| NCT04353518 |
Clinical Trial to Evaluate Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19 |
Not yet recruiting |
Phase 3 |
2020-04-30 |
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) |
Not yet recruiting |
Phase 2 |
2020-04-01 |
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 Phase 2 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.
|
| NCT04396067 |
Combination With Alvelestat and Isotretinoin May Enhances Neutralizing Antibodies in COVID -19 Infected Patients Better Than COVID-19 Inactivated Vaccines |
Not yet recruiting |
Phase 2 |
2020-06-01 |
Unfortunately, COVID-19 vaccination will be restricted to healthy people with strong immunity
and It will not be given to patients with History of contact with a SARS-CoV-2 infection
(positive in nucleic acid test). In addition to the COVID-19 viral antigens lead to stimulate
antibodies formation of IgM in acute phase and IgG type in chronic phase which is facilitate
viral entry and fusion with infected cell through uptake of the virus-IgG complex via the Fc
family of receptors and later viral fusion with antigen presenting cells like macrophages, B
cells, monocytes via FcR family, and vascular endothelium through the neonatal Fc receptor
(nFcR) instead of antibodies induced viral agglutination and this is known as antibody
dependent enhancement (ADE)(2). There are various hypotheses on how ADE happens and there is
a likelihood that more than one mechanism exists. In one such pathway, some cells of the
immune system lack the usual receptors on their surfaces that the virus uses to gain entry,
but they have Fc receptors that bind to one end of antibodies. The virus binds to the
antigen-binding site at the other end, and in this way gains entry to and infects the immune
cell. Dengue virus can use this mechanism to infect human macrophages, if there was a
preceding infection with a different strain of the virus, causing a normally mild viral
infection to become life-threatening.(3) An ongoing question in the COVID-19 pandemic is
whether—and if so, to what extent—COVID-19 receives ADE from prior infection with other
coronaviruses. 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.
Vaccine candidates for Dengue virus and feline infectious peritonitis virus (a cat
coronavirus) had to be stopped because they elicited ADE.(4) ADE in coronavirus infection can
be caused by high mutation rate of the gene that encodes spike (S) protein. A thorough
analysis of amino acid variability in SARS-CoV-2 virus proteins, that included the S-protein,
revealed that least conservative amino acids are in most exposed fragments of S-protein
including receptor binding domain (RBD).(5) High neutrophils in covid-19 infection may be the
reason of delayed antibody response and severe complications.Currently, only limited
information is available on the host innate immune status of SARS-CoV-2 infected patients. In
one report where 99 cases in Wuhan were investigated, increased total neutrophils (38%),
reduced total lymphocytes (35%),increased serum IL-6 (52%) and increased c-reactive protein
(84%) were observed.25 In a separate report also from Wuhan, it revealed that in 41 patients,
increased total neutrophils, decreased total lymphocytes in patients of ICU vs. non-ICU care
were found to be statistically different. Increased neutrophils and decreased lymphocytes
also correlate with disease severity and death.(10) B cells/plasma cells produce SARS-CoV-2
specific antibodies that may help neutralize viruses.(11)Humoral immune response, especially
production of neutralizing antibody, plays a protective role by limiting infection at later
phase and prevents reinfection in the future. In SARS-CoV, both T and B cell epitopes were
extensively mapped for the structural proteins, S, N, M and E protein.(12) Whether the
kinetic/titer of specific antibody correlates with disease severity remains to be
investigated.(14)Delayed antibodies response and secretion after covid -19 symptoms onset is
responsible for antibody dependent enhancement (ADE) A study shows the first seroconversion
day of IgA was 2 days after onset of initial symptoms, and the first seroconversion day of
IgM and IgG was 5 days after onset. The positive rate of antibodies in the 183 samples was
98.9%, 93.4% and 95.1%, for IgA, IgM and IgG, respectively. The seroconversion rate for IgA,
IgM or IgG was 100% 32 days after symptom onset. According to the cumulative seroconversion
curve, the median conversion time for IgA, IgM and IgG was 13, 14 and 14 days, respectively.
(6) Because this immune response takes a while to show up, antibody tests will be negative
for those newly infected with COVID-19, which is why they're not used for diagnosis.
"If it's the beginning of the infection, you don't pick it up, it's something that only
develops later," Dr. Melanie Ott, a virologist and immunologist at the Gladstone Institutes
So, the principal investigator expects that delayed antibodies response and delayed
immunoglobulin class switching are the main reason for antibodies inactivity and
non-specificity in the highly mutated COVID-19 infection. Finally, according to this protocol
the principal investigator will treat with two potent antibody and immunity inducing drug and
the mechanism of action will be discussed in Detailed Description
|
| 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". Lang and
colleagues investigated the role of Lf in the entry of SARS pseudovirus into Myc cells. Their
results reveal that 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.
We 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 |
MET-Covid Trial - METformin for Prevention and Outpatient Treatment of COVID-19 |
Not yet recruiting |
Phase 2/Phase 3 |
2020-09-01 |
The purpose of this trial is to:
1. Determine whether metformin can reduce the severity of COVID-19 disease;
2. Determine whether metformin can prevent symptomatic COVID-19 disease;
3. Determine whether metformin can prevent SARS-CoV-2 infection (seroconversion of
SARS-CoV2 antibody tests or PCR positivity)
|
| 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.
|
| NCT04570449 |
Pilot Randomized Controlled Trial: Fluoxetine to Reduce Hospitalization From COVID-19 Infection (FloR COVID-19) |
Not yet recruiting |
Early Phase 1 |
2020-09-01 |
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) |
Active, not recruiting |
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: a Fully-remote, Randomized Placebo Controlled Trial (Stop Covid 2) |
Not yet recruiting |
Phase 3 |
2020-12-01 |
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.
|
| NCT04695704 |
Montelukast Clinical Trial in Mild-moderate Respiratory Symptoms in Patients With Long-COVID (ESPERANZA COVID) |
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.
|
| 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 |
Recruiting |
Phase 2/Phase 3 |
2020-02-01 |
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 |
Not yet recruiting |
Phase 2/Phase 3 |
2020-02-01 |
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 in patients hospitalized with mild or common
CoVID-19 respiratory disease.
|
| NCT04280705 |
Adaptive COVID-19 Treatment Trial |
Not yet recruiting |
Phase 2 |
2020-03-12 |
This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the
safety and efficacy of novel therapeutic agents in hospitalized adult patients diagnosed with
COVID-19. The study is a multicenter trial that will be conducted in up to 50 sites globally.
