 3 |
2020-07-27 |
SINGLE CENTER PHASE III INTERVENTIONAL RANDOMIZED CONTROLLED TRIAL comparing efficacy and
safety of enoxaparin at prophylactic dose (standard treatment) and enoxaparin at therapeutic
dose (OFF-LABEL treatment) in 300 COVID-19 infected patients with moderate-severe respiratory
failure (PaO2/FiO2<250) and/or increased D-dimer levels enrolled in different Units
(Infectious disease, Internal Medicine, Emergency Medicine, Pneumology) of Azienda Socio
Sanitaria Territoriale Fatebenefratelli Sacco (ASST-FBF-SACCO).
|
| NCT04648800 ↗ |
Clinical Trial Evaluating the Effect of BCG Vaccination on the Incidence and Severity of SARS-CoV-2 Infections Among Healthcare Professionals During the COVID-19 Pandemic in Poland |
Recruiting |
Phase 3 |
2020-07-07 |
Countries that have not carried out universal mass vaccination against tuberculosis (BCG)
have been shown to have higher incidence and death rates due to COVID-19 than countries with
mass, long-term BCG immunization programmes.
The aim of the study is to answer the following questions:
1. Does BCG vaccination affect the course of COVID-19 (number of cases/deaths/severity of
symptoms)?
2. Will the course of COVID-19 be milder among subjects with a negative TB skin test (PPD
RT 23 SSI) after an additional dose of BCG than in case of non-vaccinated subjects?
3. Do people with a positive TB skin test have a milder course of COVID-19 infection than
people with a negative test result?
A multicenter, randomized, partially blinded, placebo-controlled study will be conducted in
Rzeszow/Krakow/ Katowice/Warsaw on a group of 1000 volunteers, health care workers according
to the following schedule: V 0-1: inclusion/informed consent/interview; V2: administration of
TB skin test/anti-SARS-CoV-2 IgG test/serum banking*; V3: TB skin test (TST) interpretation
and subjects' division into three groups: (I) positive TST - observation; (II) negative TST-
BCG-10 vaccination; (III) negative TST - placebo. Division into groups II and III based on
randomisation; V4: serum banking*. Parallel beginning from V3, weekly telephone monitoring
participants' health status; In case of COVID-19 symptoms a nasopharyngeal swab to confirm
SARS-CoV-2 infection + serum banking*. V5: 3 months after vaccination at the end of the
study: history/anti-SARS-CoV-2 IgG test, serum banking*.
Statistical analysis - comparison of the course of COVID-19 in groups: (I) with positive TST
+ observation, (II) with negative TST + BCG, (III) with negative TST + placebo - should
demonstrate whether mass BCG vaccination has an impact on the incidence and course of
COVID-19.
* to measure the level of cytokines involved in cell-mediated immunity process
|
| NCT04650087 ↗ |
COVID-19 Thrombosis Prevention Trials: Post-hospital Thromboprophylaxis |
Recruiting |
Phase 3 |
2021-02-15 |
A multicenter, adaptive, randomized platform trial evaluating the efficacy and safety of
antithrombotic strategies in patients with COVID-19 following hospital discharge
|
| NCT04652115 ↗ |
Defibrotide for the Treatment of Severe COVID-19 |
Recruiting |
Phase 2 |
2021-01-01 |
The goal of this study is to evaluate the safety and feasibility of defibrotide in COVID-19
pneumonia.
|
| NCT04652518 ↗ |
LYT-100 in Post-acute COVID-19 Respiratory Disease |
Recruiting |
Phase 2 |
2020-12-11 |
This study is being conducted in two parts, A and B. Part A is a randomized, double-blind,
parallel arm study to evaluate the safety and efficacy of LYT-100 compared to placebo in
adults with post-acute COVID-19 respiratory complications. Part B is an Open Label Extension
(OLE) study for patients who complete Part A.
|
| NCT04652648 ↗ |
Rapid Development and Implementation of a Remote ECG-monitored Prospective Randomized Clinical Trial During a Pandemic: Hydroxychloroquine Prophylaxis in COVID-19 Household Contacts |
Completed |
Phase 4 |
2020-05-27 |
- organizing an entirely no in-person contact clinical trial is feasible during a 22
COVID-19 pandemic 23
- Remote smartphone 6-lead ECG monitoring is possible even in a group unfamiliar 24 with
the technology 25
- Hydroxychloroquine used prophylactically at 200 mg BID had no observable 26
cardiotoxicity 27
- Additional study using this technique is warranted to look at reliability and cost-28
effectiveness
|
| NCT04653831 ↗ |
Treatment With Pirfenidone for COVID-19 Related Severe ARDS |
Recruiting |
N/A |
2020-11-08 |
A randomized, open label, two arm, pilot trial of Pirfenidone 2,403 mg administered per
nasogastric tube or orally as 801mg TID for 4 weeks in addition to Standard of Care (SoC),
compared to SoC alone, in a population of COVID-19 induced severe ARDS. Patients will be
randomized according to 1:1 ratio to one of the trial arms: Pirfenidone (intervention arm) or
SoC (control arm).
|
| NCT04655586 ↗ |
Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19 |
Recruiting |
Phase 2/Phase 3 |
2020-12-10 |
Sequential randomized, multicenter, active comparator study to evaluate the hypothesis that
rNAPc2 (AB201), a novel, potent and highly selective tissue factor inhibitor with
anticoagulant, anti-inflammatory and potential antiviral properties, shortens time to
recovery compared to heparin in hospitalized patients with COVID-19 and elevated D-dimer
levels.
|
| NCT04657484 ↗ |
Comparison of Two Corticosteroid Regimens for Post COVID-19 Diffuse Lung Disease |
Recruiting |
N/A |
2020-12-08 |
A proportion of patients with COVID-19 pneumonia have a prolonged course of illness. Some of
these patients continue to have considerable respiratory symptoms or persistent hypoxemia.
The CT abnormalities in these patients are often a combination of ground-glass opacities and
patchy multifocal consolidation consistent with a pattern of OP. In several patients, these
radiologic abnormalities persist. As with other forms of OP, patients with post-COVID OP or
post COVID diffuse lung disease (PC-DLD) may benefit from treatment with oral
glucocorticoids. The ideal dose of glucocorticoids for treating PC-DLD is unknown.
In this study, the investigatros aim to compare the efficacy and safety of a medium dose and
a low dose of prednisolone (as the initial dose) for the treatment of post-COVID. diffuse
lung disease.
|
| NCT04659304 ↗ |
Study Evaluating Safety and Tolerability of Allocetra-OTS in Patients With COVID-19 |
Not yet recruiting |
Phase 1 |
2021-12-01 |
Phase 1b, multi-center, open label, sequential dose escalation trial assessing 3 dose cohorts
using a 3+3 design to evaluate safety and tolerability of Allocetra-OTS in adult patients
with moderate COVID-19. The sample size for this trial is anticipated to range from 9 to 18
patients.
|
| NCT04659707 ↗ |
Hyperpolarized 129Xe MRI of Survivors of COVID-19 |
Recruiting |
Phase 1 |
2021-02-22 |
The purpose of this study is to evaluate pulmonary function of patients recovering from mild,
moderate, and severe COVID-19 disease using hyperpolarized 129Xe MRI.
|
| NCT04661527 ↗ |
Sarilumab Treatment In cytoKinE Storm Caused by Infection With COVID-19 |
Recruiting |
Phase 2 |
2020-04-22 |
Phase II, one-arm, open label, multicentric study, to evaluate treatment of severe COVID-19
with sarilumab prior to entry into the intensive care unit (ICU).
|
| NCT04661930 ↗ |
Fenofibrate for Patients With COVID-19 Requiring Hospitalization |
Recruiting |
Phase 3 |
2020-12-13 |
This is an open-label run-in followed by a randomized, double-blind drug treatment study of
COVID-19 infected patients requiring inpatient hospital admission.
|
| NCT04662060 ↗ |
COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Acebilustat Sub-Protocol |
Recruiting |
Phase 2 |
2021-04-23 |
The overall objective of this study is to efficiently evaluate the clinical efficacy and
safety of different investigational therapeutics among adults who have COVID-19 but are not
yet sick enough to require hospitalization. The overall hypothesis is that through an
adaptive trial design, potential effective therapies (single and combination) may be
identified for this group of patients.
COVID-19 Outpatient Pragmatic Platform Study (COPPS) is a pragmatic platform protocol
designed to evaluate COVID-19 treatments by assessing their ability to reduce viral shedding
(Viral Domain) or improve clinical outcomes (Clinical Domain). To be included into the
platform, every investigational product will collect data for both Domain primary endpoints.
Individual treatments to be evaluated in the platform will be described in separate
sub-protocols.
|
| NCT04662073 ↗ |
COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Camostat Sub-Protocol |
Active, not recruiting |
Phase 2 |
2021-04-23 |
The overall objective of this study is to efficiently evaluate the clinical efficacy and
safety of different investigational therapeutics among adults who have COVID-19 but are not
yet sick enough to require hospitalization. The overall hypothesis is that through an
adaptive trial design, potential effective therapies (single and combination) may be
identified for this group of patients.
COVID-19 Outpatient Pragmatic Platform Study (COPPS) is a pragmatic platform protocol
designed to evaluate COVID-19 treatments by assessing their ability to reduce viral shedding
(Viral Domain) or improve clinical outcomes (Clinical Domain). To be included into the
platform, every investigational product will collect data for both Domain primary endpoints.
Individual treatments to be evaluated in the platform will be described in separate
sub-protocols.
|
| NCT04662086 ↗ |
COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Master Protocol |
Recruiting |
Phase 2 |
2021-04-23 |
The overall objective of this study is to efficiently evaluate the clinical efficacy and
safety of different investigational therapeutics among adults who have COVID-19 but are not
yet sick enough to require hospitalization. The overall hypothesis is that through an
adaptive trial design, potential effective therapies (single and combination) may be
identified for this group of patients.
COVID-19 Outpatient Pragmatic Platform Study (COPPS) is a pragmatic platform protocol
designed to evaluate COVID-19 treatments by assessing their ability to reduce viral shedding
(Viral Domain) or improve clinical outcomes (Clinical Domain). To be included into the
platform, every investigational product will collect data for both Domain primary endpoints.
Individual treatments to be evaluated in the platform will be described in separate
sub-protocols.
|
| NCT04662684 ↗ |
Medically Ill Hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis With Rivaroxaban ThErapy: The MICHELLE Trial |
Active, not recruiting |
Phase 3 |
2020-10-16 |
The Michelle trial is expected to provide high-quality evidence around the role of extended
thromboprophylaxis in COVID-19 and will help guide medical decisions in clinical practice.
|
| NCT04663737 ↗ |
Evaluating Safety, Pharmacokinetics and Clinical Benefit of Silmitasertib (CX-4945) in Subjects With Moderate COVID-19 |
Active, not recruiting |
Phase 2 |
2020-12-03 |
This single-center, open-label, 2 arm parallel-group, randomized, interventional prospective
exploratory study in 20 subjects aimed to evaluate safety and explore putative clinical
benefits of Silmitasertib 1000 mg BID dose in patients with moderate COVID-19. Two-arm trial
comparing the SOC/supportive care alone to the SOC/supportive care with addition of
Silmitasertib (allocation ratio 1:1).
|
| NCT04665115 ↗ |
Ibrutinib for the Treatment of Patients With B-Cell Malignancies Who Are Infected With Coronavirus Disease 2019 (COVID-19) |
Not yet recruiting |
Phase 2 |
2021-06-30 |
This phase II trial studies the effects of ibrutinib in treating patients with B-cell
malignancies who are infected with COVID-19. Ibrutinib may stop the growth of tumor cells by
blocking some of the enzymes needed for cell growth. Ibrutinib is a first in class Bruton
tyrosine kinase inhibitor (BTKi), for the treatment of B-cell malignancies. This study is
being done to determine if taking ibrutinib after contracting COVID-19 will make symptoms
better or worse.
|
| NCT04667247 ↗ |
Mushroom-based Product for COVID-19 |
Recruiting |
Phase 1/Phase 2 |
2020-12-03 |
This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to
evaluate two polypore mushrooms, Fomitopsis officinalis and Trametes versicolor (FoTv), to
treat COVID-19-positive outpatients with mild-to-moderate symptoms assigned to
self-quarantined and home management. The study aims to establish the safety and feasibility
of the use of FoTv vs placebo in 66 total subjects.
|
| NCT04667780 ↗ |
Study to Investigate the Treatment Effect of Colchicine in Patients With COVID-19 |
Completed |
Phase 3 |
2020-12-01 |
COVID-19 is associated with a cytokine storm that leads to respiratory distress, multiorgan
failure and elevated mortality. Oral Colchicine exhibits high anti-inflammatory capacity
attributed to the inhibition of microtubules polymerization, inflammasome and production of
IL-1β and IL-6, which could prevent the inflammatory storm in COVID-19 patients at risk. The
investigators present a randomized, controlled, open-labeled, and pragmatic clinical trial to
study the treatment effect of Colchicine in COVID-19 patients requiring hospitalization, but
no intensive care yet. Colchicine will be started within the first 48 hours and continue for
14 days using a descending dose. The benefits will be studied in terms of clinical evolution
(WHO 7-point scale) and IL-6 levels, as well as other clinical and biochemical secondary
end-points. In the case of positive results, the clinical impact would be relevant given that
this oral medication is affordable and widely accessible which would help to prevent the
inflammatory complications associated with COVID-19.
|
| NCT04668222 ↗ |
Changing Susceptible Body Constitution for COVID-19 Prevention by Chinese Medicine in Hong Kong Residents |
Not yet recruiting |
Phase 1/Phase 2 |
2021-04-30 |
Chinese medicine has been used for thousands of years in the treatment of epidemic diseases.
Through the long-term struggle with the epidemic, Investigators have accumulated and explored
a lot of prevention and control experience. According to recent reports, Chinese medicine
plays an important role in the treatment of COVID-19. For example. Therefore, it is of great
clinical significance to further develop the prevention of COVID-19 by Chinese medicine.
According to the 《Diagnosis and treatment of COVID-19》published by National Health Committee
and the experience of professional TCM physician, although the disease is generally
susceptible, individuals with the body constitution of "deficiency of Qi and Yang" and
"deficiency of Qi and Yin" are more prefer to suffer from COVID-19. Therefore, "Invigorating
Qi and Yang, invigorating qi and Yin" can be regarded as the primary strategy of preventing
COVID-19. Therefore, "Invigorating Qi and Yang, invigorating qi and Yin" can be regarded as
the primary strategy of preventing COVID-19 in Chinese medicine. After a series of
questionnaire surveys and blood sample collection, investigators can estimate subjects with
body constitution is more likely to infect COVID-19.
|
| NCT04668469 ↗ |
Efficacy and Safety of Ivermectin for Treatment and Prophylaxis of COVID-19 Pandemic |
Completed |
N/A |
2020-06-08 |
Background: Up-to-date, there is no recognized effective treatment or vaccine for the
treatment of coronavirus disease (COVID-19) that emphasize urgency around distinctive
effective therapies. This study aims to evaluate the anti-parasitic medication efficacy
"Ivermectin" plus standard care (Azithromycin, Paracetamol, vitamin C, Zinc, Lactoferrin,
Acetylcystein, prophylactic or therapeutic anticoagulation if D-dimer > 1000 and/or steroids)
in the treatment of mild/moderate and severely ill cases with COVID 19 infection versus
Hydroxychloroquine plus standard care, as well as Ivermectin prophylaxis of health care and/
or household contacts.
Subject and methods: 600 subjects; 400 symptomatic confirmed COVID-19 patients and 200 health
care and household contacts distributed over 6 groups; Group I: 100 patients with
Mild/Moderate COVID-19 infection received a 4-days course of Ivermectin plus standard care;
Group II: 100 patients with mild/moderate COVID-19 infection received hydroxychlorquine plus
standard care; Group III: 100 patients with severe COVID-19 infection received Ivermectin
plus standard of care; Group IV: 100 patients with Severe COVID-19 infection received
hydroxychlorquine plus standard care. Routine laboratory investigations and real time-
polymerase chain reaction (rt-PCR) were reported before and after initiation of treatment.
Group V stick to personal protective equipment (PPE) plus Ivermectin, and Group VI stick to
PPE only and both groups were followed for two weeks.
|
| NCT04673162 ↗ |
Evaluation of the Efficacy of High Doses of Methylprednisolone in SARS-CoV2 ( COVID-19) Pneumonia Patients |
Not yet recruiting |
Phase 3 |
2020-12-01 |
This double blind, randomized study is aiming to evaluate the efficacy of three doses
(1gr/day) of methylpredisolone added to standard therapy in patients, with documented
COVID-19 pneumonia, requiring hospitalization but not mechanical ventilation.
|
| NCT04673214 ↗ |
Evaluation of Prognostic Modification in COVID-19 Patients in Early Intervention Treatment |
Completed |
Phase 3 |
2020-12-16 |
The present study is designed for patients with mild COVID-19 phase, to demonstrate if there
is a modification in the clinical evolution greater than or equal to 25% in their symptoms,
implemented in two groups of patients under an early intervention treatment, a group ( A)
will receive Azithromycin / Ivermectin / Ribaroxaban / Paracetamol and another group (B) will
receive Azithromycin / Ribaroxaban / Paracetamol followed for 14 days followed by video call
|
| NCT04678830 ↗ |
COVID-19 Long-Haulers Study |
Completed |
Phase 2 |
2021-03-01 |
The purpose of this study is to assess the safety and efficacy of leronlimab (PRO 140)
administered as weekly subcutaneous injections in subjects experiencing prolonged symptoms (>
12 weeks) of COVID-19.
|
| NCT04680949 ↗ |
suPAR-Guided Anakinra Treatment for Management of Severe Respiratory Failure by COVID-19 |
Active, not recruiting |
Phase 3 |
2020-12-23 |
The SAVE-MORE is a pivotal, confirmatory, phase III randomized clinical trial (RCT) aiming to
evaluate the efficacy and safety of early start of anakinra guided by suPAR in patients with
LRTI by SARS-CoV-2 in improving the clinical state of COVID-19 over 28 days as measured by
the ordinal scale of the 11-point World Health Organization (WHO) clinical progression scale
(CPS).
|
| NCT04681430 ↗ |
Reconvalescent Plasma/Camostat Mesylate Early in SARS-CoV-2 Q-PCR (COVID-19) Positive High-risk Individuals |
Recruiting |
Phase 2 |
2021-01-08 |
This study is a 4-arm, multicenter, randomized, partly double- blind, controlled trial to
evaluate the safety and efficacy of convalescent serum (CP) or camostat mesylate with control
or placebo in adult patients diagnosed with SARS-CoV-2 and high risk for moderate/severe
COVID-19. The working hypothesis to be tested in the RES-Q-HR study is that the early use of
convalescent plasma (CP) or camostat mesylate (Foipan®) reduces the likelihood of disease
progression to modified WHO stages 4b-8 in SARS-CoV-2 positive adult patients at high risk of
moderate or severe COVID-19 progression. The primary endpoint of the study is the cumulative
number of individuals who progressed to or beyond category 4b on the modified WHO (World
Health Organization) COVID-19 ordinal scale within 28 days after randomization.
|
| NCT04682873 ↗ |
A Clinical Study to Assess the Efficacy and Safety of Amizon® Max in the Treatment of Moderate Covid-19 |
Recruiting |
Phase 3 |
2020-05-15 |
Adult female and male patients, hospitalized with Covid-19 infection (confirmed by reverse
transcription polymerase chain reaction [RT-PCR]), will be screened for participation in this
prospective, multi-center, double-blind, randomised, placebo-controlled trial.
Enrolled patients will be randomized (1:1) into 2 treatment groups: Group 1 will receive the
active treatment with Amizon® Max (international nonproprietary name enisamium iodide), one
capsule (each containing 500 mg of enisamium iodide) 4 times daily every 6 hours for 7 days;
patients in treatment Group 2 will receive a matching placebo capsule, 4 times daily every 6
hours for 7 days. Patient observation and follow-up are planned for 29 days, unless
discharged before Day 29.
The effect of treatment on Covid-19 will be evaluated by time from day of randomization to an
increase of at least two points (from the status at randomization) on the severity rating
scale (SR), the Time to Clinical Recovery (TTCR) of main Covid-19 symptoms / complications
and the Sum of Severity Rating from Day 2 to Day 15 (SSR-15). Safety and tolerability of the
study drug will be evaluated based on the intensity and course of treatment-emergent adverse
events (TEAEs).
Enisamium iodide is an antiviral small molecule. Enisamium inhibits replication of alpha- and
beta- coronaviruses (human coronavirus NL63 and SARS-CoV-2, respectively) and influenza virus
A and B. Mechanism of action against SARS-CoV-2 includes the direct inhibition of the viral
RNA polymerase.
|
| NCT04694612 ↗ |
Efficacy of Favipiravir in Treatment of Mild & Moderate COVID-19 Infection in Nepal |
Recruiting |
Phase 3 |
2021-01-01 |
COVID-19 has affected almost all countries in the world. Every other country is constantly
working towards its treatment and development of vaccines, with little to no success so far.
Recently, several regimens have been tried as antiviral medicine. Among these medicines,
Favipiravir is considered a broad-spectrum antiviral with the spectrum of activity noted
against a wide range of RNA viruses & a good oral antiviral drug with > 97% bioavailability.
It has already proved its safety profile as it has received FDA indication for drug-resistant
Influenza. There has been increasing evidence of favorable outcome against COVID-19 in terms
of early viral clearance & quicker symptomatic relief however, most of these studies lack
strong statistical significance & are not peer-reviewed. Subjects will be categorized into
two arms based on the severity of infection due to COVID-19 defined by NMC guidelines. Each
arm will have respective two groups as the study drug group and control group. Based on the
sample size calculation, subjects will be stratified & randomly enrolled in the study after
checking the eligibility criteria at the screening visit. About 276 mild patients will be
recruited for this trial and 400 moderate patients (including 10% loss ). Study arm groups
will receive a Favipiravir treatment of 1800 mg PO BID on day 1, then 800 mg PO BID from day
2 onwards and control groups will receive the same quantity of Placebo. Treatment will be
continued till 5 days after for mild groups and 10 days for moderate groups. Eligible
patients will be randomly assigned (1:1) to either Favipiravir or Placebo among mild cases;
and Favipiravir or Remdesivir among moderate cases. Randomization will be stratified by age
group (18 to 40 years, 40 to 60 years and 60 to 80 years) and co-morbidity. The permuted
block (30 patients per block) randomization sequence, including stratification, will be
prepared by a statistician using STATA-15 software. Eligible patients will be allocated to
the respective arm and will receive individually numbered packs, according to the sequence
order as informed by the hotline. Informed written consent will be taken from the
participants before commencing the study. All safety data, patient's baseline, clinical
outcome data, data from endpoints and variables should be reported by the clinician and
his/her team in a pre-instructed case report form (CRF) via a designated website.
It is our assumption that if the study results come favorable, Favipiravir, when used in mild
or moderate cases, might prevent progression of the disease to higher severity, helps achieve
viral clearance early so as to positively impact disease transmission in the community,
increase the quality of life by quicker symptom recovery & decrease health burden by
shortening the length of stay at the hospital. These findings can also be useful in
international scenarios where the world is looking for innovative measures to curb COVID-19
infection. The study findings will be disseminated within and outside the country and will be
published in peer-reviewed journals.
|
| NCT04695197 ↗ |
Malaria as a Risk Factor for COVID-19 in Western Kenya and Burkina Faso |
Recruiting |
Phase 3 |
2021-01-08 |
It is unknown whether malaria or malaria treatment affects COVID-19 severity, immune
responses to SARS-CoV-2 virus, or viral loads and/or duration of shedding and therewith the
onwards spread of SARS-COV-2. An observational cohort study will be conducted in 708 newly
diagnosed COVID-19 patient of all ages in western Kenya and Burkina-Faso. They will be
enrolled in hospitals with COVID-19 testing facilities from a source population screened for
SARS-CoV-2 (N~4,720). Approximately 142 of the 708 COVID-19 patients are expected to be
co-infected with malaria. They will be enrolled in the nested malaria treatment trial and
randomized to receive 3-days of artemether-lumefantrine (the current standard of care) or
pyronaridine-artesunate, a highly effective antimalarial with known antiviral properties
against SARS-CoV-2 in-vitro, that is newly registered and being rolled out in Africa. Disease
progression will be assessed and nasal swabs and blood samples will be taken during
home/clinic visits on days 1, 3, 7, 14, 21, 28, and 42. Patients self-isolating will be
phoned daily in between scheduled visits for the first 14 days to assess signs and symptoms.
Hospitalisation, self-isolation and home-based care will follow national guidelines. The WHO
clinical progression scale and FLU-PRO plus scales will be used to compare disease
progression between COVID-19 patients with and without malaria, and by malaria. Other
endpoints include seroconversion/reversion rates, chemokine/cytokine responses, T and B cell
responses, viral load and duration of viral carriage. Infection prevention and control (IPC),
including the use of personal protection equipment (PPE), and measures for patient transport
will follow national guidelines in each country. Written informed consent/assent will be
sought. The study is anticipated to start in January 2021 and last for approximately 18
months.
|
| NCT04695704 ↗ |
Efficacy of Montelukast in Mild-moderate Respiratory Symptoms in Patients With Long-COVID-19: |
Not yet recruiting |
Phase 3 |
2021-04-01 |
Recently, a new clinical presentation called "long covid" has been reported, for patients
with symptoms lasting for more than 4 weeks from the onset of the disease. Typically, the
symptoms comprise dyspnea, cough, headache, arthralgia, fever, abdominal pain, asthenia and
skin manifestations This project aims to evaluate the efficacy of Montelukast in improving
the quality of life associated with respiratory symptoms in patients with persistent COVID-19
symptoms. The main objective is to compare the efficacy of low-dose Montelukast versus
placebo to improve respiratory symptoms in patients with persistent COVID-19 symptoms.
|
| NCT04701710 ↗ |
Prophylaxis Covid-19 in Healthcare Agents by Intensive Treatment With Ivermectin and Iota-carrageenan |
Completed |
Phase 1/Phase 2 |
2020-10-15 |
IMPORTANCE: The emergency of COVID-19 requires the implementation of urgent strategies to
prevent the spread of the disease, mainly in health personnel, who are the most exposed and
has the highest risk of becoming infected with the SARS-COV-2.
OBJECTIVE: To evaluate the protective effect of the combination Ivermectin - Iota-
Carrageenan, intensive treatment with repeated administration in oral- and nasal-spray,
respectively, as a prophylaxis treatment prior to exposure to SARS-CoV-2, in health personnel
at Public Healthcare Centers.
PARTICIPANTS, DESIGN AND SETTING: Randomized controlled 1-1 clinical trial in Personal
Health, n = 234. The subjects were divided into experimental (EG)and control groups (CG). The
EG received Ivermectin orally 2 drops of 6 mg = 12 mg every 7 days, and Iota-Carrageenan 6
sprays per day for 4 weeks. All participants were evaluated by physical examination COVID-19
diagnosed with negative RT-PCR at the beginning, final, and follow-up of the protocol.
Differences between the variables were determined using the Chi-square test. The proportion
test almost contagious subject and the contagion risk (Odd Ratio) were calculated using
software STATA. The level of statistical significance was reached when p-Value < 0.05.
|
| NCT04705597 ↗ |
Study to Evaluate the Safety, Tolerability, and Efficacy of BGE-175 in Hospitalized Adults With Coronavirus Disease 2019 (COVID-19) That Are Not in Respiratory Failure |
Recruiting |
Phase 2 |
2021-03-18 |
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy
of BGE-175 in participants ≥ 50 years of age hospitalized with documented COVID-19.
|
| NCT04707534 ↗ |
Dexamethasone for COVID-19 |
Recruiting |
Phase 4 |
2021-01-21 |
This open label clinical trial is to evaluate two different doses of dexamethasone on the
health outcome using World Health Organization ordinal scale at day 28 in hospitalized
patients with COVID-19.
|
| NCT04707664 ↗ |
Sargramostim Use in COVID-19 to Recover Patient Health |
Recruiting |
Phase 2 |
2021-04-27 |
The purpose of this research is to understand if the study drug, also called sargramostim or
Leukine®, can help prevent the worsening of COVID-19 when the study drug is inhaled. This
study will also help researchers understand if inhaled sargramostim can help prevent visits
to the emergency room or hospitalization, or death.
|
| NCT04707703 ↗ |
Isavuconazole for the Prevention of COVID-19-associated Pulmonary Aspergillosis |
Recruiting |
Phase 3 |
2021-03-16 |
The objective of this study is to evaluate whether antifungal prophylaxis with isavuconazole
can reduce the incidence of SARS-CoV-2-associated invasive aspergillosis in patients in the
ICU (intensive care unit) with severe COVID-19 infection.
The investigators will perform an interventional, double-blinded, randomized-controlled,
multi-center study in patients with severe COVID-19 infection admitted to the ICU. Patients
will be randomized to the isavuconazole prophylaxis plus standard of care (SOC) group or the
placebo plus SOC group. Participants will receive isavuconazole or placebo for up to 28 days
or until discharge from the hospital (whichever occurs first).
|
| NCT04708340 ↗ |
Tolerability and Efficacy of RJX in Patients With COVID-19 |
Recruiting |
Phase 1/Phase 2 |
2021-03-25 |
This study is designed as a 2-part, 2-cohort, double-blind, randomized, placebo controlled,
multicenter Phase 1/2 study to evaluate the safety, tolerability and efficacy of RJX in
patients with COVID-19.
|
| NCT04709172 ↗ |
Pilot Study of Cefditoren Pivoxil in COVID-19 Patients With Mild to Moderate Pneumonia |
Completed |
Phase 4 |
2021-01-05 |
The global pandemic of novel coronavirus disease 2019 (COVID-19) began in Wuhan, China, in
December 2019, and has since spread worldwide. The disease is mild in 85% of cases but the
remaining 15% requires hospitalization and/or intensive care.
Recent publications show that a significant number of COVID-19 patients are co-infected with
one or more pathogens. Most co-infections occurred within 1-4 days of onset of COVID-19
disease and a considerable number of patients arrive to the Emergency rooms with
mild-moderate respiratory symptoms compatible with pneumonia of presumed bacterial origin and
not severe enough for requiring hospitalization. It therefore seems reasonable to adopt
therapeutic strategies for these patients that are effective and easy to follow in the
outpatient setting.
Cefditoren (CDN) is a third-generation cephalosporin for oral administration. CDN has a broad
spectrum of activity and is particularly active against the bacterial pathogens involved in
community respiratory tract infections. Besides that, the use of CDN has been associated with
a marked decrease in circulating levels of IL-6 and other pro-inflammatory cytokines and
mediators of epithelial damage. The aim of this study is to demonstrate that CDN improves
clinical condition in patients with mild-moderate COVID-19 and symptoms of bacterial
pneumonia.
|
| NCT04710199 ↗ |
Trial to Evaluate the Safety and Efficacy of Maraviroc in Patients Hospitalized for Coronavirus Disease 2019 (COVID-19) |
Completed |
Phase 2 |
2021-02-23 |
Maraviroc (MVC) is a drug, very well tolerated, it has been seen that MVC has properties of
modulating the immune system, exerting an anti-inflammatory effect in different diseases. In
COVID-19, very high levels of inflammation occur that cause organs and systems to be damaged.
MVC could reduce this inflammation achieving a better prognosis of COVID-19.
|
| NCT04711863 ↗ |
Fluvoxamine for Adults With Mild to Moderate COVID-19 |
Suspended |
Phase 2 |
2021-01-16 |
This clinical trial aims to determine if fluvoxamine, a selective serotonin reuptake
inhibitor with high affinity for the sigma-1 receptor, can be used in mild to moderate
COVID-19 to prevent the progression to severe COVID-19. Fluvoxamine is an anti-depressant
drug approved by the FDA for the treatment of obsessive-compulsive disorder and has a
potential for immune modulation as a sigma-1 receptor agonist. The investigational use of
fluvoxamine for the treatment of COVID-19 is approved by the South Korean Ministry of Food
and Drug Safety.
This study is performed fully-remotely at COVID-19 community treatment centers, temporary
facilities in Seoul, Korea, to accommodate and monitor asymptomatic to moderately symptomatic
case-patients who do not require hospital admission.
|
| NCT04712279 ↗ |
The (HD)IVACOV Trial (The High-Dose IVermectin Against COVID-19 Trial) |
Not yet recruiting |
Phase 2/Phase 3 |
2021-01-25 |
Ivermectin, a classical antiparasitic and anti-scabies agent, has demonstrated antiviral
activity for a variety of viruses including chikungunya virus, zyka virus and dengue virus
and was tested as a potentially effective for COVID-19.
Although ivermectin demonstrated potent in vitro action by reducing viral load by 5000x after
48 hours of incubation, simultaneous pharmacokinetics simulations suggested that the minimum
effective concentrations would be unfeasible to be reached within safety range (EC-50 = 2
Micromol).
However, despite the theoretical unfeasible concentrations to be achieved, preliminary
observational yet well-structured studies followed by randomized clinical trials (RCTs)
demonstrated ivermectin efficacy when combined with hydroxychloroquine, doxycycline or
azithromycin, which was corroborated by a recent systematic review and metanalysis. In
common, a dose-response effect for effectiveness was observed, and no adverse effects was
reported at any dose between 0.2mg/kg/day and 1.0mg/kg/day.
Based on the scientific rationale combined with the preliminary evidence, ivermectin has
sufficient evidence to be tested in higher doses in a RCT for COVID-19. The investigators
propose to test ivermectin at high doses as a treatment for patients recently diagnosed with
COVID-19, aiming to explore the possible protective role of high-dose ivermectin in
SARS-CoV-2 infection in terms of reduction of clinic and virologic disease duration, and
prevention of oxygen use, hospitalization, mechanical ventilation, death, and post-COVID
persisting symptoms.
|
| NCT04712357 ↗ |
Clinical Experimentation With Tenofovir Disoproxyl Fumarate and Emtricitabine for COVID-19 |
Recruiting |
N/A |
2020-11-09 |
Clinical, control, double-blind, randomized trial with tenofovir disoproxyl fumarate and
emtricitabine for Covid-19
|
| NCT04715295 ↗ |
Safety and Efficacy of Doxycycline and Rivaroxaban in COVID-19 |
Recruiting |
Phase 4 |
2020-10-05 |
This is an exploratory study to evaluate the efficacy of Doxycycline (200mg on D1 to D7) and
Rivaroxaban (15 mg daily on D1 to D7) versus the combination of Hydroxychloroquine (400 mg on
D1 to D7) and Azithromycin (500 mg on D1 and 250mg on D2 to D5) as per national standard to
treat ambulatory mild COVID-19 patients, with the aim to achieve early negativity of RT-PCR
of SARS-CoV-2 from nasopharyngeal swab, and early clinical improvement and prevention of
severe disease.
|
| NCT04715932 ↗ |
Study of Hesperidin Therapy on COVID-19 Symptoms (HESPERIDIN) |
Completed |
Phase 2 |
2021-02-18 |
The main aim of this study is to determine the effects of short-term treatment with
hesperidin on COVID-19 symptoms in comparison with a placebo. Treatment effects will be
observed through a symptoms diary that will be completed by participants throughout the study
and by taking the oral temperature daily.
|
| NCT04715997 ↗ |
Safety and Immunogenicity Study of GX-19N, a COVID-19 Preventive DNA Vaccine in Healthy Adults |
Recruiting |
Phase 1/Phase 2 |
2020-12-30 |
The objective of our study is to evaluate safety, tolerability, and immunogenicity of
COVID-19 preventive DNA vaccine in healthy volunteers.
|
| NCT04716426 ↗ |
APT™ T3X on the COVID-19 Contamination Rate |
Completed |
N/A |
2021-01-28 |
The new coronavirus 2019 (COVID-19) was declared a pandemic by the World Health Organization
(WHO), due to the alarming levels of spread, severity and inaction. Dealing with COVID-19
must be done on different fronts, such as mitigation, treatment and prevention. Therefore,
strategies and therapies that can help reduce the COVID-19 rate of contamination are still
important alternatives at this time of the pandemic.
The Advanced Penetration Technology™ (APT™) is intellectual property owned by Patient Focused
Tele-Health, LLC, a Rockwall, Texas based company. The company's focus is improving
over-the-counter (OTC) topical formulations, allowing consumers better therapeutic outcomes
with non-prescription medications.
The Advanced Penetration Technology™ (APT™) is a patent-pending, proprietary transdermal dual
carrier formulation. This formulation provides improved dermal penetration and efficacy of
topical API's. Additionally, the APT™ imparts both a mechanical and biochemical effect on the
microbe/fungal cell walls providing a highly effective method of destruction of microbes.
These unique properties impart the broad spectrum anti-viral capability to the APT™
Tetracycline 3% formulation, breaking barriers in pharmacology and virology.
The topical formulation APT™ Tetracycline 3% formulation (APT ™ T3X), is a FDA registered,
Non-Prescription product. This formulation is used in an off label manner as an intranasal
application for prevention of COVID-19 and other viruses. The APT™ T3X as a topical
application will penetrate through and into the mucus layer and deeper. This barrier of
coverage will provide a mitigation effect to decrease the viral load of exposure and
infection. The efficacy of APT™ T3X is due to disrupting the lipid envelope in seconds, hence
neutralizing the virus.
Previous tests were performed with APT™ T3X and the results found were promising. However,
these tests were performed only in vitro and clinical studies demonstrating the ability of
the APT™ T3X to decrease viral exposure and contamination by COVID-19 are necessary to
confirm the possible prophylactic effect, allowing the formulation to be widely distributed
to the general population.