The study will be a series of 2-arm comparisons between different investigational therapeutic
agents and a placebo. 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, this
treatment will then become the control arm for comparison(s) with new experimental
treatment(s). Because of the possibility that 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
participants. 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.
Randomization will be stratified by: 1) site and 2) severity of illness at enrollment, severe
disease (requiring mechanical ventilation or oxygen, a SpO2 /= 24 breaths/min)) or mild-moderate disease (SpO2 > 94% and respiratory rate < 24
breaths/min without supplemental oxygen)). Subjects will be assessed daily while
hospitalized. Discharged patients will be asked to attend study visits at Days 15, and 29.
All subjects will undergo a series of efficacy, safety, and laboratory assessments. The
primary objective of the study is to evaluate the clinical efficacy of different
investigational therapeutics relative to the control arm in patients hospitalized with
COVID-19.
|
| NCT04285190 |
The Effect of T89 on Improving Oxygen Saturation and Clinical Symptoms in Patients With COVID-19 |
Not yet recruiting |
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 |
Not yet recruiting |
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 Distress Syndrome in COVID-2019. |
Not yet recruiting |
Phase 2 |
2020-03-01 |
We will enroll 104 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).
|
| NCT04304053 |
Treatment of Mild Cases and Chemoprophylaxis of Contacts as Prevention of the COVID-19 Epidemic |
Not yet recruiting |
Phase 2/Phase 3 |
2020-03-15 |
The investigators plan to evaluate the efficacy of the 'test and treat' strategy of infected
patients and prophylactic chloroquine treatment to all contacts. The strategy entails
decentralized COVID-19 testing and starting antiviral darunavir/cobicistat plus chloroquine
treatment immediately in all who are found to be infected. As viral loads decline to
undetectable levels, the probability of onward transmission is reduced to very low levels.
Such evaluation will require prospective surveillance to assess the population-level effect
of transmission prevention.
Drug interventions in this protocol will follow the Spanish law about off-label use of
medicines.
|
| NCT04305457 |
Nitric Oxide Gas Inhalation Therapy for Mild/Moderate COVID-19 Infection |
Not yet recruiting |
Phase 2 |
2020-03-01 |
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.
|
| NCT04310865 |
Yinhu Qingwen Granula for the Treatment of Severe CoVID-19 |
Not yet recruiting |
Phase 2/Phase 3 |
2020-03-20 |
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 COVID-19 Associated Acute Respiratory Distress |
Not yet recruiting |
Phase 2 |
2020-04-01 |
Novel Corona Virus (COVID-19) is known to cause Acute Respiratory Distress Syndrome, that
results in mortality in 35% - 50% of affected patients, despite intensive care and mechanical
ventilation. Patients with COVID-19 induced Acute Respiratory Distress Syndrome who are
admitted for intensive care including endotracheal intubation and mechanical ventilation will
be treated with Aviptadil, a synthetic version of Vasoactive Intestinal Polypeptide (VIP) and
compared to historical controls. Patients will be randomized to intravenous Aviptadil with
escalation to nebulized Aviptadil vs. nebulized Aviptadil with escalation to intravenous
Aviptadil.
|
| NCT04312243 |
NO Prevention of COVID-19 for Healthcare Providers |
Not yet recruiting |
Phase 2 |
2020-03-20 |
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 260 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) |
Not yet recruiting |
Phase 3 |
2020-03-23 |
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 |
Not yet recruiting |
Phase 3 |
2020-03-01 |
This study is a multi-centre, adaptive, randomized, open clinical trial of the safety and
efficacy of treatments of COVID-19 in hospitalized adults. The study is a
multi-centre/country trial that will be conducted in up to 50 sites globally with multiple
sponsors. Adults (≥18 year-old) hospitalized for COVID- 19 with SpO2 ≤ 94% on room air OR
acute respiratory failure requiring mechanical ventilation and/or supplemental oxygen will be
randomized between 4 treatment arms, each to be given in addition to the usual standard of
care (SoC) in the participating hospital: SoC alone versus SoC + Remdesivir versus SoC +
Lopinavir/Ritonavir versus SoC + Lopinavir/Ritonavir plus interferon ß-1a. Randomization will
be stratified by site and severity of illness at enrollment (moderate disease: patients NOT
requiring non-invasive ventilation NOR high flow oxygen devices NOR invasive mechanical
ventilation NOR ECMO and severe disease: patients requiring non-invasive ventilation OR high
flow oxygen devices OR invasive mechanical ventilation OR ECMO). The interim trial results
will be monitored by a Data Monitoring Committee, and if at any stage evidence emerges that
any one treatment arm is definitely inferior then it will be centrally decided that that arm
will be discontinued. Conversely, if good evidence emerges while the trial is continuing that
some other treatment(s) should also be being evaluated then it will be centrally decided that
one or more extra arms will be added while the trial is in progress. The primary objective of
the study is to evaluate the clinical efficacy and safety of different investigational
therapeutics relative to the control arm in patients hospitalized with COVID-19, the primary
endpoint is the subject clinical status (on a 7-point ordinal scale) at day 15.
|
| NCT04317040 |
CD24Fc as a Non-antiviral Immunomodulator in COVID-19 Treatment |
Not yet recruiting |
Phase 3 |
2020-05-01 |
The study is designed as a randomized, placebo-controlled, double blind, multicenter, Phase
III trial to compare two COVID-19 treatment regimens in hospitalized adult subjects who are
diagnosed with severe COVID 19 and absolute lymphocyte counts ≤ 800/mm^3 in peripheral blood.
Arm A: CD24Fc/Best Available Treatment Arm B: placebo/ Best Available Treatment CD24Fc will
be administered as single dose of 480 mg via IV infusion on Day 1. Total of 230 subjects will
be enrolled and randomized in 1:1 ratio to receive CD24Fc or placebo. Serum cytokine IL-6
level will be used as stratification factor in randomization. All subjects will be treated
with the best available treatment. The follow up period is 15 days.
|
| NCT04318015 |
Hydroxychloroquine Chemoprophylaxis in Healthcare Personnel in Contact With COVID-19 Patients (PHYDRA Trial) |
Not yet recruiting |
Phase 3 |
2020-04-01 |
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) |
Not yet recruiting |
Phase 2/Phase 3 |
2020-03-01 |
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. |
Recruiting |
Phase 3 |
2020-03-16 |
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.
|
| NCT04323631 |
Hydroxychloroquine for the Treatment of Patients With Mild to Moderate COVID-19 to Prevent Progression to Severe Infection or Death |
Not yet recruiting |
Early Phase 1 |
2020-03-01 |
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 |
Not yet recruiting |
Phase 3 |
2020-04-01 |
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 |
Not yet recruiting |
Phase 4 |
2020-04-01 |
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) 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 |
Not yet recruiting |
Phase 3 |
2020-03-27 |
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 |
Active, not 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) |
Recruiting |
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 |
Not yet recruiting |
Phase 3 |
2020-03-30 |
Open label, two-group, phase III randomised controlled trial in up to 4170 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 |
Not yet recruiting |
Phase 2/Phase 3 |
2020-04-25 |
We hypothesize that hyperbaric oxygen (HBO) is safe for patients with COVID-19 and that HBO
reduces the inflammatory reaction in Acute Respiratory Distress Syndrome (ARDS) associated
with COVID-19.
Also known as SARS-CoV-2, COVID-19 is declared a pandemic by World Health Organization (WHO).
No specific treatment has been successful as of March 2020. Mortality rates in patients that
develop ARDS is extremely high, 61.5-90%, almost double the mortality of ARDS of any cause.
ARDS associated with COVID-19 is associated with pulmonary edema, rapidly progressing
respiratory failure and fibrosis. The mechanism behind the rapid progress is still an enigma
but theories have evolved around severe inflammatory involvement with a cytokine storm.
Macrophage activation is involved in the early phase of ARDS and cytokine modulators have
been tried in experimental settings without proven clinical benefits. HBO significantly
reduces inflammatory cytokines and and oedema in other clinical settings. HBO has been used
for almost a century, nowadays mainly used for its anti-inflammatory effects. Several
randomized clinical trials show beneficial effects in variety of inflammatory diseases
including diabetic foot ulcers and radiation injury. HBO is generally regarded as safe with
very few adverse events and extensive experimental and clinical evidence suggest that HBO is
a promising drug to ameliorate ARDS associated with COVID-19.
|
| NCT04328285 |
Chemoprophylaxis of SARS-CoV-2 Infection (COVID-19) in Exposed Healthcare Workers |
Not yet recruiting |
Phase 3 |
2020-03-30 |
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:
|
| NCT04328493 |
The Vietnam Chloroquine Treatment on COVID-19 |
Not yet recruiting |
Phase 2 |
2020-04-01 |
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 PEP |
Not yet recruiting |
Phase 1 |
2020-03-01 |
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 |
Not yet recruiting |
Early Phase 1 |
2020-04-03 |
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.
|
| NCT04330638 |
Treatment of COVID-19 Patients With Anti-interleukin Drugs |
Not yet recruiting |
Phase 4 |
2020-04-01 |
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 |
Active, not recruiting |
Phase 2 |
2020-03-18 |
This study is an adaptive, randomized, open-label, controlled clinical trial.
Subjects will be randomized to receive either standard-of-care products or the study
medication plus standard of care, while being hospitalized for COVID-19.
Lopinavir/ritonavir will be administered 400 mg/100 mg orally (or weight based dose
adjustment for children) for a 14-day course, or until discharge from hospital, whichever
occurs first
|
| NCT04331470 |
Evaluation of Efficacy of Levamisole and Formoterol+Budesonide in Treatment of COVID-19 |
Not yet recruiting |
Phase 2/Phase 3 |
2020-03-31 |
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 |
Not yet recruiting |
N/A |
2020-04-06 |
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 |
Not yet recruiting |
Phase 3 |
2020-04-01 |
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
mild/moderate symptomatic COVID-19 with a recent positive SARS-CoV-2 test.
|
| NCT04332666 |
Angiotensin-(1,7) Treatment in COVID-19: the ATCO Trial |
Not yet recruiting |
Phase 2/Phase 3 |
2020-03-31 |
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 |
Not yet recruiting |
Phase 3 |
2020-04-01 |
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 |
Not yet recruiting |
Phase 2 |
2020-04-06 |
Patients with documented COVID-19 infection will be randomized 1:1 to receive Piclidenoson 2
mg Q12H orally with standard care (intervention arm) or standard care alone (control arm).
|
| NCT04333628 |
Chloroquine for Mild Symptomatic and Asymptomatic COVID-19 |
Not yet recruiting |
Phase 2/Phase 3 |
2020-04-01 |
19 COVID 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 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.
|
| NCT04334460 |
Safety and Antiviral Activity of BLD-2660 in COVID-19 Hospitalized Subjects |
Not yet recruiting |
Phase 2 |
2020-05-01 |
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 |
Not yet recruiting |
Phase 2 |
2020-04-01 |
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).
|
| NCT04334967 |
Hydroxychloroquine in Patients With Newly Diagnosed COVID-19 Compared to Standard of Care |
Enrolling by invitation |
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 |
Multicenter, Double-blind, Randomized Controlled Trial of Tocilizumab in the Treatment of Coronavirus Induced Disease (COVID-19) |
Not yet recruiting |
Phase 2 |
2020-04-01 |
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 |
Not yet recruiting |
Phase 2 |
2020-04-01 |
This is a Phase II interventional study testing whether treatment with hydroxychloroquine,
Vitamin C, Vitamin D, and Zinc can prevent infection with COVID-19
|
| NCT04335123 |
Study of Open Label Losartan in COVID-19 |
Recruiting |
Phase 1 |
2020-03-25 |
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 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.
|
| NCT04335201 |
Defibrotide in COVID-19 Pneumonia |
Not yet recruiting |
Phase 2 |
2020-04-06 |
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 |
Not yet recruiting |
Phase 2 |
2020-04-06 |
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 |
Not yet recruiting |
Phase 2 |
2020-04-01 |
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 |
Not yet recruiting |
Phase 4 |
2020-06-01 |
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 |
Not yet recruiting |
Phase 2 |
2020-05-01 |
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 |
Not yet recruiting |
N/A |
2020-04-01 |
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 |
Not yet recruiting |
Phase 3 |
2020-04-20 |
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 |
Not yet recruiting |
Phase 2/Phase 3 |
2020-04-01 |
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 |
Not yet recruiting |
Early Phase 1 |
2020-04-10 |
This study will investigate the security and efficacy of a daily low dose of
hydroxychloroquine, 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 |
Not yet recruiting |
Phase 3 |
2020-04-10 |
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 |
Not yet recruiting |
Phase 3 |
2020-04-07 |
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 Metro Detroit, 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 |
Recruiting |
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 in COVID-19 Patients |
Not yet recruiting |
N/A |
2020-07-01 |
Pakistan is a resource restraint country, it's not possible to carry out coronavirus testing
at mass scale. Owing to the aerosol producing nature of the dental profession, 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.