Therefore, the aim of this project is to evaluate the efficacy of the APT™ T3X compared to
placebo to decrease COVID-19 contamination rate in humans.
|
| NCT04716569 ↗ |
Evaluation of Ivermectin Mucoadhesive Nanosuspension as Nasal Spray in Management of Early Covid-19 |
Recruiting |
Phase 2/Phase 3 |
2021-01-20 |
Ivermectin showed a strong viricidal effect upon covid19 virus in vitro as proved by many
authors according to many studies , covid virus stay in postnasal space for 4 days before
starting general manifestation, so ivermectin mucoadhesive nanosuspension sprayed inside the
nose and post nasal space may help in early management of covid19 and may play a great rule
in prophylaxis as well
|
| NCT04721457 ↗ |
The Efficacy of Pre-procedural Mouth Rinses on COVID-19 Saliva Viral Load |
Recruiting |
Phase 4 |
2021-01-03 |
Preoperative antiseptic mouth rinses have been widely used as a standard protocol before
routine dental treatment reduces oral microorganism counts. During dental procedures,
aerosolized microorganisms contaminate the dental environment and nearby surfaces and remain
suspended for 4 hours. Thus, the reduction in the number of aerosolized microorganisms by
pre-procedural rinsing may reduce cross-contamination between dentists, office personnel, and
patients. Recent reviews have advocated the use of preoperative rinsing to control and reduce
the risk of SARS-CoV-2 transmission. However, no clinical studies have been done yet to
support the effectiveness of any pre-procedural oral rinses against SARS-CoV-2. The proposed
study will mitigate the spread of COVID-19 disease in dental health care facilities and
ensure the patients' good health and healthcare workers. The purpose of this clinical trial
is to determine and compare the effectiveness of four commercially available, pre-procedural
mouth rinses versus distilled water on viral load of SARS-CoV-2 found in the saliva of
COVID-19 positive patients and to measure the pre-rinsing viral load with the post-rinsing at
three-time points.
|
| NCT04723394 ↗ |
Phase III Study of AZD7442 for Treatment of COVID-19 in Outpatient Adults |
Active, not recruiting |
Phase 3 |
2021-01-28 |
This Phase III study will assess whether AZD7442 (a combination of 2 mAbs) can safely treat
outpatient adults with COVID-19 and prevent either severe COVID-19 or death.
|
| NCT04723537 ↗ |
Upamostat, a Serine Protease Inhibitor, or Placebo for Treatment of COVID-19 Disease |
Recruiting |
Phase 2/Phase 3 |
2021-02-16 |
A 2-part, multicenter, Phase 2/3, randomized, double-blind, placebo-controlled, parallel
group study to evaluate the safety and efficacy of upamostat in adult patients with COVID-19
disease who do not require inpatient care.
|
| NCT04723563 ↗ |
Nebulized Heparin for the Treatment of COVID-19 |
Completed |
Phase 4 |
2021-02-22 |
Randomized, placebo controlled study to determine if nebulized heparin may reduce the need
for mechanical ventilation in hospitalized patients with the novel coronavirus, also known as
COVID-19. This will be a part of a larger meta-trial.
|
| NCT04724720 ↗ |
Famotidine vs Placebo for the Treatment of Non-Hospitalized Adults With COVID-19 |
Active, not recruiting |
Phase 2 |
2021-01-19 |
The overall objective of this study is to evaluate the clinical efficacy of oral famotidine
in symptomatic non-hospitalized patients with confirmed COVID-19. This study is expected to
enroll up to 84 patients with mild to moderate symptoms divided into each of the two study
arms. Clinical outcomes of the two treatment arms will be compared. This study will be
conducted virtually/remotely.
|
| NCT04726098 ↗ |
Low or High Dose of Dexamethasone in Patients With Respiratory Failure by COVID-19 |
Completed |
Phase 4 |
2021-01-15 |
After RECOVERY trial publication, low dose (6 mg dexamethasone for 10 days) was recommended
as the usual care treatment in hospitalized patients with respiratory failure by COVID-19
needing oxygen therapy. RECOVERY trial showed how the use of dexamethasone 6 mg / day for ten
days compared to standard treatment without the use of corticosteroids in hospitalized
patients reduced mortality at 28 days (22.9% with dexamethasone vs 25.7% without
dexamethasone). In the dexamethasone group, the incidence of mortality was lower than
standard treatment in patients with hypoxia and the need for mechanical ventilation (29.3%
with dexamethasone vs 41.4% without dexamethasone), in patients admitted to the hospital ward
with a need for oxygen therapy (23.3% with dexamethasone vs 26.2% without dexamethasone), but
they did not find differences between those admitted patients who did not need oxygen
therapy. There are two other studies (DEXA-COVID-19 and CoDEX) where they observed benefits
of the use of dexamethasone 20 mg / day 5 days, and 10 mg / day 5 days (total 10 days) in
patients admitted for respiratory distress syndrome (ARDS) and COVID-19. At present, it is
unclear what dose of dexamethasone is most beneficial in patients with COVID-19 and
respiratory failure.
|
| NCT04727424 ↗ |
Repurposed Approved and Under Development Therapies for Patients With Early-Onset COVID-19 and Mild Symptoms |
Recruiting |
Phase 3 |
2021-01-19 |
The COVID-19 pandemic has been characterized by high morbidity and mortality, especially in
certain subgroups of patients. To date, no treatment has been shown to be effective in
patients with early-onset disease and mild symptoms. Experimental studies have demonstrated a
potential anti-inflammatory role of Fluvoxamine, Metformin and Ivermectin in SARS-CoV-2
infections and observational studies have suggested a reduced complications in patients with
COVID-19 disease.
|
| NCT04729595 ↗ |
Study to Evaluate the Effects of Tempol (MBM-02) in COVID-19 Patients. |
Recruiting |
Phase 2/Phase 3 |
2021-09-01 |
An Adaptive, Randomized, Double-blind, Placebo-controlled study to examine the Effects of
Tempol in subjects with COVID-19 infection.
|
| NCT04730206 ↗ |
The DAWN Camostat Trial for Ambulatory COVID-19 Patients |
Recruiting |
Phase 3 |
2021-06-15 |
This is a prospective, placebo controlled, individually randomized controlled phase III trial
in Primary Care, assessing the efficacy of Camostat in preventing hospital admission or death
in Covid-19 patients.
|
| NCT04730323 ↗ |
TOCILIZUMAB - An Option for Patients With COVID-19 Associated Cytokine Release Syndrome; A Single Center Experience |
Completed |
Phase 4 |
2020-05-12 |
Investigators conducted this study to see the effectiveness of Tocilizumab in COVID-19
participants who were in cytokine release syndrome and there was also a control group who
received steroids(RECOVERY TRIAL wasn't published or available at that time) this study was
conducted in the early days of 1st wave of COVID in our country Pakistan so it was need of
the day to develop some national guidelines on the basis of multiple studies' results from
Pakistan.
|
| NCT04730427 ↗ |
Safety and Preliminary Efficacy Study of GX-I7 in Patients With COVID-19 |
Recruiting |
Phase 1 |
2021-01-01 |
This study is a phase 1b clinical trial to investigate the safety and preliminary effects of
a single dose of a test drug or placebo to the subjects who has diagnosed as COVID-19
infection.
|
| NCT04730895 ↗ |
Investigating the Role of 13cis Retinoic Acid in the Treatment of COVID-19 and Enhancement of Its Spike Protein Based Vaccine Efficacy and Safety. |
Not yet recruiting |
Phase 1/Phase 2 |
2021-07-01 |
Investigating the role of 13cis retinoic acid in the treatment of COVID-19 and enhancement of
Its spike protein based vaccine efficacy and safety.
|
| NCT04731116 ↗ |
Cannabidiol Treatment for Severe and Critical Coronavirus (COVID-19) Pulmonary Infection |
Recruiting |
Phase 1/Phase 2 |
2021-01-10 |
Current management of COVID-19 (coronavirus) is mainly supportive, and respiratory failure
from acute respiratory distress syndrome (ARDS) is the leading cause of mortality. Cytokines
and chemokines are thought to play an important role in immunity and immunopathology during
virus infections. Patients with severe COVID-19 have higher serum levels of pro-inflammatory
cytokines (TNF-α, IL-1 and IL-6) and chemokines (IL-8) compared to individuals with mild
disease or healthy controls, similar to patients with severe acute respiratory syndrome
(SARS).
Cannabidiol (CBD), a nonpsychotropic ingredient of Cannabis sativa, possesses potent
anti-inflammatory and immunosuppressive properties. These effects are mediated by T cell
attrition and by inhibition of pro-inflammatory cytokine release (tumor necrosis factor-a,
Interferon gamma, IL-1b, IL-6, and IL-17) and stimulation of anti-inflammatory cytokine
production (IL-4, IL-5, IL-10, and IL-13). In a number of phase 2 trials involving more than
100 patients, our group was able to show the safety and efficacy of CBD in the prevention and
treatment of graft-versus-host disease.
Based on these data, we will test the cytokine profile, safety and efficacy of CBD treatment
in patients with severe and critical COVID-19 infection.
|
| NCT04733651 ↗ |
Study to Investigate the Clinical Efficacy of Isoquercetin in Patients With COVID-19 |
Not yet recruiting |
Phase 2 |
2021-02-20 |
The purpose of this study is to investigate the clinical efficacy of Isoquercetin in
preventing disease progression and symptoms improvement in mild-to-moderate hospitalised
COVID-19 patients.
|
| NCT04734860 ↗ |
Study to Evaluate a Single Dose of STI-2020 (COVI-AMG™) in Adults With Mild COVID-19 Symptoms |
Recruiting |
Phase 2 |
2021-04-01 |
This study investigates the safety, pharmacokinetic (PK) profile and efficacy of a single
injection of COVI-AMG in outpatient adults with mild COVID-19 symptoms.
|
| NCT04738136 ↗ |
Safety, Tolerability and Efficacy Of S-1226 in Moderate Severity Covid-19 Bronchiolitis/Pneumonia |
Suspended |
Phase 2 |
2021-09-15 |
This is a randomized, open-label, controlled, Phase II proof of concept study to evaluate the
safety, tolerability and efficacy of S-1226 in which hospitalized subjects (n≤30) with
moderate severity COVID-19 Bronchiolitis/Pneumonia will be enrolled. The safety and
tolerability of S-1226 composed of PFOB with ascending doses of carbon dioxide (4%, 8%, and
12% CO2) administered twice daily will be assessed subjects in hospitalized subjects with
moderate severity COVID-19 Bronchiolitis/Pneumonia.
|
| NCT04739410 ↗ |
Effectiveness of Ivermectin in SARS-CoV-2/COVID-19 Patients |
Completed |
Phase 4 |
2020-05-01 |
Background:
The first case of Infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
were diagnosed in Wuhan, China in 2019. In the first half of 2020 this disease has already
converted into a global pandemic. Objectives: To assess the efficacy of Ivermectin in mild
cases of COVID-19 patients on the basis of predefined assessment criteria. Study Settings:
Fatima Memorial Hospital, Lahore Study Design: Open label randomized control trial. Duration
of Study: From 1st May, 2020 to 30th June, 2020.Patients & Methods: Sample size and
technique: Sample size was 50 patients; 25 patients were kept in control group and 25
patients were kept in experimental group
|
| NCT04742725 ↗ |
A Study to Evaluate the Efficacy and Safety of Prothione™ Capsules for Mild to Moderate Coronavirus Disease 2019 (COVID-19) |
Active, not recruiting |
Phase 2 |
2021-05-25 |
The study is a phase 2 proof of concept study. The purpose of this study is to assess the
efficacy and safety of Prothione™ capsules administered orally twice a day for 30 days in
subjects with mild to moderate COVID-19. The study will have three phases: Screening Period,
Treatment Period, and Follow-Up Period.
The issued patents relevant to Prothione™ capsules and the treatment of viral disease
include: • Nutritional or Therapeutic Compositions and Methods to Increase Bodily
Glutathione Levels:
1. US Patent No. RE 42,645
2. Japanese Patent No. 5601745
3. European Patent No. 1556023
4. Canadian Patent No. 2539567
5. Australian Patent No. 2010201136
• Protective Metallothionein Analog Compounds, Their Compositions and Use
Thereof in the Treatment of Pathogenic Disease:
6. Canadian Patent No. 2963131
7. Australian Patent No. 2018279015
|
| NCT04746183 ↗ |
AGILE (Early Phase Platform Trial for COVID-19) |
Recruiting |
Phase 1/Phase 2 |
2020-07-03 |
The AGILE platform master protocol allows incorporation of a range of identified and
yet-to-be-identified candidates as potential treatments for adults with COVID-19 into the
trial. Candidates will be added into the trial via candidate-specific trial (CST) protocols
of this master protocol as appendices. Having one master protocol ensures different
candidates are evaluated in the same consistent manor and opening up new trials for new
candidates is more efficient. Inclusion of new candidates will be determined by the AGILE
Scientific Advisory Board based on pre-clinical data, evidence in the clinical setting and
GMP capabilities.
|
| NCT04746339 ↗ |
Apixaban for PrOphyLaxis of thromboemboLic Outcomes in COVID-19 |
Recruiting |
Phase 4 |
2021-03-04 |
Randomized, double-blinded, placebo-controlled trial comparing oral anticoagulation with
placebo for community-dwelling patients with symptomatic COVID-19 infection and risk factors
for thrombosis.
|
| NCT04746365 ↗ |
Ivermectin Role in Covid-19 Clinical Trial |
Completed |
Phase 4 |
2020-12-06 |
Because ivermectin is being used to treat COVID-19 with insufficient evidence, the
investigator conducted a randomized clinical trial to investigate the efficacy and safety of
ivermectin in comparison to hydroxychloroquine and placebo in severe COVID-19 patients. The
study was conducted in Shebin-Elkom teaching hospital and recruited patients from December 6,
2020, to January 31, 2021.
|
| NCT04747574 ↗ |
Evaluation of the Safety of CD24-Exosomes in Patients With COVID-19 Infection |
Recruiting |
Phase 1 |
2020-09-25 |
This is an open-label Phase I study, four dose escalation groups, to evaluate the safety of
CD24-exosomes in patients with moderate/severe COVID-19 disease.
Patients with moderate/severe COVID-19 infection and factors predictive of a cytokine storm
are recruited from the Corona department of the Tel Aviv Sourasky Medical Center (TASMC), who
have provided informed consent are being recruited in four dose groups who will receive the
exosome treatment as an add-on treatment to standard treatment.
|
| NCT04748783 ↗ |
Antiviral Efficacy and Acceptability of Mouth Rinses for Inactivation of COVID-19 |
Terminated |
Phase 2 |
2021-03-26 |
Subjects (125) will be randomized to one of five mouthrinses and will be asked to give a
saliva sample immediately before and after a 30-60 second mouthwash.
Saliva samples will be collected from subjects at 15-minute intervals thereafter up to one
hour (15, 30, 45 and 60 min). The saliva will be used for RT-PCR detection of Severe Acute
Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) and viral infectivity assays, along with
quantitative cytokine and chemokine concentration (pg/mL, Luminex).
Subjects will complete a short survey on the taste and experience of using the mouthwash.
Peripheral blood will be collected at the end of salivary collection. Subjects, except
controls, will be provided materials and oral hygiene instruction related to daily use of
oral hygiene products. In the seven-day period between study visit one and study visit two,
subjects will be directed to brush with Colgate toothpaste (at least twice per day) and rinse
with the Colgate mouthrinse (according to on-label procedures). Controls are asked to carry
out their typical oral hygiene regimen with the products they typically use.
All subjects keep a daily diary of oral hygiene performance, product usage, COVID-19 symptoms
and exposures. Subjects complete study visit two one week after the baseline visit during
which additional salivary (1 time point, 2 mL of saliva over 5 min, no rinse) will occur and
blood samples collected. each subject will undergo a periodontal exam.
|
| NCT04750317 ↗ |
Efficacy and Safety of Tofacitinib in Patients With COVID-19 Pneumonia |
Completed |
Phase 2 |
2020-05-11 |
TOFA-COV-2 is a cohort study of the efficacy of tofacitinib in reducing the risk of
mechanical ventilation and/or death in patients with moderately severe COVID-19 pneumonia who
received standard of care treatment (SoC). The study population consists of adults (≥18
years) with COVID-19, who are admitted to the university hospitals and don't require invasive
or noninvasive ventilation on admission. All patients are divided into four groups depending
on nadir levels of oxygen saturation and therapy: (1) patients with oxygen saturation ≤93%
who received tofacitinib and SoC, (2) patients with oxygen saturation ≤93% who received only
SoC, (3) patients with oxygen saturation >93% who received tofacitinib and SoC, (4) patients
with oxygen saturation >93% who received only SoC. The aim of the study is to test the
hypothesis that addition of tofacitinib to SoC could reduce the risk of mechanical
ventilation and/or death.
|
| NCT04753476 ↗ |
Treatment of Severe COVID-19 Patients Using Secretome of Hypoxia-Mesenchymal Stem Cells in Indonesia |
Recruiting |
Phase 2 |
2020-06-08 |
In this randomized controlled trial (RCT), severe cases of COVID-19 infection will be treated
with secretome of hypoxia-mesenchymal stem cells. The improvement in clinical, laboratory,
and radiological manifestations will be evaluated in treated patients compared with the
control group.
|
| NCT04756128 ↗ |
Impact of Colchicine and Low-dose Naltrexone on COVID-19 |
Enrolling by invitation |
Phase 2 |
2021-01-25 |
The purpose of this study is to explore the impact of two medications-colchicine and low-dose
naltrexone (LDN)-relative to standard of care (SOC) on COVID-19 disease progression to
severe/critical illness and/or intubation in patients hospitalized with moderate COVID-19. As
researchers have learned, COVID-19's clinical course suggests that the hyperinflammatory
response seen in severe/critical cases is involved in the pathogenesis of associated adverse
sequelae such as acute respiratory distress syndrome (ARDS), thromboembolic disease, and
acute cardiac injury. Given colchicine has demonstrated clinical utility in inflammatory
syndromes within these systems (e.g. endothelial/vascular/myocardial), and LDN acts both to
boost the immune system, and limit an excessive response; they may prove useful in minimizing
the risk of disease progression and associated adverse sequelae.
|
| NCT04757857 ↗ |
COVID-19 Antithrombotic Rivaroxaban Evaluation |
Recruiting |
Phase 4 |
2020-09-29 |
There are several ways in which the COVID-19 pandemic may affect the prevention and
management of thrombotic and thromboembolic disease, either direct effect or the indirect
effects of infection, such as through severe illness and hypoxia, may predispose patients to
thrombotic events. The severe inflammatory response, critical illness, and underlying
traditional risk factors may all predispose to thrombotic events. Therefore, considering the
high-risk profile of cardiovascular comorbidities in patients with COVID-19, it is
scientifically relevant to evaluate the use of anticoagulants as an adjunctive treatment in
the context of COVID-19. Indeed, it will be tested the hypothesis that the use of moderate
dose of rivaroxaban has a beneficial effect in the treatment of patients with a confirmed or
probable diagnosis of COVID-19 infection, with no clear indication for hospitalization (mild
and moderate cases) upon initial medical care, by reducing the need of hospitalization due to
complications related to COVID-19.
|
| NCT04760821 ↗ |
Prevention of Acute Myocardial Injury by Trimetazidine in Patients Hospitalized for COVID-19 |
Recruiting |
Phase 2 |
2020-12-10 |
Acute myocardial injury has been a finding of variable frequency among patients diagnosed
with COVID-19. It is now recognized that cTnI levels are strongly associated with increased
mortality. The mechanisms underlying the myocardial injury remain unknown, and it is not
clear whether they reflect local/systemic inflammatory process and/or cellular ischemia.
Both myocardial ischemia and ventricular dysfunction result in dramatic changes in
mitochondrial oxidative metabolism. These changes involve an increase in the rate of
cytoplasmic anaerobic glycolysis to compensate for the decrease in mitochondrial adenosine
triphosphate (ATP) production. The rest of the mitochondrial oxidative metabolism originates
mainly from the β-oxidation of free fatty acids, which occurs at the expense of glucose
oxidation.
Trimetazidine is a competitive inhibitor of the enzyme 3-ketoacyl coenzyme A (CoA) long-chain
thiolase (3-KAT), the last enzyme involved in the oxidation of fatty acids. Stimulation of
glucose oxidation by trimetazidine results in a better coupling between glycolysis and
glucose oxidation, with a consequent decrease in lactate production and intracellular
acidosis, present in situations of myocardial ischemia or heart failure.
Thus, the PREMIER-COVID-19 study was designed to test the hypothesis that the use of
trimetazidine associated with usual therapy in patients admitted with a diagnosis of moderate
to severe acute respiratory syndrome by SARS-CoV2 infection reduces the extent of acute
myocardial injury assessed by the peak release of ultra-sensitive troponin compared to usual
therapy.
|
| NCT04762771 ↗ |
Colchicine for the Treatment of Cardiac Injury in Hospitalized Patients With COVID-19 (COLHEART-19) |
Suspended |
Phase 1/Phase 2 |
2020-12-01 |
This is an open-label unblinded, randomized study to treat hospitalized covid-19 patients
with colchicine plus current care (per institution treating physicians) vs. current care per
institution treating physicians alone (the control arm)
|
| NCT04765371 ↗ |
Comparison Between Prednisolone and Dexamethasone on Mortality in Patients on Oxygen Therapy, With CoViD-19 |
Recruiting |
Phase 3 |
2021-03-03 |
The aim of the study is to evaluate two differents regimens of corticosteroids (prednisolone
versus dexamethasone) on D28 mortality in patients with CoViD 19 pneumonia requiring oxygen
supplementation
|
| NCT04765449 ↗ |
Transfer of Infection Fighting Immune Cells Generated in the Laboratory to High Risk Patients With COVID-19 Infection |
Recruiting |
Phase 1 |
2021-09-15 |
This clinical trial will study the safety and efficacy of COVID-19-specific T cells when
given as treatment to adult patients (age ≥ 18 years) with a COVID-19 infection. This
immunologic treatment is aimed at patients, who are at high risk of progression due to their
advanced age, or other underlying health conditions. The outcomes of patients receiving the T
cells (Arm A) will be compared to patients treated with standard of care (Arm B).
|
| NCT04768179 ↗ |
Safety & Efficacy of Low Dose Aspirin / Ivermectin Combination Therapy for Treatment of Covid-19 Patients |
Not yet recruiting |
Phase 2/Phase 3 |
2021-02-19 |
COVID-19, caused by the novel Severe Acute Respiratory Syndrome Corona Virus 2 (SARSCoV-2),
has become a global pandemic. Fortunately, most of the COVID-19 cases confirmed are
categorized as mild for whom home- based symptomatic management with monitoring of clinical
deterioration is recommended. Despite providing symptomatic management, a therapeutic drug
that would limit the course of infection is greatly needed to stop COVID-19 disease
progression. Considering the current SARS-CoV-2 epidemiology and the legitimate rash towards
appropriate therapies, our study seeks to evaluate the safety and efficacy of low dose
aspirin and ivermectin combination therapy in COVID-19 patients.
|
| NCT04771000 ↗ |
A Study of Micro Dose Ambrisentan in Hospitalized Patients With Respiratory Insufficiency Due to COVID-19 |
Recruiting |
Phase 2 |
2021-02-08 |
Patients with COVID-19 frequently develop lower respiratory complications. Difficulty
breathing and a low concentration of oxygen in the blood are of concern in patients with
COVID-19, as they indicate that the lungs may be significantly affected. In some patients,
respiratory symptoms may progress to the point where oxygen support is needed (i.e. use of an
oxygen prongs, mask or ventilator).
The exact mechanism of why patients with COVID-19 develop low concentrations of oxygen in
blood is not fully understood. Some data suggest that the Severe Acute Respiratory Syndrome
Coronavirus 2 (SARS-CoV-2), the virus causing Coronavirus Disease 2019 (COVID-19), can affect
the body's blood vessels directly and extensively. In the lung, blood vessels participate in
the absorption of oxygen.
Endothelin is a potent hormone produced by human blood vessels. When increased, endothelin
can result in the narrowing of blood vessels in the lung and decrease the volume of blood
flowing through the lungs. This decrease in in blood flow through the lungs may be one of
many factors affecting normal lung function. Ambrisentan can block the effects of endothelin
in the body, and this could theoretically improve blood flow through the lungs.
This study will evaluate whether ambrisentan, by blocking the effects of the hormone
endothelin in the lungs, improves the breathing capacity of patients with COVID-19, increases
the concentration of oxygen in the blood and prevents the progression to respiratory failure
and death. Ambrisentan is a drug that is currently used to treat patients with pulmonary
hypertension, a disease where blood flow through the lungs is decreased.
Subjects participating in this study are those patients hospitalised with severe respiratory
symptoms related to COVID-19, and are considered to be at high-risk of developing respiratory
complications. Ambrisentan will be administered in the hospital, and will be continued at
home for up to 28 days. In this study, ambrisentan will be administered at much lower doses
that those used in patients with pulmonary hypertension.
|
| NCT04771351 ↗ |
Study to Evaluate a Single Dose of STI-2020 (COVI-AMG™) in Hospitalized Adults With COVID-19 |
Recruiting |
Phase 2 |
2021-04-01 |
This is a placebo-controlled study to investigate the safety and efficacy of a single
injection of COVI-AMG in inpatient adults with COVID-19.
|
| NCT04771611 ↗ |
COVFIS-HOME: COVID-19 Pilot Study of Fisetin to Alleviate Dysfunction and Decrease Complications |
Enrolling by invitation |
Phase 2 |
2021-07-14 |
The purpose of this study is to test whether Fisetin, a senolytic drug can assist in the
reduction of complications in patients with COVID-19 infection.
|
| NCT04780321 ↗ |
JS016 (Anti-SARS-CoV-2 Monoclonal Antibody)With Mild and Moderate COVID-19 or SARS-CoV-2 Asymptomatic Infection Subects |
Recruiting |
Phase 1/Phase 2 |
2020-10-30 |
JS016-002-Ib/II is a randomized, double-blinded, placebo-controlled study, to investigate the
safety, PK profiles, preliminary efficacy and immunogenicity of intravenous Recombinant Human
Anti-SARS-CoV-2 Monoclonal Antibody (JS016) in participants with mild and moderate COVID-19
or of SARS-CoV-2 Asymptomatic Infection.
Three doses of JS016 are to be investigated, including 25mg/kg, 50mg/kg and 100mg/kg, given
as single dose of intravenous infusion. In total, 90 participants will be enrolled with 30
participants each for 25, 50 and 100mg/kg dose cohort at a ratio of 2:1 to receive
investigational product or placebo treatment, respectively.
|
| NCT04780581 ↗ |
Glucocorticoid Therapy in Coronavirus Disease COVID-19 Patients |
Recruiting |
Phase 4 |
2021-02-01 |
Treatment with glucocorticoids in COVID patients. Low-intervention, phase IV, open-label,
randomised, low-intervention clinical trial comparing 2 active treatments.
|
| NCT04784481 ↗ |
Ivermectin Reproposing for Mild Stage COVID-19 Outpatients |
Completed |
Phase 1/Phase 2 |
2020-09-20 |
Background:
The emergency of COVID-19, along with the current difficulties in responding to the high
demand for vaccines, requests to the scientific community to find alternative treatments
based on reuse of drugs as a strategy to prevent the progression of the disease in patients
infected with SARS COV 2.
Objetive This study aims to evaluate the use of ivermectin in mild-stage patients to increase
outpatient discharge and prevent the progression to moderate or severe stages of the disease.
Added value of this study We found that an intervention with ivermectin has impacted on the
PPS in a population of outpatients care, between the 5th and 9th day. Also, the treatment
increased the probability to obtain outpatient discharge, even in the presence of
comorbidities.
Implications of all available evidence.
Research in Context According to the COVID-19 Treatment Guidelines by the NIH, most trials
have several limitations. It needs results from adequately powered and well-designed clinical
trials to provide evidence-based guidance on the role of ivermectin in the treatment of
COVID- 19. However, our study shows overlaps in benefits with other authors, and taking
together, these results are encouraging for further study about repurposing ivermectin for
the treatment of COVID-19.
|
| NCT04784559 ↗ |
Trial to Determine the Efficacy/Safety of Plitidepsin vs Control in Patients With Moderate COVID-19 Infection |
Recruiting |
Phase 3 |
2021-06-04 |
Treatment of patients hospitalised for management of moderate COVID-19 infection
|
| NCT04784754 ↗ |
Dose-Ranging Study to Assess the Safety and Efficacy of Melatonin in Outpatients Infected With COVID-19 |
Recruiting |
Phase 2 |
2021-04-01 |
A pilot placebo-controlled randomized double-blind trial of Melatonin in outpatients with
COVID-19 infection to evaluate Safety, Efficacy and Dose-ranging.
|
| NCT04784767 ↗ |
SARS-COV-2-Spike-Ferritin-Nanoparticle (SpFN) Vaccine With ALFQ Adjuvant for Prevention of COVID-19 in Healthy Adults |
Active, not recruiting |
Phase 1 |
2021-04-05 |
The purpose of this study is to evaluate the safety, reactogenicity, and immune response of
the SpFN COVID-19 vaccine with Army Liposomal Formulation QS21 (ALFQ) adjuvant in healthy
adults ages 18-55.
|
| NCT04784897 ↗ |
A Study to Evaluate the Efficacy and Safety of Brilacidin in Hospitalized Participants With COVID-19 |
Completed |
Phase 2 |
2021-02-22 |
The study will assess the efficacy and safety of Brilacidin for the treatment of COVID-19 in
hospitalized participants
|
| NCT04789499 ↗ |
Smell in Covid-19 and Efficacy of Nasal Theophylline |
Recruiting |
Phase 2 |
2021-03-15 |
Evidence of COVID-19 related anosmia and dysgeusia continues to accumulate daily.
Currently, up to 80% of patients report subjective olfactory dysfunction (OD), and prevalence
using objective olfactory testing could be even higher.
We propose a phase II single-site, double-blinded, placebo-controlled randomized clinical
trial to determine the efficacy and safety of intranasal theophylline, a known
phosphodiesterase inhibitor in the treatment of asthma, as a possible treatment for COVID-19
related OD. Theophylline has shown benefit in similar clinical trials for post-viral OD.
|
| NCT04792021 ↗ |
Effect of N-acetylcysteine on Oxidative Stress in COVID-19 Patients |
Recruiting |
Phase 3 |
2021-03-09 |
The purpose of the study is to assess the potential therapeutic effect of N-acetylcysteine
"NAC" in COVID 19 patients.
|
| NCT04794088 ↗ |
Intravenous Imatinib in Mechanically Ventilated COVID-19 Patients |
Recruiting |
Phase 2 |
2021-03-14 |
The SARS-CoV2 pandemic and resulting COVID-19 infection has led to a large increase in the
number of patients with acute respiratory distress syndrome (ARDS). ARDS is a severe,
life-threatening medical condition characterised by inflammation and fluid in the lungs.
There is no proven therapy to reduce fluid leak, also known as pulmonary oedema, in ARDS.
However, recent studies have discovered that imatinib strengthens the cell barrier and
prevents fluid leak in the lungs in inflammatory conditions, while leaving the immune
response intact. The investigators hypothesize that imatinib limits pulmonary oedema observed
in ARDS due to COVID-19, and may thus help to reverse hypoxemic respiratory failure and to
hasten recovery.
The hypothesis will be tested by conducting a randomised, double-blind, parallel-group,
placebo-controlled multi-centre clinical study of intravenous imatinib in 90
mechanically-ventilated, adult subjects with COVID-19-related ARDS.
Study participants will receive the study drug (imatinib or placebo) twice daily for a period
of 7 days. The effect of the intervention will be tested by measuring extravascular lung
water (i.e. pulmonary oedema) difference between day 1 and day 4, using a PiCCO catheter (=
pulse contour cardiac monitoring device).
Other measurements will include regular blood tests to investigate the safety and the
pharmacokinetic properties of imatinib, as well as biomarkers of inflammation and cellular
dysfunction. Furthermore, parameters of ventilation and morbidity and mortality will be
recorded as secondary outcome measures.
|
| NCT04794803 ↗ |
Reparixin in COVID-19 Pneumonia - Efficacy and Safety |
Terminated |
Phase 2/Phase 3 |
2020-05-05 |
- Phase 2 Study Objectives: efficacy and safety of of Reparixin treatment as compared to
the control arm in adult patients with severe COVID-19 pneumonia
- Phase 3 Study Objectives: efficacy and safety of Reparixin treatment as compared to the
control arm in adult patients with moderate or severe COVID-19 pneumonia
|
| NCT04795583 ↗ |
Corticosteroids for COVID-19 |
Not yet recruiting |
Phase 3 |
2021-08-01 |
This trial is an interventional, randomized, placebo-controlled, adaptive clinical trial in
outpatients with symptomatic microbiologically-confirmed SARS-CoV-2, in stable clinical
condition, and increased levels of serum C-reactive protein. The hypothesis of this study is
that early administration of prednisone for 7 days in patients with evidence of increased
C-reactive protein will decrease the progression of COVID-19, prevent clinical deterioration,
and hospital admission. Objectives: Primary Objective: To evaluate if early administration of
corticosteroids in non-hospitalized participants with proven SARS-CoV-2 infection with
compatible clinical symptoms and increased C-reactive protein can prevent hospital admission
or early death
|
| NCT04797936 ↗ |
BNO 1030 Extract (Imupret) in the Treatment of Mild Forms of COVID-19 |
Completed |
Phase 4 |
2020-05-01 |
According to WHO (World Health Organisation) data, about 40% of patients with COVID-19
(Corona Virus SARS-CoV-2) have a mild course of the disease, namely, cases of mild course are
of great danger from the point of view of the spread of infection, since the main source of
infection is a sick person. The mild course of COVID-19 is characterized by a number of
nonspecific symptoms: fever, cough, sore throat, nasal congestion, malaise, headache, muscle
pain. Evidence has emerged of loss of smell as a symptom of COVID-19 infection.
Anosmia/hyposmia in the absence of other respiratory diseases, such as allergic rhinitis,
acute rhinosinusitis, or chronic rhinosinusitis, are considered as a clinical marker of
COVID-19 infection in a pandemic.For people with a mild course of the disease, WHO recommends
providing home care, and the recommendations come down to observing a sanitary-hygienic
regimen and taking antipyretics if necessary. Unfortunately, the treatment of patients with a
mild course is still outside the interest of medical science. In its updated strategy to curb
the spread of COVID-19, WHO states the need for diagnosis, effective isolation, and treatment
of patients with mild to moderate severity of the clinical course of patients.Currently,
there is experience with the use of the drug Imupret for the treatment of nasopharyngitis
associated with other viral pathogens, in particular Epstein-Barr virus. It was shown that
the use of a Phyto preparation helps to accelerate the regression of symptoms characteristic
of nasopharyngitis, as well as accelerate the elimination of the virus from the body.
Obviously, the proven activity of Imupret is important in relation to the activation of
factors of nonspecific immunity, which is important in confronting viruses, including
COVID-19. Another obvious factor that is important for the treatment of viral diseases is the
synergism of the active substances in oak bark and walnut leaves with respect to inhibition
of reverse transcriptase of a wide range of respiratory viruses, as well as the
anti-inflammatory effect of the drug. Confirmation of the therapeutic effect of Imupret for
the treatment of nasopharyngitis associated with COVID-19 would allow the development of new
therapeutic tools to combat this infection and put into practice updated WHO emphasis on
national health systems: it is important to identify, treat and isolate all cases of
COVID-19, including cases with mild or moderate severity of the disease.
|
| NCT04799743 ↗ |
The Anti-fibrotic Therapeutic Effects of Resveratrol for Discharged COVID-19 Patients |
Recruiting |
N/A |
2021-04-01 |
A randomized controlled trial (RCT) will be conducted to evaluate the anti-fibrotic
therapeutic effects of resveratrol on the clinical symptoms in discharged COVID-19 patients.
|
| NCT04800224 ↗ |
Brazilian Green Propolis Extract (EPP-AF) as an Adjunct Treatment for Hospitalized COVID-19 Patients (BeeCovid2) |
Recruiting |
Phase 2/Phase 3 |
2021-04-12 |
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) promotes challenging immune and
inflammatory phenomena. Though various therapeutic possibilities have been tested against
coronavirus disease 2019 (COVID-19), the most adequate treatment has not yet been
established. Among candidate adjunct treatment options, propolis, produced by honey bees from
bioactive plant exudates, has shown potential against viral targets and has demonstrated
immunoregulatory properties.
|
| NCT04801017 ↗ |
A Study to Evaluate the Safety and Efficacy of OT-101+Artemisinin in Hospitalized COVID-19 Subjects |
Not yet recruiting |
Phase 2 |
2021-04-01 |
Primary Objective is to evaluate the safety and efficacy of OT-101+Artemisinin when used in
combination with standard of care (SoC) in hospitalized COVID 19 subjects versus SoC+
Artemisinin+Placebo.
|
| NCT04801056 ↗ |
Study of TB006 in Outpatient Patients With Mild to Moderate COVID-19 |
Withdrawn |
Phase 1 |
2021-05-01 |
TB006, a monoclonal antibody, is an anti-inflammatory and anti-fibrotic agent that reduces
the severity of underlying diseases in COVID-19 patients. The primary objective of TB006
treatment is to decrease the potential acute severe deterioration in outpatient COVID-19
patients with underlying diseases, such as diabetes, hypertension, and cancer. TB006 has been
developed to treat the ambulatory patients with diagnosed mild to moderate COVID-19 who are
considered at low risk for severe disease or hospitalization.
|
| NCT04802382 ↗ |
Clinical Study Designed to Evaluate the Effect of CimetrA in Patients Diagnosed With COVID-19 |
Recruiting |
Phase 3 |
2021-06-11 |
A preparation of CimertrA, comprising Artemisinin, Curcumin, and Boswellia, and Vitamin C in
a nanoparticular formulation, is proposed as a treatment for the disease associated with the
novel coronavirus SARS-CoV-2. This initiative is presented under the urgent circumstances of
the fulminant pandemic caused by this lethal disease, which is known as COVID-19 and has
spread across the globe causing death and disrupting the normal function of modern society.
The grounds for the proposal are rooted in existing knowledge on the components and
pharmacological features of this formulation and their relevance to the current understanding
of the disease process being addressed.
The severe acute respiratory syndrome-associated coronavirus disease 2019 (COVID-19) illness
results from the immediate response to the viral infection as well as from a subsequent host
inflammatory response. Systemic proinflammatory cytokines and biomarkers are elevated as the
disease progresses towards its advanced stages, and correlate with worse chances of survival.
Serum cytokine levels that are elevated in patients with Covid-19-associated cytokine storm
include interleukin-1β, interleukin-6, IP-10, TNF, interferon-γ, macrophage inflammatory
protein (MIP) 1α and 1β, and VEGF. Higher interleukin-6 levels are strongly associated with
shorter survival. The relative frequencies of circulating activated CD4+ and CD8+ T cells and
plasmablasts are increased in Covid-19. In addition to the elevated systemic cytokine levels
and activated immune cells, several clinical and laboratory abnormalities, such as elevated
CRP and d-dimer levels, hypoalbuminemia, renal dysfunction, and effusions, are also observed
in Covid-19. Laboratory test results reflecting hyper inflammation and tissue damage were
found to predict worsening outcomes in Covid-19.
CimetrA, comprising Artemisinin, Curcumin, Boswellia, and Vitamin C in a nanoparticular
formulation, has been studied on patients with COVID-19 in a randomized double-blind control
Phase II study (MGC-006 - under a previous product name - ArtemiC). The study product
demonstrated excellent safety and efficacy profiles.
Experiments performed in vitro with CimetrA demonstrated the ability to reduce cytokine
elevation in response to stimulation of human PBMC preparations.
The currently proposed Multi-center multinational-controlled study is designed to include 252
adult patients who suffer from moderate COVID-19 infection. Safety will be assessed through
collection and analysis of adverse events, blood and urine laboratory assessments, and vital
signs.
After the screening visit, the study drug will be administrated twice a day morning and
evening (every 12 hours) during (day 1 and day 2) The patients will be randomized in 1:1:1
ratio to study drug (CimetrA) in addition to Standard of Care (Arm 1 (CimetrA-1) or Arm 2
(CimetrA-2)) or Placebo in addition to Standard of Care (Arm 3).
|
| NCT04803227 ↗ |
Safety and Tolerability of Emricasan in Symptomatic Outpatients Diagnosed With Mild-COVID-19 |
Recruiting |
Phase 1 |
2021-03-11 |
Treatments for COVID-19 are urgently needed. Emricasan (EMR) is a pan caspase inhibitor.
Caspase-1 plays a role in a form of cell death called pyroptosis. EMR inhibits pyroptosis.
The Investigators have shown that peripheral blood lymphocytes of COVID-19 patients
overexpress caspase-1, providing evidence for pyroptosis. A recent European study corroborate
the Investigators finding as they have shown evidence for the activation of the inflammasome
in COVID-19.
|
| NCT04806061 ↗ |
Urine Alkalinisation in COVID-19 |
Not yet recruiting |
N/A |
2021-04-15 |
Since the outbreak of coronavirus disease 2019 (COVID-19), more than 100,000 patients have
died in the United Kingdom. Acute kidney injury is common in critically ill patients with
COVID-19. It is associated with a high risk of dying. At present, it is not clear how to
prevent or treat kidney failure in these patients.
Recent research has shown that the coronavirus can directly infect kidney issue. It uses a
particular protein on the cell surface (the ACE2 receptor) for entry into cells. Entry into
cells is easier if the blood is more acidic.