Identifying an antiviral gargle that could substantially reduce the colonies of COVID-19
residing in mouth and oro-pharynx is likely to reduce the viral load. This topical therapy is
speculated to substantially reduce the transmission of infection in micro-aerosol generated
in the dental practice. Such topical anti-viral therapy could also help to improve the
overall symptoms of the patient.
|
| NCT04342169 |
University of Utah COVID-19 Hydrochloroquine Trial |
Not yet recruiting |
Phase 2 |
2020-04-14 |
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 |
Recruiting |
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 |
Not yet recruiting |
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 |
Not yet recruiting |
Phase 3 |
2020-05-01 |
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 |
Not yet recruiting |
Phase 3 |
2020-04-01 |
The CRASH-19 trial is a multinational, open-label, factorial, randomised trial in adults
hospitalised with suspected or confirmed acute COVID-19 infection.
|
| NCT04343248 |
A Randomized, Double-Blind, Placebo Controlled, 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) |
Not yet recruiting |
Phase 3 |
2020-04-30 |
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 |
Not yet recruiting |
Phase 4 |
2020-04-10 |
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.
|
| NCT04343976 |
Pegylated Interferon Lambda Treatment for COVID-19 |
Not yet recruiting |
Phase 2 |
2020-05-01 |
Prospective randomized, two-stage trial to assess the antiviral efficacy of Pegylated
Interferon Lambda (180 mcg SC injection) vs. standard of care in up to 40 subjects (20
inpatient and 20 outpatient) with COVID-19 infection.
|
| 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 |
Recruiting |
Phase 2 |
2020-03-31 |
In this study clazakizumab will be administered 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 1:1:1 ratio to three study arms
that will receive clazakizumab at a dose of 12.5 mg, 25 mg or placebo
|
| NCT04344184 |
Early Infusion of Vitamin C for Treatment of Novel COVID-19 Acute Lung Injury (EVICT-CORONA-ALI) |
Not yet recruiting |
Phase 2 |
2020-04-22 |
This study will test to see if a 72-hour intravenous vitamin C infusion protocol (100 mg/kg
every 8 hours) in patients with hypoxemia and suspected COVID-19 will reduce the lung injury
caused by the SARS-Cov-2.
|
| NCT04344236 |
Gargling and Nasal Rinses to Reduce Oro- and Nasopharyngeal Viral Load in Patients With COVID-19 |
Recruiting |
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 |
Recruiting |
Phase 3 |
2020-04-10 |
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 |
Not yet 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 |
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.
|
| NCT04345419 |
A Real-life Experience on Treatment of Patients With COVID 19 |
Not yet recruiting |
Phase 2/Phase 3 |
2020-04-15 |
COVID 19 treatment using Chloroquine with or without Azithromycin, Faviprevir, Nitazoxanide,
Ivermectin.
|
| NCT04345692 |
A Randomized Controlled Clinical Trial: Hydroxychloroquine for the Treatment of COVID-19 in Hospitalized Patients |
Recruiting |
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.
|
| NCT04347174 |
A Clinical Trial of Mycobacterium w in Critically Ill COVID 19 Patients |
Not yet recruiting |
N/A |
2020-04-20 |
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 Cancer Patients With COVID-19 |
Not yet recruiting |
Phase 2 |
2020-04-01 |
This study is for cancer 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 cancer participants infected with
COVID-19. This is the first in-human study of this investigational product specifically in
cancer 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 |
Efficacy of Nigella Sativa and Natural Honey Against COVID-19: an RCT |
Recruiting |
Phase 3 |
2020-04-15 |
To evaluate the effectiveness of Nigella Sativa/ Black Cummins (2gm seed powder in a capsule
orally) and 30ml of honey stirred in 250ml of distilled water 12 hourly till patient becomes
asymptomatic or a maximum of 14 days with standard hospital care vs standard hospital care
alone with placebo capsule and 250ml 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).
|
| NCT04348071 |
Safety and Efficacy of Ruxolitinib for COVID-19 |
Not yet recruiting |
Phase 2/Phase 3 |
2020-04-01 |
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 |
Not yet recruiting |
Phase 3 |
2020-04-15 |
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 |
Not yet recruiting |
N/A |
2020-04-12 |
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 |
Not yet recruiting |
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 |
Not yet recruiting |
Phase 3 |
2020-04-20 |
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 |
Recruiting |
Phase 2 |
2020-04-01 |
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 |
Enrolling by invitation |
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 |
Qatar Prospective RCT Of Therapy Eliminating Covid Transmission |
Not yet recruiting |
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 |
Randomized Open-blind Controlled Trial to Study the Benefit of Colchicine in Patients With COVID-19 |
Not yet recruiting |
Phase 3 |
2020-04-20 |
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 |
IgIV in COVID-19 Related ARds |
Not yet recruiting |
Phase 3 |
2020-04-01 |
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 |
Recruiting |
Phase 3 |
2020-04-15 |
This is an international, multicenter, parallel-group, randomized, double-blind, placebo
controlled, study in hospitalized adult patients with COVID-19 in the US and other countries
with high prevalence of COVID-19. 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, in reducing disease progression, complications, and all-cause mortality.
|
| NCT04350671 |
Interferon Beta 1a in COVID-19: A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial |
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 COVID-19: A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial |
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 Hospitalized Patients With COVID-19 Pneumonia |
Not yet recruiting |
Phase 3 |
2020-05-01 |
The primary objective of this study is to assess whether the use of lenzilumab in addition to
current standard of care (SOC) can alleviate the immune-mediated cytokine release syndrome
(CRS) and prevent progression to respiratory failure and/or death in high risk patients with
COVID-19 pneumonia.
|
| NCT04351295 |
Efficacy of Faviprevir in COVID-19 Treatment |
Not yet recruiting |
Phase 2/Phase 3 |
2020-04-17 |
Faviprevir in COVID-19 treatment
|
| NCT04351347 |
The Efficacy of Ivermectin and Nitazoxanide in COVID-19 Treatment |
Not yet recruiting |
Phase 2/Phase 3 |
2020-04-17 |
Efficacy of Ivermectin and Nitazoxanide 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) |
Not yet recruiting |
Phase 2/Phase 3 |
2020-04-01 |
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) |
Not yet recruiting |
Phase 3 |
2020-04-01 |
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 60 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 |
Recruiting |
Phase 2 |
2020-04-07 |
Our 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. We believe there is enough information to launch a clinical trial of
hydroxychloroquine for COVID-19.
|
| NCT04353180 |
Assessment the Activity Value of Retinoic Acid in the Treatment of COVID-19 |
Recruiting |
Phase 3 |
2020-04-01 |
( Research protocol byAssistant researcher Mahmoud Ramadan Abdel-Hamid EL-kazzaz
(Corresponding Author and Principal Investigator) Department of chemistry and biochemistry,
Master of Virology and Molecular biology , Faculty of Science, Damietta University
Mail:mahmoudramadan2051@yahoo.com Tel:00201090302015)
_____________________________________________________________________________________________
_________________________________________________ Severe acute respiratory syndrome (SARS) is
an infectious and highly contagious disease that is caused by SARS coronavirus (SARS-CoV) and
for which there are currently no approved treatments. Here, the investigator reports
according to previous research studies that retinoic acid could strongly affect both
inflammation and cellular viral entry in severe acute respiratory syndrome (SARS-CoV) and
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection via modulating and
reducing cytokine storm factors (IL- 6,IL-1 and tumor necrosis factors alpha ) which are over
expressed in COVID 2019 infection and contribute to disease progression and poor outcomes,
poor prognosis and bad survival in patients infected with severe acute respiratory
syndrome(SARS-CoV). And also, via blocking viral entry by inhibition of (Serine protease 2)
rather than inhibition of ACE2 and AT1 protein and Ang II-mediated intracellular calcium
release pathway which is responsible for SARS-CoV-2 cell fusion and entry.Retinoic acid which
induce FOXP3 and CD8+,CD4+,CD25+,FOXP3+ Tregs which were dramatically reduced in COVID-19
patients to exert its anti-inflammatory effect protecting lung cell and neural cells from the
inflammatory and destructive effect of IL-6. In addition to inducing 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 of IFN type1 in COVID
2019 infection .
|
| NCT04353271 |
Trial of Hydroxychloroquine In Covid-19 Kinetics |
Recruiting |
Phase 2/Phase 3 |
2020-04-15 |
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 in COVID-19 Treatment |
Not yet recruiting |
Phase 2/Phase 3 |
2020-04-17 |
Chloroquine in COVID-19 treatment
|
| NCT04353596 |
Stopping ACE-inhibitors in COVID-19 |
Not yet recruiting |
Phase 4 |
2020-04-15 |
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
|
| NCT04354389 |
DAS181 for STOP COVID-19 |
Not yet recruiting |
Phase 2/Phase 3 |
2020-04-25 |
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 |
Not yet recruiting |
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 Chloropromazine as a Treatment for COVID-19 |
Not yet recruiting |
Phase 1/Phase 2 |
2020-05-01 |
In this study, defined cases of COVID-19 confirmed with PCR, with a mild, moderate or severe
pneumonia will be treated with chlorpromazine IV injection. 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 |
2020-04-13 |
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 |
Recruiting |
Phase 2 |
2020-04-01 |
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 and will be monitored for development of acute
respiratory distress syndrome. Other variables regarding lung function, systemic inflammation
and cardiovascular function will also be evaluated.
|
| NCT04355962 |
Sevoflurane in COVID-19 ARDS (SevCov) |
Not yet recruiting |
Phase 2 |
2020-04-15 |
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.
|
| NCT04356690 |
Etoposide in Patients With COVID-19 Infection |
Not yet recruiting |
Phase 2 |
2020-04-01 |
This is a single arm, open label study designed to evaluate the safety and efficacy of
etoposide in patients with the 2019 novel coronavirus (COVID-19) infection. Treatment will be
comprised of etoposide administered intravenously at a dose of 150 mg/m2 on Days 1 and 4 as
prevention of cytokine storm in patients with COVID-19 infection.
|
| NCT04356833 |
Nebulised Rt-PA for ARDS Due to COVID-19 |
Not yet recruiting |
Phase 2 |
2020-04-14 |
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 first 12 consented patients will receive nebulised rt-PA in addition to standard of care
(SOC). The second group of 12 patients will receive SOC alone as a comparison. 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 (after Day 3) both groups will be followed up in
accordance with SOC.
|
| NCT04357730 |
STudy of Alteplase for Respiratory Failure in SARS-Cov2 (COVID-19) |
Not yet recruiting |
Phase 2 |
2020-04-01 |
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 |
Recruiting |
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) |
Recruiting |
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 |
Not yet recruiting |
Phase 2 |
2020-05-01 |
The purpose of this study is to evaluate the efficacy of hydroxychloroquine (HCQ) and
azithromycin (Azithro) to prevent hospitalization or death in symptomatic adult outpatients
with COVID-19.
|
| NCT04358406 |
Rhu-pGSN for Severe Covid-19 Pneumonia |
Not yet recruiting |
Phase 2 |
2020-06-01 |
Study Objectives:
Primary
- To assess the efficacy (survival without organ failure) of three doses of rhu-pGSN to
hospitalized subjects with a primary diagnosis of COVID-19 pneumonia
- To evaluate the safety and tolerability of three doses of rhu-pGSN
Secondary
- To examine individual components of the primary composite endpoint
- To assess the relationship of pGSN levels at baseline with clinical outcomes
- To assess changes in WHO 9 point severity score
Immunogenicity
• To investigate the development of antibodies against pGSN post-treatment
|
| NCT04358549 |
Study of the Use of Favipiravir in Hospitalized Subjects With COVID-19 |
Recruiting |
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 |
Not yet recruiting |
Phase 2/Phase 3 |
2020-05-11 |
Introduction: The COVID-19 pandemic is characterized by significant morbidity and mortality.
It is caused by a novel coronavirus with no current specific prevention nor treatment
therapies. Treatments have been administered to patients with COVID-19 in order to control
viral infection, among them: Chloroquine (CQ) and Hydroxychloroquine (HCQ),
Lopinavir/Ritonavir (Lop/r), Remdesivir, Favipavir, acting over bacterial co-infection
Azithromycin (Azithro), or modifying the inflammatory response of the host (Tocilizumab).
Clinical trials offer conflicting evidence regarding the effectiveness and safety of
therapies The real effectiveness and safety profile of the treatments for COVID-19 remains
unknown.
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) for 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), prolonged QT interval, glomerular filtration rate lesser than 30
ml/min/1.73m^2, history of lung fibrosis, advanced or metastatic cancer. Sample size: 1,600
participants. The study will be carried out in two phases. The first phase will be conducted
with 480 participants and aims to identify treatments with higher or minimum potential,
discontinue treatments with higher toxicity and have opportunity of introducing new
treatments with potential efficacy. The second phase will be conducted with 1,120
participants to evaluate the effectiveness of the selected treatments. Four interventions
have been defined: I1 HCQ, I2 HCQ plus Lop/r, I3 HCQ plus Azithro 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 a central telephone. 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).