The aim of this project is to find out whether urinary alkalisation using intravenous
bicarbonate is feasible and can reduce the risk of acute kidney injury in critically ill
patients with COVID-19.
|
| NCT04808895 ↗ |
Acetylsalicylic Acid in the Prevention of Severe SARS-CoV2 Pneumonia in Hospitalised Patients With COVID-19 |
Not yet recruiting |
Phase 3 |
2021-04-01 |
Inflammatory diseases favour the onset of venous thromboembolic events in hospitalized
patients. Thromboprophylaxis with a fixed dose of heparin/low molecular weight heparin (LMWH)
is recommended if concomitant inflammatory disease. In severe acute respiratory syndrome
coronavirus 2 (SARS-CoV2) pneumonia an inflammation-dependent thrombotic process occurs and
platelet activation may promote thrombosis and amplify inflammation, as indicated by previous
experimental evidence, and the similarities with atherothrombosis and thrombotic
microangiopathies. Antiplatelet agents represent the cornerstone in the prevention and
treatment of atherosclerotic arterial thromboembolism, with limited efficacy in the context
of venous thromboembolism. The use of acetylsalicylic acid may improve inflammation and
respiratory function in humans as indicated by the results of observational studies. There
are no validated protocols for thrombosis prevention in Covid-19. There is scientific
rationale to consider acetylsalicylic acid for the prevention of thrombosis in the pulmonary
circulation and attenuation of inflammation. This is supported by numerous demonstrations of
the anti-inflammatory activity of antiplatelet agents and the evidence of improvement in
respiratory function both in human and experimental pathology. The hypothesis underlying the
present study project is that in Covid-19 platelet activation occurs through an
inflammation-dependent mechanism and that early antithrombotic prophylaxis in non-critical
patients could reduce the incidence of pulmonary thrombosis and respiratory and multi-organ
failure improving clinical outcome in patients with SARS-CoV2 pneumonia. The prevention of
thrombogenic platelet activity with acetylsalicylic acid could be superior to fixed dose
enoxaparin alone. The proposed treatment is feasible in all coronavirus disease 2019
(COVID-19) patients, regardless of the treatment regimen (antivirals, anti-inflammatory
drugs), except for specific contraindications. To this aim, the investigators a randomised,
placebo-controlled, double blind, parallel arms study to investigate the potential protection
of acetylsalicylic acid towards the progression of lung failure in patients admitted to a
medical ward for SARS-CoV-2 pneumonia. A 15-day treatment period is considered. Primary
endpoint is the occurrence of one of the following events: admission to an intensive care
unit, requirement of mechanical ventilation, PaO2/FiO2 less than 150 mm Hg.
|
| NCT04810637 ↗ |
A Study to Evaluate the Safety and Efficacy of GX-I7 in Elderly Patients With Asymptomatic or Mild Symptoms of COVID-19 |
Recruiting |
Phase 2 |
2020-11-01 |
This is a Phase 2 prospective, randomized, placebo-controlled, double-blinded, parallel
group, single administration, multi-center study to assess the safety and efficacy of
efineptakin alfa single treatment compared to placebo in elderly participants (adults
≥50years) with asymptomatic or mild COVID-19
|
| NCT04810689 ↗ |
Pilot Trial of XFBD, a TCM, in Persons With COVID-19 |
Recruiting |
Phase 2 |
2021-03-01 |
The purpose of this study is to document the safety of taking traditional Chinese medicine
(TCM) in patients with COVID-19 and to gain information to determine whether a study with TCM
can be conducted. The study will test a traditional Chinese medicine that has been made into
a granule formulation called Xuanfei Baidu Granules.
|
| NCT04810728 ↗ |
Efficacy of Psidii Guava's Extract For COVID-19 |
Completed |
Phase 3 |
2020-06-20 |
This study was an experimental, randomized clinical trial, with a parallel design, with aims
were seeing the effectiveness of extracted Psidii guava on white blood cells (WBCs) count,
neutrophil, lymphocyte, monocyte, neutrophil-lymphocyte ratio (NLR), high sensitive C
reactive protein (hs-CRP), proportion and duration COVID-19 seroconversion subjects compared
to controls.
One of the herbs standardized that was commonly used in Indonesia is extracted Psidii guava,
which is known as a guava leaf extract. Extract Psidii guava contains chemical substances
saponins, oleanolic acid, xylopyranoside, flavonoids, quercetin, arabinopyranoside, and
Guaijavarin. The Previous study on Psidii guava stated that guava leaves contain lots of
flavonoids, especially quercetin. An in vitro study of dengue virus type 2 found that
quercetin significantly inhibited the activity of the DEN-2 virus, while other flavonoids
looked weaker. On the other hand, in an in vitro test of glycosylated flavonoids from Psidium
Geunesse, which is a guava leaf from Brazil, received the use of flavonoids in Psidium
Geunesse to inhibit HIV-1 virus activity with a 50% inhibition concentration of about 8.5 μg
/ ml compared to single active substances. Quercetin with a 50% inhibitory concentration of
about 53μg / ml. These flavonoids also inhibited the enzyme reverse transcriptase
HIV-1(RT)with an inhibition concentration of 7.2 μM compared to quercetin 0.6 μM single.
Another study found that quercetin in Psidii guava inhibits RNA polymerase, which is
important in dengue virus replication. In addition, quercetin can inhibit protease enzyme,
helicase domain, and viral ATPase enzyme.
There is an antiviral effect based on limited in vitro studies but with quite a lot of
literature studies, and considering that there are no effective antiviral drugs against
COVID-19, especially mild and moderate cases, also considering the length of healing time for
patients COVID-19 with the risk of isolation. For a long time with various consequences,
researchers tried to examine the effectiveness of extract Psidii guava inpatients COVID-19 at
the quarantine location of the West Sumatra Provincial Government. Extract Psidii guava is
hypothesized to improve WBCs, neutrophil, lymphocyte, monocyte, NLR, hs-CRP level, to
increase proportion and shorten the duration of COVID-19 seroconversion in mild and
symptomless cases.
|
| NCT04813471 ↗ |
Managing Endothelial Dysfunction in Critically Ill COVID-19 Patients at LAUMCRH |
Recruiting |
Phase 3 |
2021-01-20 |
COVID-19 Infection has been found to cause endothelial dysfunction and most of the adverse
events stem to this mechanism. So we seek to target endothelial dysfunction in critically Ill
patients with covid by giving them an endothelial protocol ( L-arginine, Folic Acid, Statin,
Nicorandil, Vitamin B complex) and monitor clinical outcome in those patients.
|
| NCT04815096 ↗ |
Imaging Immune Activation in COVID-19 |
Recruiting |
Early Phase 1 |
2021-04-15 |
This is a single center, single arm exploratory imaging study involving up to two intravenous
microdoses of [18F]F-AraG (the second tracer dose is optional) followed by whole-body PET-CT
imaging in participants with convalescent COVID-19. Up to 20 participants will be enrolled
over an accrual period of approximately 24 months. Each participant will undergo one PET-CT
scan following 50 +/- 10 minutes uptake following a single bolus injection of [18F]F-AraG in
order to determine the tissue distribution of tracer in pariticpants with recent SARS-CoV-2
infection. A second optional [18F]F-AraG dose and PET-CT will be offered approximately 4
months following the initial imaging time point.
|
| NCT04816071 ↗ |
Essential Amino Acid Supplementation in Older Adult COVID-19 Patients |
Withdrawn |
Phase 2/Phase 3 |
2021-05-01 |
A 4-week treatment of essential amino acids or placebo to participants with: 1) negative
COVID-19 test with exposure, or 2) positive COVID-19 test and no or mild symptoms. The study
team will measure change in symptoms. Participants will complete symptom surveys for 4 weeks
and once at 8 and 12 weeks as well as pre- and post-assessments.
|
| NCT04816682 ↗ |
Silymarin in COVID-19 Patients Admitted to Hospital With Elevated Liver Enzymes |
Recruiting |
Phase 4 |
2021-03-17 |
Of patients admitted to an internal medicine ward with internistic diagnosis/es together with
COVID-19, substantial proportion has elevated liver enzymes. silymarin / silibinin (milk
thistle extract) has been approved as an add-on therapy in various acute and chronic liver
diseases; moreover, there is evidence to suggest that it's dual effect (anti-viral and
immune-modulatory) might be of benefit in patients infected with SARS-CoV-2. As there is no
effective/approved pharmacotherapy for COVID-19, a pilot study with Silymarine in
hospitalised patients has been undertaken
|
| NCT04817332 ↗ |
STOP-COVID19: Superiority Trial Of Protease Inhibition in COVID-19 |
Completed |
Phase 3 |
2020-06-05 |
COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes
substantial morbidity and mortality. There is currently no vaccine to prevent infection with
SARS-CoV-2 and no therapeutic agent to treat COVID-19. This clinical trial is designed to
evaluate the potential of Brensocatib (INS1007) as a novel host directed therapy for the
treatment of adult patients hospitalized with COVID-19. The investigators hypothesise that
Brensocatib, by blocking damaging neutrophil proteases, will reduce the incidence of acute
lung injury and acute respiratory distress syndrome (ARDS) in patients with COVID-19, thereby
resulting in improved clinical outcomes at day 15 and day 29, fewer days dependent on oxygen
or mechanical ventilation, and shorter length of hospital stay.
High rates of patients requiring mechanical ventilation and overwhelming intensive care unit
capacity has been the major issue contributing to excess deaths in Italy and Spain during the
pandemic and is likely to be a major issue in other countries such as the United Kingdom in
the coming weeks. Treatments that could prevent the requirement for mechanical ventilation or
shorten the duration of ICU stay by reducing the severity of ARDS are therefore the number 1
target for COVID19 therapy.
The investigators recently conducted a large phase 2 study of Brensocatib in patients with
bronchiectasis designed to test if treatment with Brensocatib could reduce infective
exacerbations and reduce neutrophil elastase activity in the lung in bronchiectasis patients.
The study met its primary endpoint of time to first exacerbation and key secondary endpoint
of the frequency of exacerbations as well as showing marked reductions in neutrophil elastase
concentrations in sputum.
Participants will be randomised to receive Brensocatib or placebo 25mg orally once daily for
28 days.
|
| NCT04818216 ↗ |
Nicotinamide Riboside in SARS-CoV-2 (COVID-19) Patients for Renal Protection |
Recruiting |
Phase 2 |
2021-06-11 |
An interventional clinical trial using oral nicotinamide riboside (NR) in hospitalized
patients with COVID-19 infection and acute kidney injury to determine the effect of NR on
whole blood nicotinamide adenine dinucleotide (NAD+) levels and to evaluate safety of the use
of NR.
|
| NCT04824365 ↗ |
Sodium Pyruvate Nasal Spray Treatment of COVID-19 and Influenza Infections |
Recruiting |
Phase 2/Phase 3 |
2021-04-12 |
Cellular Sciences Inc has submitted over 17 human clinicals (phase I, II, III including
animal safety data) to the FDA for the reduction of respiratory inflammation and inflammatory
cytokines including IL-6 the cause of the cytokine storm in COVID patients. These clinicals
demonstrated a reduction of inflammation in all lung and sinus diseases, in patients with
COPD, Pulmonary fibrosis, CF, asthma, sinusitis , the flu and nasal inflammation and
congestion. Inhaled sodium pyruvate reduces inflammation, congestion and in our phase III
clinical study with Idiopathic Pulmonary Fibrosis patients we demonstrated statistically and
clinical significant increase in FEV-1, SaO2, FVC, FEV-1/FVC ratios (form 52% to 86%) and a
decrease in hypoxemia, and a reduction in coughing. Inhaled sodium pyruvate alleviated the
symptoms associated with COVID-19 patients in Pulmonary Fibrosis, and may be a solution to
the lingering COVID-19 symptoms in patients that had the COVID-19 infection for example long
haulers. In flu and COVID infected mice, nebulized sodium pyruvate decreased morbidity,
weight loss, inflammatory cytokines and decreased viral titers compared to placebo controls.
The study to be done at Missouri State University is titled ( Two week sub-chronic
double-blinded placebo controlled trial designed to determine if sodium pyruvate nasal spray
will reduce the symptoms, duration and replication of COVID-19 and influenza infections)
|
| NCT04828135 ↗ |
Dual MRI for Cardiopulmonary COVID-19 Long Haulers |
Recruiting |
Phase 2 |
2021-05-26 |
The next phase of the COVID-19 pandemic is likely to see a surge in an associated chronic
cardiopulmonary disease that will challenge health systems. Recovered patients are presenting
with persistent dyspnea at the Duke Pulmonary Post-COVID clinic. Evidence is now mounting
that recovered patients have significant residual pulmonary disease, while myocardial injury
has also been increasingly reported. To optimally care for these patients, Duke Pulmonary
study team must comprehensively assess and monitor the changes in cardiopulmonary function
and relate the changes to physiologic and quality of life outcomes. The study team will
deploy cutting-edge MRI to fully characterize cardiopulmonary function in enrolled 30
subjects (accrual 23 subjects) at time point 60-120 days post recovery and 6-9 months later.
Cardiac MRI will assess the myocardial status and right ventricular function, while
hyperpolarized 129Xe MRI will provide a 3D assessment of pulmonary ventilation, interstitial
barrier integrity, and pulmonary vascular hemodynamics. The overall objective outlined in
this study is to demonstrate the feasibility and value of comprehensive longitudinal imaging
characterization of cardiopulmonary structure and function in patients recovered from
Covid-19.
|
| NCT04828161 ↗ |
A Dose Finding, Efficacy and Safety Study of Ensovibep (MP0420) in Ambulatory Adult Patients With Symptomatic COVID-19 |
Recruiting |
Phase 2/Phase 3 |
2021-05-24 |
The purpose of this study is to establish the antiviral efficacy of ensovibep against severe
acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in humans, identify the optimal dose,
and demonstrate its clinical value for treating COVID-19 in adult ambulatory patients
|
| NCT04828564 ↗ |
Efficacy and Safety of Favipiravir and Ribavirin Formulation for Treatment of COVID-19 |
Not yet recruiting |
Phase 2/Phase 3 |
2021-04-01 |
This is a national, multicenter, open-label, randomized, phase II/III trial that evaluates
the efficacy and safety of favipiravir and ribavirin in the treatment of patients with
confirmed COVID-19 observed within 72 hours. Approximately 100 patients will be randomized in
1:1 ratio and divided into two groups.
|
| NCT04830735 ↗ |
Dasatinib for the Treatment of Moderate and Severe COVID-19 |
Not yet recruiting |
Phase 2 |
2021-12-15 |
This phase II trial investigates how well dasatinib works in treating patients with moderate
and severe COVID-19. Dasatinib is a drug used to treat chronic leukemia which may help reduce
the strong inflammation caused by COVID-19 that can damage the lungs or other organs.
|
| NCT04830943 ↗ |
Cerebrolycin for Treatment of Covid-related Anosmia and Ageusia |
Completed |
Phase 4 |
2020-08-01 |
The loss of smell and taste is a prominent symptom of COVID-19. Studies found that patterns
of smell loss due to Covid-19 infection differ from that of other respiratory viruses being
much more profound in the Covid-19 patents and did not associate with runny, congested, or
blocked-up nose. The researchers suggest that smell and taste testing can be used for fast
COVID-19 screening. Studies found that the Covid-19 virus has similarities with severe acute
respiratory syndrome coronavirus (SARS-CoV), which has been reported to enter the brain, via
smell receptors in the nose. The sudden onset and relatively fast recovery in some patients
suggest that COVID-19 anosmia is not caused by damage to the central nervous system but
rather by the loss of smell information before it gets to the brain (smell receptors). They
also found that it has different behavior from other respiratory viruses as it causes
over-reaction of the immune system (or a cytokine storm). Trials to treat post-COVID anosmia
using local steroid applications, sniffing of strong odors or scents or use of different
vitamins (for several weeks to months) did not provide rapid, satisfactory or even
significant recovery of olfactory dysfunction. Fortunately, the olfactory neurons can
regenerate, however, studies reported variable prognoses, some patients recovered within
weeks which others may have persistent deficits for months or even a year. In this study, the
researchers hypothesize that cerebrolysin, a drug of neurotrophic and neuroprotective
properties, can be used to treat patients with persistent post-COVID anosmia or ageusia or
promote functional recovery of smell and taste deficits.
|
| NCT04834115 ↗ |
Efficacy of Ivermectin in Outpatients With Non-severe COVID-19 |
Recruiting |
Phase 3 |
2020-11-17 |
This is a randomized controlled trial to evaluate the efficacy of ivermectin in reducing the
risk of progression to severe disease and hospitalizations in COVID-19 patients.
|
| NCT04834128 ↗ |
TCB008 in Patients With COVID-19 |
Not yet recruiting |
Phase 2 |
2021-08-01 |
A Phase II safety and tolerability study of expanded gamma delta T cell lymphocytes (TCB008)
in patients diagnosed with COVID-19.
|
| NCT04836052 ↗ |
Omega-3 Oil Use in COVID-19 Patients in Qatar |
Recruiting |
Phase 3 |
2020-12-24 |
COVID-19 infection has been widely spread since December 2019 and causing many comorbidities
and fatalities. The most common clinical presentation of COVID-19 patients admitted to ICUs
is respiratory failure , hypoxia and acute lung injury.
While new therapies and vaccines are urgently being investigated, they may take an inordinate
time to get to right people. Omega-3-oil has been shown to have less proinflammatory
mediators that may have immunomodulating, anti-inflammatory and antiviral effect. Two main
fatty acids in omega-3-oil including eicosapentaenoic acid and docosahexaenoic acid have
shown benefit in patients with ARDS as well.
So, the investigators proposed a randomized controlled study to evaluate the effectiveness of
omega-3-oil supplementation 2 gm PO/NGT/OGT twice daily for 28 days or till discharge or till
death in COVID-19 critically ill patients admitted to ICU who require oxygen support.
|
| NCT04836780 ↗ |
DEXamethasone EARLY Administration in Hospitalized Patients With Covid-19 Pneumonia |
Recruiting |
Phase 3 |
2021-06-10 |
The aim of this study is to evaluate the efficacy of dexamethasone in hospitalized adults
with COVID-19 pneumonia who do not require supplementary oxygen on admission, but have high
risk of developing acute respiratory distress syndrome (ARDS).
This is a prospective, multicenter, phase 4, parallel-group, randomized and controlled trial
that is open-label to investigators, participants and clinical outcome assessors.
Eligible participants include adults (age 18 years or older), diagnosed with SARS-CoV-2
infection, evidence of infiltrates on chest radiography or computerized tomography,
peripheral capillary oxygen saturation ≥94% and 22 breaths per minute breathing room air, and
high risk of developing ARDS defined by a lactate dehydrogenase higher than 245 U/L,
C-Reactive Protein higher than 100 mg/L, and absolute lymphocytes lower than 800 cells/µL.
Eligible participants will meet two of the three before analytical criteria associated with
severe COVID-19. Patients will provide written informed consent. Exclusion criteria include
patients with a history of allergy to dexamethasone, pregnant or lactating women, oral or
inhaled corticosteroids treatment within 15 days before randomization, immunosuppressive
agent or cytotoxic drug therapy within 30 days before randomization, neutropenia <1000
cells/µL, human immunodeficiency virus infection with CD4 cell counts <500 cells within 90
days after randomization, dementia, chronic liver disease defined by ALT or AST ≥5 times the
upper limit of normal, chronic kidney injury defined by a glomerular filtration rate ≤30
ml/min, hemodialysis or peritoneal dialysis, uncontrolled infection, and patients who are
already enrolled in another clinical trial.
Study participants will be randomized in a 1:1 ratio to receive dexamethasone base 6 mg once
daily for seven days or standard of care.
The primary endpoint is to prevent of development of moderate ARDS. Based on the Berlin
criteria, moderate ARDS is defined by a PaO2/FiO2 ratio >100 mmHg and ≤200 mmHg.
Study participants will be randomized in a 1:1 ratio to receive dexamethasone versus standard
of care using a randomization platform. Included participants will be hospitalized at the
time of randomization.
The study will be undertaken at Infanta Leonor-Virgen de la Torre University Hospital,
Enfermera Isabel Zendal Emergency Hospital, and Infanta Cristina Hospital, Madrid, Spain.
|
| NCT04836806 ↗ |
Cetirizine and Famotidine for COVID-19 |
Withdrawn |
Phase 4 |
2021-08-01 |
This study is a randomized, double-blind, placebo-controlled trial to evaluate the efficacy
of cetirizine and famotidine in reducing the duration of symptoms in patients with COVID-19.
Secondary aims are to determine if cetirizine and famotidine decrease severity and duration
of symptoms, incidence of hospitalizations, ICU admissions, and death.
|
| NCT04842448 ↗ |
Safety and Efficacy of Hyperbaric Oxygen Therapy for Long COVID Syndrome |
Recruiting |
Phase 2 |
2021-09-15 |
Long COVID Syndrome (Long COVID), Post Acute COVID-19 Syndrome (PACS) or Post COVID-19
Syndrome (PCS) is defined as 'signs and symptoms that develop during or following an
infection consistent with COVID-19, continue for more than 12 weeks and are not explained by
an alternative diagnosis'. 1 in 10 infected individuals may suffer persistent symptoms, and
we are facing an emerging problem that will severely affect individuals, health care systems
and society for years to come.
We explore hyperbaric oxygen administered in a randomized placebo-controlled clinical trial
as a potential treatment for patients suffering from Long COVID.
The overall hypothesis to be evaluated is that hyperbaric oxygen (HBO2) alleviates symptoms
associated with Long COVID.
|
| NCT04842721 ↗ |
Effect of Hypertonic Saturated Saline Mouth Rinse on Covid-19 Virus in Vivo. |
Not yet recruiting |
Phase 2 |
2021-07-01 |
Sars-Cov2 virus is transmitted through the respiratory route and by direct contact with
contaminated surfaces and subsequent contact with nasal, oral or ocular mucosa. Many studies
have found that the oral cavity and specifically the saliva may be a high-risk route for
SARS-CoV-2 infection. Thus, strategies reducing salivary viral load could contribute to
reduce the risk of transmission. Furthermore, studies have shown that SARS-CoV persists for
two days in oral mucous membranes before its diffusion to the lower respiratory tract. This
offers an interesting preventive and therapeutic window of opportunity for the control of
this disease. In addition, Naso-pharyngeal viral load was linked with lung disease severity
in a study of 12 patients with pneumonia.**. Some current studies around the world, as listed
on ClinicalTrials.gov, are testing the effect of some common mouth rinses/gargles on the
Covid-19 viral load, including Chlorhexidine gluconate, Hydrogen peroxide Povidone Iodine,
Saline (1.102% w/v, slightly hypertonic) and Alcohol.
This study aims to test whether Prolonged Hypertonic Saline Mouth Rinse would
reduce/eliminate*** the viral load in the Oro- Naso-Pharyngeal cavity, and could therefore be
used as a strategy to reduce transmission risk in clinical and social settings.
The investigator hypothesizes that COVID-19-positive participants who use Hypertonic Saline
Prolonged Rinse treatment will have an reduction/elimination of their Covid viral load, will
develop a negative Covid test 7 days after intervention completion and will improve their
clinical symptoms, potentially reducing lung disease severity.
|
| NCT04843761 ↗ |
ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19 |
Recruiting |
Phase 3 |
2021-04-20 |
This study looks at the safety and effectiveness of different drugs in treating COVID-19 in
people who have been hospitalized with the infection and who have acute respiratory failure.
Participants in the study will be treated with either a study drug plus current standard of
care (SOC), or with placebo plus current SOC.
|
| NCT04843787 ↗ |
SLV213 Treatment in COVID-19 Patients |
Not yet recruiting |
Phase 2 |
2021-05-01 |
This Phase 2a trial recruits adult ambulatory patients who have been determined to be
COVID-19 positive. The study drug SLV213 will be administered to examine its safety,
tolerability and provide assessment of its effect on clinical symptoms of COVID-19. Blood
samples will be taken pre-dose and at several time points post-dose for pharmacokinetic (PK)
analysis.
|
| NCT04844658 ↗ |
Covid-19, Hospitalized, PatIents, Nasafytol |
Recruiting |
N/A |
2021-02-17 |
The objective of this study is to evaluate the efficacy and safety of NASAFYTOL® on COVID-19
positive hospitalized patients as a supportive treatment to standard-of-care in improving
clinical parameters safely during hospital admission (maximum 14 days).
The study is a standard-of-care comparative, open, parallel two-arms and randomized trial in
50 adult patients positive to COVID-19 infection and hospitalized. It will be monocentric but
may be extended to several investigation sites (multicentric) depending on the evolution of
the epidemic within the hospitals.
|
| NCT04847375 ↗ |
Exogenous Surfactant Through Nebulizer Mask on Clinical Outcomes in Covid-19 Patients |
Not yet recruiting |
N/A |
2021-04-20 |
Covid-19 disease is one of the most important health system challenges which is the result of
the recent SARS CoV-2 virus outbreak. So far, despite the use of different types of
pharmaceuticals, none has been served as a curative treatment and research is continued to
find one or more effective drugs; either palliative or curative ones.
One of the most important clinical problems in Covid-19 patients is lung involvement, which
may causes significant sequels; leading to a main part of morbidity and/or mortality.
Surfactant is one of the drugs that can have valuable effects on the lungs, both by reducing
the alveolar surface tension and by exerting immunomodulatory effects.
In a previous study by the same team, favorable effects were seen in intubated patients;
however, the aim of this study was to evaluate the effect of exogenous nebulized surfactant
in the pre-intubation stages of the disease.
|
| NCT04847518 ↗ |
Assessment of Efficacy of KAN-JANG® in Mild COVID-19 |
Recruiting |
Phase 2/Phase 3 |
2021-05-26 |
The complexity of COVID-19 suggests a potential need for a range of therapies, including
antiviral agents, immunostimulants, immunosuppressants, adaptogens, and anticoagulants. In
this context, implementation of polyvalency drugs, which exhibit a wide range of biological
activities and multitarget effects that is common for herbal medicines and specifically for
Kan Jang, the fixed combination of Andrographis paniculata (Burm. F.) Wall. ex. Nees and
Eleutherococcus senticosus (Rupr. & Maxim.) Maxim which are known to exhibit antiviral,
immunomodulatory, and anti-inflammatory effects and clinical efficacy in the respiratory
tract of patients with infectious diseases. The purpose of this study is to provide
scientific evidence on the effectiveness of Kan Jang for the treatment of mild COVID-19. We
hypothesize that Kan Jang will have superior efficacy in amelioration COVID symptoms compared
to placebo with a comparable safety profile to placebo. We hypothesize that Kan Jang will
increase patients' recovery rate and decrease the duration of illness.
The objective of the study is to assess the efficacy and tolerability of adjuvant treatment
with Kan Jang for alleviating the severity of inflammatory symptoms (headache, loss of smell,
gustatory dysfunction, rhinorrhea, nasal congestions, cough, sore throat, asthenia, myalgia,
and fever) and shortening of their duration in mild COVID-19 patients.
|
| NCT04847661 ↗ |
Efficacy of Mefloquine as Prophylaxis Against COVID-19: A Placebo-control, Randomized Clinical Trial |
Recruiting |
Phase 2/Phase 3 |
2021-03-28 |
The aim of this study is to evaluate the efficacy and safety of Mefloquine as a prophylaxis
against SARS-Cov-2 infection in household contacts of COVID 19 confirmed. This study is an
open-label, randomized, placebo controlled trial.
A total of 1500 household contacts of COVID-19 confirmed cases who will attend triaging
clinic of 5 Egyptian university centers (Helwan university hospital, Ain Shams university
hospital, Assiut University Hospital, Fayoum university hospital and Tanta university
hospital). The household contacts of COVID-19 confirmed subjects with a decision for
home-isolation will be recruited to participate into this study. The recruited subjects from
each center will be randomly assigned (locally in that center) into 2 groups (750 volunteer
in each group). The 1st group will receive Mefloquine (1100-1650 mg according to body
weight), orally, while the other group will receive the same number of placebo tablets
(control group). Previous infection will be excluded for all recruited subjects by testing
for the presence of anti-bodies against COVID-19 to exclude previous infection. Subjects who
are tested negative will be allocated into one of the 2 study groups after randomization, and
treatment will be started immediately (either mefloquine or placebo). In addition, a
nasopharyngeal swap will be taken from each recruited subject and tested by PCR for COVID-19
to exclude current infection. After having the PCR results, positive cases will be analyzed
separately to test for the disease severity.
Neurological and cardiac assessment will be done for all volunteers before recruitment to
exclude the presence of any contraindication for Mefloquine intake. Both groups will be
followed up clinically to detect any symptom or sign of COVID-19 infection for 2 weeks
(during the period of home isolation). Nasopharyngeal swap with PCR for COVID-19 will be done
for all included subjects at the end of the follow-up period (14 days), or at the appearance
of symptoms or signs suggesting COVID-19 infection.
Primary end points of the study are either:
- End of follow up period (2 weeks)
- Confirmed diagnosis of COVID-19 infection during the study time Initial severity
assessment of COVID-19 infection will be done in all infected subjects in both groups to
compare severity, in addition to following up of the fate of the infected subjects.
|
| NCT04849637 ↗ |
Virgin Coconut Oil as Adjunctive Therapy for Hospitalized COVID-19 Patients |
Recruiting |
Phase 2 |
2020-10-22 |
This is a research that will investigate the safety and efficacy of virgin coconut oil (VCO)
as an adjunctive therapy for Coronavirus Disease 2019 (COVID-19)
|
| NCT04851821 ↗ |
The Effectiveness of Phytotherapy in SARS-COV2(COVID-19) |
Completed |
Phase 1 |
2021-01-04 |
Quercetin is one of the flavonoids. Quercetin as well as rutin are recognized to be among the
most active of the flavonoids. It is to quercetin that several medicinal plants, including
ginkgo and St. John's Wort, owe part of their therapeutic effects. Often combined with
vitamin C in supplements, it improves absorption by the body and delays its elimination.
Quercetin is extracted from a variety of plant sources, including the onion peel and seeds
and pods of Dimorphandra mollis, a tree in the legume family native to South America.
At present, there is no scientific data to demonstrate the effectiveness of herbal medicine,
regardless of the plant, to prevent or treat COVID-19. On the other hand, some plant-based
food supplements have anti-inflammatory or immunomodulatory properties that may disrupt
inflammatory defense mechanisms useful in fighting infections, and in particular against
COVID-19.
|
| NCT04853901 ↗ |
Remdesivir Efficacy In Management Of COVID-19 Patients |
Completed |
Phase 3 |
2020-07-27 |
The study is open label randomized interventional phase 3 clinical trial. Patients with
confirmed Covid-19 cases who was hospitalized in Two university isolation hospitals (Ain
Shams University and Assiut University ) assigned hospitals for isolation.
|
| NCT04853927 ↗ |
Proxalutamide Treatment for COVID-19 Patients in Intensive Care Unit |
Recruiting |
Phase 3 |
2021-02-08 |
The purpose of this study is to assess the efficacy and safety of Proxalutamide as a
treatment for COVID-19 patients in the intensive care unit
|
| NCT04858620 ↗ |
A Study to Evaluate the Efficacy of Xlear vs. Placebo for Acute COVID-19 Infection |
Withdrawn |
Phase 3 |
2020-08-30 |
This study aims to find out the efficacy of Xlear nasal spray as an adjunct medication
against COVID-19. This encompasses reduction in the number of days to negativization via
nasal swab PCR from the average 14 days and early improvement of symptoms.
|
| NCT04859517 ↗ |
Evaluation of ADG20 for the Prevention of COVID-19 |
Recruiting |
Phase 2/Phase 3 |
2021-04-23 |
This placebo-controlled study is intended to evaluate ADG20's safety and ability to prevent
COVID-19 infection.
|
| NCT04860284 ↗ |
Hydroxychloroquine for Treatment of Non-Severe COVID-19 |
Active, not recruiting |
Phase 2 |
2020-09-18 |
Currently there are no proven treatments for COVID-19 and current standard therapy is
supportive care with oxygen supplementation and treatment of symptoms. Several re-purposed
and new drugs have been investigated but none is conclusive for efficacy against COVID-19
.Both Hydroxychloroquine(HCQ) and Chloroquine(CQ) have demonstrated activity against severe
acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and have been investigated in small
clinical trials with contradicting reports on their benefits or harm in treatment of COVID-19
.Several authors agree that the use of HCQ for treatment of COVID-19 needs to be assessed in
large randomized controlled trials
|
| NCT04861298 ↗ |
Study to Investigate the Clinical Benefits of Dietary Supplement Quercetin for Managing Early COVID-19 Symptoms at Home |
Completed |
N/A |
2021-01-11 |
Quercetin is a flavonoid dietary supplement that occurs in many edible fruits and vegetables.
It has remarkable antioxidant, anti-inflammatory, immunoprotective and antiviral properties.
It is widely used to boost the body immune system against infections and keeping healthy
life-style. The purpose of the present study is to investigate the potential benefits of
quercetin for preventing COVID-19 disease progression and symptoms improvement in the early
stage of infection.
|
| NCT04865029 ↗ |
Estradiol and Progesterone in Hospitalized COVID-19 Patients |
Recruiting |
Phase 2 |
2021-07-22 |
The purpose of this study is to determine to what extent a short systemic steroid therapy
with estradiol and progesterone, administered early to hospitalized and confirmed COVID-19
positive patients of both sexes in addition to standard of care (SOC) can reduce the severity
of symptoms and outcomes compared to SOC alone.
|
| NCT04867226 ↗ |
Effectiveness of Colchicine Among Patients With COVID-19 Infection |
Completed |
Phase 2 |
2021-05-08 |
In November 2019, there were a lot of cases of an acute respiratory illness (then named at
February 11th as COVID_19) which first case was reported in Wuhan, China,The SARS COV-2 had
been spread in a fast way to involve whole world, As it's obvious that Colchicine is a drug
that is most commonly and widely used to treat and prevent acute attacks of Gout, other
crystal induced arthropathy,colchicine has important role in inhibiting activation of NLRP3
inflammasome these lead to decrease cytokine production , aim of study To evaluate whether
colchicine is effective in the treatment of COVID-19 cases. And to measure the effectiveness
of colchicine in alleviating and controlling pulmonary and extra pulmonary complications of
COVID-19
|
| NCT04869579 ↗ |
Selenium as a Potential Treatment for Moderately-ill, Severely-ill, and Critically-ill COVID-19 Patients. |
Not yet recruiting |
Phase 2 |
2021-08-15 |
Given its anti-viral, anti-oxidative, immune-enhancing, cytokine-modulating, and
anticoagulant properties, the investigators hypothesize that Selenium infusion at
supranutritional doses for moderately-ill, severely-ill, and critically-ill COVID-19 patients
will prevent further clinical deterioration thus decreasing overall mortality and improving
survival. To test this hypothesis, a prospective, single-center, phase II trial is proposed
to assess the efficacy of Selenium in hospitalized adult patients with moderate, severe, and
critical COVID-19 infections.
|
| NCT04870333 ↗ |
PROphylaxis for paTiEnts at Risk of COVID-19 infecTion -V |
Recruiting |
Phase 2/Phase 3 |
2021-02-19 |
COVID-19 (novel coronavirus-induced disease) was declared a global pandemic by the WHO on
11th March 2020. Currently there are no drugs proven to prevent COVID-19 or to reduce the
severity of illness if given as prophylaxis. Although vaccines are now available, there
remains a need for other prophylactic agents until vaccine use becomes widespread globally
and effectiveness and durability is established, particularly in immunocompromised
individuals. Efforts are underway to repurpose established drugs with well understood drug
interactions and safety profiles.
The PROTECT-V is a platform clinical trial and aims to enrol patients at particularly high
risk of COVID-19 and its complications. the first agent to be tested is nasal nicolosamide
treatment as a prophylactic measure that either might prevent the disease from occurring or
may reduce the number of cases where the disease becomes serious or life-threatening.
PROTECT-V is a randomised, double blind, placebo controlled event driven trial.
Patients will be eligible for recruitment to the trial if they fall within one of the
following vulnerable populations: a)patients receiving dialysis, b)kidney transplant
patients, c)patients with vasculitis or glomerulonephritis.
Approximately 1500 participants will be randomised to active treatment or placebo, stratified
by PROTECT sub-population, age and participating sites. Enrolment to the trial will be via an
online platform following informed consent with a face to face screening visit. Subsequent
assessments, aside from an in person end of trial visit, will be done via email or telephone
together with utilising the routine collected health data thus reducing the burden to
participants as well as reducing their exposure to COVID-19.
|
| NCT04871633 ↗ |
Effectiveness of Remedesvir in COVID-19 Patients Presenting at Mayo Hospital Lahore |
Completed |
N/A |
2020-08-01 |
Currently, several drugs including Remdesivir, hydroxychloroquine, chloroquine,
ritonavir+lopinavir, Tocilizumab, Arbidol and interferon are under randomised controlled
trials (RCTs) for efficacy and/or safety evaluations in patients with COVID-19 in different
countries. Remdesivir (GS-5734) is among these investigational drugs and some studies
reported promising results. Remdesivir is a nucleotide analogue intravenous pro-drug
developed by Gilead Sciences, an American biopharmaceutical company, for treatment of Ebola
virus during the 2014 Ebola outbreak in Western Africa. Remdesivir shows broad-spectrum
antiviral activity against many RNA viruses including SARS-CoV-2 through blocking RNA
polymerase thereby terminating RNA transcription. Remdesivir was among the first treatments
used in China as the outbreak emerges and it has been reported as potential treatment options
for COVID-19 in the USA, China and Italy.
|
| NCT04871815 ↗ |
Effects of Sodium Pyruvate Nasal Spray in COVID-19 Long Haulers. |
Active, not recruiting |
Phase 2/Phase 3 |
2021-04-27 |
There are approximately 12 million Americans with COVID-19 Long Hauler Symptoms, including
athletes. The symptoms include hypoxemia (low SaO2), fatigue, coughing/sneezing, dyspnea,
trouble breathing, body aches, headaches. This chronic disease is referred to as COVID-19
Long Haulers. 7-10% of COVID-19 long haulers are also at serious risk of developing Pulmonary
Fibrosis. Conversely, patients with Pulmonary Fibrosis have an increased risk and
susceptibility to COVID-19 infection, which can reach a mortality rate of 50%. In a Phase III
Clinical Trial in patients in Pulmonary Fibrosis and Idiopathic pulmonary fibrosis, the
inhalation of the sodium pyruvate nasal spray demonstrated a statistically and clinically
significant improvement in all lung functions, compared to baseline, including an increase in
FEV-1, SaO2, FVC, FEV-1/FVC ratios (from 52% to 86%) and a reduction in coughing and fatigue.
EmphyCorp/Cellular Sciences Inc. has submitted over 17 human clinicals (Phase I, II, III
including animal safety data) to the FDA, demonstrating that the inhalation of sodium
pyruvate, significantly reduced respiratory and nasal Inflammation, including oxygen radicals
and inflammatory cytokines including IL-6, that causes the so-called cytokine storm COVID-19
patients. Thousands of patients treated with inhaled sodium pyruvate including patients with
COPD, Pulmonary Fibrosis, CF, Allergic Rhinitis, Chronic Rhinitis, Sinusitis, and Flu,
demonstrated statistically and clinically significant improvement in lung functions with no
adverse events reported. This study will examine the effects of N115 (Sodium pyruvate nasal
spray) treatment on the symptoms associated with COVID-19 Long Haulers.
|
| NCT04871854 ↗ |
Evaluating Tocilizumab for Sever COVID-19 Infection in Breast Cancer vs. Non Cancer Pateints |
Recruiting |
Phase 2 |
2021-04-26 |
To compare evaluating Clinical outcomes for patients treated with Tocilizumab for sever
COVID-19 infection in breast cancer patients versus non cancer patients
|
| NCT04872686 ↗ |
Virucidal Effect of PVP-I on COVID-19 and as Well as Safety of Its Application on Nasopharynx & Oropharynx |
Recruiting |
Phase 3 |
2021-04-10 |
The COVID-19 pandemic is the defining global health crisis of our time and the greatest
challenge we have faced since World War-II.Corona virus is transmitted via respiratory
droplets or aerosol, produced from sneezing or coughing of infected persons to healthy
individual through mouth, nose and eye. PVP-I gargle/spray used in throat and nose are shown
to have broad spectrum antimicrobial activity and may have preventive effect on SARS-CoV-2.
0.6% PVP-I oro-nasal spray phase 3 clinical trial will be conducted in three dedicated
Covid-19 hospitals namely Dhaka Medical College Hospital, Kurmitola General Hospital,
Kuwait-Moitree Hospital. Chemical compound of the oro-nasal spray which was developed and
tested at Bangladesh Reference Institute for Chemical Measurements, for its quality control/
quality assurance, shelf life and related stability following GLP guideline.
This study aims to evaluate virucidal efficacy of 0.6% PVP-I against SARS-CoV-2 along with
its safe uses in oronasal mucosa of healthy and SARS-CoV-2 exposed persons.
The participant will be divided into three groups: Group A 768 COVID-19 positive, moderately
ill admitted patient who will receive intervention once. Group B 20 asymptomatic to mild
COVID-19 patients having multiple comorbidity will receive intervention 4 times hourly and
Group C 10 healthy individual who accept intervention 0.6% PVP-I oronasal spray 3-4 times
interval in a day for 30 days. Placebo will be used among control group for better
comparison.
The chemical which will be used in this study is available inside the country and also
registered to open use in Bangladesh. BRiCM ensures raw material & impurities
characterization as per BP 2019, AOAC and AWWA and determination of shelf life by performing
the stability studies will be conducted according to Stability Zone Iva and ICH guidelines.
A written consent will be taken by concern participant and a short interview will be taken on
the spot prior to intervention. Participant's medical documents will be used and swab from
nasopharynx & oropharynx will be taken for performing necessary test (RT-PCR) to confirm
viral presence.
There is no potential risk for application of this oro-nasal spray. Even though if any
adverse reaction occur while using the oro-nasal spray, necessary medical management will be
carried out in the respected hospital.
|
| NCT04876573 ↗ |
Pilot Study for Cyproheptadine in Hospitalized Patient for COVID-19 |
Not yet recruiting |
Phase 2 |
2021-06-01 |
This is a Pilot study for evaluating the feasibility, security and efficacy of the use of
Cypropheptadine, an antihistaminic and antiserotonin drug, as an adjunct of the standardized
treatment in a population of patient who are hospitalized and requiring oxygen therapy for
COVID-19.
|
| NCT04878055 ↗ |
Study on Efficacy and Safety of Reparixin in the Treatment of Hospitalized Patients With Severe COVID-19 Pneumonia. |
Recruiting |
Phase 3 |
2021-02-14 |
The study objective is to assess Efficacy and safety of Reparixin treatment as compared to
placebo (both on top of standard treatment) in adult patients with severe COVID-19 pneumonia.
|
| NCT04878211 ↗ |
A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab |
Recruiting |
Phase 4 |
2021-06-10 |
This study will evaluate if participants treated with ofatumumab 20 mg subcutaneous (s.c.)
administered once monthly can develop an adequate immune response to the COVID-19 mRNA
vaccine compared to participants on an interferon or glatiramer acetate.
|
| NCT04880694 ↗ |
A Study to Evaluate the Safety and Effect of STC3141 Continuous Infusion in Subjects With Severe Corona Virus Disease 2019（COVID-19）Pneumonia |
Recruiting |
Phase 2 |
2021-05-20 |
The study is a Randomized, Open-Label, Multi-Centre, Phase 2a Study to Evaluate the Safety
and Effect of STC3141 Continuous Infusion in Subjects with Severe Corona Virus Disease
2019（COVID-19）Pneumonia.
|
| NCT04883138 ↗ |
Recombinant Hyperimmune Polyclonal Antibody (GIGA-2050) in COVID-19 Patients |
Recruiting |
Phase 1 |
2021-05-24 |
The purpose of this study is to evaluate the safety and tolerability of single ascending IV
dose administrations of GIGA-2050 in patients hospitalized with COVID-19.
|
| NCT04883203 ↗ |
The Effect of Vitamin D Supplementation on COVID-19 Recovery |
Completed |
Phase 3 |
2020-04-22 |
The COVID-19 caused by SARS-CoV-2 has transmitted quickly as a global public health
emergency. The median duration for Sars-CoV-2 carrying in COVID-19 patients was 20 days (IQR
16-28) What is the role of vitamin D supplementation on the recovery time of asymptomatic and
pauci-symptomatic COVID-19 subjects? the intervention group will have vitamin D
supplementation (200,000 IU / 1 ml of Cholecalciferol (1 ml) Oral form). Control group will
have a placebo treatment (physiological saline).
the negative RT-PCR date will be compared in the two groups
|
| NCT04884490 ↗ |
The Role of High Dose Co-trimoxazole in Severe Covid-19 Patients |
Not yet recruiting |
Phase 2/Phase 3 |
2021-05-15 |
Coronavirus Disease 19 (COVID-19) is a worldwide pandemic and a major global health concern
which is caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). The newly
emerged Coronavirus disease 2019 (COVID-19), which was first identified in Wuhan, China, has
swept through 219 countries, killing a staggering number of people. According to WHO reports,
the number of deaths had risen to 3,155,168by March 30, 2021, out of 149,910,744 confirmed
cases. In Bangladesh, the outbreak has infected over 745,322confirmed cases, with over 11,053
deaths reported. Though the patient may be asymptomatic or present with mild symptoms,
mortality is quite high in the severe form of the disease which often progresses to critical
phase presented as Acute Respiratory Distress Syndrome (ARDS). This is due to exaggerated
response of immune system to the virus termed as cytokine storm syndrome (CSS). There is
currently no effective antiviral therapy for SARS-CoV-2 and supportive care is the mainstay
of therapy. As a result we are still searching for a better therapeutic agent which will help
in treating Covid-19 cases in terms of mortality, morbidity, oxygen requirement, length of
stay in hospital. Co-trimoxazole (composed of one-part Trimethoprim and five parts
Sulfamethoxazole)is a sulphur containing anti-folate bactericidal drug which is being used
for over 60 years for various indications esp. respiratory tract infections. It is known to
have immunomodulatory and anti-inflammatory properties that may help to prevent progression
to critical phase and cytokine storm syndrome in severe COVID-19 patients. It acts rapidly
when given in high dose due to its better bioavailability and lung penetration. Low cost and
a good safety profile can make it an ideal candidate for treatment of COVID -19 in a low
resource country like Bangladesh.
Methods and materials:
This interventional double-blind place controlled randomized trial will be conducted in the
department of medicine at Bangabandhu Sheikh Mujib Medical University (BSMMU) for a duration
of 6 months following approval of this protocol. It will recruit at least 94 consecutive
adults (18 years or older) patients with clinically suspected COVID-19 and severe illness as
per WHO criteria. After taking informed written consent patients will be randomly assigned in
a 1:1 ratio to either oral high dose co-trimoxazole in addition to standard therapy or
placebo along with standard therapy. Baseline characteristics, changes in the physiological
and biochemical parameters like (SpO2/FiO2 ratio, respiratory rate, body temperature and C -
reactive protein), length of hospital stay, side effects of drugs, requirement for
ventilatory support (non-invasive and invasive ventilation) and 28- day mortality between the
two groups will be compared. Data will be collected from case record forms, anonymised and
stored securely in a secure online web based portal. Statistical analysis will be performed
using t-test or Mann -Whitney U test or Wilcoxon signed rank test for continuous variables
and Chi- square test or Fisher's exact test for categorical variables. Survival will be
assessed by the Kaplan-Meier method. Comparisons between two groups will be performed using
the log-rank test. A p-value of < 0.05 will be considered to be significant. The statistical
software SPSS version 25 will be used for the analysis.
Conclusion If the results from this clinical trial demonstrate the beneficial effects of high
co-trimoxazole in patients with severe COVID-19 it could help to reduce the need for
respiratory support for thousands of patients, saving valuable lives and decrease the burden
of healthcare system in countries with limited resources.
|
| NCT04885491 ↗ |
A Study to Evaluate the Efficacy, Safety and Tolerability of PDNO Infusion in Covid-19 Patients With aPH |
Recruiting |
Phase 1/Phase 2 |
2021-05-07 |
This is an open-label, multicentre study evaluating the effect, safety and tolerability of
the two regio isomers 1-(nitrosooxy)propan-2-ol and 2- (nitrosooxy)propan-1-ol (PDNO)
infusion given to COVID-19 patients with acute pulmonary hypertension (aPH).
|
| NCT04885530 ↗ |
ACTIV-6: COVID-19 Study of Repurposed Medications |
Recruiting |
Phase 3 |
2021-06-08 |
The purpose of this study is to evaluate the effectiveness of repurposed medications (study
drug(s) in reducing symptoms of non-hospitalized participants with mild to moderate COVID-19.
Participants will receive either study drug or placebo. They will self-report any new or
worsening symptoms or medical events they may experience while taking study drug or placebo.
This study is intended to be all remote with no in person visits, unless the study team feels
it is in the best interest of a participant to see them in person.
|
| NCT04894266 ↗ |
An Open-Label Study of Apabetalone in Covid Infection |
Recruiting |
Phase 2/Phase 3 |
2021-11-01 |
The primary objective of the study is to evaluate the safety and effect on clinical course of
oral apabetalone in hospitalized subjects with Covid-19 infection
|
| NCT04894617 ↗ |
Amantadine for COVID-19 |
Recruiting |
Phase 3 |
2021-06-01 |
Introduction:
Corona virus disease 19 (COVID-19) is a devastating pandemic. By early February 2021, more
than 102 million people were infected globally with more than 2.2 million reported deaths.
Current treatments are approved for hospitalized patients with severe COVID-19 only. No
treatment is approved to prevent progression to severe COVID-19 in the early stages of
disease. Previous studies have indicated that amantadine is effective against severe acute
respiratory syndrome corona virus 1 (SARS-CoV-1). Trials are needed to determine if this
translates to a beneficial effect in patients with COVID-19. We hypothesize that preemptive
therapy with amantadine of non-hospitalized high-risk adults with SARS-CoV-2 infection
disease will prevent disease progression and hospitalization.
Methods and analysis:
The study is a randomized, double-blinded, placebo-controlled, single center study with two
treatment arms; oral amantadine or placebo. Individuals with confirmed SARS-CoV-2 infection
and one of following; i) age ≥ 40 years or ii) ≥ 18 years of age with at least one
comorbidity or iii) ≥ 18 years of age with a body mass index (BMI) above 30 will be enrolled
in the study. We plan to enroll 121 persons in each arm, with a total of 242 participants.
Follow up period is 90 days. The primary outcome is disease severity on day 14 assessed by
the 8-point COVID outcome scale proposed by the world health organization.
Ethics and dissemination:
Approvals by the Ethics Committee and National Competent Authorities will be obtained prior
to study initiation. Results will be submitted for publication in a peer-reviewed journal and
presented at international conferences.
Impact:
The results of the study will contribute with important knowledge on the efficacy and safety
of oral amantadine in the treatment of non-hospitalized high-risk individuals with SARS-CoV-2
infection.
|
| NCT04900155 ↗ |
Evaluation of the Effect of Long-term Lipid-lowering Therapy in STEMI Patients With Coronavirus Infection COVID-19 |
Recruiting |
N/A |
2020-11-20 |
It is planned to include 200 patients hospitalized with primary myocardial infarction with
and without ST segment elevation (STEMI or NSTEMI) in combination with COVID-19 within the
first 15 days from the disease onset. The total follow-up period is 96 weeks.
Hypotheses:
1. An integrated approach in assessing myocardial contractility, regulation of the heart
and the structural and functional state of arteries will make it possible to more
accurately assess the heart pumping function; explain the mechanisms of the relationship
between left ventricular (LV) contractile function and its volumetric indices; to study
the mechanisms of ventriculo-arterial coupling and the influence of autonomic
regulation, the role of markers of the sudden cardiac death (late ventricular
potentials, pathological turbulence of the heart rate, dispersion of the QT interval).
2. In patients who have had myocardial infarction in combination with the new coronavirus
infection SARS-CoV-2 (COVID-19), long-term highly effective lipid-lowering therapy,
regardless of the drugs prescribed, has an antiarrhythmic effect and has a beneficial
effect on the autonomic regulation of the heart rate. Highly effective lipid-lowering
therapy leads to an improvement in LV contractility and structural and functional
properties of the large arteries.
Methods and variables
1. Office blood pressure
2. 12-lead ECG
3. Coronary angiography. Percutaneous coronary intervention
4. Chemistry blood test
5. 2D and 3D transthoracic echocardiography (Vivid GE 95 Healthcare (USA)
6. Multi-day 3-lead ECG monitoring with assessment of the parameters of myocardial
electrical instability.
7. Ultrasound of common carotid arteries using high-frequency radio-frequency signal
technology
8. Applanation tonometry (SphygmoCor, AtCor, Australia)
9. Assessment of the arterial stiffness by volume sphygmography.
10. Flow-mediated vasodilation
11. Six-minute walk test
12. Computer pulse oximetry (PulseOx 7500 (SPO medical, Israel)
13. Adherence to Treatment: Counting remaining pills and completing the Morisky-Green
Questionnaire
14. Assessment of quality of life
15. Assessment of physical activity: International Questionnaire On Physical Activity - IPAQ
16. Hospital Anxiety and Depression Scale (HADS)
|
| NCT04900337 ↗ |
Safety, Tolerability and Efficacy of Amorphous Calcium Carbonate (ACC) Compared to Placebo and Best Available Care (BAT), for the Treatment of Moderate to Severe COVID-19 Patients. |
Recruiting |
Phase 1/Phase 2 |
2021-02-09 |
This is a phase I/II study with Amorphous Calcium Carbonate (ACC) administered sublingual and
in Inhalation concomitantly with BAT (Best Available Care) as Compared to Placebo and BAT for
the treatment of Moderate to Severe COVID-19 patients. The purpose of this study is to assess
the Safety, Tolerability and Efficacy of Amorphous Calcium Carbonate (ACC).
|
| NCT04900415 ↗ |
Olfactory and Neurosensory Rehabilitation in COVID-19-related Olfactory Dysfunction |
Recruiting |
Phase 2 |
2020-07-22 |
A combination of oral vitamin A (VitA) and intense aromatic chemosensory smell training (ST)
by pulse aromatic stimulation will expedite the neurosensory recovery of olfaction in
patients suffering from prolonged COVID-19-related olfactory dysfunction (OD).
|
| NCT04901676 ↗ |
Leronlimab in Moderately Ill Patients With COVID-19 Pneumonia |
Recruiting |
Phase 3 |
2021-09-09 |
Leronlimab (PRO 140) is a humanized IgG4,k monoclonal antibody (mAb) that recognizes the C-C
chemokine receptor type 5 (CCR5). Disruption of the C-C chemokine ligand 5 (CCL5)-CCR5 axis
via leronlimab-mediated CCR5 blockade might prevent pulmonary trafficking of pro-inflammatory
leukocytes and dampen pathogenic immune activation in coronavirus disease 2019 (COVID-19).
The purpose of the study is to assess the safety and efficacy of leronlimab plus standard of
care in patients hospitalized with COVID-19 pneumonia who are not requiring mechanical
ventilation or extracorporeal oxygenation (ECMO).
|
| NCT04901689 ↗ |
Leronlimab in Patients With Coronavirus Disease 2019 (COVID-19) With Need for Mechanical Ventilation or Extracorporeal Membrane Oxygenation |
Recruiting |
Phase 3 |
2021-10-23 |
Leronlimab (PRO 140) is a humanized IgG4,k monoclonal antibody (mAb) that recognizes the C-C
chemokine receptor type 5 (CCR5). Disruption of the C-C chemokine ligand 5 (CCL5)-CCR5 axis
via leronlimab-mediated CCR5 blockade might prevent pulmonary trafficking of pro-inflammatory
leukocytes and dampen pathogenic immune activation in coronavirus disease 2019 (COVID-19).
The purpose of the study is to assess the safety and efficacy of leronlimab plus standard of
care in critically ill patients hospitalized with COVID-19 pneumonia who are requiring
mechanical ventilation or extracorporeal oxigenation (ECMO).
|
| NCT04902183 ↗ |
Safety and Efficacy of Exosomes Overexpressing CD24 in Two Doses for Patients With Moderate or Severe COVID-19 |
Recruiting |
Phase 2 |
2021-06-09 |
This is a phase II randomized, single-blind dose study to evaluate the safety and efficacy of
exosomes overexpressing CD24 of two doses, Dose 1 - 10^9 exosome particles (per dose) versus
Dose 2 - 10^10 exosome particles (per dose), to prevent clinical deterioration in patients
with Moderate or Severe COVID-19 infection.
|
| NCT04903327 ↗ |
Study of Intravenous COVI-MSC for Treatment of COVID-19-Induced Acute Respiratory Distress |
Not yet recruiting |
Phase 2 |
2021-07-01 |
This is a Phase 2 randomized controlled study to assess the safety and efficacy of COVI-MSC
in the setting of current standard of care treatments for COVID-19 infection in hospitalized
subjects with acute respiratory distress syndrome.
|
| NCT04904536 ↗ |
Statin TReatment for COVID-19 to Optimise NeuroloGical recovERy |
Not yet recruiting |
Phase 3 |
2021-10-11 |
STRONGER is an international, investigator initiated and conducted, pragmatic clinical trial
to determine whether 40mg atorvastatin daily can improve neurocognitive function in adults
with long COVID neurological symptoms. The objective is to determine effectiveness of
treatment with 40mg atorvastatin over 18 months on attenuating cognitive decline and
neuroinflammatory biomarkers in adults with long COVID neurological symptoms. The study
design is a prospective, randomised, open-label, blinded endpoint (PROBE) study of
atorvastatin 40mg on top of standard care, in patients with long COVID neurological symptoms.
|
| NCT04905836 ↗ |
Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Treatment of COVID-19 Acute Respiratory Distress |
Not yet recruiting |
Phase 2 |
2021-10-01 |
This is a Phase 2 study to assess COVI-MSC in the setting of current standard of care in
hospitalized subjects with RT-PCR confirmed SARS-CoV-2 (COVID-19) infection and acute
respiratory distress / acute respiratory distress syndrome.
|
| NCT04909879 ↗ |
Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Non-COVID-19 Acute Respiratory Distress Syndrome |
Withdrawn |
Phase 2 |
2021-09-01 |
This is a Phase 2 randomized study to assess the safety and efficacy of COVI-MSC in the
setting of current standard of care treatments for subjects hospitalized subjects with acute
respiratory distress syndrome not related to COVID-19 infection.
|
| NCT04909918 ↗ |
Impact of Steroids on Inflammatory Response in Covid-19 |
Completed |
Phase 3 |
2021-05-28 |
we designed this study to observe the efficacy and safety of dexamethasone versus
methylprednisolone in covid-19 diseased patients upon monitoring the inflammatory response
and to compare the outcome when these steroids will be given in covid-19 diseased patients in
our ICU.
|
| NCT04911777 ↗ |
Proof of Principle Study to Evaluate the Safety, PK, Viral Shedding and Efficacy of Pentarlandir™ UPPTA for Patients With Early COVID-19 |
Recruiting |
Phase 2 |
2021-08-24 |
This is a clinical trial to evaluate the safety, PK, viral shedding and clinical effects of
Pentarlandir™ UPPTA in patients with early COVID-19. Approximately 90 ambulatory subjects
with mildly symptomatic early COVID-19, who have been diagnosed with COVID-19 within the
prior 4 days will be enrolled.
|
| NCT04913779 ↗ |
Safety and Effectiveness of an Immunobiological Drug in CoViD-19 |
Recruiting |
Phase 2/Phase 3 |
2021-06-01 |
The aims of this study is to analyze the efficacy and safety of a passive immunotherapy
strategy using hyperimmune equine serum known as Anti-SARS-CoV-2 elaborated by the National
Institute for the Production of Biologicals (ANLIS-Malbrán) as an addition to the standard
therapeutic approach for hospitalized patients with COVID-19, in patients with severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) infection aged 18 to 80 years.
|
| NCT04914767 ↗ |
Nigella 5 in the Treatment of SARS COV2 (COVID-19) |
Recruiting |
Phase 1 |
2021-03-01 |
The world is currently facing a crisis because of this potentially fatal situation of the
COVID-19 epidemic without proven efficacy for any drug treatment, while the vaccination is
not yet.
This epidemic is caused by a new betacorona virus, now called SARS-CoV-2. The most common
symptoms reported are fever, cough or chest tightness, and dyspnea. Most cases have a mild
course
|
| NCT04915989 ↗ |
Safety and Immunogenicity of GX-19N, a COVID-19 Preventive DNA Vaccine in Elderly Individuals |
Active, not recruiting |
Phase 1 |
2021-02-16 |
The objective of our study is to demonstrate safety and immunogenicity of COVID-19 preventive
DNA vaccine in elderly individuals.
|
| NCT04918914 ↗ |
Critical Care Results of SARS-CoV-2 ARDS by Dapsone and Standard COVID-19 Treatment |
Recruiting |
Early Phase 1 |
2020-10-18 |
Abstract Background: Clinicians in pulmonary critical care medicine and critical care
medicine considered dapsone administration to treat SARS-CoV-2 inflammasome. Dapsone is
useful in the molecular regulation of Nod-like receptor family pyrin domain-containing 3
(NLRP3).
Objective: To study the targeting of NLRP3 itself or up-/downstream factors of the NLRP3
inflammasome by dapsone must be responsible for its observed preventive effects, functioning
as a competitor.
Methods:
Patients who were on standard COVID-19 therapy are also after obtaining off label uses and
explanation of side effects are started on dapsone 100-200 mg daily along with Cimetadine 400
mg three times daily.
|
| NCT04918927 ↗ |
Favipiravir +/- Nitazoxanide: Early Antivirals Combination Therapy in COVID-19 |
Recruiting |
Phase 2 |
2021-10-12 |
The 2020 pandemic of SARS-CoV-2 causing COVID-19 disease is an unprecedented global
emergency. COVID-19 appears to be a disease with an early phase where the virus replicates,
coinciding with first presentation of symptoms, followed by a later 'inflammatory' phase
which results in severe disease in some individuals. It is known from other rapidly
progressive infections such as sepsis and influenza that early treatment with antimicrobials
is associated with better outcome. The hypothesis is that this holds for COVID-19 and that
early antiviral treatment may prevent progression to the later phase of the disease.
The plan is to conduct a proof-of-principle placebo-controlled clinical trial of favipiravir
plus or minus nitazoxanide in health workers, their household members and IMSS beneficiaries.
Participants with or without symptomatic COVID-19 or tested positive will be assigned to
receive favipiravir plus nitazoxanide or favipiravir plus nitazoxanide placebo. The primary
outcome will be the difference in the amount of virus ('viral load') in the upper respiratory
tract after 5 days of therapy. Secondary outcomes will include hospitalization, major
morbidity and mortality, pharmacokinetics, and impact of antiviral therapy on viral genetic
mutation rate.
If favipiravir with nitazoxanide demonstrates important antiviral effects without significant
toxicity, there will be a strong case for a larger trial in people at high risk of
hospitalization or intensive care admission, for example older patients and/or those with
comorbidities and with early disease.
|
| NCT04920916 ↗ |
Safety and Efficacy of Dupilumab for Treatment of Hospitalized COVID-19 Patients |
Recruiting |
Phase 2 |
2021-05-25 |
This is a randomized, double-blind, placebo-controlled, superiority phase IIa trial to assess
the safety and efficacy of dupilumab use in hospitalized patients with moderate to severe
COVID-19 infection.
|
| NCT04920942 ↗ |
Ivermectin Treatment Efficacy in Covid-19 High Risk Patients |
Completed |
Phase 4 |
2021-06-01 |
This is a multicenter study, which is aimed to investigate the efficacy of the Ivermectin
drug in high risk COVID-19 patients. This study will compare Ivermectin treatment efficacy
with standard of care alone. Target cohort is mild to moderate symptomatic Covid-19 (Stage
2-3), high risk patients aged 50 years and above with comorbidity, who presented to hospitals
within first 7 days of illness.
|
| NCT04922827 ↗ |
Infliximab in the Treatment of Patients With Severe COVID-19 Disease |
Recruiting |
Phase 2 |
2021-06-18 |
In this trial, patients that are severely affected by the disease COVID-19 will either
receive infliximab, an anti-inflammatory drug, or standard therapy. Infliximab is a drug that
inhibits inflammation by blocking a molecule called TNFα. The patients receive the drug via
an infusion into a vein. The primary goal of this trial is to see whether the drug infliximab
affects how many people died from COVID-19 after 28 days by comparing patients receiving the
drug in addition to standard therapy with patients only receiving standard therapy.
Furthermore, this trial will look at whether the drug is safe to use in these patients,
whether it has an effect on the inflammation and whether it can affect how ill patients are
after surviving the disease.
The trial is conducted in more than one hospital. As COVID-19 is responsible for a global
pandemic, positive results of this trial could affect patients, healthcare and economic
systems worldwide.
|
| NCT04922957 ↗ |
A Phase 2b Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study, Evaluating Efficacy and Safety of Allocetra-OTS in Patients With Severe or Critical COVID-19 With Associated Acute Respiratory Distress Syndrome (ARDS) |
Recruiting |
Phase 2 |
2021-09-01 |
This is a Phase 2b multi-center, randomized, double-blind, placebo-controlled study
evaluating the efficacy and safety of intravenous (IV) Allocetra-OTS 10x10^9 cells vs placebo
(1:1) in adult hospitalized patients with severe or critical Coronavirus Disease 2019
(COVID-19) with associated acute respiratory distress syndrome (ARDS). Patients will be
followed for efficacy and safety for 6 months. The trial will include periodic and ad-hoc
DSMB review during the study period.
|
| NCT04924660 ↗ |
Novel Experimental COVID-19 Therapies Affecting Host Response |
Recruiting |
Phase 2/Phase 3 |
2021-07-15 |
The overarching goal of the Master Protocol is to find effective strategies for inpatient
management of patients with COVID-19. Therapeutic goals for patients hospitalized for
COVID-19 include hastening recovery and preventing progression to critical illness,
multiorgan failure, or death. Our objective is to determine whether modulating the host
tissue response improves clinical outcomes among patients with COVID-19.
|
| NCT04928495 ↗ |
Clinical Trial With N-acetylcysteine and Bromhexine for COVID-19 |
Not yet recruiting |
Phase 3 |
2021-07-15 |
Clinical, control, double-blind, randomized experimentation with N-acetylcysteine and
bromhexine for COVID-19.
|
| NCT04930861 ↗ |
Study of Codivir in Patients With COVID-19 |
Completed |
Phase 1 |
2021-03-29 |
This is an open-label study to evaluate the safety and preliminary efficacy of Codivir in 12
mild or moderate COVID-19 patients and onset of symptoms within 72h prior to their inclusion.
Treatment will begin in the hospital, participants will be discharged at Day 4 and continue
the treatment up to Day 10 at home and followed up to day 28.
|
| NCT04931238 ↗ |
Efficacy and Safety of JS016 in Patients With SARS-CoV-2 Infection (COVID-19) |
Recruiting |
Phase 2 |
2021-01-20 |
The human monoclonal antibody CB6 showed potent neutralization activity in vitro against
SARS-CoV-2. CB6-LALA (also called JS016) has been developed for clinical use. Phase I trials
among healthy volunteers has demonstrated a tolerable and safe drug profile of JS016. We aim
to evaluate the efficacy and safety of JS016 in patients hospitalized with COVID-19.
|
| NCT04933799 ↗ |
IRAK 4 Inhibitor (PF-06650833) in Hospitalized Patients With COVID-19 Pneumonia and Exuberant Inflammation. |
Recruiting |
Phase 2 |
2021-01-06 |
The aim of the current clinical study is to evaluate the efficacy and safety of inhibition of
Interleukin-1 receptor associated kinase 4 (IRAK4) in ameliorating the proinflammatory state
and improving outcomes in severe COVID-19.
|
| NCT04933864 ↗ |
COVID-19 Treatment Using Methylene Blue and Photodynamic Therapy |
Completed |
Phase 1 |
2020-04-24 |
According to the epidemiological situation worldwide and the number of vaccinations made,
there is little success in the fight against COVID-19. For many reasons, methylene blue is a
promising drug for an active treatment against SARS-CoV-2 infected patients. Since methylene
blue can work as a photosensitizer, photodynamic therapy as an antiviral treatment has great
potential in the treatment of COVID-19. This clinical study investigated the effectiveness of
SARS-CoV-2 infected people treatment using methylene blue and the following photodynamic
therapy on the base of the L.L. Levshin Institute of Cluster Oncology (Department of
Infectious Diseases №13) of I.M. Sechenov First Moscow State Medical University.
|
| NCT04934111 ↗ |
Safety and Immunogenicity of LNP-nCOV saRNA-02 Vaccine Against SARS-CoV-2, the Causative Agent of COVID-19 |
Not yet recruiting |
Phase 1 |
2021-09-01 |
COVAC Uganda is a study that is looking at the use of an innovative self-amplifying RNA
(saRNA) vaccine (LNP-nCOV saRNA-02) against the virus (SARS-CoV-2) that causes COVID-19 and
assessing the immune response in SARS-CoV-2 antibody seronegative and seropositive
individuals. saRNA is designed to amplify the quantity of RNA upon injection to produce
further antigen, thereby enabling lower doses for administration. In the trial "COVAC1",
Imperial College London is currently evaluating one COVID-19 saRNA vaccine candidate in doses
from 0.1-10ug for individuals who are seronegative for SARS-CoV-2 antibodies at baseline.
Interim analyses of COVAC1 has shown a dose dependent response; however, up to 50% of
seronegative participants receiving doses of 2.5-10ug do not seroconvert. The investigators
hypothesize that a lack of seroconversion is due to type I and III interferon (IFN)
production, which can inhibit translation and degrade cellular mRNA. Another variable that
can enhance antibody production is serological history: recent studies have shown that
seropositive individuals respond significantly better than naïve individuals who received the
Pfizer or Moderna RNA-based COVID-19 vaccine. Therefore, designing the saRNA backbone to
dampen IFN production and evaluating this in individuals seropositive at baseline will inform
the optimised use of this innovative technology. In COVAC Uganda, the investigators aim to
test an saRNA vaccine modified to dampen the activation of type I and III IFN, to increase
antibody production, for individuals who are seronegative and seropositive for SARS-CoV-2
antibodies at baseline, to evaluate whether people with pre-existing seropositivity have
enhanced immune responses compared to those without. This trial is NOT looking at whether or
not the vaccine is effective in terms of protection. It is just assessing whether and how
well the immune system responds based on SARS-CoV-2 antibodies at baseline and its safety.
|
| NCT04935476 ↗ |
Dapsone Coronavirus SARS-CoV-2 Trial (DAP-CORONA) COVID-19 |
Not yet recruiting |
Phase 3 |
2021-10-18 |
This is a multi-center, randomized, triple-blind, placebo-controlled (RCT) study to evaluate
the efficacy and safety of Dapsone in older adults, and/or in adult patients (≥40yrs of age)
with at least one high-risk comorbidity, among those with confirmed SARS-CoV-2 infection.
3000 infected patients diagnosed with COVID-19, non-hospitalized at the time of enrollment,
meeting all inclusion and no exclusion criteria will be randomized (1:1 allocation ratio) to
receive either Dapsone or placebo tablets for 21 days, and will be followed up for 7 days
after treatment termination for outcome assessment and up to 30 days for safety monitoring.
|
| NCT04935515 ↗ |
C Reactive Protein in Home Quarantined Coronavirus Disease 2019 (COVID -19) Patients. |
Completed |
N/A |
2021-04-15 |
During the peak of the second COVID -19 wave, the hospitals were over-crowded. Many COVID -19
positive patients had to stay at home and reach out to their family physicians for guidance.
Medical follow-up for these patients was a daunting challenge. As in - patient hospital
facilities were not readily accessible due to over crowding, early objective tests to
identify home quarantined patients prone to deterioration and timely medical intervention to
avoid hospitalization were required.
Based on early assessment of inflammatory markers like CRP and clinical signs like persistent
high-grade fever, need-based early medical intervention was initiated in home quarantined
COVID -19 patients prior to the onset of hypoxia, in order to avoid complications and
hospitalization
|
| NCT04937569 ↗ |
Ivermectin Versus Standard Treatment in Mild COVID-19 |
Not yet recruiting |
Phase 3 |
2021-07-01 |
Rationale: Ivermectin, an inexpensive and available antiparasitic drug, with favourable
safety profile, showed inhibitory effect on SARS-CoV2 viral replication in-vitro and in
animal models. Several research groups investigated Ivermectin in COVID-19, particularly in
mild symptomatic disease. There is high degree of uncertainty on its effects on clinical
outcomes and larger studies are needed.
Objectives: Plan to study the effect of Ivermectin versus standard treatment in patients with
confirmed mild COVID-19.
Study design: Multi-centre prospective cohort study Settings: Assiut University Hospital
(Assiut University), Aswan and others, Egypt.
Study Population: Patients with confirmed mild COVID-19. Intervention: Patients with mild
symptomatic COVID-19 attending the participating out-patient clinics in different centers
will receive either Ivermectin + Standard treatment or Standard treatment only. All new mild
symptomatic COVID-19 patients will receive Ivermectin + Standard treatment for the first two
weeks of the study. During the following four weeks, all new patients will receive standard
treatment only. These cycles will be repeated until 822 patients are recruited in each arm.
Patients assigned to Ivermectin + Standard treatment or standard treatment only will remain
as such throughout the study and during the follow- up period.
Primary outcome measures: The primary outcome will be rate of intensive care admission.
Secondary outcome measures: Secondary outcomes will be time to clinical improvement, the
clinical state using 7-point ordinal scale at different time points, need for home
oxygenation, hospitalization, hospital supplemental oxygen >24 hours, Non- invasive
ventilation ( High- flow nasal cannula, High- velocity nasal insufflation or BiPAP), duration
of hospitalization, duration of ICU stay and deaths within 21 days,.
Power calculation:
With a prospective cohort design, a sample size of 822 cases per group is estimated (1644 for
the whole study). This calculation depends on a rate of ICU admission in mild symptomatic
COVID-19 cases of 8.5%, an assumption that Ivermectin can reduce this rate by 50%, at a study
power of 80%, and confidence limit of 0.95.
|
| NCT04940182 ↗ |
A Study to Assess the Efficacy and Safety of XC221 in Patients With Mild COVID-19 |
Recruiting |
Phase 3 |
2021-06-26 |
The innovative drug XC221 100 mg tablet is designed for the treatment of COVID-19 (SARS-CoV-2
infection). A multicenter, adaptive, randomized, double-blind, placebo-controlled Phase III
clinical study is aimed to assess the efficacy and safety of XC221 100 mg tablet, in mild
COVID-19 patients during a 14-days treatment.
The primary objective of the study is to demonstrate the efficacy of XC221 100 mg tablet (200
mg daily dose) in achieving clinical improvement of mild COVID-19 symptoms.
The secondary objective of the study is to evaluate the safety of XC221 100 mg tablet (200 mg
daily dose) in mild COVID-19 patients.
|
| NCT04941703 ↗ |
"CHANGE COVID-19 Severity" |
Recruiting |
Phase 1/Phase 2 |
2021-06-25 |
We are conducting an investigator-initiated, single center, blinded, placebo-controlled,
randomized clinical trial evaluating magnesium citrate combined with a probiotic for the
treatment of adults hospitalized with COVID-19.
|
| NCT04944121 ↗ |
Phase 2 Study of RSLV-132 in Subjects With Long COVID |
Recruiting |
Phase 2 |
2021-06-25 |
The purpose of this study is to assess the efficacy (decrease in severe fatigue), safety and
pharmacokinetics of RSLV-132 in subjects with long Corona Virus (COVID) syndome
|
| NCT04949386 ↗ |
Safety, Tolerability and Efficacy of S-1226 in Post-COVID-19 Subjects With Persistent Respiratory Symptoms. |
Not yet recruiting |
Phase 2 |
2021-09-01 |
This is a randomized (1:1) , placebo-controlled phase II study to evaluate the safety,
tolerability and efficacy of S-1226 in Post-COVID-19 subjects (n≤48) with persistent
respiratory symptoms. Subjects will receive twice daily treatments of either Placebo or
S-1226 (8%) for 7 days.
|
| NCT04951349 ↗ |
Safety and Efficacy of Intranasal Application of GX-03 as a Treatment and Prevention for COVID-19. |
Completed |
Phase 2 |
2021-01-21 |
Phase 2b clinical trial to evaluate the safety and efficacy of intranasal application of
GX-03 as a treatment and prevention for COVID-19.
|
| NCT04952519 ↗ |
Efficacy of Amantadine Treatment in COVID-19 Patients |
Recruiting |
Phase 3 |
2021-03-30 |
Demonstration of the efficacy of amantadine over placebo in the population of patients with
moderate or severe COVID-19 in the initial stage of the disease treated in the hospital
|
| NCT04952805 ↗ |
Study to Select the Dose and Evaluate Safety and Efficacy of Monoclonal Antibody in Adult With Recently Diagnosed Asymptomatic to Moderately Severe COVID-19. |
Recruiting |
Phase 2/Phase 3 |
2021-06-06 |
MAD0004J08, the experimental drug, is a potent neutralizing IgG1 monoclonal antibody (mAb)
targeting the spike protein of SARS-CoV-2. MAD0004J08 blocks viral attachment and entry into
human cells and neutralizes the virus. Because of its high affinity and potency, MAD0004J08
may accelerate clearance of the virus and prevent clinical deterioration of COVID-19
patients, especially when administered shortly after infection, and prevent SARS-CoV-2
infection in uninfected subjects. Because of its high potency, MAD0004J08 is expected to be
effective at low doses (mg range) and thus will be administered by intramuscular (IM)
injection, as opposed to the intravenous bolus required by high dose mAbs.
The goals of this Phase II-III seamless adaptive clinical trial are:
Stage-1 (Phase II)
1. Select one dose level for progression to Stage-2 Stage-1 + Stage-2 (Phase III)
2. Provide confirmatory evidence of safety and efficacy for regulatory approval.
|
| NCT04954040 ↗ |
Prevention and Treatment With Hydroxychloroquine + Azithromycin of Acute Respiratory Syndrome Induced by COVID-19 |
Recruiting |
Phase 2 |
2021-02-10 |
Multi-centered, randomized, open label clinical trial to study the safety and effectivity of
hydroxychloroquine + azithromycin to treat COVID-19 symptoms in primary care patients.
|
| NCT04959786 ↗ |
MANS-NRIZ Trial for COVID-19 Treatment : Extension Study |
Recruiting |
Phase 2/Phase 3 |
2021-04-01 |
This search will focus on patients with COVID 19 infection this study is a prospective cohort
study based on the analysis of response in comparative panel between two arm Nitazoxanide,
Ribavirin and Ivermectin plus Zinc arm and other arm without any intervention as regards the
safety and efficacy and cost effective result. Two years duration of the project would be
enough to cover the stages of the work as shown below in the time plan. Initial stage of
collecting materials and patients' clinical data, each patient will undergoes strict follow
up period to reveal the clinical, laboratory and radiological response. The procedures are to
be approved by the institutional ethical committee.
|
| NCT04960215 ↗ |
Coenzyme Q10 as Treatment for Long Term COVID-19 |
Recruiting |
Phase 2 |
2021-05-25 |
This study is a randomized, placebo-controlled, double-blinded, cross-over designed clinical
trial investigating the effect of high-dose Coenzyme Q10 treatment in subjects with
persisting symptoms more than 12 weeks af SARS-CoV-2 infection, Long Term COVID-19 (LTC).
|
| NCT04964414 ↗ |
Treatment of Pediatric Patients That Lost Sense of Smell Due to COVID-19 |
Recruiting |
Phase 1/Phase 2 |
2021-09-30 |
This research study is a randomized controlled trial in pediatric and young adult patients
who have lost their sense of smell due to COVID-19 viral infection. The goals are:
1. to learn more about the effects of smell retraining therapy on smell loss following
COVID-19 and
2. to determine if budesonide-saline irrigations make smell retraining therapy more
effective.
|
| NCT04967430 ↗ |
TOGETHER - Toronto: Trial to Evaluate the Effect of Peginterferon Lambda for the Treatment of COVID-19 |
Recruiting |
Phase 3 |
2021-08-27 |
Interferon (IFN) lambda is one of the fundamental responses of the innate immune system.