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.
|
| NCT04359290 |
Ruxolitinib for Treatment of Covid-19 Induced Lung Injury ARDS |
Not yet recruiting |
Phase 2 |
2020-05-01 |
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.
|
| NCT04359537 |
Efficacy of Various Doses of Hydroxychloroquine in Pre-Exposure Prophylaxis for COVID 19 |
Not yet recruiting |
Phase 2 |
2020-04-25 |
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 |
Not yet recruiting |
Phase 2 |
2020-05-01 |
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- or Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers |
Not yet recruiting |
Phase 3 |
2020-04-30 |
Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- or Post Exposure
Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers
|
| NCT04360096 |
Inhaled Aviptadil for the Treatment of Non-Acute Lung Injury in COVID-19 |
Not yet recruiting |
Phase 2/Phase 3 |
2020-06-01 |
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 Acute Respiratory Distress Syndrome and the need for
mechanical ventilation. Mortality rates as high as 80% have been reported among those who
develop ARDS, despite intensive care and mechanical ventilation.
Patients with COVID-19 induced non-Acute Lung Injury who have demonstrated reduction in blood
oxygenation, dyspnea, and exercise intolerance but do not require endotracheal intubation and
mechanical ventilation will be treated with Aviptadil, a synthetic version of Vasoactive
Intestinal Polypeptide (VIP) plus Standard of Care vs. placebo + Standard of Care. Patients
will be randomized to intravenous Aviptadil will receive inhaled Aviptadil, 100 μg 3x daily
vs. placebo 3x daily. The primary outcome will be progression to ARDS 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 |
2020-04-20 |
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 |
Not yet recruiting |
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. We 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 |
Not yet recruiting |
Phase 4 |
2020-04-16 |
This prospective, randomized, open-label, single-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 |
Not yet recruiting |
Phase 2 |
2020-05-01 |
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 |
Not yet recruiting |
Phase 1 |
2020-04-01 |
This study aims to examine the tolerability of high dose of leflunomide in patients with
COVID-19 who are not yet hospitalized, but have risk factors for disease progression and
complications.
|
| NCT04361422 |
Isotretinoin in Treatment of COVID-19 |
Not yet recruiting |
Phase 3 |
2020-04-21 |
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.
|
| NCT04362085 |
Coagulopathy of COVID-19: A Pragmatic Randomized Controlled Trial of Therapeutic Anticoagulation Versus Standard Care |
Not yet recruiting |
Phase 3 |
2020-04-01 |
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 with COVID-19 and an elevated D-dimer (≥2X upper limit of normal
{ULN}).
|
| NCT04362111 |
Early Identification and Treatment of Cytokine Storm Syndrome in Covid-19 |
Not yet recruiting |
Phase 3 |
2020-05-01 |
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 |
Phase 3 Randomized, Double-blind, Placebo-controlled Multi-center Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm (RUXCOVID) |
Not yet recruiting |
Phase 3 |
2020-04-30 |
This is 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 pneumonia.
|
| 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 |
Recruiting |
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 |
Not yet recruiting |
Phase 3 |
2020-04-30 |
This is 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 adult 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) |
Not yet recruiting |
Phase 4 |
2020-04-01 |
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 |
2020-04-01 |
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 |
Not yet recruiting |
Phase 1 |
2020-05-04 |
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 |
the COMBAT-COVID-19 Pilot Study |
Recruiting |
Phase 2 |
2020-04-23 |
COVID-19 infection is a respiratory infectious disease caused by a virus called SARS-CoV-2 .
This virus is transmitted from person to person through close contacts or respiratory
droplets. Symptoms usually start 4 or 5 days after exposure. Some common symptoms include
fever, dry cough, feeling tired, muscle aches, and trouble breathing. Although it may affect
all organs in our body, it mainly attacks our lungs' ability to help us breathe.
There are currently no FDA approved medications to treat COVID-19 infection. Patients are
given medications to help alleviate the symptoms. When patients are admitted to the hospital,
they are given medications to reduce fever, relieve pain and supplement oxygen. In severe
cases, patients are put on a ventilator, a machine designed to to support the lungs. There
are a number of drugs undergoing clinical study to see if they are effective in treating the
COVID-19 virus.
At Maimonides Medical Center, we are taking the appropriate steps to find an effective
treatment for COVID-19. The COMBAT COVID-19 Pilot Study is designed for patients diagnosed
with COVID-19 infection who require oxygen supplementation to be treated with colchicine to
reduce the chance of needing a mechanical ventilator.
Colchicine is an FDA approved medication that is used to treat inflammatory disorders such as
Gout and Familial Mediterranean Fever. It has also been used to treat other inflammatory
conditions such as inflammation around the heart and been demonstrated to help patients who
have had an acute heart attack. Colchicine is a readily available drug which is usually well
tolerated by patients. We believe that colchicine may reduce the inflammation in the lungs.
If so, the lungs may be able heal at a quicker pace and we hope that this may reduce the need
for mechanical ventilation.
The research will be a randomized trial, patient will be randomly selected to be in either
the colchicine treatment group or the standard medicines group. The treatment group will
receive colchicine for 14 days or until the day of discharge. The standard medicines group
will receive the usual medical therapy as determined by attending physician.
|
| NCT04363450 |
Hydroxychloroquine as Prophylaxis for COVID-19 in Healthcare Workers (HCQPreP) |
Not yet recruiting |
Phase 3 |
2020-05-04 |
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 |
Not yet recruiting |
Phase 2 |
2020-04-01 |
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
1:1:1 ratio to three study arms that will receive clazakizumab at a dose of 12.5 mg, 25 mg or
placebo.
|
| NCT04363827 |
Protect: A Randomized Study With Hydroxychloroquine Versus Observational Support for Prevention and Early Phase Treatment of Coronavirus Disease (COVID-19) |
Not yet recruiting |
Phase 2 |
2020-05-01 |
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 |
Not yet recruiting |
Phase 3 |
2020-04-01 |
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 |
Recruiting |
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 to Reduce Deterioration of Cardiac and Respiratory Function Due to COVID-19 |
Recruiting |
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 |
2020-04-30 |
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 |
Not yet recruiting |
Phase 3 |
2020-04-28 |
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.