Peginterferon lambda is a long-acting form that has been studied extensively in human trials
in viral hepatitis, confirming it safety and tolerability. It is particularly attractive for
consideration in the use of acute respiratory illness due to the high expression of the
lambda receptor in lung epithelia. We propose to evaluate peginterferon-lambda in ambulatory
patients with mild to moderate COVID-19.
|
| NCT04969991 ↗ |
Study of Varespladib in Patients Hospitalized With Severe COVID-19 |
Recruiting |
Phase 2 |
2021-06-30 |
This is a 2-part, multi-center, randomized, double-blind, placebo-controlled, phase 2 study
designed to evaluate the safety, tolerability, and efficacy of oral varespladib, in addition
to standard of care, in patients hospitalized with severe COVID-19 caused by SARS-CoV-2.
|
| NCT04970719 ↗ |
Baricitinib in Hospitalized Covid-19 Patients With Diabetes Mellitus |
Recruiting |
Phase 3 |
2021-07-10 |
To date, some of the most promising drugs used in the treatment of COVID pneumonia are
systemic corticosteroids, remdesivir and baricitinib. Dexamethasone has been found
efficacious in reducing mortality in patients requiring supplemental oxygen and mechanical
ventilation. There is a trend towards reduced mortality in patients who receive remdesivir
and dexamethasone combination, supporting the hypothesis that an antiviral drug combined with
an anti-inflammatory agent improve outcomes in COVID-19. Baricitinib plus remdesivir is
superior to remdesivir alone in reducing recovery time and accelerating improvement in
clinical status among patients with COVID-19, notably among those receiving high-flow oxygen
non-invasive ventilation. Diabetes mellitus increases the risk for COVID-19 morbidity and
mortality. Patients with diabetes have coexisting morbidities and already immune-compromised.
Steroids cause further immunosuppression and may contribute to uncontrolled blood glucose in
this group of patients, resulting in worse outcomes. Baricitinib can be an alternative to
corticosteroids in diabetic patients. This open-label multi-centre non-inferiority randomized
controlled trial will be conducted in seven hospitals in Bangladesh. The primary objective is
to evaluate the clinical efficacy of baricitinib plus remdesivir compared to dexamethasone
plus remdesivir in hospitalized COVID-19 patients with diabetes mellitus, as assessed by the
proportion of patients, need "rescue treatment" between two groups by day 29. Hospitalized
adult (≥18 years) diabetic patients with confirmed SARS-CoV-2 infection have ordinal scale
category 5 will be included in the study. Subjects will be randomized in a 1:1 (by tossing a
coin) ratio in two groups. The total sample size is 362. Group 1 subjects will receive 200 mg
of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily dose of
remdesivir while hospitalized for up to 5 days and 4 mg of baricitinib administered as 2
tablets taken orally daily while hospitalized for up to 14 days. Group 2 will receive the
same dose of remdesivir plus 6 mg of dexamethasone administered as an intravenous injection
daily while hospitalized for up to 10 days. Subjects will be assessed daily while
hospitalized. Discharged subjects will be evaluated on days 15, 22 and 29 (in person; if not
possible, over the telephone). Assessment will be done clinically using an 8-point Ordinal
Scale and National Early Warning Score.
|
| NCT04978259 ↗ |
SOLIDARITY Finland Long COVID-19 |
Recruiting |
Phase 4 |
2021-07-24 |
The primary aim of the SOLIDARITY Finland Long-COVID trial is to assess the long-term effects
of remdesivir use during hospitalisation on long-COVID symptoms and quality of life (QoL)
using questionnaires at one and two years post-discharge. The primary research questions are
whether remdesivir lowers the risk of long-COVID symptoms and leads to better QoL in the long
term.
Objectives include:
i) Long-COVID symptoms
- To investigate the effect of remdesivir (vs. usual care only) on the occurrence of
symptoms that have been associated with the long-COVID syndrome. The questionnaires will
take place one and two years after the hospital admission. The questionnaire was
developed by our multidisciplinary team of physicians, including the representation of
multiple specialties such as general practice, lung diseases, neurology, internal
medicine, rheumatology, genetics, and clinical epidemiology, and two patient partners.
- The symptom questionnaire - that will be completed by patients at one and two years -
measures basic patient information (age, height, weight, smoking status, major
comorbidity, and working status) and a wide variety of potential long-COVID-symptoms and
their bother (1. Fatigue; 2. Attention deficits; 3. Memory problems; 4. Sleeping
difficulties; 5. Depressive mood; 6. Anxiety; 7. Dizziness; 8. Headache; 9. Tinnitus;
10. Paresthesias; 11. Changes in taste/smell perceptions; 12. Postexertional malaise;
13. Palpitations; 14. Chest discomfort; 15. Nausea; 16. Skin rash; 17. Joint aches; 18.
Muscle pains; 19. Continuous cough; 20. Respiratory tract mucous discharges) in
remdesivir and usual care arms
ii) Quality of life
- The EQ-5D-5L questionnaire will be used to compare patients' quality of life in
remdesivir and usual care arms.
- EQ-5D-5L questionnaire assesses the following domains: 1. Mobility; 2. Self-care; 3.
Usual activities; 4. Pain and discomfort; 5. Anxiety and depression; 6. The visual
analog scale of subjective perception of overall health.
Additionally (at 1 or 2 years; depending on future funding and ethical approval decisions;
currently the study has ethical approval for long-COVID and quality of life assessments
only):
- The Finnish healthcare registries (Statistics Finland Mortality Database and the HILMO
Care Register for Health Care) will be used to estimate long-term mortality and
incidence of major comorbidity in remdesivir and usual care arms
- Lung function will be assessed using spirometry and diffusing capacity, as well as the
six-minute walk test (6 mwt) in remdesivir and usual care arms
- Whole-genome genotyping will be performed for a genome-wide association study to
investigate genetic correlates of long-COVID-19 -symptoms in remdesivir and usual care
arms
|
| NCT04981314 ↗ |
Echinacea Drug for Covid-19 |
Recruiting |
Phase 4 |
2021-06-18 |
The main objectives of ECCO-2 are: 1) Efficacy: to study whether EQUINACEA ARKOPHARMA, hard
caplets containing cryogenized root of the plant Echinacea purpurea, show an improvement of
the clinical manifestations and disease course in ambulatory patients with covid-19 with a
respiratory presentation and not requiring hospitalization (i.e., mild covid-19). The drug
being evaluated will be added as a supplement of the standard treatment, with its current
recommended dose for treatment of the common cold. 2) Safety: to determine that the incidence
of adverse events is not higher than that seen with the standard treatment applied in each
case.
|
| NCT04981379 ↗ |
Clinical Trial For Early SARS-CoV-2 (COVID-19) Treatment |
Completed |
Phase 3 |
2020-11-16 |
This study is a randomized, double-blinded, and placebo controlled phase III clinical trial
which aims to investigate the superiority of hydroxychloroquine, favipiravir or
hydroxychloroquine + favipiravir treatment, initiated especially in the early period in the
treatment of COVID-19, over the patients being followed up with placebo in adults aged 18~59
Years.
|
| NCT04983446 ↗ |
In-patient COVID-19 Study of Intranasal Foralumab |
Not yet recruiting |
Phase 2 |
2021-10-25 |
This is a Phase 2, randomized, placebo-controlled, double-blind, proof-of-concept study of
intranasal foralumab in hospitalized subjects with severe COVID-19 and pulmonary
inflammation.
Foralumab is a fully human second generation anti-CD3 mAb with a modified Fc unit (two amino
acid substitutions) composed of 2 heavy chains with an immunoglobulin (Ig) G1constant region
and 2 light chains with a kappa constant region.
In a separate Phase 2 randomized, controlled, pilot trial conducted to assess safety,
tolerability, and efficacy in 39 patients with mild to moderate COVID-19 in Brazil, showed
that intranasal foralumab may be of benefit in modulating immune reactivity and in reducing
pulmonary inflammation. Importantly, intranasal administration of foralumab was well
tolerated with no clinically significant changes in blood cell counts (including blood
lymphocytes), no evidence of hypersensitivity, and no serious adverse events (SAEs) were
reported in the study.
|
| NCT04986176 ↗ |
HC-1119 Adjuvant Treatment for Hospitalized COVID-19 Patients |
Not yet recruiting |
Phase 3 |
2021-08-15 |
The primary purpose of this study is to evaluate the efficacy of HC-1119 as an adjuvant
treatment for hospitalized COVID-19 male and female patients.
|
| NCT04988035 ↗ |
ACTIV-5 / Big Effect Trial (BET-C) for the Treatment of COVID-19 |
Recruiting |
Phase 2 |
2021-07-21 |
This is a platform trial to conduct a series of randomized, double-blind, placebo-controlled
trials using common assessments and endpoints in hospitalized adults diagnosed with COVID-19.
BET is a proof-of-concept study with the intent of identifying promising treatments to enter
a more definitive study. The study will be conducted in up to 70 domestic sites and 5
international sites. The study will compare different investigational therapeutic agents to a
common control arm and determine which have relatively large effects. In order to maintain
the double blind, each intervention will have a matched placebo. However, the control arm
will be shared between interventions and may include participants receiving the matched
placebo for a different intervention.
The goal is not to determine clear statistical significance for an intervention, but rather
to determine which products have clinical data suggestive of efficacy and should be moved
quickly into larger studies. Estimates produced from BET will provide an improved basis for
designing the larger trial, in terms of sample size and endpoint selection. Products with
little indication of efficacy will be dropped on the basis of interim evaluations. In
addition, some interventions may be discontinued on the basis of interim futility or efficacy
analyses.
One or more interventions may be started at any time. The number of interventions enrolling
are programmatic decisions and will be based on the number of sites and the pace of
enrollment. At the time of enrollment, subjects will be randomized to receive any one of the
active arms they are eligible for or placebo. Approximately 200 (100 treatment and 100 shared
placebo) subjects will be assigned to each arm entering the platform and a given site will
generally have no more than 3 interventions at once.
The BET-C stage will evaluate the combination of remdesivir with danicopan vs remdesivir with
a placebo. Subjects will be assessed daily while hospitalized. Once subjects are discharged
from the hospital, they will have a study visit at Days 8, 15, 22, 29, and 60 as an
outpatient. The Day 8, Day 22 and Day 60 visits do not have laboratory tests or collection of
samples and may be conducted by phone. All subjects will undergo a series of efficacy and
safety laboratory assessments. Safety laboratory tests and blood (serum, plasma and RNA)
research samples on Day 1 (prior to study product administration) and Days 3, 5, 8, and 11
while hospitalized. Blood research samples plus safety laboratory tests will be collected on
Day 15 and 29 if the subject attends an in-person visit or is still hospitalized. However, if
infection control considerations or other restrictions prevent the subject from returning to
the clinic, Day 15 and 29 visits may be conducted by phone and only clinical data will be
obtained.
The primary objective is to evaluate the clinical efficacy of danicopan relative to the
control arm in adults hospitalized with COVID-19 according to clinical status (8-point
ordinal scale) at Day 8.
|
| NCT04990557 ↗ |
CRISPR/Cas9-modified Human T Cell ( PD-1and ACE2 Knockout Engineered T Cells ) for Inducing Long-term Immunity in COVID-19 Patients |
Not yet recruiting |
Phase 1/Phase 2 |
2021-08-01 |
T-cell exhaustion may limit long-term immunity in COVID-19 patients. T cells can lose their
ability to fight viruses and tumors when they have prolonged exposure to these enemies. New
data suggests people who experience mild COVID-19 symptoms show the molecular signs of
exhausted memory T cells and therefore could have a reduced ability to fight reinfection. On
contrary people who develop severe COVID-19 symptoms may be better protected from
reinfection. A recent study reported that the 82.1% of COVID-19 cases displayed low
circulating lymphocyte counts . It has been reported that, in the case of chronic viruses,
continuous PD-1 expression causes T-cell exhaustion, and impairs the ability of killing the
infectious cells . The adumbration of patients with COVID-19 is characterized by a diminished
lymphocyte percentage, with a similar proportion of CD4+ and CD8+ T-cells. The quantity of
T-cells, mostly CD8+ T-cells, presenting high expression rates of late activity marker CD25
and exhaustion marker PD-1 increases. Therefore, SARS-CoV-2 is able to make changes by
modifying the acquired immune system, including B and T cells. According to experiments,
PD-1's expression, as an important factor in the induction and maintenance of circumferential
tolerance keeping the stability of T-cells, has been found to have a higher percentage in
different cells of COVID-19 patients. In an experiment conducted by Diao et al., on the
patients with SARS-CoV-2, it was observed that the expression of PD-1 on the surface of
T-cells was increased significantly; it was also shown that during the SARS-CoV-2 -induced
disease, additional expressions of PD-1 and Tim-3 on the T-cells were directly related to the
disease's severity; the factors that were also increased in other viral infections. T cell
exhaustion" phenomenon could be reversed relatively easily, for example when the T cells are
no longer exposed to the virus or tumor. But unfortunately, although exhausted T cells
recovered from chronic infection (REC-TEX) regain some function and features of memory T
cells (TMEM), they retain epigenetic scars indicating the control of gene expression is
"locked in" to their exhaustion history. Once T cells become exhausted, they remain
fundamentally 'wired' to be exhausted-thus it may be hard to get them to become effective
virus- and cancer-fighters again," said John Wherry, PhD, chair of the department of Systems
Pharmacology and Translational Therapeutics and director of the Penn Institute of Immunology
in the Perelman School of Medicine at the University of Pennsylvania. Furthermore, COVID-19
may infect T lymphocyte cells and induce apoptosis and apoptotic markers. Lymphocytopenia was
also found in the Middle East respiratory syndrome (MERS) cases. MERS-CoV can directly infect
human primary T lymphocytes and induce T-cell apoptosis through extrinsic and intrinsic
apoptosis pathways, but it cannot replicate in T lymphocytes. However, it is unclear whether
SARS-CoV-2 can also infect T cells, resulting in lymphocytopenia. A study showed that T cells
express a very low expression level of hACE2 on its cell surface and T-cell lines were
significantly more sensitive to SARS-CoV-2 infection when compared with SARS-CoV . In other
words, these results tell us that T lymphocytes may be more permissive to SARS-CoV-2
infection. Therefore, it is plausible that the S protein of SARS-CoV-2 might mediate potent
infectivity, even on cells expressing low hACE2, which would, in turn, explain why the
transmission rate of SARS-CoV-2 is so high. Through recent advances in genomic editing, T
cells can now be successfully modified via CRISPR/Cas9 technology. For instance, engaging
(post-)transcriptional mechanisms to enhance T cell cytokine production, the retargeting of T
cell antigen specificity or rendering T cells refractive to inhibitory receptor signaling can
augment T cell effector function. Therefore, CRISPR/Cas9-mediated genome editing might
provide novel strategies for inducing long term immunity against COVID-19.Immunotherapies
with autologous T cells have become a powerful treatment option for many diseases like viral
infection or cancer. These include the adoptive isolation and transfer of naturally-occurring
virus/tumor-specific T cells and the transfer of T lymphocytes that have been genetically
modified . According to the investigator, exhausted virus-reactive CD8+ memory T cells will
be isolated from patients with mild infection using a modified antigen-reactive T cell
enrichment (ARTE) assay. exhausted virus-reactive CD8+ memory T cells will be collected and
both Programmed cell death protein 1(PDCD1) gene and ACE2 gene will be knocked out by CRISPR
Cas9 in the laboratory. The lymphocytes will be selected and expanded ex vivo and infused
back into patients.
|
| NCT04990830 ↗ |
Effects of Low Molecular Weight Heparin Therapy With Soft-Mist Inhaler for COVID-19 Induced Hypoxemia |
Completed |
Phase 2/Phase 3 |
2021-02-03 |
This is an investigator initiated, single-center, open-label, Phase IIb clinical trial with
40 patients (for a total of 80 patients) to assess efficacy of Low molecular weight heparin
using soft mist inhaler in the treatment of critically ill patients with COVID-19
(coronavirus disease of 2019) induced ARDS (acute respiratory distress syndrome). The
patients will be assigned in a 1:1 ratio to receive standard treatment protocol plus inhaled
Low molecular weight heparin. The primary objective is to determine the hypoxemia improvement
on a 5-point clinical scale for COVID-19 induced ARDS patients.
|
| NCT05000216 ↗ |
COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders |
Recruiting |
Phase 2 |
2021-08-13 |
This is a randomized, multi-site, adaptive, open-label clinical trial comparing the immune
response to different COVID-19 vaccine booster doses in participants with autoimmune disease
requiring immunosuppressive medications. All study participants will have negative serologic
or sub-optimal responses (defined as a Roche Elecsys® Anti-SARS-CoV-2 S (RBD) result ≤ 50
U/mL) to initial COVID-19 vaccine regimen with Moderna COVID-19 vaccine, Pfizer-BioNTech
COVID-19 vaccine, or Janssen COVID-19 vaccine.
The study will initially focus on 5 autoimmune diseases:
- Systemic Lupus Erythematosus (SLE)
- Rheumatoid Arthritis (RA)
- Multiple Sclerosis (MS)
- Systemic Sclerosis (SSc), and
- Pemphigus.
|
| NCT05000346 ↗ |
Clinical Trial to Assess the Efficacy and Safety of Inhaled AQ001S in the Management of Acute COVID-19 Symptoms |
Not yet recruiting |
Phase 2 |
2021-11-01 |
Double-blind parallel trial to assess the efficacy and safety of inhaled AQ001S in the
management of acute COVID-19 symptoms compared.
|
| NCT05002530 ↗ |
Investigating the Potential Role of Aerosolized Retinoic Acid, a Potent Vitamin A Metabolite for Treating COVID-19 Anosmia and Retinoic Acid Insufficiency .A Novel Approach for Regaining Sense of Smell. |
Not yet recruiting |
Phase 4 |
2021-11-01 |
Investigating the potential role of Aerosolized retinoic acid, a potent Vitamin A metabolite
for treating COVID-19 Anosmia and retinoic acid insufficiency .A novel approach for regaining
Sense of Smell.
Mahmoud ELkazzaz(1),Tamer Haydara(2), Abedelaziz Elsayed(3) ,Yousry Abo-amer(4), Hesham
Attia(5), Quan Liu(6) and Amr Ahmed(7)
1. Department of chemistry and biochemistry, Faculty of Science, Damietta University,
Egypt.
2. Department of Internal Medicine, Faculty of Medicine, Kafrelsheikh University, Egypt
3. Department of Pharmaceutical Biotechnology, Faculty of Pharmacy, Tanta University,
Egypt.
4. Hepatology,Gastroenterology and Infectious Diseases Department, Mahala Hepatology
Teaching Hospital, Egypt
5. Department of Immunology and Parasitology, Faculty of Science, Cairo University, Egypt.
6. School of Life Sciences and Engineering, Foshan University, Laboratory of Emerging
Infectious Disease, Institute of Translational Medicine, The First Hospital of Jilin
University, Changchun, China.
7. Director of tuberculosis program Ghubera, public health department ,First health cluster
,Ministry of health ,Saudia Arabia.
- Very important Note: This clinical study is the first clinical study in literature
(First posted August 12, 2021) which demonstrated depending on molecular findings
that Vitamin A /Retinoic Acid will treat smell loss resulted by COVID-19
Recent rapidly accumulating evidences and reports indicate that partial loss of the sense of
smell or even total anosmia are early markers of SARS-CoV-2 infection and frequently reported
symptoms associated with the COVID-19 pandemic (Lechien J. R et al., 2020) However, the
cellular mechanisms of this phenomenon are unknown. The rates of insomnia and depression were
26.45% and 9.92% in the COVID-19 patients after recovery. Therefore, finding an effective
treatment for COVID-19 Anosmia is a critical point. Although, ACE2 has been identified as the
principal host cell receptor of 2019-nCoV, and it is thought to play a critical role in the
virus's entrance into the cell and subsequent infection, many cells can be infected by
COVID-19 while also expressing little or no ACE2. Even though the COVID-19 entry receptor,
angiotensin-converting enzyme 2 (ACE2), is not expressed in the receptor of olfactory
neurons, or its synthesis is limited to to a minor fraction of these neurons.of these
neurons, COVID-19 infection causes a loss of smell (anosmia) (Katarzyna Bilinska et
al.,2021). Our recent findings showed that COVID-19 binds directly to STRA6 receptors of
retinol leading to retinol depletion and retinoic acid insufficiency (M Elkazzaz et al,.
2021) . Retinoic acid insufficiency in the olfactory epithelium, both in mouse and chick
models, causes progenitor cell maintenance failure and, consequently, olfactory neurons
differentiation is not maintained . An explant system, showed that renewal of olfactory
neurons is inhibited if retinoic acid synthesis was failed in the olfactory epithelium
(Paschaki M et al., 2013) . It's worth noting that vitamin A shortage also causes olfactory
and taste problems, In a study by Garrett-Laster et al., (1984), the patients had vitamin A
deficiency because of malnutrition and alcoholic liver cirrhosis; they lost their sense of
smell after that disorder. LaMantia and Rawson et al.,( 2007) reported that administration of
retinoid acid after the damage of olfactory system motivates an immune response and produces
a more quick recovery of olfactoryguided behavior. It was showed that Isotretinoin improved
the significantly performance of patients in the olfactory test(Demet Kartal et al.,2017)
Moreover, there is increasing evidence that retinoic acid (atRA) influences gene expression
of components of renin-angiotensin system (RAS), which plays a pivotal role in the
pathophysiology of essential hypertension. Retinoic acid induced ACE2 expression in different
animal models. Moreover, a study suggests that topical retinoids may have applicability in
promoting sinus regeneration and wound healing. In a study comparing treated and untreated
nasal mucosa ,untreated regenerated mucosa showed expected changes of submucosal gland loss,
basal lamina and lamina propria fibrosis and loss of cilia. Reinoic acid treatment appeared
to result in better mucosal regeneration marked by less cellular atypia and fibrosis(Mendy S.
Maccabee et al,. 2003).. Aerosolized retinoic acid will have an effective role in treating
post COVID-19 anosmia (loss of smell) via upregulating ACE2, STRA 6 and regenerating of
olfactory receptors and olfactory sensory cells and neurons.
|
| NCT05003492 ↗ |
Utilizing the Crosstalk Among Aerosolized Phenformin , Methylene Blue, Photodynamic Therapy , Zinc and Potassium for Treating Severe COVID-19 Infection and Its Inflammatory Complication |
Not yet recruiting |
Phase 1/Phase 2 |
2021-09-01 |
Utilizing the crosstalk among aerosolized phenformin, methylene blue, photodynamic therapy ,
zinc and potassium for treating severe COVID-19 infection and its inflammatory complication
Amr Ahmed(1), Mahmoud Elkazzaz(2), Tamer Haydara(3), and Abdullah Alkattan(4)
1. Director of tuberculosis program Ghubera, public health department ,First health cluster
,Ministry of health ,Saudia Arabia.
2. Department of chemistry and biochemistry, Faculty of Science, Damietta University,
Egypt.
3. Department of Internal Medicine, Faculty of Medicine, Kafrelsheikh University, Egypt.
4. Ministry of Health, Riyadh, Saudi Arabia.
SARS-CoV-2 represents the largest current health challenge for the society. Moreover,
numerous variants of the virus that causes COVID-19 are being tracked in the United States
and globally during this pandemic. Here, we will use combination therapy which involve agents
with significant activity and different mechanisms of action against covid-19 and its
inflammatory complication. Excessive activities of cysteinyl cathepsins (CysCts) contribute
to the progress of many diseases. however, therapeutic inhibition has been problematic.
Cathepsin L are crucial in terms of the endocytosis by cleaving the spike protein, which
permits viral membrane fusion with endosomal membrane, and succeeded by the releasing of
viral genome to the host cell. Thereby, inhibition of cathepsin L may be advantageous in
terms of decreasing infection caused by SARS-CoV-2. It is well known that zinc (Zn) possesses
a variety of direct and indirect antiviral properties, which are realized through different
mechanisms. Administration of Zn supplement has a potential to enhance antiviral immunity and
to restore depleted immune cell function, in particular in immunocompromised patients. It has
been found that Zn 2+ deficiency leads to an exaggerated activity of Cysteine cathepsin
increasing the autoimmune/inflammatory response. . Zn2+ is a natural inhibitor of proteases
with CysHis dyads or CysHis(Xaa) triads. cysteine protease Cathepsin L (CatL) involvement
with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and COVID-19 from different
points of view. At this purpose Zn 2+ metal can be safely combined with phenformin a drug
that increases the anti-proteolytic effect of endogenous Zn 2+ lowering the excessive
activity of some CysCts.; A study found that phenformin-Zn2+ complex is identified as a
modifiable pharmacophore for synthesis of therapeutic CysCt inhibitors with a wide range of
potencies and specificities. Phenformin stabilizes a "Zn2+ sandwich" between the drug and
protease active site. Additionally, phenformin was found to be potent inhibitor of IL-6 R,
with phenformin (100 µM) treatment for 48 h, decreased IL-6R expression in ANBL6, RPMI, U266,
MM1S, and JJN3 was 5.51 (p = 0.0025), 3.03 (p = 0.0005), 1.55 (p < 0.05), 2.09 (p = 0.0082)
and 1.19-fold, respectively. Furthermore, phenformin was discovered to potentially and
strongly bind to ACE2 receptors, according to a docking research being conducted by the
principle investigators of this clinical study therefore, Phenformin is expected to
potentially attach to ACE2 receptors and lead to its downregulation, an inhibitory mechanism
which may combat and block COVID-19 infection in lung epithelial cells. Phenformin may induce
lactic acidosis therefore according to the principal investigator The phenformin will be
utilized as aerosolized by inhalation for COVID-19 treatment and this may be an effective
novel treatment strategy that would limit the risk of systemic side-effects associated with
biguanides due to the low inhaled dose. In addition, we will use aerosolized phenformin in
combination with methylene blue. A study found that a very marked improvement in lactate and
pyruvate concentrations occurred within six hours of the beginning of méthylène blue
administration in human . It has been known for some time that méthylène blue is a moderately
efficient hydrogen acceptor in several enzyme sys¬ tems and significantly reduce oxidative
stress by scavenging ROS. Moreover, Methylene Blue has antiviral activity and was found to
Inhibit the Spike-ACE2 Protein-Protein Interaction-a Mechanism that can contribute to its
Antiviral Activity Against COVID-19 For many reasons, methylene blue is a promising drug for
an active treatment against SARS-CoV-2 . Since methylene blue can work as a photosensitizer,
photodynamic therapy as an antiviral treatment has great potential in the treatment of
COVID-19.. This clinical study will investigate the effectiveness of SARS-CoV-2 infected
people treatment using methylene blue and the following photodynamic therapy after that our
clinically approved patients will receive phenformin and zinc . But methylene blue may lead
to lowering in potassium concentration.Therefore, we will add potassium supplement to this
combination.
|
| NCT05004805 ↗ |
COVID-19 Methylene Blue Antiviral Treatment |
Active, not recruiting |
Phase 2 |
2021-08-06 |
This is a pilot study of a single-center, blind, randomized, placebo-controlled,
parallel-group study testing for the efficacy and safety of Methylene blue when administered
topically as a 0.02% solution for nasopharyngeal and oropharyngeal irrigation in COVID-19
patients requiring hospitalization.
|
| NCT05007522 ↗ |
Ketotifen and Indomethacin Combination Treatment Clinical Trial for COVID-19 |
Not yet recruiting |
Phase 2 |
2021-09-01 |
The purpose of this study is to evaluate the safety and effectiveness of ketotifen and
indomethacin taken together to improve symptoms related with COVID-19. Ketotifen and
indomethacin are medications approved by the Food and Drug Administration (FDA) to treat
diseases other than COVID-19. Their use in this study is investigational, meaning they have
not been approved by the FDA to treat COVID-19.
|
| NCT05007678 ↗ |
Targeting de Novo Pyrimidine Biosynthesis by Leflunomide for the Treatment of COVID-19 Virus Disease |
Active, not recruiting |
Phase 3 |
2020-09-16 |
The global COVID-19 pandemic has caused unprecedented strain on health care services around
the world.The absence of specific anti-viral medications to treat the underlying infection
led to a proliferation of clinical studies and trials aimed at re-purposing existing
medications.
Human dihydroorotate dehydrogenase (DHODH) is vital enzyme utilised by viruses to replicate
in the host cell. Leflunomide, a drug that is already licenced to treat rheumatoid arthritis,
is a potent inhibitor of the enzyme DHODH. Importantly, this drug has dual anti-viral and
anti-inflammatory properties so it targets viral replication and suppresses host inflammatory
response which plays a role at more progressive stages of infection.
DEFEAT-COVID is a multi-site, international, interventional, pragmatic, parallel group
design, open label, randomised CTIMP with a pilot phase that will allow to adapt procedures
and assessments if required.
A phase III clinical trial of leflunomide for treating COVID-19 has been registered in China,
Registration number: ChiCTR2000030058). The current proposal extends the original clinical
study of leflunomide in China (People's Hospital of Wuhan University) to the UK through a
structured collaboration.
|
| NCT05008003 ↗ |
Dietary Supplements Vit D, Quercetin and Curcumin Combination for Early Symptoms of COVID-19 |
Recruiting |
N/A |
2021-09-05 |
There is currently no specific treatment available for COVID-19 disease. There is an urgent
need for affordable, worldwide available and safe agents for treatment of COVID-19. Dietary
supplements Curcumin, Quercetin and Vitamin D are widely used to boost the body's immune
system against infections. In the present study, the combination of dietary supplements
curcumin, quercetin and vitamin D, all contained in one soft capsule (Nasafytol), will be
investigated for early COVID-19 symptoms improvement and viral clearance in outpatients.
|
| NCT05009732 ↗ |
A Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Hospitalized COVID-19 Subjects |
Recruiting |
Phase 3 |
2021-09-30 |
This study is an adaptive Phase III randomized double-blind placebo-controlled trial to
evaluate the efficacy and safety of Proxalutamide (GT0918) in hospitalized adults diagnosed
with COVID-19. The study is a multicenter trial that will be conducted at approximately 80
sites globally. The study will compare GT0918 plus standard of care (SOC) with the placebo
plus SOC. Approximately 1030 subjects will be randomized in a 1:1 ratio to either GT0918 plus
SOC or placebo plus SOC group.
|
| NCT05012319 ↗ |
Phase 3 Clinical Study Evaluating Nitric Oxide Nasal Spray (NONS) Efficacy To Treat and Prevent the Exacerbation of Infection in Individuals With Documented Asymptomatic or Mild COVID-19 |
Recruiting |
Phase 3 |
2021-08-05 |
Study Design: This is a double-blind, placebo-controlled, Phase 3 clinical efficacy study
evaluating NONS in adult volunteers as a treatment for high-risk asymptomatic and symptomatic
individuals with mild COVID-19 infection. thru facility).
|
| NCT05018975 ↗ |
Tazemetostat for the Treatment of Moderate to Severe COVID-19 Infection |
Not yet recruiting |
Phase 2 |
2021-09-22 |
The purpose of this study is to assess the safety and efficacy of repurposing tazemetostat
for the treatment of Acute Respiratory Distress Syndrome (ARDS) or Systemic Cytokine Release
Syndrome (SCRS) in COVID-19 patients.
|
| NCT05028374 ↗ |
COVID-19 VAX Booster Dosing in Patients With Hematologic Malignancies |
Recruiting |
Phase 2 |
2021-08-17 |
To determine whether protective antibody levels increase after booster dosing with the
Moderna COVID-19 vaccine in patients diagnosed with Hematologic Malignancies who have low
antibody levels after a prior first vaccination with any of the SARS-CoV2 vaccines that were
authorized for use in the USA. Researchers will also assess whether the booster dosing with
the Moderna COVID-19 vaccine is safe in patients with multiple myeloma, amyloidosis, or other
blood cancers.
|
| NCT05029037 ↗ |
High-dose Intravenous Vitamin C (HDIVC) as Adjuvant Therapy in Critical Patients With Positive COVID-19. A Pilot Randomized Controlled Dose-comparison Trial. |
Not yet recruiting |
Phase 3 |
2021-09-15 |
The objective of this study is to evaluate the impact of this HDIVC therapy in the first
treatment of symptomatic Covid-19 patients in a time period of one week.
|
| NCT05035524 ↗ |
A Randomized Controlled Trial to Investigate The Role of Adjuvant Inhalable Sodium Bicarbonate Solution 8.4% in Treatment of COVID-19 |
Active, not recruiting |
N/A |
2021-09-01 |
The aim of the study is to investigate the role of SB 8.4% as adjuvant therapy in the
treatment of COVID- 19 patients proved to be RT-PCR positive (mild, moderate and severe).
|
| NCT05037162 ↗ |
Study Designed to Evaluate the Effect of CimetrA in Patients Diagnosed With COVID-19 |
Not yet recruiting |
Phase 2 |
2021-09-01 |
Multi-center multinational-controlled study in Israel, Brazil, Spain, and South-Africa.
240 adult patients who suffer from moderate COVID-19 infection. Safety will be assessed
through collection and analysis of adverse events, blood and urine laboratory assessments and
vital signs.
After Screening visit, the study drug will be administrated twice a day morning and evening
(every 12 hours) during (day 1 and day 2) The patients will be randomized in 1:1:1 ratio to
study drug (CimetrA) in two dosages in addition to Standard of Care - Arm 1, 2 or (Placebo)
in addition to Standard of Care- Arm 3.
|
| NCT05037253 ↗ |
COVID-19 Morbidity in Healthcare Workers and Vitamin D Supplementation |
Completed |
Phase 4 |
2020-10-30 |
[Aim] Purpose of the study: to analyze the effect of vitamin D supplementation in reducing
COVID-19 morbidity and severity in healthcare workers.
The study will involve a minimum of 120 medical staff. All participants in the study will
assess twice for serum 25(OH)D level: baseline and after 3 months of Vitamin D
supplementation. After the baseline examination, the subjects will be randomized into 2
groups. In the first (No. 1), vitamin D therapy will initiate at a dosage of 50,000 IU on the
first and second week, followed by a switch to a daily intake of 5,000 IU for 3 months. In
the second group (No. 2), vitamin D therapy will prescribe for 3 months at a dosage of 2,000
IU/day. After 3 months of vitamin D supplementation, all participants will undergo to repeat
testing of serum 25(OH)D level with an assessment of the effectiveness of the therapy. Body
mass index (BMI), height, weight, SARS-CoV-2 antibodies (IgG), 25-hydroxycalciferol (25(OH)D)
and presence of acute viral infection futures, parameters assessed after treatment.
|
| NCT05038488 ↗ |
Phase 2a MIB-626 vs. Placebo COVID-19 |
Not yet recruiting |
Phase 2 |
2021-09-15 |
The proposed phase 2a trial will determine whether MIB-626 treatment in adults with COVID-19
infection and stage 1 acute kidney injury is more efficacious than placebo in preventing
worsening of kidney function, as assessed by longitudinal changes in serum creatinine
concentration, and in attenuating the inflammatory response to the infection.
|
| NCT05040724 ↗ |
Evaluation of the Impact of the Administration of Single Dose of Ivermectin in the Early Phase of COVID-19 |
Active, not recruiting |
Phase 3 |
2021-05-28 |
The action of ivermectin in vitro on the viral replication of SARS-CoV-2 was demonstrated and
published by an Australian team in June 2020. On the other hand, the doses to be administered
in vivo to reach the concentrations described in vitro would lead to toxicities especially
neurological, in treated patients, . However, some trials and studies, such as the ICON3
study, demonstrate the clinical efficacy of ivermectin administered at lower doses (200 µg /
kg) in hospitalized patients with COVID-19.
The use of ivermectin in the early stages of the disease has not yet been studied. The
administration of the maximum authorized dose (MA) of ivermectin could at least slow down the
replication of the virus in vivo before the inflammatory phase of COVID-19, and reduce the
duration of symptoms as well as the risk of hospitalization of patients, especially in
critical care.
Unlike other studies conducted so far on COVID-19, IVERCoV will target the "viral" phase of
the disease by screening patients in the city. In addition, home visits (symptom recording
+/- PCR) will make it easier to monitor patients during the study.
|
| NCT05040776 ↗ |
COVID-19 ThromboprophylaXIs Study of Novel FXIa Inhibitor EP-7041 in ICU Patients |
Not yet recruiting |
Phase 2 |
2021-12-01 |
This is a multicenter, open-label, single cohort study of patients with confirmed COVID-19
syndrome who based on clinical judgment require care in an intensive care unit, regardless of
whether or not mechanical ventilation is in use or is anticipated. Patients should be
enrolled on the first day of the ICU stay; withdrawal of prior thromboprophylaxis, if any,
will follow specific protocol guidance. Enrolled patients will thereafter be administered
intravenous EP-7041 until disposition from the hospital (including post-ICU non-critical care
management)
|
| NCT05042141 ↗ |
Safety and Efficacy of KOVIR in the Combination Regimen With Background Treatment in COVID-19 Patients (KOVIR) |
Active, not recruiting |
Phase 2 |
2021-07-28 |
The acute pneumonia pandemic caused by a new strain of corona virus 2019 named as COVID-19 by
the World Health Organization (WHO) is a pandemic caused by SARS-CoV-2 virus. The reported
symptoms vary from fever or chills, cough, shortness of breath, to muscle aches, headaches,
loss of taste or smell.
The hard capsule KOVIR is a product based on the traditional medicine named "Nhân sâm bài độc
táng" which is used to treat the cold conditions, also known as the initial plague according
to the theory of traditional medicine.
|
| NCT05043350 ↗ |
Combined Antihistaminics Therapy in COVID 19 Patients |
Not yet recruiting |
Phase 2/Phase 3 |
2021-09-13 |
The use of antihistaminic medications could result in a significant immune modulation which
may help in the treatment of cytokine storm of COVID-19.Thus, the aim of this study is to
evaluate efficacy and safety of famotidine and loratadine combination in covid 19 treatment
protocol.
|
| NCT05043376 ↗ |
Study to Investigate the Treatment Benefits of Probiotic Streptococcus Salivarius K12 for Mild-to-moderate COVID-19 |
Recruiting |
N/A |
2021-09-10 |
This is a randomised, open-label and controlled clinical trial aimed to investigate the
adjuvant treatment benefits of probiotic Streptococcus salivarius K12 in hospitalised
mild-to-moderate patients with COVID-19 disease.
|
| NCT05047783 ↗ |
Masitinib in Patients With Symptomatic Mild to Moderate COVID-19 |
Not yet recruiting |
Phase 2 |
2021-11-01 |
The objective of the study is to evaluate the anti-viral efficacy of 3 different dosages of
masitinib in patients with symptomatic mild to moderate COVID-19.
|
| NCT05047952 ↗ |
Vortioxetine for Post-Covid-19 Syndrome |
Recruiting |
Phase 2 |
2021-09-16 |
A randomized, double-blinded, placebo-controlled trial will be conducted to evaluate
vortioxetine, an antidepressant with established pro-cognitive properties, for the treatment
of cognitive deficits which develop during or after an infection consistent with COVID-19,
continue for more than 12 weeks and are not explained by an alternative diagnosis (i.e.,
post-COVID-19 syndrome). Participants will receive vortioxetine (10-20 mg) or placebo for 8
weeks. Changes in cognitive functioning from baseline to endpoint (week 8) will be assessed
via the Digit Symbol Substitution Test (DSST).
|
| NCT05049213 ↗ |
Effect of Local Treatment(Carrageenan Nasal Spray and PVP-I Mouthwash) in Reducing Viral Load in Patients With COVID-19 |
Recruiting |
Phase 4 |
2021-09-20 |
The goal of this study is to recruit confirmed Covid-19 patients, to evaluate whether the
topical anti-septic can improve clinical outcome in early Severe acute respiratory syndrome
coronavirus 2(SARS-CoV-2) infection. During the global pandemic period, an effective and
highly available method once be identified, it will reduce the risk of disease transmission
and lower the medical burden.
|
| NCT05054114 ↗ |
Study of the Use of Nasal IFN-γ in Patients for the Prevention of Acute Respiratory Viral Infections, Icluding COVID-19 |
Completed |
N/A |
2020-12-21 |
It is known that the pretreatment with exogenous interferon blocks SARS-CoV-2 infection, but
intervention is much more effective if administered prior to infection. In this study the
primary aim is to investigate 28-day regime of nasal interferon gama use in healthy
participants for COVID-19 and other respiratory infections prevention.
|
| NCT05054322 ↗ |
FLuticasone in cOvid Treatment (FLOT) |
Recruiting |
Phase 2/Phase 3 |
2021-09-22 |
A multicenter, open-label, randomized controlled trial to evaluate the efficacy of
fluticasone propionate (metered dose inhaler - MDI) added to standard care at early stage of
COVID-19 in reducing the incidence of adverse outcomes (any of those following: oxygen
therapy, systemic corticosteroids, hospitalization, mechanical ventilation, and mortality) in
symptomatic patients either from 18 to 49 years of age with risk factors or older than 50
years.
|
| NCT05055414 ↗ |
Arformoterol/Budesonide for COVID-19 |
Not yet recruiting |
Phase 2 |
2021-11-01 |
This is a multi-center, randomized, double-blind, placebo-controlled, parallel, phase 2 study
to evaluate the efficacy and safety of UI030 in COVID-19 patients
|
| NCT05055427 ↗ |
Efficacy Evaluation of Shen Cao Gan Jiang Tang on Mild and Moderate COVID-19 Patients |
Recruiting |
Phase 2/Phase 3 |
2021-08-20 |
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the virus that causes
COVID-19 (coronavirus disease 2019). Patients with COVID-19 may experience various clinical
manifestations, from no symptoms to critical illness such as severe pneumonia and acute
respiratory distress syndrome (ADRS). So far, there is no specific medication for COVID-19;
hence, the current available treatments mostly aim at symptoms management and supportive
care. From traditional medicine perspective, COVID-19 is classified as warm-disease (Wen-yi).
The main points of treatment for COVID-19 in early stage based on traditional medicine
perspective are strengthen the Protective Qi (Wei Qi - the body immune system), and restore
the balance of Qi, which is vital biological energy to prevent the invasion of external
pathogens, including the SARS-CoV-2 virus. The Shen Cao Gan Jiang Tang have including Gan Cao
Gan Jiang Tang (GGT) with the addition of Ginseng. This formula is originated from Shang Han
Lun (Treatise on Febrile Diseases Caused by Cold) by Zhang Zhong-jing, used to enhance the
Protective Qi, treat the early stage of Febrile Diseases, This clinical trial aims to
evaluate the efficacy of the Shen Cao Gan Jiang Tang on mild and moderate COVID-19 patients
|
| NCT05057221 ↗ |
Safety, Tolerability and Efficacy of Uproleselan (GMI-1271) in Patients With COVID-19 Pneumonia |
Recruiting |
Phase 1/Phase 2 |
2021-11-01 |
The purpose of this study is to find out whether the drug uproleselan can help patients with
severe COVID-19 pneumonia. Investigators will study both the side effects of the drug and
assess if the drug will help patients recover more quickly and slow down the progression of
acute respiratory failure.
|
| NCT05060991 ↗ |
Impact of Immunosuppression Adjustment on COVID-19 Vaccination Response in Kidney Transplant Recipients |
Recruiting |
Phase 4 |
2021-09-24 |
Immunocompromised individuals, such as solid organ transplant (SOT) recipients are at high
risk of COVID-19 associated complications and mortality. Retrospective studies so far have
shown that a majority of SOT recipients did not develop appreciable anti-spike antibody
response after a first, second, or even third dose of mRNA vaccine. Treatment with
antimetabolites was associated with poor vaccine response. The goal of this study is 1)
examine whether transient immunosuppression reduction improves the immune response to a third
dose of SARS-CoV-2 mRNA vaccine in kidney transplant recipients and 2) to assess the safety
of immunosuppression reduction before and after third dose SARS-CoV-2 mRNA vaccination.
|
| NCT05067933 ↗ |
A Ph 2 Trial With an Oral Tableted COVID-19 Vaccine |
Recruiting |
Phase 2 |
2021-10-01 |
Part 1: An open label, dose and age escalation phase to evaluate the safety and
immunogenicity of VXA-CoV2-1.1-S with a repeat-dose vaccination schedule in healthy adults
aged 18 - 75 years old that are either vaccine naive or have received prior vaccination with
an mRNA (messenger ribonucleic acid) vaccine for the prevention of COVID-19.
Part 2: This phase will assess the efficacy of prophylactic VXA-CoV2-1.1-S against confirmed
COVID-19 occurring from 7 days after second dose with a repeat-dose vaccination schedule in
healthy adults compared to placebo. Safety and immunogenicity of VXA-CoV2-1.1-S will also be
evaluated in this phase.
|
| NCT05069649 ↗ |
Efficacy and Safety of Ergoferon for COVID-19 Prevention During Vaccination Against SARS-CoV-2 |
Recruiting |
Phase 3 |
2021-10-06 |
The multicenter, double-blind, placebo-controlled, parallel-group, randomized clinical trial.
The objective of this study is to evaluate the efficacy and safety of Ergoferon as a
non-specific preventive medicine for COVID-19 in individuals vaccinated against a new
coronavirus infection (SARS-CoV-2)
|
| NCT05074121 ↗ |
NAC for Attenuation of COVID-19 Symptomatology |
Not yet recruiting |
Phase 2 |
2021-11-15 |
The objective of this study is to determine whether oral NAC is effective at attenuating
COVID-19 disease symptom severity and duration of symptoms.
|
| NCT05074394 ↗ |
Randomized Study to Evaluate Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With Mild COVID-19 Infection |
Not yet recruiting |
Phase 2 |
2021-11-01 |
This is prospective double-blind study in the United States is designed to investigate the
efficacy and safety of a single dose of COVI-DROPS or matched placebo in outpatient adults
with mild symptoms associated with COVID-19 and a recent positive COVID-19 test.
|
| NCT05074888 ↗ |
Сlinical Trial of Efficacy and Safety of Prospekta in the Treatment of Post-COVID-19 Asthenia. |
Recruiting |
Phase 3 |
2021-10-15 |
The multicenter, double-blind, placebo-controlled, parallel-group, randomized clinical trial.
The objective of this study is to evaluate the efficacy and safety of Prospekta in the
treatment of asthenia in patients after the coronavirus infectious disease (COVID-19).
|
| NCT05077254 ↗ |
COVID Protection After Transplant-Immunosuppression Reduction |
Not yet recruiting |
Phase 2 |
2021-11-01 |
This study will enroll individuals who have:
- Completed, at a minimum, a full 2-dose course of either the Moderna messenger RNA (mRNA)
based coronavirus infectious disease 19 (COVID-19) vaccine or the Pfizer-BioNTech mRNA
based COVID-19 vaccine, and
- A negative or indeterminate (<0.8 U/mL) antibody response measured at least 30 days
after the last dose of vaccine.
This group of patients is at high risk for severe COVID-19 disease due to pharmacologic
immunosuppression and a high prevalence of non-transplant risk factors such as obesity and
diabetes.
|
| NCT05077917 ↗ |
Cromolyn Sodium for Treatment of COVID-19 Pneumonia |
Not yet recruiting |
Phase 3 |
2021-11-01 |
The study hypothesis is that cromolyn, when combined with standard COVID-19 treatment, will
improve patient symptoms and reduce the number of days to improved quality of life.
Investigators will study the effects of adding cromolyn to the standard treatment of
hospitalized patients with COVID-19 pneumonia and who require supplemental oxygen. Cromolyn
will be administered as a nebulized treatment four times a day for four days followed by
intranasal administration for two weeks. Investigators may also screen for biomarkers that
could indicate inflammatory responses and treatment-induced improvement.
Participants will receive either study drug or placebo which will be administered by
nebulization for 4 days followed by 14 days of intranasal administration. Participants will
be followed while in the hospital and then as outpatients up to day 21 following
randomization.
|
| NCT05077930 ↗ |
Convalescent Plasma Therapy for Hospitalized Patients With COVID-19 |
Recruiting |
Phase 2 |
2021-10-01 |
Plasma from donors who have recovered from coronavirus disease 2019 (COVID-19) contain
antibodies to SARS-CoV-2 and may be a potential therapy for hospitalized patients with
COVID-19. The efficacy of high-titer convalescent plasma for COVID-19, however, still
unclear. The present study aims to evaluate the efficacy and safety of using convalescent
plasma for treating hospitalized patients with COVID-19.
|
| NCT05077969 ↗ |
Leidos-Enabled Adaptive Protocol (LEAP-CT) for Evaluation of Post-exposure Prophylaxis for Newly-infected COVID-19 Patients (Addendum 2) |
Not yet recruiting |
Phase 2 |
2021-10-01 |
This study is designed to test the efficacy and safety of combinations of two well-understood
agents - famotidine and celecoxib. Each of these agents separately demonstrate clinical
activity in mitigating COVID-19 disease symptoms or severity, and each of which appear to
have separate and complementary mechanisms of action.
|
| NCT05080218 ↗ |
COVID-19 VaccinE Response in Rheumatology Patients |
Not yet recruiting |
Phase 4 |
2021-10-01 |
The COVID-19 VaccinE Response in Rheumatology patients (COVER) study is a multicenter
randomized controlled trial designed to evaluate the efficacy and safety of a mRNA COVID-19
vaccine supplemental dose (booster) in patients with autoimmune conditions and to evaluate
the impact of different immunomodulatory therapies on vaccine response. The investigators
propose to recruit up to 1000- patients with autoimmune conditions who have a completed
2-dose regime of mRNA COVID-19 vaccine (>28 days prior) and who are planning to receive an
additional dose of mRNA COVID-19 vaccine (i.e., booster). Participants in this study will be
men and women 18 years and older with confirmed rheumatic disease, including psoriatic
arthritis (PsA), axial spondyloarthritis (SpA) and rheumatoid arthritis (RA) who express a
decision to receive the mRNA vaccination booster within 30 days post enrollment.
A primary objective of this study is to test the hypothesis that holding certain medications
for a brief period of time around the time of COVID-19 vaccination might improve the response
to the vaccine while not unduly having safety concerns with respect to the effects of their
disease. During the study, participants using the immunomodulatory therapies described
outlined in protocol will be randomized to temporarily hold (for 2 weeks) versus continue
after they receive the COVID-19 vaccine supplemental dose. Patients who temporarily stop one
of their medications for their autoimmune inflammatory disease may be at increased risk of
flares of their autoimmune condition. If these occur, they are expected to occur within 2 - 4
weeks of treatment interruption. Detailed protocol outlines the hold schedules for the
therapies to be randomized in this study.
|
| NCT05082714 ↗ |
Tocilizumab Versus Baricitinib in Patients With Severe COVID-19 |
Recruiting |
N/A |
2021-10-18 |
The purpose of this study is to compare safety and effectiveness of tocilizumab and
baricitinib in severe COVID-19.
|
| NCT05083000 ↗ |
Reducing Hypoxia in Patients With Coronavirus Disease (COVID-19) Using Topotecan With Standard of Care |
Recruiting |
Phase 1 |
2021-08-16 |
The primary objective of the phase 1 trial is to identify a dose of topotecan that will be
safe to take forward into a Phase 2 trial, with no unexpected toxicities or drug-drug
interactions with standard therapy for COVID-19. The investigators hypothesise that a single
dose of low-dose Topotecan will blunt the expression of inflammatory genes in patients with
moderate COVID-19, without cytotoxic side effects.
|
| NCT05087381 ↗ |
Randomized-controlled Trial of the Effectiveness of COVID-19 Early Treatment in Community |
Recruiting |
Phase 4 |
2021-10-01 |
There is an urgent need to identify effective treatments for SARS-CoV-2 infection that helps
people recover quicker and reduces the need for hospital admission. The investigators develop
an open, adaptive, platform trial to evaluate treatments, Fluvoxamine, Bromhexine,
Cyproheptadine, and Niclosamide suitable for use in the community for treating
COVID-like-illness that might help people recover sooner and prevent hospitalisation.
|
| NCT05088928 ↗ |
Efficacy and Safety of Apixaban in COVID-19 Coagulopathy Patients With Respiratory Severity Under Critical Care |
Not yet recruiting |
Phase 4 |
2021-11-01 |
The purpose of the study is to describe the safety and efficacy outcomes of a cohort of ICU
patients with severe COVID-19 respiratory disease treated with therapeutic dose Apixaban for
COVID-19 at a tertiary public health care setting.
|
| NCT05096884 ↗ |
Post-Acute Sequelae of Coronavirus-19 (COVID-19) With Dyspnea on Exertion And Associated TaChycardia TrEatment Study |
Not yet recruiting |
Early Phase 1 |
2022-02-01 |
Most patients with acute COVID-19 (Coronavirus 19) recover within weeks, however a
significant number of individuals will develop the post-acute COVID 19 syndrome (PASC). As of
July 2021, the post COVID syndrome qualifies as a disability under the Americans with
Disabilities Act. The symptoms which comprise this condition are highly variable and often
extraordinarily debilitating. They may be distinct from the initial presentation or may mimic
those which defined the initial infection. The post COVID syndrome can be diagnosed when
symptoms persist longer than 3 months and may extend to beyond one year. There are risks for
permanent levels of disability. Patients who seemingly did not have active COVID-19 symptoms
in the days following infectious exposure may also develop post Covid syndromes. These
syndromes are considered to constitute a distinct clinical entity which has of yet no clearly
defined pathogenic mechanism or validated treatment algorithms.
International investigative efforts are now underway to determine who might develop the post
COVID syndrome, it's long term consequences and how best to treat its many problematic
symptoms.
|
| NCT05104424 ↗ |
The Study of Quadruple Therapy Intranasal Insulin, Zinc, Gabapentin, Ice Cube Stimulation for Post COVID-19 Smell and Taste Dysfunctions |
Not yet recruiting |
Phase 1 |
2021-12-26 |
post covid-19 smell and taste dysfunction are common globally and affect the quality of life
and also have phycological impact and anxiety, also affect on economy as the patients not
able to do cooking or buy prepared foods and not eaten, also not able to enter the cooking
room and prepare foods for themselves, also the risk of loss of smell the fire accidents
because anosmia, many forms of smell dysfunction like anosmia ,hyposmia, and dysosmia
,Phantosmia , parosmia may occurred, the same taste disorders may has many forms like
Dysgeusia, phantom taste perception, hypogeusia with dysgeusia. until now no definite
treatments for post covid-19 smell and taste disorders , this study is novel study as
quadruple therapy Intranasal Insulin, Zinc, Gabapentin, Ice Cube Stimulation may suspect
having promising results
|
| NCT05109611 ↗ |
Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Individuals at Risk of Exposure to COVID-19 Infection |
Not yet recruiting |
Phase 3 |
2021-12-20 |
A decentralized, randomized, double-blinded, placebo-controlled, phase 3 clinical efficacy
study evaluating nitric oxide nasal spray (NONS) as prevention for treatment of individuals
at risk of exposure to COVID-19 infection.
|
| NCT05118737 ↗ |
Adding Colchicine to Tocilizumab in Patients With Severe COVID-19 Pneumonia. |
Recruiting |
Early Phase 1 |
2021-10-01 |
Colchicine acts upstream in the cytokines cascade by inhibiting the NLRP3 inflammasome while
IL-6 receptor antagonists (tocilizumab) block the end result of the cytokines cascade. Hence,
adding colchicine to tocilizumab with the aim of blocking the early and end products of the
cytokines cascade, might reduce the risk of developing cytokine storm and hence the need for
invasive mechanical ventilation and eventually death. Therefore, we aim to conduct an
open-label randomized controlled trial to evaluate the efficacy and safety of adding
colchicine to tocilizumab among patients with severe COVID-19 pneumonia in an attempt to
reduce the rate of invasive mechanical ventilation and mortality. We will include patients
with severe COVID-19 pneumonia and already received tocilizumab according to local protocol.
Enrolled patient will be then randomized in 1:1 to colchicine versus no colchicine. Patients
will be followed up until discharge or for 30 days, whichever comes first. Data will be
collected from electronic medical profiles. The primary efficacy outcome will be rate of
invasive mechanical ventilation and will be determined using Cox proportional hazard model.
|
| NCT05123755 ↗ |
AV-001 for Hospitalized Patients With COVID-19 Disease |
Not yet recruiting |
Phase 2 |
2021-11-01 |
A Phase 2a, randomized, double-blind, placebo-controlled, dose-escalation study in patients
hospitalized with confirmed severe coronavirus disease 2019 (COVID-19). The purpose of this
study is to examine the safety, tolerability and efficacy of AV-001 Injection administration
daily to the earlier of day 28 or EOT (day prior to hospital discharge) to patients with
severe COVID-19 disease. A total of 120 eligible patients (20 patients in each of cohort 1, 2
and 3 and 60 patients in cohort 4) will be recruited from up to 20 participating
institutions/hospitals. Patients will be randomized in a 1:1 ratio to receive either AV-001
Injection or AV-001 placebo Injection, together with standard of care (SOC).
|
| NCT05130671 ↗ |
Nutritional Supplementation of Vitamin D, Quercetin and Curcumin With Standard of Care for Managing Mild Early Symptoms of COVID-19 |
Recruiting |
N/A |
2021-10-25 |
The purpose of this study is to investigate the therapeutic benefits of combination of
nutritional supplements of Vit D, Quercetin and Curcumin with standard of care for managing
mild early symptoms of COVID-19.
|
| NCT05135546 ↗ |
Inhaled Recombinant Non-immunogenic Staphylokinase vs Placebo in Patients With COVID-19 - FORRIF Trial |
Not yet recruiting |
Phase 2/Phase 3 |
2021-12-01 |
Objective: to evaluate the tolerability, safety and efficacy of inhaled usage of the
Recombinant Non-immunogenic Staphylokinase (Fortelyzin®) vs placebo in patients with
COVID-19.
|
| NCT05137795 ↗ |
AVICOVID-3 Inhaled Use of Zyesami for Treatment of Severe COVID-19 |
Not yet recruiting |
Phase 2/Phase 3 |
2021-12-15 |
Brief Summary:
SARS-CoV-2 virus infection is known to cause Lung Injury that begins as dyspnea and exercise
intolerance, but may rapidly progress to Critical COVID-19 with Respiratory Failure and the
need for noninvasive or mechanical ventilation. Mortality rates as high as 80% have been
reported among those who require mechanical ventilation, despite best available intensive
care.
Patients with severe COVID-19 by FDA definition who have not developed respiratory failure be
treated with nebulized ZYESAMI™ (aviptadil acetate, a synthetic version of Vasoactive
Intestinal Polypeptide (VIP)) 100 μg 3x daily plus Standard of Care vs. placebo + Standard of
Care using an FDA 501(k) cleared mesh nebulizer.
The primary outcome will be progression in severity of COVID-19 (i.e. critical OR severe
progressing to critical) over 28 days. Secondary outcomes will include blood oxygenation as
measured by pulse oximetry, dyspnea, exercise tolerance, and levels of TNFα IL-6 and other
cytokines.
|
| NCT05142527 ↗ |
Study to Evaluate the Safety and Efficacy of a Monoclonal Antibody Cocktail for the Prevention of COVID-19 |
Not yet recruiting |
Phase 2/Phase 3 |
2021-12-01 |
This is a Phase 2/3, randomized, double-blind, placebo-controlled, multi-center study to
evaluate the safety, tolerability, and efficacy of ADM03820 to prevent symptomatic COVID-19
in adult subjects (≥ 18 years of age).
|
| NCT05164120 ↗ |
Safety, Tolerability, and Treatment Effect of Belnacasan in Patients With COVID-19 |
Recruiting |
Phase 2 |
2021-12-14 |
The purpose of this trial is to assess the safety, tolerability and treatment effect of the
orally administered Caspase-1 inhibitor, belnacasan, for the treatment of patients with mild
to moderate COVID-19 and to generate proof of concept for future trials.
|
| NCT05166005 ↗ |
Severity of COVID-19 and Vitamin D Supplementation |
Active, not recruiting |
Phase 4 |
2020-04-01 |
Purpose of the study: to analyze the interlinks between serum 25(OH)D level and severity of
new coronavirus infection (COVID-19) in hospitalized patients, as well as the effect of
adding colecaciferol to standard therapy for patients in the acute period of the disease.
The study will involve at least 300 hospitalized patients with confirmed COVID-19. All study
participants will be twice assessed for serum 25 (OH) D levels: baseline and 8-10 days of
hospitalization. Following a baseline examination, patients will be randomized into 2 groups.
Group I (No. 1), vitamin D therapy begins with a dosage of 50,000 IU in the first and second
weeks. Group II (No. 2), vitamin D therapy is prescribed at a dosage of 2000 IU / day. On
8-10 days of vitamin D supplementation, all participants will be retested for serum 25 (OH) D
levels to assess the effectiveness of therapy. On 14-21 days we assessed severity of the
course, ICU hospitalization, duration of hospitalization, outcome of the disease, duration of
glucocorticoid therapy, the need for specific therapy (inhibitors IL-6), changes in
cytokine/chemokine, APPs concentration.
|
| NCT05171920 ↗ |
A Placebo-Controlled Study of Auxora for the Extended Treatment of High- Risk Patients With Critical COVID-19 Pneumonia |
Not yet recruiting |
Phase 2 |
2022-01-01 |
Up to 240 patients with confirmed COVID-19 pneumonia with a baseline imputed PaO2/FiO2 ≤200
receiving oxygen therapy via a high flow nasal cannula (HFNC) or non-invasive ventilation
(NIV) will be enrolled at up to 40 sites. All patients will receive three doses of Auxora.
Patients who continue to have severe hypoxemic respiratory failure at 48 hours will be
randomized to receive three additional doses of Auxora or three doses of placebo. All
patients will be followed for 60 days after enrollment into the study.
|
| NCT05171946 ↗ |
Phase-I Study to Evaluate the Safety and Immunogenicity of a Prophylactic pDNA Vaccine Candidate Against COVID-19 in Healthy Adults |
Not yet recruiting |
Phase 1 |
2022-02-01 |
A pneumonia of unknown cause detected in Wuhan, China, was first reported in December 2019.
On 08 January 2020, the pathogen causing this outbreak was identified as a novel coronavirus
2019. The outbreak was declared a Public Health Emergency of International Concern on 30
January 2020. On 12 February 2020, the virus was officially named as severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2), and the WHO officially named the disease caused by
SARS-CoV-2 as coronavirus disease 2019 (COVID-19). On 11 March 2020, the WHO upgraded the
status of the COVID-19 outbreak from epidemic to pandemic, which is now spreading globally at
high speed.
There are currently few licensed vaccines to prevent infection with SARS-CoV-2 or COVID-19
and the duration of response is unknown. Given the rapid transmission of COVID-19 and
incidence of disease on a worldwide basis, the rapid development of effective vaccines with
sufficient protection and duration of response is of utmost importance.
IAU has developed a thermally stable plasmid DNA (pDNA)-based vaccine candidate using a
platform approach that enables the rapid development of vaccines against emerging viral
diseases, including SARS-CoV-2. The pDNA vaccine developed by IAU is a synthetic,
codon-optimized, encode either the full-length Spike (S) gene or S1 domain of SARS-CoV-2 as
genes of interest. Here, we aim to test a synthetic, codon optimized pDNA encoding S.opt.FL
as vaccine candidate against COVID-19.
A key advantage of pDNA vaccine is that multiple immunization can be used without the
limitations of anti-vector responses.
This study is intended to investigate the safety, immunogenicity, and tolerbilty of this
prophylactic vaccine against COVID-19 administered as intramuscular immunization (i.m.).
|
| NCT05172050 ↗ |
Multicenter Double Blind, Parallel-group Phase 2/3 Trial, to Study Raloxifene in Adult COVID-19 Patients. |
Completed |
Phase 2/Phase 3 |
2021-01-22 |
The objective of the study is to evaluate the efficacy and safety of two different doses of
raloxifene orally administered compared to placebo in patients with early diagnosis of
paucisymptomatic COVID-19.
Primary objectives:
- Evaluation of the effectiveness of therapy in reducing the proportion of subjects who
still have viruses in the upper airways after 7 days of therapy
- Evaluation of the effectiveness of therapy in reducing the proportion of subjects who
requires supplemental oxygen therapy and/or mechanical ventilation within 14 days of
starting therapy
Secondary objectives:
- Evaluation of the effectiveness of therapy in reducing the proportion of subjects who
still have viruses in the upper airways after 14 and 28 days of therapy
- Evaluation of the effectiveness of therapy in reducing the proportion of subject
patients who requires supplemental oxygen therapy and/or mechanical ventilation within 7
or 28 days of starting therapy
- 7, 14 and 28 days drug safety and tolerability profile
- Assessment of body temperature, blood and biochemical parameters between T0 and T28
|
| NCT05182515 ↗ |
Plasma Exchange in Covid-19 Patients With Anti-interferon Autoantibodies |
Recruiting |
Phase 3 |
2021-12-22 |
COVID-19 associated mortality remains high despite the advances in therapeutics such as
dexamethasone. The severity of COVID-19 results from direct viral cytotoxicity, and the
inflammatory response, which is associated with a hypercoagulable state, contribute to lethal
hypoxemic pneumonia. During the SARS-CoV-2 replication phase, infected cells secrete
chemokines and die by activating the immune system locally. A local inflammatory loop induces
tissue destruction, which activates the immune system's circulating cells, leading to another
amplifying loop called the cytokine storm. In these phenomena, the integrity of the
interferon pathway plays a significant role.
Specific impairment of the interferon pathway has been identified in a subset of patients and
is associated with high Covid-19 severity. This subset of patients presents preexisting
autoimmune disease mediated by autoantibodies directed against IFN. It represents 10.2%
(101/987) of patients admitted in ICU with COVID-19 pneumonia, and the observed mortality in
this subgroup is 40%.
The investigators hypothesized that plasma exchanges (PE) would eliminate these
autoantibodies while acting on other mechanisms of the pathogenesis of severe COVID-19, such
as cytokine storm or hypercoagulability(7).
The EPIC trial aims to demonstrate the efficacy of plasma exchange in the subpopulation of
patients with anti-interferon autoantibodies and severe COVID-19 hospitalized in intensive
care and on oxygen therapy, high flow or not, receiving non-ventilation or invasive
ventilation, on D28 survival.
|
| NCT05184127 ↗ |
Evaluation of Safety & Efficacy of MIR 19 ® Inhalation Solution in Patients With Moderate COVID-19 |
Completed |
Phase 2 |
2021-04-27 |
This is Phase 2 multi-center controlled randomized study to assess the efficacy and safety of
MIR 19® via 14 days of treatment of participants with symptomatic moderate COVID-19.
The purpose of this study is to evaluate the efficacy, safety and daily dose of MIR 19 ® for
the treatment of the hospitalized patients with infection caused by SARS-CoV-2 (COVID-19) who
did not require treatment in the intensive care unit.
Based on preclinical data studying antiviral effect of MIR 19® in vitro and in vivo (Khaitov
M.R. et all 2021), the investigators hypothesized that SARS-CoV-2 inhibition with MIR 19®
could potentially reduce pulmonary inflammation, thereby improving COVID-19 patient outcomes.
|
| NCT05184218 ↗ |
Evaluation of IGM-6268 in Healthy Adults and Patients With Mild to Moderate COVID-19 |
Not yet recruiting |
Phase 1 |
2022-01-20 |
This is a Phase 1, multi-center, randomized, double-blinded, placebo-controlled study to
assess the safety, tolerability, and pharmacokinetics (PK) of IGM-6268 administered
intranasally and intraorally in healthy volunteers and in outpatients with mild-moderate
COVID-19. IGM-6268 or placebo will be administered by intranasal + intraoral spray using a
Teleflex Mucosal Atomization Device Nasal™ Intranasal Mucosal Atomization Device once, or
once or twice each day for 5 days.
|
| NCT05185284 ↗ |
Randomized Multicenter Study on the Efficacy and Safety of Favipiravir for Parenteral Administration Compared to Standard of Care in Hospitalized Patients With COVID-19 |
Completed |
Phase 3 |
2021-08-11 |
This is open-labe randomized multicenter comparative Phase III study conducted in 7 medical
facilities. The objective of the study is to assess the efficacy and safety of Favipiravir
for parenteral administration compared with the Standard of care (SOC) in hospitalized
patients with moderate COVID-19 pneumonia.
|
| NCT05185804 ↗ |
Clinical Trial of Dimolegin (DD217) in Prevention of Thrombotic Complications in Patients With COVID-19 |
Completed |
Phase 3 |
2021-02-08 |
Study purpose was to study the safety and efficacy of Dimolegin - DD217 as a drug for
prevention of thrombotic complications compared to Clexane (enoxaparin sodium) - the standard
therapy currently prescribed to patients hospitalized with COVID-19.
Patients who met all inclusion criteria and no exclusion criteria were randomized into two
therapy groups:
- Group 1 - test drug Dimolegin - DD217 (60 mg orally, 1 time per day);
- Group 2 - reference drug Clexane (40 mg subcutaneously, 1 time per day).
The study drugs were taken once a day until:
- the discharge from the hospital due to recovery or positive dynamics;
- or up to 30 days of the patient's stay in the hospital;
- or until the Investigator decides to discontinue the therapy for other reasons. Planned:
screening of up to 450 patients, randomization: 430 (215 per group). The required number
of patients is 200 per group as a result of the entire study.
|
| NCT05195749 ↗ |
A Prospective, Phase II Study to Evaluate Safety of 101-PGC-005 ('005) for Moderate to Severe COVID-19 Disease Along With Standard of Care |
Recruiting |
Phase 2 |
2022-01-13 |
In December 2019, a novel pneumonia caused by a previously unknown pathogen emerged in Wuhan,
China. The pathogen was soon identified as a novel coronavirus (SARS-CoV-2), which is closely
related to severe acute respiratory syndrome CoV (SARS-CoV) COVID-19, caused by the
SARS-CoV-2 virus, leading to a major global public health threat. Many COVID-19 patients
develop acute respiratory distress syndrome (ARDS) leading to death. The recent RECOVERY
Trial demonstrated the success of dexamethasone in treating late-stage COVID-19 patients.
However, use of dexamethasone increases mortality in the early stage of the disease, and
dexamethasone is further limited because the therapeutic dose and duration is insufficient to
safely and effectively treat most COVID-19 patients. As the majority of cells have
glucocorticoid receptors to which dexamethasone binds, highly toxic doses would be needed to
effectively treat COVID-19, which results in increased mortality as well as decreased natural
immunity (via T-cell and other immune cell modulation). The investigational product
101-PGC-005 ('005) - a prodrug of dexamethasone that is targeted to only activated
macrophages - will address the many safety and efficacy issues that limit dexamethasone. '005
can achieve much higher anti-inflammatory doses and avoid all undesirable immunosuppressive
activities caused by standard dexamethasone administration, resulting in an even greater
reduction in mortality among hospitalized patients and significantly reducing long term
morbidity in patients who survive.
|
| NCT05204550 ↗ |
Intranasal Heparin Treatment to Reduce Transmission Among Household Contacts of COVID 19 Positive Adults and Children |
Not yet recruiting |
Phase 2/Phase 3 |
2022-04-01 |
Coronavirus-induced disease 2019 (COVID-19) is an infection caused by a virus whose full name
is severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This is a new and
rapidly-spreading infectious disease which carries a significant risk of death, has brought
massive economic impact globally and has proved hard to contain through public health
measures. While we currently have effective vaccines, they do not protect the whole community
and the constant threat of new mutations means there is an urgent need to identify new
approaches to reducing community spread of infection.
Heparin is a naturally occurring sugar molecule which has been used for a century to treat a
range of medical problems including heart attacks, strokes, and blood clots. It has also been
investigated as a treatment for pneumonias. Recent research suggests it binds to the
SARS-CoV-2 virus in such a way it may reduce the virus' ability to enter cells. This may be
an important way to tackle the early stages of infection which occurs inside the nose.
Therefore, this medication could be used amongst people with early COVID-19 infection and
amongst their household contacts to reduce the rate of virus transmission during local
outbreaks. If proven effective there are many other potential uses as primary prophylaxis for
people working in high risk areas, for travel, for protection in high risk crowded
environments such as nightclubs, or sporting events. Heparin is safe, inexpensive, available
worldwide and if effective could be rapidly used across the world to slow progression of the
current pandemic.
Further there are recent studies suggesting that the risk of brain complications as part of
"long COVID", are directly related to the amount of virus in the nose. Reducing the viral
load in the nose is thought to be effective in reducing these "long COVID" complications.
This study will explore the effect of the intervention on viral load and long COVID.
In this study, researchers want to investigate this medicine in people who have been
identified by a COVID-19 swab test to be in the early stages of infection(defined as the
index case), and amongst their household contacts. Each participant would take the medicine
or a dummy control solution by spray into their nose three times a day for 10 days. The study
will investigate if there are fewer people who contract SARS-CoV-2 infection by day 10
amongst households who receive the medicine than households which receive the dummy control.
|
| NCT05212532 ↗ |
A Proof-of-Concept Study Evaluating EOM613 in COVID-19 Infected Patients With Severe Symptoms |
Recruiting |
Phase 1 |
2021-08-09 |
The purpose of this study is to evaluate the safety, tolerability and preliminary efficacy of
EOM613, a peptide nucleic acid with novel immune-modulating properties, in treating patients
with severe COVID-19 infections. This proof-of-concept study is the first clinical trial of
EOM613 in this patient population.
|
| NCT05212662 ↗ |
Study of Cysteamine-pantetheine Disulfide (TTI-0102) in Mild to Moderate COVID-19 |
Not yet recruiting |
Phase 2 |
2022-06-01 |
This is multi-center, randomized, double-blind, placebo-controlled study to assess the
safety, tolerability, pharmacodynamics (PD) and efficacy of TTI-0102 for the treatment of
patients with mild to moderate COVID-19. This is a phase 2 study of cysteamine-pantetheine
disulfide (TTI-0102), an antiviral, anti-infectious, antioxidant and anti-CRS (cytokine
release syndrome) investigational drug. Subjects will be randomized 2:1 to receive TTI-0102
or placebo daily for up to 14 days. Up to 5 centers in the US and Canada will conduct this
study. 60 patients will be enrolled.
|
| NCT05216562 ↗ |
Efficacy and Safety of EXOSOME-MSC Therapy to Reduce Hyper-inflammation In Moderate COVID-19 Patients |
Recruiting |
Phase 2/Phase 3 |
2021-07-01 |
In COVID-19 infection caused by the Severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2), there is a dysregulation of the immune system response that causes cytokine
storm syndrome. SARS-CoV-2 works like a hijacker (hackers), sabotaging communication between
cells so that the immune system, like T-cells, kills not only infected cells but also healthy
cells. This dysregulation results in hyper-inflammation which cause damage to organs, not
just the lungs. This is the cause of the high mortality rate in COVID-19 patients.
Exosomes are vesicles with a size of 30-100 nanometers originating from within cells that
function to communicate with other cells. Exosomes are transport containers that contain
bioactive cargo: such as proteins, genetic material, and various other molecules. These
containers move from cells of origin, flowing through blood vessels or other body fluids to
target cells. Exosomes penetrate the cell membrane and act on various organelles within the
target cell.
All cell types can produce exosomes. What differentiates them is the cargo they contain. The
exosome produced by mesenchymal stem cells (MSCs) contains bioactive cargo derived from
mesenchymal stem cells, such as anti-inflammatory cytokines, growth factors, messengerRNA
(mRNA) and microRNA (miRNA). The target cells are immune system cells, infected cells and
progenitor cells from infected organs. On target immune cells, the anti-inflammatory
cytokines work as immunomodulators to relieve hyper-inflammation. In infected cells, the
miRNAs work to prevent viral replication by inhibiting the expression of SARS-CoV-2 virus RNA
(viral mRNA silencing and degrading). In lung progenitor cells and other infected organs, the
growth factors work to stimulate protein synthesis processes that function for organ
regeneration.
This study is a multi-center, double-blind, randomized controlled trial (RCT) clinical trial
with two arms: one intervention arm, and one control arm. The EXOSOME-MSC will be tested as
adjuvant, on top of standard COVID-19 drugs. It will be injected to participants via
intravenous route twice, in day-1 and day-7 of 14 days of study participation.
|
| NCT05220280 ↗ |
SOLIDARITY Finland Plus Long COVID-19 |
Not yet recruiting |
Phase 4 |
2022-02-06 |
The SOLIDARITY PLUS Finland Long-COVID trial aims to assess the long-term effects of imatinib
and infliximab, used during acute hospitalization due to COVID-19-infection, on long-COVID
symptoms and quality of life (QoL) using questionnaires at six months, one and two years
post-discharge. The primary research questions are whether imatinib or infliximab lower the
risk of long-COVID symptoms and leads to better QoL in the long term.
Objectives include:
i) Long-COVID symptoms
To investigate the effect of imatinib (vs. usual care only) and infliximab (vs. usual care
only) on the occurrence of symptoms that have been associated with the long-COVID syndrome.
The questionnaires will take place at six months, one and two years after the hospital
admission. The questionnaire will be the same that has been used in the SOLIDARITY Finland
Long-COVID trial on remdesivir. The questionnaire was developed by our multidisciplinary team
of physicians, including the representation of multiple specialties such as general practice,
lung diseases, neurology, internal medicine, rheumatology, genetics, and clinical
epidemiology, and two patient partners.
The symptom questionnaire - that will be completed by patients at one and two years -
measures basic patient information (age, height, weight, smoking status, major comorbidity,
and working status) and a wide variety of potential long-COVID-symptoms and their bother (1.
Fatigue; 2. Attention deficits; 3. Memory problems; 4. Sleeping difficulties; 5. Depressive
mood; 6. Anxiety; 7. Dizziness; 8. Headache; 9. Tinnitus; 10. Paresthesias; 11. Changes in
taste/smell perceptions; 12. Postexertional malaise; 13. Palpitations; 14. Chest discomfort;
15. Nausea; 16. Skin rash; 17. Joint aches; 18. Muscle pains; 19. Continuous cough; 20.
Respiratory tract mucous discharges).
ii) Quality of life
The EQ-5D-5L questionnaire will be used to compare patients' quality of life in imatinib,
infliximab, and usual care arms.
EQ-5D-5L questionnaire assesses the following domains: 1. Mobility; 2. Self-care; 3. Usual
activities; 4. Pain and discomfort; 5. Anxiety and depression; 6. The visual analog scale of
subjective perception of overall health.
Additionally (at 1 or 2 years; depending on future funding and ethical approval decisions):
- The Finnish healthcare registries (such as Statistics Finland Mortality Database, the
HILMO Care Register for Health Care, and/or Digital and Population Data Services Agency
(Finnish Digital Agency)) will be used to estimate long-term mortality and incidence of
major comorbidity in treatment arms.
- Lung function will be assessed using spirometry and diffusing capacity, as well as the
six-minute walk test (6 mwt) in treatment arms.