|
| NCT04365699 |
Cardiovascular Effects of COVID-19 |
Recruiting |
Phase 2 |
2020-04-08 |
This is a prospective single-center registry with an embedded open-label single-arm clinical
trial to determine the effects of standard of care treatment vs. standard of care plus AT-001
on cardiac structure and function and in-hospital survival in patients hospitalized for
management of COVID-19 infection. Eligible subjects with COVID-19 infection will be
identified at the time of hospital admission based on existing infection control surveillance
protocols, and will have clinical data extracted from the electronic medical record to
determine clinical characteristics associated with cardiac structure and function and
in-hospital survival. A subset of patients with history of diabetes mellitus and/or acute
hyperglycemia (any glucose measurement >126 mg/dl) and evidence of acute or chronic heart
disease will be treated in an open-label fashion to receive an investigational aldose
reductase inhibitor, AT-001 plus standard of care.
|
| NCT04365985 |
Study of Immunomodulation Using Naltrexone and Ketamine for COVID-19 |
Not yet recruiting |
Phase 2 |
2020-04-01 |
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 |
Not yet recruiting |
Phase 1/Phase 2 |
2020-06-01 |
This is a randomized, double-blind, placebo-controlled, single-ascending dose study of
AVM0703 administered as a single intravenous (IV) infusion to patients with COVID-19. The
study is designed to evaluate the safety, tolerability, and pharmacokinetics of
single-ascending dosing of AVM0703 in patients with COVID-19.
|
| 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 |
Not yet recruiting |
Phase 3 |
2020-05-01 |
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 |
Not yet recruiting |
Phase 4 |
2020-05-01 |
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 Using Hydroxycholoroquine for COVID-19 |
Recruiting |
Phase 3 |
2020-04-07 |
The overall objective of the study will be to evaluate the clinical efficacy of COVID-19
treatments consisting of standard of care (SOC) combined with pharmaceutical antiviral
management using hydroxychloroquine, or SOC with hydroxychloroquine combined with high-dose
intravenous famotidine, in hospitalized patients meeting nucleic acid diagnostic and
radiologic criteria for COVID-19 disease. The trial will statistically compare the clinical
benefit afforded by the two treatment strategies to internal historical "standard of care"
data from Northwell patents treated without benefit of either hydroxychloroquine or high-dose
famotidine. We will compare clinical outcomes associated with hydroxychloroquine and the
addition of high-dose intravascular famotidine. The trial is designed to enroll at least 600
COVID-19 patients hospitalized with moderate to severe disease into each of the two active
treatment arms, with a total enrollment target of at least 1200 patients. The proposed trial
has been designed for rapid enrollment and completion and powered to support two 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 |
Not yet recruiting |
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 |
Not yet recruiting |
Phase 3 |
2020-04-01 |
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 |
Not yet recruiting |
Phase 3 |
2020-05-02 |
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 Sn-protoporphyrin IX (SnPPIX) and Sulfonated Tetranaphthyl Porphyrin Against Covid-19 |
Not yet recruiting |
Phase 1 |
2020-05-01 |
Efficacy of Sn-protoporphyrin IX (SnPPIX) and sulfonated tetranaphthyl porphyrin Against
Covid-19
Mahmoud ELkazzaz(1)
1-Principal Investigator Department of chemistry and biochemistry, Faculty of Science,
Damietta University, GOEIC, Egypt
Mail:mahmoudramadan2051@yahoo.com Tel:00201090302015
_____________________________________________________________________________________________
_________________________________________________________________________
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). 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. Therefore, the principal
investigator expects that treatment with x-ray induced visible luminescence of porphyrins
will be effective in targeting of COVID-19.
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 |
Not yet recruiting |
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 ) |
Not yet recruiting |
N/A |
2020-05-01 |
The purpose of the study is to evaluate the efficacy of therapeutic-dose parenteral heparin
versus usual care in hospitalized COVID-19 patients (e.g. reduced intubation, mortality).
|
| NCT04372628 |
Trial of Early Therapies During Non-hospitalized Outpatient Window for COVID-19 |
Not yet recruiting |
Phase 2 |
2020-05-01 |
Blinded, multicenter, placebo-controlled, randomized clinical trial evaluating
hydroxychloroquine vs lopinavir/ritonavir vs placebo in early outpatient treatment of adults
with COVID-19
|
| NCT04373044 |
Antiviral Therapy and Baricitinib for the Treatment of Patients With Moderate or Severe COVID-19 |
Not yet recruiting |
Phase 2 |
2020-04-24 |
This phase II trial studies how well antiviral therapy works when given in combination with
baricitinib for the treatment of moderate or severe coronavirus disease-2019 (COVID-19).
Antiviral therapy such as hydroxychloroquine, lopinavir/ritonavir, and remdesivir may act
against infections caused by the virus responsible for COVID-19. Baricitinib may reduce lung
inflammation and help prevent the need for being placed on a ventilator should the disease
worsen. Giving antiviral therapy in combination with baricitinib may reduce the risk of the
disease from getting worse compared to antiviral therapy alone.
|
| NCT04373733 |
A Randomised Controlled Trial of Early Intervention in COVID-19: Favipiravir Verses HydroxycholorquiNe & Azithromycin & Zinc vErsEs Standard CaRe |
Not yet 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 a combination of azithromycin,
hydroxychloroquine and zinc or favipiravir, alongside 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 |
Not yet recruiting |
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 |
A Phase II, Open Label, Randomized Controlled Trial to Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications |
Not yet 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 |
Not yet recruiting |
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 |
Not yet 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 COVID-19 Infection- and Lung Injury Preventing Drug Better Than Recombinant Human ACE2 |
Not yet recruiting |
Phase 1 |
2020-08-01 |
Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP could be promising COVID-19
infection- and lung injury preventing drug better than recombinant human ACE2
Mahmoud ELkazzaz1
1Department of chemistry and biochemistry, Faculty of Science, Damietta University, GOEIC,
Egypt.
_____________________________________________________________________________________________
_______________________________________________________________________
B38-CAP is a bacteria-derived ACE2-like enzyme that suppresses hypertension and cardiac
dysfunction Angiotensin-converting enzyme 2 (ACE2) is critically involved in cardiovascular
physiology and pathology, and is currently clinically evaluated to treat acute lung failure.