- Whole-genome genotyping will be performed for a genome-wide association study to
investigate genetic correlates of long-COVID-19 -symptoms in treatment arms.
|
| NCT05222425 ↗ |
Treatment of Non-Severe COVID-19 Outpatients With Xagrotin, Phase 3 |
Not yet recruiting |
Phase 3 |
2022-03-01 |
This is an interventional, multi-center, randomized study. Adults with confirmed covid-19
disease not more than 10 days before enrollment date will be recruited (n=1000). Patients in
same condition who get treated with standard of care will be randomly assigned to the control
group (n=1000), and patients in same condition who get treated with standard of care will be
randomly assigned to the placebo group (n=1000). The investigators analyze the effect of
Xagrotin, and also investigate impact of different characteristics for instance gender, age,
duration of disease, smoking habits and concomitant diseases on the outcome.
|
| NCT05226754 ↗ |
Study Design of the Diacerein in Patients With Covid-19 |
Not yet recruiting |
Phase 2 |
2022-02-07 |
This is a randomized, placebo-controlled, double-blind trial pilot study. This study will
include individuals over 18 years of age who have been hospitalized with a confirmed
diagnosis of COVID-19 to assess whether DIACEREIN treatment is safe and effective in
controlling or decreasing inflammation in the body and viral load (amount of virus in the
body in these patients).
|
| NCT05228626 ↗ |
Safety and Efficacy of COVIDEX™ Therapy in Management of Adult COVID-19 Patients in Uganda. |
Not yet recruiting |
Phase 2 |
2022-03-01 |
The SARS-CoV-2 pandemic continues to grow, with over 350,000 new infections and over 7,000
daily global deaths in May 2021 (WHO, 2021a). The current supplies of protective vaccines are
too low to cover the worldwide demand hence researchers worldwide are urgently looking for
interventions to prevent new infections, prevent disease progression, and lessen disease
severity for those already infected.
While a number of claims on efficacy of herbal remedies on COVID-19 have been made, to our
knowledge none of such claims have gained on scientific basis for continued use or further
research and development of the constituents into investigational products.
In Uganda, one of such herbal remedies is COVIDEX, this study therefore seeks to investigate
the safety and efficacy of COVIDEX in the management of COVID-19.
|
| NCT05228899 ↗ |
Zofin to Treat COVID-19 Long Haulers |
Not yet recruiting |
Phase 1/Phase 2 |
2022-02-07 |
The purpose of this study is to assess the safety and potential efficacy of Zofin
administered intravenously in subjects experiencing prolonged symptoms (> 6 weeks and < 12
months) of COVID-19.
|
| NCT05231603 ↗ |
Ivermectin for Post Exposure Prophylaxis of Covid-19 |
Recruiting |
Phase 3 |
2022-02-07 |
Post exposure prophylaxis of healthy contacts is among the measures used for outbreak control
of several infectious diseases (e.g., pandemic influenza). No agent is known to be effective
in preventing COVID-19, but Ivermectin is one of the drugs that have shown antiviral activity
against SARS-CoV-2 in the laboratory. This study aims to evaluate the effect of post exposure
prophylaxis with Ivermectin after exposure to COVID-19 among the asymptomatic close contacts.
|
| NCT05234320 ↗ |
Study in Healthy Subjects and Symptomatic Covid-19 Positive Patients to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of the Novel Self-administered Intranasal CG- SpikeDown Antiviral Drug |
Not yet recruiting |
Phase 1/Phase 2 |
2022-02-01 |
This is a phase 1/2, randomized, placebo-controlled, double-blinded study, to assess safety
of Caregen Intranasal CG-SpikeDown in healthy subjects and and safety and efficacy (via viral
load profile) in non-hospitalized symptomatic COVID-19 patients within 3 days of symptoms
onset.
All randomized COVID-19 patients will receive active drug or placebo in addition to standard
of care treatment. Patients randomized to the DP active treatment will receive CG-SpikeDown
intranasally once daily for seven days at either low (25 mg) or planned (50 mg) dose. The
treatment period in this study, during both study stages, is 7 days.
The study will be divided into 2 stages:
Stage I will be conducted on 10 healthy subjects. This stage's purpose is to In Stage II will
include 60 symptomatic non-hospitalized COVID-19 patients and will be conducted at patients'
homes during their self-isolation.
|
| NCT05241067 ↗ |
Multicentric, Randomized Study to Assess Safety and Efficacy of Centhaquine in COVID-19 Patients With ARDS |
Not yet recruiting |
Phase 2 |
2022-05-31 |
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel coronavirus causing
coronavirus disease 2019 (COVID-19), which has been a global pandemic since March 2020.
According to WHO, more than 289 million cases have been confirmed worldwide, with just over
5.4 million reported deaths as of January 2022. SARS-CoV-2 variants continue to emerge, with
the omicron variant causing the increased surge in cases. Currently, Johns Hopkins University
of Medicine reports a case fatality rate of 1.5% for the United States. COVID-19 infections
may be asymptomatic in some cases, while most cases cause mild to moderate illness with
respiratory and flu-like symptoms. However, a significant number of COVID-19 cases develop
severe life-threatening illness involving severe pneumonia and acute respiratory distress
syndrome (ARDS), requiring admission to the intensive care unit (ICU)
Although there have been breakthroughs in the treatment for COVID-19, most of these are
directed at mild-to-moderate disease rather than patients with severe disease on mechanical
ventilators. There is still a need for novel and effective treatment options in severe
COVID-19 illness with continued vaccine hesitancy, decreased social distancing, and new
emerging variants.
Centhaquine is a first-in-class resuscitative agent for the hypovolemic shock that is
approved for marketing in India. Centhaquine has been found to be an effective resuscitative
agent in rat, rabbit, and swine models of hemorrhagic shock. Its safety and tolerability have
been demonstrated in a human phase I study in 25 subjects (CTRI/2014/06/004647). Clinical
phase II (CTRI/2017/03/008184) and phase III (CTRI/2019/01/017196) results indicate that
centhaquine is a novel first-in-class, highly effective resuscitative agent for hypovolemic
shock. Centhaquine provided hemodynamic stability and significantly improved acute
respiratory distress syndrome (ARDS) and multiple organ dysfunction score (MODS) in clinical
trials conducted in India. A total of 155 patients with hypovolemic shock have been studied
(combined phase II and III). Centhaquine is safe and reduced the mortality from 10.71% in
patients receiving standard treatment to 2.20% in patients that received centhaquine (odds
ratio 5.340; 95% CI 1.270-26.50; P=0.0271). In a phase 3 study of hypovolemic shock, ARDS and
MODS were secondary endpoints, and centhaquine reduced both with a significant p-value.
|
| NCT05249777 ↗ |
A Phase III, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of TD0069 Capsule as a Combination Regimen With Standard Treatment for Patients With Mild to Moderate COVID-19 |
Recruiting |
Phase 3 |
2022-01-06 |
The acute pneumonia pandemic caused by a new strain of corona virus 2019, namely as COVID-19
by the World Health Organization (WHO), is a pandemic caused by SARS-CoV-2 virus. The
reported symptoms vary from fever or chills, cough, shortness of breath, to muscle aches,
headaches, loss of taste or smell.
The capsule TD0069 is a product based on the traditional medicine named "Ren shen bai du san"
which is used to treat the cold conditions, also known as the initial plague according to the
theory of traditional medicine.
|
| NCT05254990 ↗ |
Reparixin as add-on Therapy to Standard of Care to Limit Disease Progression in Adult Patients With COVID-19. |
Not yet recruiting |
Phase 3 |
2022-03-01 |
Primary objective:
- To evaluate the efficacy of oral reparixin versus standard care alone in limiting disease
progression in adult patients hospitalised for COVID-19.
Secondary objectives:
- To determine the effect of reparixin on several disease severity/progression measures
including recovery, ventilatory free days and mortality.
Safety objectives:
- To evaluate the safety of oral reparixin versus placebo in the specific clinical setting.
|
| NCT05255848 ↗ |
Nebulised Heparin in Patients With COVID-19 Pneumonia |
Not yet recruiting |
Phase 2/Phase 3 |
2022-02-20 |
While the pandemic continues to incite panic and the guideline recommendations regarding
management of COVID continue to change, we have growing evidence that ARDS secondary to
Covid-19 is associated with disseminated intravascular and alveolar fibrin deposition1.
Strategies devised to reduce mucous and fibrin plugs will greatly help in preventing patients
from progressing to invasive ventilation2 which if happens will obviously overburden the
compromised intensive care facilities. Offering heparin in nebulized form has greatly reduced
levels of coagulation activation in the lungs both in animal studies and in patients with
acute lung injury3. As Heparin prevents further fibrin deposition but is ineffective in the
removal of pre-existing fibrin plug, so early use of heparin during the course of the disease
may help in limiting the complications of ARDS and hence reducing the burden faced by our
intensive care units.
A prospective randomized controlled trial will be carried out in patients admitted to COVID
complex to see its effects on disease progression and its role in preventing patients from
progressing to require Invasive Mechanical Ventilation while being administered through local
route rather than systemic. Moreover, it will also give insight and way forward regarding the
improvement in the survival and earlier discharge
|
| NCT05258682 ↗ |
Safety of Nebulized Combination Therapy BromAc® in COVID-19 Respiratory Disease |
Not yet recruiting |
Phase 1/Phase 2 |
2022-05-01 |
COVID-19 has multiple facets including cytokine storm, thromboembolism and gelatinous
secretions. It is known that oxygen exchange is the main problem in patients with COVID-19
and hypoxia is one of the most serious, in which patients succumb to acute respiratory
distress syndrome (ARDS). In other severe respiratory disease such as ventilator associated
pneumonia (VAP), formation of biofilm in the endotracheal tube causes infection to spread to
the lungs, resulting in respiratory decline and high mortality. The development of gelatinous
sputum plugs correlates with negative outcome. Both groups of patients still have limited
therapy options. BromAc is a potent mucolytic, biofilm degrader, cleaves the glycoproteins of
the SARS-CoV-2 virus (antiviral), and down regulates cytokines and chemokine in COVID-19
sputum. The investigators seek to examine the safety and attempt to gain preliminary efficacy
of nebulised BromAc in moderate to severe COVID-19 and other mucus producing, severe,
respiratory diseases.
|
| NCT05268419 ↗ |
Inhalational Ethanol Therapy (Spray and Nebulized ETHO) in COVID-19 Treatment |
Completed |
Phase 3 |
2021-09-02 |
Cytokine storm is the cause of many deaths in COVID -19. The antiviral in-vitro effects of
ethanol with solving the fat layer and destroying the glycoprotein of coronavirus have
already been established. Proven antiviral effects of ethyl alcohol on extracellular surfaces
have been demonstrated by researchers. Immunological studies have shown that acute
administration of ethanol can have immunomodulatory effects on innate immunity system
mediated by TNFamRNA protein and mitogen-activated protein kinas and reduce cytokine storm by
reducing inflammatory factors such as -TLR, TLR, TL-9, interleukin-6 and TL9. It also helps
with the chemotaxis of bronchoalveolar macrophages. Other demonstrated effects of ethanol are
including: inhibition of virus replication by inhibition of RNA-dependent polymerase, the
bronchial dilation by relaxing their involuntary smooth muscles, sedating and relaxation of
the participant, muscular analgesic effects.
Ethanol administration has previously been reported for the treatment of methanol poisoning,
fat embolism, prevention of preterm labor, pre-eclampsia, and pulmonary edema. The
histological safety of inhalation ethanol therapy in the lungs and respiratory tracts of
rabbits has been shown by Anna Castro-Balado et al. Ethanol is approved by the Food and Drug
Administration. Given these effects of ethanol on virus wall destruction, inhibition of
proliferation, and inhibition of immune hyperactivity, the question now is, "Can ethanol
inhalation therapy be effective in controlling COVID-19?" There is no a prior knowledge of
the inhalation ethanol therapy in COVID-19. This idea was first suggested and published one
month after COVID-19 pandemic in Iran (February 2020). To find the answer, a clinical trial
was conducted to evaluate the effectiveness of ethanol therapy on clinical state and
prognosis of participants. The study was approved by the Medical University of Isfahan,
research and ethics committees and is registered at https://irct.ir/trial/58201.
|
| NCT05269017 ↗ |
Vitamin D Nasal Drops in Post COVID Parosmia |
Not yet recruiting |
Phase 2 |
2022-04-01 |
The current study will be a pilot study for a randomized controlled trial conducted on
patients recruited from the outpatient clinic of the Otorhinolaryngology Department, Menoufia
Faculty of Medicine To evaluate the effect of vitamin D nasal drops in the treatment of post
COVID 19 parosmia
|
| NCT05269030 ↗ |
Ivermectin Nasal Drops in Post COVID Parosmia |
Not yet recruiting |
Phase 2 |
2022-04-01 |
The current study will be a pilot study for a randomized controlled trial conducted on
patients recruited from the outpatient clinic of the Otorhinolaryngology Department, Menoufia
Faculty of Medicine To evaluate the effect of ivermectin nasal drops in the treatment of post
COVID 19 parosmia
|
| NCT05276375 ↗ |
Effect of Bronchipret on Antiviral Immune Response in Patients With Mild COVID-19 |
Recruiting |
Phase 2 |
2022-01-14 |
There is currently an urgent need for effective and safe treatments of Coronavirus Disease
(COVID) - 19 and the cytokine storm that is responsible for the development of patient's
Acute Respiratory Distress Syndrome (ARDS).
As Bronchipret has been proven to be a very safe medicine, it is not expected that it would
lead to the development of severe adverse effects in COVID-19 patients. Bronchipret can
therefore be recommended as effective and safe supplementary treatments of COVID-19, even
more so considering the positive effects shown in vitro. Thus, this randomized study is
conducted to assess the effect of Bronchipret on the immune response and recovery in patients
with mild COVID-19 by assessing several blood parameters as well as the symptom recovery and
improvement in comparison to patients who do not receive Bronchipret. Another aim of this
feasibility study is to determine the best possible primary endpoint, i.e. which shows the
greatest effect according to Cohen.
|
| NCT05277285 ↗ |
STS Administration on Coronavirus Disease (COVID-19) Patients in Critical Care |
Recruiting |
Phase 2 |
2022-03-16 |
The primary purpose is to describe the safety of administration of three doses of STS to
critically ill patients with confirmed COVID-19. A secondary purpose is to describe data on
the clinical efficacy of administration of up to three doses of STS in critically ill
patients with confirmed COVID-19.
|
| NCT05283954 ↗ |
Use of a Combined Regimen of Fluoxetine, Prednisolone and Ivermectin in the Treatment of Mild COVID-19 to Prevent Disease Progression Progression in Papua New Guinea |
Not yet recruiting |
Phase 2/Phase 3 |
2022-05-01 |
The Fluo-Pred-Iver clinical trial will test the efficacy of a combined regimen of Fluoxetine,
Prednisolone and Ivermectin (Fluo-Pred-Iver), as treatment for ambulatory patients with mild
COVID-19. The overarching idea of the work proposed herein is to investigate the use of
Fluo-Pred-Iver to treat COVID-19, conducting a randomized controlled clinical trial to
evaluate a new indication for these widely available drugs. It is estimated to include 954
participants.
|
| NCT05289037 ↗ |
COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial) |
Recruiting |
Phase 1/Phase 2 |
2022-03-30 |
This phase 2 clinical trial will evaluate the safety and immunogenicity of additional doses
of prototype and variant (alone or in combination) vaccine candidates in previously
vaccinated participants with or without prior severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) infection and will evaluate innate, cellular, and humoral immune responses to
inform on how to shift the immune response to cover new variants as they emerge. A randomized
open-label, non-placebo controlled, multi-site, multi-stage clinical trial in individuals, 18
years of age and older, who are in a stable state of health, has received a complete
authorized/approved vaccine series (primary series + booster either with homologous or
heterologous vaccine products) >/ = 16 weeks prior to enrollment. Subjects will be stratified
by i) age (18-64 years and >/= 65 years of age) and ii) history of confirmed prior SARS-CoV-2
infection, and randomly assigned to receive one of several variant vaccines. Enrollment will
target a goal of approximately 45% of each of the variant vaccine arms to be in older adults
(>/= 65 years of age) and approximately 20% to have had confirmed COVID-19.The primary
objective is to evaluate humoral immune responses of candidate SARS-CoV-2 variant vaccines,
alone or in combination.
|
| NCT05305508 ↗ |
Assessment of the Efficacy of Calcium Dobesilate vs. Placebo on SARS-CoV-2 Viral Load Amongst Outpatients With COVID-19. |
Not yet recruiting |
Phase 2 |
2022-05-01 |
The purpose of this study is to evaluate the efficacy and safety of CaD in reducing
SARS-CoV-2 viral load in non-hospitalized adult patients diagnosed with COVID-19, documented
with a positive SARS-CoV-2 PCR and with the occurrence of COVID-19 symptoms.
|
| NCT05311813 ↗ |
Safety and Efficacy of Enoxaparin and Hydroxychloroquine in COVID-19 |
Completed |
N/A |
2021-06-01 |
In this randomized controlled study, two hundred patients with positive PCR and laboratory
confirmed COVID-19 will be classified randomly into four groups. The first group is the
control group and will be given the conventional treatment of covid-19 only. The second group
will be given enoxaparin plus the conventional treatment of Covid-19. The third group will be
given hydroxychloroquine (HCQ 400 mg/day) for five days plus the conventional treatment of
covid-19. The last group will be given combined therapy of HCQ 400 mg/day and enoxaparin plus
the conventional therapy of covid-19
The efficacy will be assessed by the time of undetectable viral RNA, duration of treatment
and length of hospital stay. The safety will be assessed by measuring the severity of side
effects by following up the patients after treatment.
|
| NCT05315362 ↗ |
Establishing Immunogenicity and Safety of Needle-free Intradermal Delivery of mRNA COVID-19 Vaccine |
Recruiting |
Phase 2 |
2022-05-01 |
COVID-19 vaccines are limited in supply, especially in low- and middle-income countries,
leading to substantial morbidity and mortality. Despite the COVID-19 Vaccines Global Access
(COVAX) Facility initiated by the WHO to provide vaccine access for low-income countries,
probably 80% of the vaccine needs of participating countries will not be met soon.
In addition, there is an increasing demand for revaccination of the population globally,
because of waning immunity which will further limit vaccine supplies. Exploring dose-sparing
techniques, could therefore provide the solution to immunise more people with the same
vaccine stockpile.
The intramuscular injection (IM) is the standard inoculation route of vaccines. However, the
skin (dermis) is much richer in antigen presenting dendritic cells than muscle. As a
consequence, a fractional vaccine dose introduced directly into the dermis (intradermal
administration, ID) might be as effective as the intramuscular administration of the full
standard dose to achieve a protective immune response. This principle has recently been
demonstrated for the ID dermal delivery of one-fifth fractional dose mRNA-1273 (Spikevax,
Moderna) vaccine.
However, needle-based immunisation has several limitations. Fear of needles makes
immunisation a stressful event. In addition, needle stick injuries, as well as unsafe
injection practices carry serious health risks. Therefore, the development of needle-free
delivery has been identified as an important goal in global health care. The WHO reported
that microneedle vaccine delivery is top priority and requires additional research to explore
the benefits in more detail. A big advantage of intradermal delivery via a solid needle patch
is not only the absence of needles and pain since no nerves are at the proximity where the
needles are presented, but also the local delivery close to immune cells as with the above
mentioned intradermal injection enables a much lower dose as compared to IM dosing. And since
with the patch a larger skin surface is involved as compared to intradermal injection, even
lower doses are possibly still immunogenic.
In this study, we will investigate the immunogenicity and safety in healthy volunteers of the
needle-free intradermal delivery of a single fractional dose of 20µg mRNA-1273 LNP vaccine
(Spikevax, Moderna) more than 3 months after primary vaccination with Comirnaty (Pfizer)
vaccine and/or after having contracted COVID-19.
|
| NCT05351437 ↗ |
To Assess the Safety and Tolerability of MTx-COVAB36 as a Therapeutic and Prophylactic Treatment Against COVID-19. |
Not yet recruiting |
Phase 1 |
2022-05-05 |
This is a single blind, placebo-controlled clinical trial designed to determine the safety
and tolerability of MTx-COVAB36 after a single administration in a dose escalation, dose
limiting toxicity (DLT)-driven approach in healthy volunteers. Additional data to define the
recommended phase II dose (RP2D) will also be determined.
MTx-COVAB36 is a fully human monoclonal IgG1 antibody derived from the memory B cells of
convalescent COVID-19 donors and directed against SARS-CoV-2 spike protein with potent virus
neutralising activity.
The trial will comprise four dose cohorts, each composed of 6 participants receiving
MTx-COVAB36 and 2 participants receiving placebo, with pre-defined dose levels. The
pre-defined investigational medicinal product (IMP) doses are: 100 mg, 500 mg, 1,000 mg and
2,000 mg, respectively. Participants will be administered a single dose of either IMP or
placebo on Day 1 of the study and will be followed up until 63 days post administration.
|
| NCT05354128 ↗ |
Thrombolysis in STEMI Patients Compared With pPCI on Recanalization Time in the Context of the COVID-19 Outbreak. |
Not yet recruiting |
N/A |
2022-05-01 |
During the outbreak of COVID-19, for patients with acute ST-segment elevation myocardial
infarction with unclear infection, the time of primary PCI is uncertain, and it is often
expected to exceed 90 minutes or even 120 minutes. In indicated patients, intravenous
thrombolysis has significantly improved the recanalization time of criminal vessels.
|
| NCT05366192 ↗ |
The Safety of Paxlovid in Hemodialysis Patients With Covid-19 |
Not yet recruiting |
Phase 4 |
2022-04-30 |
Infection with SARS-CoV-2 continue to threaten global health. Persons with chronic kidney
disease, including dialysis treatment are at hight risk for severe Covid-19 and associated
adverse outcomes. Paxlovid (Nirmatrelwei/Ritonavir) decreases risk of progression to severe
Covid-19. It is not recommended for dialysis patients because due to lack of data. The aim of
the present study is evaluate the safety of Paxlovid in hemodialysis patients with SARS-CoV-2
infection.
This is a prospective study. In stage 1 arm, 10 hemodialysis patients with SARS-COV-2
infection will be treated with nirmatrelwei 150mg qd (another 75mg will be supplied after
hemodialysis treatment) and ritonavir 100mg bid everyday for 5 days. In stage 2 arm, 10
patients will be treated with nirmatrelwei 300mg qd (another 150mg will be supplied after
hemodialysis treatment) and ritonavir 100 bid everyday for 5 days. The primary outcome is the
change of liver function. The secondary outcome is the change of CT value of SARS-CoV-2
nucleic acid.
|
| NCT05369676 ↗ |
To Evaluate SSD8432/ Ritonavir in Adults With COVID-19 |
Not yet recruiting |
Phase 1/Phase 2 |
2022-05-02 |
This is a randomized, double-blind, Phase 1b clinical trial to evaluate the safety,
Pharmacodynamics, and Pharmacokinetic of SSD8432 combined with ritonavir tablets in adults
with COVID-19.
|
| NCT05371275 ↗ |
Phase II Safety Single-arm Study of CDK4/6 Inhibition With Palbociclib in Hospitalized, Moderate COVID-19 Cases to Prevent Thromboinflammation |
Active, not recruiting |
Phase 2 |
2022-04-21 |
This is a one-site, interventional, prospective, single-arm, open-label, controlled phase-IIa
trial evaluating the safety and efficacy of palbociclib in hospitalized, moderate COVID- 19
cases.
|
| NCT05371925 ↗ |
Endothelial Protection in Post COVID-19 Patients With Sulodexide |
Not yet recruiting |
Phase 3 |
2022-05-25 |
This is a Prospective, multicenter, randomized (1:1, placebo use) trial with a parallel-group
design to assess if the use of sulodexide influences serum levels of biomarkers for
endothelial dysfunction on convalescent COVID-19 patients who suffered a moderate (or more
severe) clinical presentation and have chronic comorbidities of high risk for endothelial
dysfunction.
The recruitment period is estimated at 6 months. The follow-up period of all participants
will be 8 weeks.
The participant will receive according to group allocation after randomization
1. study group: sulodexide oral dose of 250LRU capsule bid for 8 weeks.
2. control group: placebo oral dose of 1 capsule bid for 8 weeks.
Participants in both groups will continue the standard of care recommended by national
healthcare guidelines for each Country, including any concomitant medication indicated by
their primary physician.
|
| NCT05372783 ↗ |
Study to Evaluate the Efficacy of IN STI-9199 in Treating Symptomatic COVID-19 in Outpatient Adults and Adolescents |
Not yet recruiting |
Phase 2 |
2022-07-01 |
This is a Phase 2 global, randomized, double-blind, placebo-controlled study designed to
investigate the safety and preliminary efficacy of intranasal STI-9199 in adults and
adolescents who are COVID-19 positive with mild to moderate symptoms.
|
| NCT05373433 ↗ |
To Evaluate SSD8432/Ritonavir in Adults With COVID-19 |
Not yet recruiting |
Phase 2/Phase 3 |
2022-05-26 |
This is a randomized, double-blind, placebo-controlled, phase II/III clinical study to
evaluate the efficacy and safety of SSD8432 in combination with ritonavir in adult subjects
with mild/common COVID-19.
|
| NCT05373446 ↗ |
Evaluation of SSD8432 and Ritonavir in Adult Subjects With COVID-19 Placebo-Controlled, Phase II Clinical Study |
Not yet recruiting |
Phase 2 |
2022-05-20 |
This is a Randomized, double-blind, Placebo-Controlled, Phase II Clinical Study to evaluate
SSD8432 in combination with Ritonavir in asymptomatic infections or mild/common safety study
of efficacy and safety in adult subjects with COVID-19.
|
| NCT05381363 ↗ |
Inhaled Interferon α2b Treatment in Mild-to-moderate COVID-19 Infected Children |
Recruiting |
Phase 1/Phase 2 |
2022-05-01 |
In the COVID-19 pandemic era, a convenient and effective treatment for pediatric patients is
unavailable. A multi-center Chinese clinical trials with the aim to using Interferon-α2b
spray inhalation to develop new treatment strategies for the treatment of pediatric patients
with mild or moderate type of COVID-19. The purpose of this study is to determine the safety
and efficacy for Interferon α2b spray inhalation as first line treatment.
|
| NCT05387239 ↗ |
Safety and Effectiveness of EV-Pure + WJ-Pure Treatment on Pulmonary Fibrosis Secondary to Covid-19 |
Recruiting |
Phase 1 |
2022-05-01 |
The COVID-induced fibrotic lung damage continues long after viral infection has subsided and
is exhibited by severe respiratory pathology and concomitant symptoms. The long-lasting
sequelae in patients who have recovered from severe COVID indicate that there is a 30% chance
of developing a persistent respiratory system pathology and a 10% chance of developing a
severe pathology. The symptoms of lung fibrosis include a severe disruption of respiration,
reduction of exercise tolerance, and concomitant development of persistent fibrotic lung
damage. This study intends to evaluate benefits of a combination of WJPure and EVPure in
Covid-19 patients exhibiting pulmonary fibrosis.
|
| NCT05387278 ↗ |
Safety and Effectiveness of Placental Derived Exosomes and Umbilical Cord Mesenchymal Stem Cells in Moderate to Severe Acute Respiratory Distress Syndrome (ARDS) Associated With the Novel Corona Virus Infection (COVID-19) |
Recruiting |
Phase 1 |
2022-05-01 |
Recent advances have been made in prevention of the viral infection via vaccines but there is
still need for effective treatment options for patients. Novel therapies need to be developed
to further improve clinical outcomes. The biggest medical challenge in the response to
COVID-19 is ARDS requiring hospitalization in an intensive care setting and ventilator
dependence. Intravenously administered umbilical cord derived exosomes and stem cells have
been reported in literature to alleviate pulmonary distress in such patients.
The purpose of this study is to explore the safety and benefits of intravenous administration
of WJPure and EVPure in the treatment of COVID-19 patients with moderate to severe ARDS. .
|
| NCT05398965 ↗ |
Eucalyptus Oil as Adjuvant Therapy for Coronavirus Disease 19 (COVID-19) |
Completed |
Phase 2 |
2020-11-18 |
Background :
Based on several clinical trials, eucalyptus oil can suppress edema formation and reduce
inflammation, where the effect of 1,8-cineole is due to the inhibition of cytokine secretion
by T lymphocytes. This but not limited to the reduction of interleukin (IL) of IL-4, IL-5,
and IL-10 in nasal lavage fluids and levels of IL- 1β, IL-6, Tumor Necrosis Factor-α (TNF-α),
and Interferon-γ (IFN-γ) in lung tissue of mice infected with influenza virus. Hence the
researchers assume that Eucalyptus may possess benefits in COVID-19 as adjuvant therapy.
Objectives :
The primary objective of this study is to evaluate the efficacy of Eucalyptus oil as adjuvant
therapy in mild-moderate COVID-19 patients.
Hypothesis :
Eucalyptus oil may reduce the inflammatory cytokines which eventually improves clinical
symptoms
|
| NCT05415254 ↗ |
Calcitriol Supplementation in COVID-19 Patients |
Not yet recruiting |
N/A |
2022-06-12 |
This is a randomized, open label study to evaluate the efficacy and safety of calcitriol
supplementation in COVID-19 patients with vitamin D deficiency.
|
| NCT05417997 ↗ |
Effect of Kunamin in SARS-CoV-2 RT-PCR Positive Covid-19 Patients |
Completed |
Phase 3 |
2021-05-29 |
The primary objective of this study is to determine the safety and efficacy profile of the
food supplement (KUNAMIN®) containing grape juice, seed, stem, and bark given to patients
treated with the established treatment regimen against novel coronavirus infectious disease
(COVID-19) via comparing Kunamin® group versus control group in a clinical trial.
In this study, both the therapeutic effect and the safety of the Kunamin® product has been
evaluated. The study has been conducted on COVID-19 infected patients. Within the scope of
the study, Covid-19 patients consisting of male and female patients are examined to evaluate
the therapeutic effect.
COVID-19 infected patients are divided into 2 groups and the treatment group received grape
food supplements for 15 days in addition to their standard treatment. The other group
received only standard therapy. The effects of supplements containing grape products on the
COVID-19 infection process of patients are investigated, as indicated in the primary,
secondary, and tertiary endpoints. For this purpose, both the observation of routine
examination findings and the effectiveness of food supplements on viral load and antibody
levels are investigated. In the follow-up that continues for 30 days, COVID-19 Rapid Antigen
test made in USA approved by FDA is used to monitor the efficacy of Kunamin® as patient
treated by Kunamin® viral load is diminished either after 5 days, 10 days or 15 days,
COVID-19 Rapid Antibody test made in USA approved by FDA has been used to monitor the
development of IgM and IgG antibodies on day 0, day 5th, day 10th, day 15th and day 30th in
addition to PCR test of Perkinelmer by Kayseri hospital. In conjunction, the sponsor used AIT
Laboratories A HealthTrackRx Company PCR test CLIA and FDA approved for not only COVID-19 but
also 27 kinds of cold and flu viruses and 90 different kinds of bacteria.
The number of patients planned for randomization was 240, however due to dropouts the
hospital was able to screen 132 patients. Out of 132 patients we were able to enroll
randomized total of 71 patients, 47 patients in the research arm and 24 in the control arm.
|
| NCT05421195 ↗ |
Clinical Treatment Research of COVID-19-related Olfactory Dysfunction |
Recruiting |
N/A |
2022-06-15 |
Studies have demonstrated improved olfaction in patients with COVID-19- related olfactory
dysfuntion after olfactory training. but the efficacy of oral corticosteroids is
Controversial. Some evidences support the possible role of corticosteroid therapy in the
treatment of olfactory dysfuntion in COVID-19 patients and the purpose of this study is to
evaluate its efficacy.
|
| NCT05429021 ↗ |
IMM-BCP-01 in Mild to Moderate COVID-19 |
Recruiting |
Phase 1 |
2022-06-03 |
The primary objective of this study is to evaluate the safety and tolerability of intravenous
(IV) IMM-BCP-01 in subjects with mild to moderate COVID-19 through Day 28.
The secondary objectives of the study are to:
- Determine pharmacokinetics (PK) and evaluate viral clearance after single ascending
doses of IV IMM-BCP-01 in subjects with mild to moderate COVID-19 through Day 28.
- Evaluate the safety and tolerability, determine PK, and evaluate viral clearance of
single ascending doses of IV IMM-BCP-01 in subjects with mild to moderate COVID-19
through Week 12.
|
| NCT05430152 ↗ |
Low-dose Naltrexone for Post-COVID Fatigue Syndrome |
Not yet recruiting |
Phase 2 |
2022-07-01 |
This study aims to determine if low-dose naltrexone (LDN) reduces fatigue, improves related
symptoms, and reduces inflammatory markers in peripheral blood in cases with Post-COVID-19
Fatigue Syndrome (PCFS) from COVID-19 (i.e. confirmed SARS-CoV-2 case) in the past 3-6
months. LDN refers to naltrexone given in doses of 1-4.5 mg. Overall, studies have found that
LDN is safe and well-tolerated. It may help to reduce pain and inflammation and improve
well-being and immune function.The trial will be conducted by the Complex Chronic Diseases
Program (CCDP) at BC Women's Hospital and the Post-COVID Recovery Clinics (PCRC) in British
Columbia and will demonstrate whether LDN could benefit a large number of people with PCFS.
|
| NCT05441631 ↗ |
Can Intensive Insulin Therapy Improve Outcomes of COVID-19 Patients |
Completed |
Phase 1 |
2020-04-01 |
Evaluation of the reciprocal relation between hyperglycemia/diabetes mellitus (HG/DM) and
COVID-19 disease and the effect of mode of insulin therapy; intensive (IIT) or conventional
(CIT) on patients' outcomes All patients admitted to the quarantine hospitals with
mild-severe COVID disease were evaluated using the COVID-GRAM Critical Illness Risk Score and
gave blood samples for estimation of random blood glucose. Diabetic patients and non-diabetic
patients with persistent HG were randomly divided according to mode of IT. Patients who were
free HG were included as control normoglycemic (NG) patients. Study outcomes included the
incidence of progress to critical illness and mortality rate (MR), and the effect of IT on
such outcomes
|
| NCT05445921 ↗ |
Stellate Ganglion Block for COVID-19-Induced Olfactory Dysfunction |
Recruiting |
Phase 1/Phase 2 |
2022-09-01 |
Chronic olfactory dysfunction from the COVID-19 pandemic is a growing public health crisis
with up to 1.2 million people in the Unites States affected. Olfactory dysfunction impacts
one's quality of life significantly by decreasing the enjoyment of foods, creating
environmental safety concerns, and affecting one's ability to perform certain jobs. Olfactory
dysfunction is also an independent predictor of anxiety, depression, and even mortality.
While the pandemic has increased the interest by the scientific community in combating the
burgeoning health crisis, few effective treatments currently exist for olfactory dysfunction.
Furthermore, patients impacted by "long COVID," or chronic symptoms after an acute COVID-19
infection, experience impairments other than olfactory and gustatory dysfunction, such as
chronic dyspnea, impaired memory and concentration, and severe fatigue. These symptoms have
been hypothesized to be a result of sympathetic positive feedback loops and dysautonomia.
Stellate ganglion blocks have been proposed to treat this hyper-sympathetic activation by
blocking the sympathetic neuronal firing and resetting the balance of the autonomic nervous
system. Studies prior to the COVID-19 pandemic have supported a beneficial effect of stellate
ganglion blocks on olfactory dysfunction, and recent news reports and a published case series
have described a dramatic benefit in both olfactory function and other long COVID symptoms in
patients receiving stellate ganglion blocks. Therefore, we propose a single cohort
prospective study to generate pilot data on the efficacy and safety of sequential stellate
ganglion blocks for the treatment of COVID-19-induced olfactory dysfunction and other long
COVID symptoms.
|
| NCT05445934 ↗ |
Evaluate the Efficacy and Safety of FB2001 in Hospitalized Patients With Moderate to Severe COVID-19 (BRIGHT Study) |
Not yet recruiting |
Phase 2/Phase 3 |
2022-07-05 |
This study is a double-blind, randomized, placebo-controlled study to evaluate the efficacy
and safety of FB2001 in hospitalized high risk patients with moderate to severe Coronavirus
Disease 2019 (COVID-19). A total of about 1188 subjects are planned to be enrolled. The
subjects will be randomized in a 1:1 ratio to FB2001 group or placebo group while both
receiving standard of care treatment.
|
| NCT05449405 ↗ |
Chlorpheniramine Nasal Spray to Accelerate COVID-19 Clinical Recovery in an Outpatient Setting: ACCROS-I |
Completed |
Phase 2/Phase 3 |
2021-12-07 |
The goal of this clinical trial is to examine the effectiveness of intranasal-administered
Chlorpheniramine Maleate in COVID-19-positive participants as part of early treatment for
COVID-19. The main questions it aims to answer are:
- To assess the efficacy of nasal spray with Chlorpheniramine (1.0%) for improving
clinical recovery in COVID-19 patients.
- To assess the efficacy, safety, and tolerability of nasal spray with Chlorpheniramine
(1%) as an adjunct to the standard of care in reducing hospitalizations and improving
clinical recovery in adult patients with mild COVID-19.
|
| NCT05453214 ↗ |
Mineralocorticoid Use in COVID-19 Patients |
Completed |
Phase 3 |
2021-12-04 |
There is a considerable variability in aldosterone levels between individuals, and this may
explain the wide variability in disease severity among those infected so we designed a pilot
study to test for the safety and efficacy of fludrocortisone addition to standard of care in
hospitalised COVID-19 patients.
|
| NCT05459532 ↗ |
A Randomised, Multi-centre, Double-blind, Phase 3 Study to Observe the Effectiveness, Safety and Tolerability of Molnupiravir Compared to Placebo Administered Orally to High-risk Adult Outpatients With Mild COVID-19 Receiving Local Standard of Care |
Not yet recruiting |
Phase 3 |
2022-07-01 |
This is a multi-centre, double-blind, phase 3 study to observe the effectiveness, safety, and
tolerability of molnupiravir 800 mg administered 12-hourly for five days in adult patients
with mild COVID-19 at the time of enrolment, who are at risk of progression to severe
disease, compared to a placebo.
|
| NCT05465798 ↗ |
Beta-glucans for Hospitalised Patients With COVID-19 |
Not yet recruiting |
Phase 2 |
2022-10-01 |
This randomised trial aims to assess the role of beta1-3 glucan supplementation in improving
clinical symptoms and other outcomes amongst hospitalised patients with COVID-19.
|
| NCT05481177 ↗ |
Ivabradine for Long-haul COVID With POTS Cohort |
Not yet recruiting |
Phase 4 |
2022-09-01 |
The purpose of the study is three-fold. The primary aim is to identify the proportion of
Long-Haul COVID (LHC) and non-LHC volunteers with relevant symptoms actually have postural
orthostatic tachycardia syndrome (POTS). The second is to determine benefit of ivabradine
treatment. Ivabradine is a drug approved to treat tachycardia in persons with heart failure.
The third is to characterize risk factors and outcomes among volunteers with and without LHC.
This will include comparison with COVID-19-positive individuals who did not develop
long-COVID symptoms.
The study will improve basic and applied knowledge of LHC and its associated cardiovascular
and autonomic consequences. Cellular and molecular characterization of LHC and non-LHC
participants will be performed with a nested clinical trial for Ivabradine responsiveness on
reduction of tachycardia. It is hoped that a greater understanding of LHC, and related
autonomic dysfunction in particular will help to identify treatment paradigms and therapeutic
targets for improving recovery and enhancing health for those affected.
|
| NCT05485584 ↗ |
rSIFN-co Among Healthy Subjects and Subjects With Mild or Asymptomatic COVID-19 |
Recruiting |
Phase 1/Phase 2 |
2022-07-01 |
This is a phase II pilot, international, multicenter, randomized, double-blind,
placebo-controlled study that aims to evaluate the safety and preliminary efficacy of
rSIFN-co nasal spray in healthy subjects in close contact with confirmed COVID-19 case(s) as
well as subjects with mild or asymptomatic COVID-19.
|
| NCT05502081 ↗ |
Clinical Study to Compare Efficacy and Safety of Casirivimab and Imdevimab Combination, Remdesivir and Favipravir in Hospitalized COVID-19 Patients |
Completed |
Phase 4 |
2021-11-01 |
Introduction:
Corona Virus induced disease - 2019 (COVID-19) pandemic stimulates research works to find a
solution to this crisis from starting 2020 year up to now. With ending of 2021 year, various
advances in pharmacotherapy against COVID-19 have emerged.
Regarding antiviral therapy, Casirivimab and imdevimab antibody combination is a type of new
immunotherapy against COVID-19. Standard antiviral therapy against COVID-19 includes
Remdesivir and Favipravir.
Aim of Study:
1. To compare the efficacy of antibodies cocktail (casirivimab and imdevimab), Remdesivir
and Favipravir in reducing 28-day mortality in hospitalized patients with moderate,
severe or critical COVID19
2. To compare safety of antibodies cocktail (casirivimab and imdevimab), Remdesivir and
Favipravir by monitoring hypersensitivity and infusion related reactions or other
significant adverse effects
Patients and Population:
265 COVID-19 Polymerase Chain Reaction (PCR) confirmed patients with indication for antiviral
therapy is included in this study and will be divided into 3 groups (1:2:2):
1. Group A: REGN3048-3051(Antibodies cocktail (casirivimab and imdevimab))
2. group B: Remdesivir
3. group C: Favipravir
Methods:
Study design is single blind non-Randomized Controlled Trial (non-RCT). The drugs of the
study are owned by Mansoura University Hospital (MUH), and prescribed by chest diseases
lectures of faculty of medicine-Mansoura University. The duration of study is about 6 months
after ethical approval.
|
| NCT05507372 ↗ |
Treatment for Post Acute COVID-19 Syndrome |
Not yet recruiting |
N/A |
2022-10-01 |
Post-acute COVID-19 tinnitus has not been treated successfully. As tinnitus may be related to
SARS-CoV-2 neurological manifestations. This study aims to investigate if the dopamine
receptor antagonists can be used effectively treat COVID-19 induced tinnitus.
|
| NCT05516550 ↗ |
Study to Assess Efficacy and Safety of Treamid for Patients With Reduced Exercise Tolerance After COVID-19 |
Not yet recruiting |
Phase 2/Phase 3 |
2022-08-01 |
The innovative drug Treamid is planned for use in the treatment of patients with persistent
lung damage and reduced exercise tolerance exertion after COVID-19 pneumonia in a
multicenter, randomized, double-blind, placebo-controlled Phase IIb/III clinical study to
assess the efficacy and safety of Treamid during a 28-day treatment.
The primary objective of the study is to prove that in the Treamid group, the proportion of
patients achieving clinically significant load tolerance is statistically significantly
higher than in the placebo group.
The secondary objective of the study is to evaluate the safety of Treamid and achievement of
clinically significant improvements in indicators for various questionnaires and spirometry
data.
|
| NCT05531149 ↗ |
Efficacy and Safety of Trimodulin (BT588) in Subjects With Moderate or Severe COVID-19 |
Not yet recruiting |
Phase 3 |
2022-09-01 |
The main objectives of the trial are to assess the efficacy and safety of trimodulin as
adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in adult
hospitalized subjects with moderate or severe COVID-19.
Other objectives are to determine pharmacokinetic (PK) and pharmacodynamic (PD) properties of
trimodulin.
|
| NCT05542095 ↗ |
Simvastatin Nasal Rinses for the Treatment of COVID-19 Mediated Dysomsia |
Not yet recruiting |
Phase 1 |
2022-09-01 |
Olfactory dysfunction (OD) or changes in smell and/or taste is one of the cardinal presenting
symptoms of COVID-19. Despite the prevalence of COVID and resultant OD, the pathophysiology
of COVID-mediated OD is not fully understood, but recent evidence indicates that local
inflammatory and oxidative injury play a major role.
This phase 1 safety trial evaluates the use of simvastatin nasal irrigations for the
management of COVID-mediated OD. We will determine the maximum tolerable dose and evaluate
the safety and tolerability of high-volume simvastatin nasal irrigations in subjects with
persistent COVID-mediated OD.
Each subject will complete bloodwork at baseline and then at the completion of their
participation in the study. During this trial, we will observe olfactory function for each
participant at baseline and completion of this study via the University of Pennsylvania Smell
Identification Test (UPSIT). Investigational product will be shipped directly to the subject
for daily irrigation each day for 4 weeks. Weekly throughout the study for a total of 4
weeks, subjects will complete the Sino-Nasal Outcome Test-22.
The current study would provide the support for Phase II and III clinical trials.
Additionally, the study has applications for other disease processes affecting the sinonasal
cavities.
|
| NCT05552625 ↗ |
The Efficacy and Safety of TADIOS as an Adjuvant Therapy in Patients Diagnosed With Mild to Moderate COVID-19 |
Completed |
Phase 2/Phase 3 |
2021-05-06 |
This study will assess the safety and efficacy and tolerability of TADIOS compared to placebo
in patients with mild to moderate COVID-19.
|
| NCT05582629 ↗ |
JT001 (VV116) for the Treatment of COVID-19 |
Not yet recruiting |
Phase 3 |
2022-10-21 |
The purpose of this study is to evaluate the efficacy and safety of JT001 (VV116) in
participants with mild to moderate COVID-19.
|
| NCT05587894 ↗ |
OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients: a Randomized Factorial Controlled Strategy Trial |
Not yet recruiting |
Phase 2/Phase 3 |
2022-10-01 |
The overall purpose of the trial is to evaluate the efficacy and safety of possible
combination antiviral therapy (mAbs (T/C)∞ + nirmatrelvir/r) versus the reference monotherapy
(nirmatrelvir/r alone) and to assess the efficacy and safety of increasing the nirmatrelvir/r
course from 5- to 10 days in immunocompromised patients diagnosed with asymptomatic or mild
to moderate COVID-19.
|
| NCT05592418 ↗ |
Study to Evaluate the Efficacy and Safety of Ampligen in Patients With Post-COVID Conditions |
Not yet recruiting |
Phase 2 |
2023-03-01 |
The purpose of this study is to assess the efficacy and safety of Ampligen® administered
twice weekly by intravenous (IV) infusions in subjects experiencing the Post-COVID Condition
of fatigue.
|
| NCT05593770 ↗ |
International Sites: Novel Experimental COVID-19 Therapies Affecting Host Response |
Not yet recruiting |
Phase 2/Phase 3 |
2022-11-01 |
The overarching goal of the Master Protocol is to find effective strategies for inpatient
management of patients with COVID-19. Therapeutic goals for patients hospitalized for
COVID-19 include hastening recovery and preventing progression to critical illness,
multiorgan failure, or death. Our objective is to determine whether modulating the host
tissue response improves clinical outcomes among patients with COVID-19.
|
| NCT05595824 ↗ |
Open Multicenter Study for Assessment of Efficacy and Safety of Molnupiravir in Adult Patients With COVID-19 |
Completed |
Phase 3 |
2021-12-01 |
This is open-labe randomized multicenter comparative Phase III study conducted in 12 medical
facilities. The objective of the study is to evaluate efficacy and safety of the drug
JCBC00101, capsules in the setting of pathogenetic and symptomatic therapy as compared to
standard therapy in outpatients with COVID-19.
|
| NCT05597800 ↗ |
Nivolumab/Ipilimumab and Chemotherapy Combination in Advanced NSCLC Patients With HIV, HBV, HCV and Long Covid Syndrome |
Not yet recruiting |
Phase 2 |
2023-02-01 |
Study type: Phase 2 - Interventional Trial Number of patients to be enrolled: 105
Participating countries: Italy Study drugs: nivolumab and ipilimumab Cohort A: HBV and HCV
patients Cohort B: HIV patients Cohort C: Long COVID syndrome The stratification factors are
HBV/HCV positive (cohort A), HIV positive (cohort B), patients with Long Covid syndrome
(Cohort C), histology (squamous vs non-squamous histology), and gender (male vs female).
|
| NCT05599919 ↗ |
Nitric Oxide Nasal Spray (NONS) To Treat and Prevent the Exacerbation of Infection in Individuals With Mild COVID-19 |
Completed |
Phase 3 |
2021-11-01 |
Primary:
The primary objective of this study is to evaluate the efficacy of Nitric Oxide Nasal Spray
combined with standard supportive care compared with standard supportive care alone in adult
subjects with COVID-19 not requiring hospitalization
Secondary:
The secondary objective is to evaluate the safety and tolerability of Nitric Oxide Nasal
Spray combined with standard supportive care compared with standard supportive care alone in
adult subjects with COVID-19 not requiring hospitalization.
|
| NCT05601167 ↗ |
Open Multicentre Study of the Safety and Efficacy Against COVID-19 of Nirmatrelvir/Ritonavir in the Adult Population |
Completed |
Phase 3 |
2021-02-17 |
This is open-labe randomized multicenter comparative Phase III study conducted in 11 medical
facilities. The objective of the study is to evaluate efficacy and safety of the drug
JTBC00201, tablets in the setting of pathogenetic and symptomatic therapy as compared to
standard therapy in outpatients with COVID-19.
|
| NCT05614349 ↗ |
Canadian Adaptive Platform Trial of Treatments for COVID in Community Settings |
Not yet recruiting |
Phase 3 |
2022-12-01 |
CanTreatCOVID is an open-label, individually randomized, multi-centre, national trial.
CanTreatCOVID aims to establish an adaptive platform trial aimed at evaluating the clinical-
and cost-effectiveness, practical challenges, and outcomes of therapeutics for SARS-CoV-2 for
non-hospitalized patients in Canada. Participants will be randomized to receive usual care
(i.e. supportive care and symptom relief) or a study therapeutic, which will be determined by
the Canadian COVID-19 Out-Patient Therapeutics Committee. The primary outcomes being
evaluated is hospitalization and/or death at 28 days, as well as time to recovery.
|
| NCT05618587 ↗ |
Effect of Lithium Therapy on Long COVID Symptoms |
Recruiting |
Phase 2 |
2022-11-18 |
This study will assess low-dose lithium's effects on several different symptoms experienced
by long COVID patients.
|
| NCT05633407 ↗ |
Efficacy and Safety Study of Efgartigimod in Adults With Post-COVID-19 POTS |
Recruiting |
Phase 2 |
2022-09-23 |
The study aims to investigate the safety, tolerability, efficacy, pharmacodynamics (PD),
pharmacokinetics (PK), and immunogenicity of efgartigimod compared to placebo in participants
with post-COVID-19 postural orthostatic tachycardia syndrome (POTS) (post-COVID-19 POTS).
|
| NCT05633420 ↗ |
Pilot Clinical Trial to Explore Efficacy and Safety of Pyramax in Mild to Moderate COVID-19 Patients |
Completed |
Phase 2 |
2022-07-24 |
This study is a multi-center, single-arm, open-label, pilot clinical trial to explore
efficacy and safety of Pyramax in mild to moderate COVID-19 patients
|
| NCT05638620 ↗ |
Dual Sympathetic Blocks for Patients Experiencing Sympathetically-Mediated Symptoms From Long COVID |
Recruiting |
Phase 1 |
2022-12-01 |
The main purpose of this study is to gather data and assess changes in patient-reported
outcomes with the stellate ganglion blocks as treatment for their sympathetically-mediated
long COVID symptoms.
|
| NCT05638672 ↗ |
COVID-19 Huashi Baidu Formula Clinical Study |
Not yet recruiting |
N/A |
2022-12-15 |
Combined with the regional and population characteristics of Asia and Africa, Huashi Baidu
Granule was used to intervene in mild and ordinary patients with COVID-19, evaluate its
efficacy and safety, and clarify its characteristics of action.
|
| NCT05648799 ↗ |
Pharmacokinetics, Safety and Efficacy Study of GP30341 (GEROPHARM, Russia) in Healthy Volunteers and Outpatients With COVID-19 |
Completed |
N/A |
2022-03-17 |
Pharmacokinetics, safety and efficacy study of GP30341, 200 mg capsules (GEROPHARM LLC,
Russia) in healthy volunteers and patients with novel coronavirus infection 2019 (COVID-19)
with a high risk of adverse outcome
|
| NCT05656495 ↗ |
Comparative Study of the Efficacy and Safety of Ambervin and Standard Therapy in Hospitalized Patients With COVID-19 |
Completed |
Phase 3 |
2022-02-28 |
This is open-labe randomized multicenter comparative Phase III study conducted in 8 medical
facilities. The objective of the study is to assess the efficacy, safety and tolerability of
Ambervin for intramuscular and inhaled administration in complex therapy COVID-19 compared
with the Standard of care (SOC) in hospitalized patients with moderate COVID-19.
|
| NCT05656521 ↗ |
101-PGC-005 for the Treatment of COVID-19 |
Recruiting |
Phase 2/Phase 3 |
2022-12-06 |
This is a prospective, randomized, comparative, multi-centric, adaptive design clinical study
to evaluate efficacy, safety, and tolerability of 101-PGC-005 ('005) when used alongside
standard of care (SOC) for the treatment of hospitalized patients with coronavirus disease
(COVID-19).
|
| NCT05658549 ↗ |
Effect of N-Acetylcysteine on Neutrophil Lymphocyte Ratio And Length of Stay In COVID-19 Patients |
Completed |
Phase 1/Phase 2 |
2021-05-01 |
This research is a study that compares the administration of N-acetylcysteine at various
doses with the outcomes of COVID-19 patients, namely the neutrophil-to-lymphocyte ratio and
length of stay.
|
| NCT05664919 ↗ |
Efficacy and Safety of Anti-COVID-19 Antibody SA58 Nasal Spray to Prevent Infection in High-risk Populations |
Recruiting |
N/A |
2022-10-30 |
This is an open, blank controlled clinical trial to evaluate the efficacy and safety of SA58
nasal spray in the prevention COVID-19 infection among health care workers at high risk of
SARS-CoV-2 infection.
|
| NCT05667714 ↗ |
Efficacy and Safety of SA58 Nasal Spray in Close Contact With COVID-19 People |
Recruiting |
N/A |
2022-11-26 |
This is a randomized, single-blind, placebo-controlled clinical trial to evaluate the
efficacy and safety of SA58 nasal spray in close contact with COVID-19 people.
|
| NCT05675072 ↗ |
Evaluate the Efficacy and Safety of FB2001 for Inhalation in Patients With Mild to Moderate COVID-19 |
Recruiting |
Phase 2/Phase 3 |
2023-01-04 |
This study is a double-blind,randomized,placebo-controlled study to evaluate the efficacy and
safety of FB2001 for Inhalation in patients with mild to moderate Coronavirus Disease
2019(COVID-19). A total of about 1336 subjects are planned to be enrolled. The subjects will
be randomized in a 1:1 ratio to FB2001 group or placebo group while both receiving standard
of care treatment.
|
| NCT05676073 ↗ |
Study of SHEN26 Capsule in Patients With Mild to Moderate COVID-19 |
Recruiting |
Phase 2 |
2022-12-08 |
This is a multicenter, randomized, double-blind, placebo-parallel-controlled phase II
clinical trial. It is designed to evaluate the efficacy, safety, tolerability, and
pharmacokinetic (PK) profile of SHEN26 capsules in Chinese patients with mild to moderate
COVID-19.
|
| NCT05684952 ↗ |
The Efficacy and Safety of a Chinese Herbal Medicine for Long COVID Associated Fatigue |
Not yet recruiting |
Phase 2 |
2023-02-01 |
This is a randomized, double-blinded, placebo-controlled clinical trial to determine the
efficacy and safety of a Chinese herbal medicine (Shenlingcao oral liquid) for treating long
COVID associated fatigue.
|
| NCT05689827 ↗ |
Safety and Efficacy of the Therapy With BREINMAX® for the Treatment of Patients With Asthenia After COVID-19 |
Completed |
Phase 4 |
2022-04-05 |
This is prospective multicentre comparative randomized double blind placebo controlled study
conducted in 6 medical facilities.The objective of the study is to assess the safety and
efficacy of the sequential therapy with BREINMAX®, solution for intravenous infusion and
intramuscular injection, and BREINMAX®, capsules for the treatment of patients with asthenia
after having the novel coronavirus infection (COVID-19)
|
| NCT05697016 ↗ |
Sivelestat for Acute Respiratory Distress Syndrome Due to COVID-19 |
Not yet recruiting |
N/A |
2023-01-31 |
A randomized, double-Blind, placebo-controlled trial aimed to investigate the safety and
efficacy of sivelestat on treating adult patients with COVID-19-related acute respiratory
distress syndrome (ARDS)
|
| NCT05697029 ↗ |
Tetrandrine Tablets Used in Hospitalized Adults With COVID-19 |
Not yet recruiting |
Phase 4 |
2023-01-31 |
The primary objective of this study is to evaluate the effectiveness of tetrandrine tablets
in preventing the progression of COVID-19 from severe to critical.
|
| NCT05697640 ↗ |
Study to Investigate Improvement in Physical Function in SF-36 With Vericiguat Compared With Placebo in Participants With Post-COVID-19 Syndrome |
Not yet recruiting |
Phase 2 |
2023-02-01 |
The goal of this clinical trial is to evaluate the therapeutic value of an approved drug
(Vericiguat) in patients with post-COVID-19 syndrome, who suffer from profound tiredness or
fatigue, regardless of bed rest.The main questions it aims to answer are: • Does Vericiguat
relieve fatigue and/or other symptoms associated with post-COVID-19 syndrome? • What are the
side effects of Vericiguat in this patient population; and how common are they?
Participants will be asked to participate for approx. 18 weeks. After screening, participants
will receive assigned intervention of either 10 weeks of treatment with Vericiguat or
matching placebo tablet, followed by 30 day follow-up period. Every participant will undergo
trial, cardiovascular safety, and monitoring assessments.
The results of this study will provide information on whether Vericiguat can alleviate
PCS-related symptoms as well as insights into the pathophysiological processes of PCS, which
in turn can help to develop therapies.
|
| NCT05715944 ↗ |
Incidence of COVID-19 Following Vaccination in Botswana Against SARS CoV 2 |
Completed |
Phase 3 |
2021-09-15 |
The AstraZeneca Study is a single-arm, open-label, interventional, Phase 3b study to
determine the incidence of laboratory-confirmed COVID-19 hospitalizations, disease severity,
and deaths and attributable adverse events (AEs) in participants in Botswana given 1 to 2
injections of AZD1222 eight to twelve weeks apart as primary series and/or 1 injection as
booster dose. Length of follow-up will be 6 to 12 months, depending upon at which dose a
participant is enrolled.
|
| NCT05716425 ↗ |
Study to Access the Efficacy and Safety of STI-1558 in Adult Subjects With Mild or Moderate (COVID-19) |
Not yet recruiting |
Phase 3 |
2023-02-01 |
This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study
to evaluate the efficacy and safety of STI-1558 in adult subjects with mild/moderate
COVID-19. One thousand and two hundred adult subjects with mild/moderate COVID-19 (including
subjects with high risk factors for progression into severe cases) are planned to be enrolled
and randomized in a ratio of 1:1 into the test group or the placebo group (600 in the test
group and 600 in the placebo group).
|
| NCT05721144 ↗ |
Inhaled NO in Surgical Patients With Recent COVID-19 Infection |
Not yet recruiting |
Phase 2 |
2023-02-10 |
The aim of this study is to evaluate the effect of perioperative inhalation of NO on reducing
the incidence of postoperative pulmonary complications in patients with recent COVID-19
infection, and to evaluate whether inhaled NO can improve the prognosis of patients.
The investigators will enroll 660 surgical patients who was infected with SARS-CoV-2 within
42days (7 weeks ) prior to planed surgery under general anesthesia. Patients will be
randomized to receive either inhaled nitric oxide (per protocol) or a placebo. Perioperative
standards of care will be the institution's own protocols (such as ventilation strategies and
use and dose of anesthetics, analgesia and fluid management, etc).
|
| NCT05722691 ↗ |
Study for Efficacy and Safety Assessment of the Drug RADAMIN®VIRO for COVID-19 Postexposure Prophylaxis |
Completed |
Phase 3 |
2022-06-09 |
This is Double-Blind, Placebo-Controlled Multicentre Clinical Phase III Study conducted in 10
medical facilities. The objective of the study is to evaluate efficacy and safety of the drug
Drug RADAMIN®VIRO, Lyophilisate for Preparation of Solution for Intramuscular and
Subcutaneous Administration for COVID-19 Postexposure Prophylaxis
|
| NCT05736861 ↗ |
ACTIV-6: COVID-19 Study of Repurposed Medications - Arm A (Ivmermectin 400) |
Completed |
Phase 3 |
2021-06-08 |
The purpose of this study is to evaluate the effectiveness of repurposed medications (study
drug(s) in reducing symptoms of non-hospitalized participants with mild to moderate COVID-19.
Participants will receive either study drug or placebo. They will self-report any new or
worsening symptoms or medical events they may experience while taking study drug or placebo.
This study is intended to be all remote with no in person visits, unless the study team feels
it is in the best interest of a participant to see them in person.
Prior and current drug arms are listed on clinicaltrials.gov and will be updated with the
activation of any new drug arms. This protocol was originally registered under NCT04885530.
Per recent guidance on reporting master protocol research programs (MPRPs), a separate record
for Arm A was created.
|
| NCT05736874 ↗ |
ACTIV-6: COVID-19 Study of Repurposed Medications - Arm C (Fluticasone) |
Completed |
Phase 3 |
2021-08-06 |
The purpose of this study is to evaluate the effectiveness of repurposed medications (study
drug(s) in reducing symptoms of non-hospitalized participants with mild to moderate COVID-19.
Participants will receive either study drug or placebo. They will self-report any new or
worsening symptoms or medical events they may experience while taking study drug or placebo.
This study is intended to be all remote with no in person visits, unless the study team feels
it is in the best interest of a participant to see them in person.
Prior and current drug arms are listed on clinicaltrials.gov and will be updated with the
activation of any new drug arms. This protocol was originally registered under NCT04885530.
Per recent guidance on reporting master protocol research programs (MPRPs), a separate record
for Arm C was created.
|
| NCT05747534 ↗ |
AT1001 for the Treatment of Long COVID |
Not yet recruiting |
Phase 2 |
2023-03-31 |
The primary objective of this study is to evaluate the safety and efficacy of Larazotide
(AT1001) versus placebo in children and young adults 7 to ≤21 years of age who present with
symptoms of Long COVID in the presence of SARS-CoV-2 antigenemia. AT1001 (n=32) or placebo
(n=16) will be administered orally four times a day (QID) for 21 days.
|
| NCT05765617 ↗ |
Effect Of Calcitriol On Neutrophil To Lymphocytes Ratio And High Sensitivity C-Reactive Protein Covid-19 Patients |
Completed |
Phase 2 |
2021-07-01 |
This research is a study that compares the administration of calcitriol with the outcomes of
COVID-19 patients
|
| NCT05774405 ↗ |
Short-term Effects of Transdermal Estradiol on Female COVID-19 Patients |
Completed |
Phase 2 |
2020-07-01 |
The goal of this randomized placebo-controlled study is to investigate the short-term effects
of transdermal estrogen therapy on postmenopausal women with COVID-19 disease.
The main question[s] it aims to answer are:
- the clinical outcomes with adding estrogen treatment to conventional therapy of Covid-19
disease
- the biochemical outcomes with adding estrogen treatment to conventional therapy of
Covid-19 disease
All participants received favipiravir for a week according to the national guidelines
published by the Health Ministry of Turkish Republic at that time.
As an intervention, transdermal estradiol patch (7.8 mg patch/week) was applied for 14 days
on the upper buttock of the patients in experimental arm. As a placebo, hydrogel patch
(adhesive hydrogel patch/week) was applied to the female patients for 14 days.
Researchers compared experimental and control groups to see if the impact of adding estrogen
on the clinical course of Covid-19 disease
|
| NCT05780463 ↗ |
MP0420 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial) |
Active, not recruiting |
Phase 3 |
2021-06-11 |
This study looks at the safety and effectiveness of MP0420 in treating COVID-19 in people who
have been hospitalized with the infection. Participants in the study will be treated with
either MP0420 plus current standard of care (SOC), or with placebo plus current SOC. This is
ACTIV-3/TICO Treatment Trial H5.
|
| NCT05780541 ↗ |
PF-07304814 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial) |
Suspended |
Phase 3 |
2021-09-15 |
This study looks at the safety and effectiveness of PF-07304814 in treating COVID-19 in
people who have been hospitalized with the infection. Participants in the study will be
treated with either PF-07304814 plus current standard of care (SOC), or with placebo plus
current SOC. This is ACTIV-3/TICO Treatment Trial H6.
|
| NCT05783180 ↗ |
LACTYFERRIN™ Forte and ZINC Defense™ and Standard of Care (SOC) vs SOC in the Treatment of Non-hospitalized Patients With COVID-19 |
Not yet recruiting |
Phase 2 |
2023-06-01 |
The goal of this clinical trial is to learn about the safety and efficacy of Sesderma
LACTYFERRIN™ Forte and Sesderma ZINC Defense™ in non-hospitalized patients with COVID-19.
The main question is:
Is there a reduction in the signs and symptoms of COVID-19 from baseline to end of treatment?
Participants will complete the following activities.
- Screening and first day of treatment
- Treatment that will be administered for up to 10 days, two treatment evaluation visits
will be completed
- After treatment completion. Two visits are scheduled, one 28 days after the last dose
and the other 60 days after the last dose.
Researchers will compare Treatment Group (Sesderma LACTYFERRIN™ Forte and Sesderma ZINC
Defense™ + Standard of care (SOC)) with the Control group (Placebo +SOC) to see if there is
Reduction in the signs and symptoms of COVID-19 at the end of treatment
|
| NCT05783206 ↗ |
Evaluation of Safety & Efficacy of MIR 19 ® Inhalation Solution in Patients With Mild COVID-19 |
Completed |
Phase 2/Phase 3 |
2022-02-10 |
In this study, we aimed to evaluate the effectiveness and safety of MIR 19 ® in preventing
development of moderate and/or severe course of the disease in mild COVID-19 outpatients.
Primary endpoint:
The proportion of patients with the development of moderate or severe COVID-19 disease (in
accordance with the criteria specified in the Interim Guidelines "Prevention, diagnosis and
treatment of new coronavirus infection (COVID-19)" by the Ministry of Health of the Russian
Federation, version 14 of 27.12.2021 or current at the time of the study) by the 28th day of
observation.
|
| NCT05785390 ↗ |
Study of the Safety, Tolerability and Efficacy of NP-101 in Treating High Risk Participants Who Are Covid-19 Positive. |
Recruiting |
Phase 2 |
2023-02-22 |
The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of
NP-101 in treating high-risk participants who have tested positive for Covid-19. The main
question[s] it aims to answer are:
- To evaluate the safety of NP-101, as well as establish the maximum tolerated dose in
high risk Covid-19 positive patients.
Participants will [describe the main tasks participants will be asked to do, treatments
they'll be given and use bullets if it is more than 2 items]. If there is a comparison group:
Researchers will compare [insert groups] to see if [insert effects].
|
| NCT05787327 ↗ |
RCT for Yinqiaosan-Maxingganshitang in the Treatment of COVID-19 |
Not yet recruiting |
Phase 2 |
2023-05-01 |
This is a randomized, double-blinded, placebo-controlled clinical trial. This study is to
evaluate the effectiveness and safety of Yinqiaosan-Maxingganshitang in the treatment of the
major symptoms of mild and moderate COVID-19 patients by telemedicine.
|
| NCT05793736 ↗ |
Prevention of Long Covid Syndrome |
Recruiting |
N/A |
2023-02-02 |
Biofeedback equipment is classified by the Food and Drug Administration (FDA) as medical
device class II and this type of equipment/treatment has shown evidence regarding stress
management in post-Covid-19 syndrome.
The main objective of the study is to verify the feasibility of an HVR biofeedback training
protocol in patients with long covid, and also to verify improvement induced by the technique
in relation to: cognitive performance; pain perception; fatigue; quality of life; depressive
and anxious symptoms
|
| NCT05808231 ↗ |
Effectiveness and Safety of Quinine Sulfate as add-on Therapy for COVID-19 in Hospitalized Adults in Indonesia ( DEAL-COVID19 ) |
Recruiting |
N/A |
2021-04-26 |
This is a multicenter, randomized, open-label, controlled trial to evaluate the effectiveness
and safety of Quinine Sulfate as an add-on therapy in hospitalized adults with COVID-19.
The study is a multi-center trial that will be conducted in up to approximately 2 sites
nationally. New sites may be added as needed after appropriate assessment. Interim monitoring
will be conducted to evaluate the arms and for safety and effectiveness. Any changes would be
accompanied by an updated sample size.
Subjects will be assessed while hospitalized. All subjects will undergo a series of
laboratory tests (CBC, SGOT, SGPT, Ureum, Creatinine, EKG, and PCR), clinical examination
(clinical assessment, vital signs, accompanying drugs, and other medical conditions) and
safety assessment (serious adverse events/ SAE)
Randomization will be performed 1:1 for each arm. Arm 1 = Standard of Care (SoC) alone, arm 2
= SoC + Quinine Sulfate
|
| NCT05808322 ↗ |
Clinical Study for the Efficacy and Safety of Ropeginterferon Alfa-2b in Adult COVID-19 Patients With Comorbidities |
Not yet recruiting |
Phase 2/Phase 3 |
2023-05-15 |
To evaluate the efficacy of subcutaneous ropeginterferon alfa 2b ( P1101 combined with
standard of care (SOC) compared with standard care alone in adult COVID-19 patients with
comorbidities.
|
| NCT05817019 ↗ |
Postoperative Sugammadex After COVID-19 |
Not yet recruiting |
Phase 4 |
2023-04-20 |
Researcher want to compare and evaluate the effect of sugammadex on postoperative recovery,
with a focus on the occurrence of postoperative urinary dysfunction, in patients who have
undergone regular abdominal surgery within a year of being infected with and treated for
COVID-19.
Post COVID-19 condition is a new and poorly understood clinical syndrome with potentially
significant and life-altering consequences. Recent studies suggest that patients who have
recovered from COVID-19 may experience autonomic dysfunction and be at risk for autonomic
dysregulation/syndrome. In most patients undergoing general anesthesia, neuromuscular
blockers are used, and their residual effects delay the recovery of autonomic function after
surgery, leading to problems such as worsening bladder and bowel function. Therefore,
reversal agents are used to aid in postoperative muscle recovery, with sugammadex and
neostigmine being commonly used in clinical practice. While sugammadex is generally expected
to result in faster postoperative recovery, limited reports exist on its effectiveness in
patients who have recovered from COVID-19. This study aims to verify whether sugammadex is
more effective than neostigmine in aiding the recovery of bowel and pulmonary function after
surgery in patients who have recovered from COVID-19.
|
| NCT05823896 ↗ |
imPROving Quality of LIFe In the Long COVID Patient |
Not yet recruiting |
Phase 2 |
2023-05-01 |
The purpose of this study is to investigate the efficacy of orally administered
nirmatrelvir/ritonavir compared with placebo/ritonavir to improve quality of life in
non-hospitalized adult participants suffering from post-acute COVID-19 syndrome.
|
| NCT05852873 ↗ |
PAxlovid loNg cOvid-19 pRevention triAl With recruitMent In the Community in Norway |
Not yet recruiting |
Phase 3 |
2023-05-01 |
The goal of this clinical trial is to compare treatment with oral Paxlovid
(nirmatrelvir/ritonavir) and placebo for acute COVID-19 as an intervention to prevent
long-COVID (post-COVID-19 condition) in adults aged 18-64 years old.
The main question it aims to answer is:
Does treatment with Paxlovid for acute COVID-19 reduce the prevalence of long-COVID compared
to placebo.
Participants with acute COVID-19, documented with positive lateral flow test or PCR, within
the last 5 days will be randomised to take either Paxlovid or placebo. All participants will
receive standard of care in addition. Participants will respond to electronic questionnaires
at 14 time points during follow-up. The primary outcome is presence of long-COVID symptoms at
3 months follow-up.
Researchers will compare participants who received Paxlovid and placebo to see if Paxlovid
treatment can prevent the occurrence of long-COVID.
|
| NCT05855330 ↗ |
Arginine Replacement Therapy in COVID-19 |
Not yet recruiting |
Phase 2 |
2023-07-01 |
The purpose of this study is to investigate if receiving doses of arginine (a protein in the
body) will improve mitochondria function in children with COVID-19.
The study will be performed in Children's Healthcare of Atlanta, Egleston campus. Patients
will be randomized to receive one of three doses of arginine three times a day for five days
or at discharge whichever comes first.
|
| NCT05855395 ↗ |
The Standard of Care Combined With Glucocorticoid in Elderly People With Mild or Moderate COVID-19 |
Not yet recruiting |
N/A |
2023-05-05 |
This study is aimed to explore the dual-dimensional early intervention strategy of standard
of care combined with host immunomodulation in elderly patients with mild and moderate
COVID-19.
|
| NCT05859919 ↗ |
Conducting Clinical Trials of the Medicine "Rutan Tablets 0.1g" No. 10 in the Complex Therapy of COVID-19 |
Completed |
Phase 2 |
2020-10-12 |
The purpose of this clinical trial is to evaluate the efficacy and safety of the registered
drug Rutan 0.1 against SARS-CoV-2 in patients with COVID-19.
The main group (30 people) - patients with COVID-19 who are on inpatient treatment who were
prescribed the drug Rutan 0.1, 1 tablet 2 times a day for 10 days.
The control group (27 people) - patients with COVID-19 who are hospitalized and received
therapy according to the National Temporary Protocol for the management of patients with
COVID-19.
|
| NCT05862883 ↗ |
Studying the Efficiency of the Natural Preparation Rutan in Children in the Treatment of COVID-19, ARVI |
Completed |
Phase 2 |
2021-06-01 |
Clinical research includes Determination of efficacy and acceptability of the local medicine
"Rutan tablets 0,025" in children and teenagers 6-18 years old with COVID-19 and/or acute
respiratory viral infections. And also the purpose of the study was to study clinical and
laboratory changes when using Rutan in patients with Covid 19 clinical methods such as
collection of anamnesis, dynamic examination of patients, catamnestic observation - a
telephone survey, as well as biochemical, immunological, virologic PCR and ELISA tests.
|
| NCT05874037 ↗ |
Fluvoxamine for Long COVID |
Recruiting |
Phase 2/Phase 3 |
2023-05-15 |
This clinical trial aims to test the effects of fluvoxamine as a treatment for Long COVID.
Fluvoxamine is an FDA approved SSRI for Obsessive Compulsive Disorder (OCD), that has already
had success in preventing hospitalization in patients with COVID-19 (STOP COVID and TOGETHER
trials). This trial is testing whether fluoxamine helps to improve symptoms and the negative
impacts of long COVID.
|
| NCT05886816 ↗ |
Mitoquinone/Mitoquinol Mesylate as Oral and Safe Postexposure Prophylaxis for Covid-19 |
Not yet recruiting |
Phase 2 |
2023-09-01 |
Adults who do not have major health, kidney, gastrointestinal disease will be randomized to
receive oral mitoquinone/mitoquinol mesylate (Mito-MES) versus placebo to prevent the
development and progression of COVID-19 after high-risk exposure to a person with confirmed
SARS-CoV-2 infection.
|
| NCT05890534 ↗ |
Pycnogenol® in Post-COVID-19 Condition |
Not yet recruiting |
Phase 3 |
2023-06-12 |
To determine the effect of Pycnogenol® versus placebo on patient-reported health status in
people with post COVID-19 condition.
|
| NCT05890573 ↗ |
Efficacy of Bailing Capsule on Pulmonary Fibrosis After COVID-19 |
Not yet recruiting |
N/A |
2023-05-31 |
Pulmonary fibrosis is a sequela of severe infection COVID-19.The prevalence of PCFP ranged
from 2% to 45%,and the pathogenesis of PCFP has not been clearly elucidated.The ingredient of
Bailing capsule is Cs-C-Q80,it has obvious protective effect on lung.
Studies have shown that Bailing capsule may improve the clinical symptoms of PCPF patients
through anti-fibrosis, oxidation and anti-inflammatory effects in multiple pathways.
The purpose of this study was to evaluate the efficacy and safety of bailing capsule in
treating PCFP after COVID-19 infection.
|
| NCT05890586 ↗ |
ACTIV-6: COVID-19 Study of Repurposed Medications - Arm B (Fluvoxamine) |
Completed |
Phase 3 |
2021-06-08 |
The purpose of this study is to evaluate the effectiveness of repurposed medications (study
drug(s) in reducing symptoms of non-hospitalized participants with mild to moderate COVID-19.
Participants will receive either study drug or placebo. They will self-report any new or
worsening symptoms or medical events they may experience while taking study drug or placebo.
This study is intended to be all remote with no in person visits, unless the study team feels
it is in the best interest of a participant to see them in person.
Prior and current drug arms are listed on clinicaltrials.gov and will be updated with the
activation of any new drug arms. Each study arm will also have its own clinicaltrials.gov
entry and will include "Pro00107921" in the Unique Protocol ID.
|
| NCT05894538 ↗ |
ACTIV-6: COVID-19 Study of Repurposed Medications - Arm D (Ivermectin 600) |
Completed |
Phase 3 |
2022-02-16 |
The purpose of this study is to evaluate the effectiveness of repurposed medications (study
drug(s) in reducing symptoms of non-hospitalized participants with mild to moderate COVID-19.
Participants will receive either study drug or placebo. They will self-report any new or
worsening symptoms or medical events they may experience while taking study drug or placebo.
This study is intended to be all remote with no in person visits, unless the study team feels
it is in the best interest of a participant to see them in person.
Prior and current drug arms are listed on clinicaltrials.gov and will be updated with the
activation of any new drug arms. Each study arm will also have its own clinicaltrials.gov
entry and will include "Pro00107921" in the Unique Protocol ID.
|
| NCT05894564 ↗ |
ACTIV-6: COVID-19 Study of Repurposed Medications - Arm E (Fluvoxamine 100) |
Completed |
Phase 3 |
2022-08-25 |
The purpose of this study is to evaluate the effectiveness of repurposed medications (study
drug(s) in reducing symptoms of non-hospitalized participants with mild to moderate COVID-19.
Participants will receive either study drug or placebo. They will self-report any new or
worsening symptoms or medical events they may experience while taking study drug or placebo.
This study is intended to be all remote with no in person visits, unless the study team feels
it is in the best interest of a participant to see them in person.
Prior and current drug arms are listed on clinicaltrials.gov and will be updated with the
activation of any new drug arms. Each study arm will also have its own clinicaltrials.gov
entry and will include "Pro00107921" in the Unique Protocol ID.
|
| NCT05894577 ↗ |
ACTIV-6: COVID-19 Study of Repurposed Medications - Arm F (Montelukast) |
Recruiting |
Phase 3 |
2023-01-27 |
The purpose of this study is to evaluate the effectiveness of repurposed medications (study
drug(s) in reducing symptoms of non-hospitalized participants with mild to moderate COVID-19.
Participants will receive either study drug or placebo. They will self-report any new or
worsening symptoms or medical events they may experience while taking study drug or placebo.
This study is intended to be all remote with no in person visits, unless the study team feels
it is in the best interest of a participant to see them in person.
Prior and current drug arms are listed on clinicaltrials.gov and will be updated with the
activation of any new drug arms. Each study arm will also have its own clinicaltrials.gov
entry and will include "Pro00107921" in the Unique Protocol ID.
|
| NCT05911022 ↗ |
Probiotic and Colchicine in COVID-19 |
Completed |
Phase 1 |
2021-07-01 |
Coronavirus disease 2019 (COVID-19) is a newly emerging human disease caused by a novel
coronavirus causing a global pandemic crisis.
Currently there is no specific treatment for COVID-19, Probiotics and or Colchicine may be
considered as an option of treatment since they have anti-viral effect anti-inflammatory and
immunomodulatory effect.
|