Here we show that the B38-CAP, a carboxypeptidase derived from Paenibacillus sp. B38, is an
ACE2-like enzyme to decrease angiotensin II levels in mice. In protein 3D structure analysis,
B38-CAP homolog shares structural similarity to mammalian ACE2 with low sequence identity. In
vitro, recombinant B38-CAP protein catalyzed the conversion of angiotensin II to angiotensin
1-7, as well as other known ACE2 target peptides. Treatment with B38-CAP suppressed
angiotensin II-induced hypertension, cardiac hypertrophy, and fibrosis in mice. Moreover,
B38-CAP inhibited pressure overload-induced pathological hypertrophy, myocardial fibrosis,
and cardiac dysfunction in mice. Our data identify the bacterial B38-CAP as an ACE2-like
carboxypeptidase, indicating that evolution has shaped a bacterial carboxypeptidase to a
human ACE2-like enzyme. Bacterial engineering could be utilized to design improved protein
drugs for hypertension and heart failure.On the contraryTreatment with recombinant human ACE2
protein (rhACE2), which is devoid of its membrane-anchored domain thus soluble, has been
demonstrated to exhibit beneficial effects in various animal models including heart failure,
acute lung injury, and diabetic nephropathy, and so forth. rhACE2 is currently tested in the
clinic to treat ARDS and COVID-19 infected patients . Using cell cultures and organoids,
researchers from the Karolinska Institutet in Sweden and the University of British Columbia
(UBC) in Canada, showed that by adding a genetically modified variant of ACE2, called human
recombinant soluble angiotensin-converting enzyme 2 (hrsACE2), COVID-19 was prevented from
entering cells.The paper, published in Cell, shows that hrsACE2 had a dose dependent effect
of viral growth of SARS-CoV-2 and was able to reduce it by a factor of 1,000 to 5,000 in cell
cultures. Despite its beneficial effects, rhACE2 is a glycosylated protein and thus its
preparation requires time- and cost-consuming protein expression system with mammalian or
insect cells, which may not be advantageous in drug development and medical economy Although
it had been reported that an immune response is associated with the chronic infusion of
rhACE2 resulting in the degradation of rhACE226, this was not observed for B38-CAP; there
were no antibodies against B38-CAP detectable in the serum of mice infused with B38-CAP for 2
weeks. Implantation of B38-CAP-filled osmotic mini-pumps significantly suppressed Ang
II-induced hypertension in conscious mice .without affecting the heart rate. These results
indicate that B38-CAP antagonizes the vasopressor effect of Ang II. So the principle
investigator expects and suggests that treating with cloned Bacterial ACE2 receptors -like
enzyme of B38-CAP could be promising COVID-19 infection- and lung injury preventing drug
better than recombinant human ACE2 in addition to brsACE2, expected to lure the virus to
attach itself to the copy instead of the actual cells… It distracts the virus from infecting
the cells to the same degree and should lead to a reduction in the growth of the virus in the
lungs and other organs. A study showed that recombinant B38-CAP protein downregulates Ang II
levels in mice and antagonizes Ang II-induced hypertension, pathological cardiac hypertrophy,
and myocardial fibrosis. We also show beneficial effects of B38-CAP on the pathology of
pressure overload-induced heart failure in mice without overt toxicities.
Keywords: COVID 2019 ,Infection, B38-CAP , Bacterial ACE2 receptors -like enzyme , rhACE226.
_____________________________________________________________________________________________
________________________________________________________________________
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 rbACE2 or control patients, to help determine whether a subsequent
Phase 2B trial is warranted.
|
| 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 |
Not yet recruiting |
Phase 2 |
2020-05-05 |
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 |
2020-06-12 |
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. DeltaRex-G is a safe, non-pathogenic, replication incompetent, RNA virus-based gene
vector. DeltaRex-G nanoparticles (~100 nm) can mimic RNA virus SARS-CoV-2 by binding to
viral receptors in human cells and may serve as a decoy to prevent SARSCoV-2 cell entry
by crowding/neutralizing the SARS-CoV-2 even where the receptors may be different.
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. The 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) |
Not yet recruiting |
Phase 2/Phase 3 |
2020-05-01 |
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 Mild or Moderate COVID-19 Infection in Cancer Patients |
Not yet recruiting |
Phase 1/Phase 2 |
2020-05-30 |
This phase I/IIa trial studies the side effects of rintatolimod and interferon (IFN) alpha-2b
in treating cancer patients with mild or moderate 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 in COVID-19 |
Not yet recruiting |
Phase 2 |
2020-05-08 |
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) |
Recruiting |
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
|
| NCT04381052 |
Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection |
Not yet recruiting |
Phase 2 |
2020-05-01 |
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 |
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 |
Recruiting |
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 |
Not yet recruiting |
Phase 2 |
2020-05-07 |
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 |
Randomized Evaluation of COVID-19 Therapy |
Recruiting |
Phase 2/Phase 3 |
2020-03-19 |
RECOVERY is a randomised trial investigating whether treatment with either
Lopinavir-Ritonavir, Hydroxychloroquine, Corticosteroids, Azithromycin or Tocilizumab
prevents death in patients with COVID-19.
|
| NCT04381962 |
A Multi-centre Open-label Two-arm Randomised Superiority Clinical Trial of Azithromycin Versus Usual Care In Ambulatory COVID-19 (ATOMIC2) |
Not yet recruiting |
Phase 3 |
2020-05-13 |
A multi-centre open-label two-arm randomised superiority clinical trial of two weeks of oral
Azithromycin 500mg once daily versus usual care in adult patients presenting to secondary
care with clinically-diagnosed COVID-19 but assessed as appropriate for initial ambulant
(outpatient) management, in preventing progression to respiratory failure or death.
|
| NCT04382040 |
A Phase II, Controlled Clinical Study Designed to Evaluate the Effect of ArtemiC in Patients Diagnosed With COVID-19 |
Recruiting |
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 in a nanoparticular formulation, 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 |
Not yet recruiting |
Phase 2 |
2020-05-15 |
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 |
Recruiting |
Phase 1 |
2020-05-07 |
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 |
Not yet recruiting |
Phase 2 |
2020-05-15 |
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 Confirmed COVID-19 Infected Hospitalized Patients |
Not yet recruiting |
Phase 2/Phase 3 |
2020-07-01 |
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
100 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 |
Recruiting |
Phase 4 |
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.
|
| NCT04384458 |
COVID-19 Prophylaxis With Hydroxychloroquine Associated With Zinc For High-Risk Healthcare Workers |
Not yet recruiting |
N/A |
2020-05-01 |
We have to be aware of the challenge and concerns brought by 2019-nCoV to our healthcare
workers. Front-line healthcare workers can become infected in the management of patients with
COVID-19; the high viral load in the atmosphere, and infected medical equipment are sources
for the spread of SARS-CoV-2. If prevention and control measures are not in place, these
healthcare workers are at great risk of infection and become the inadvertent carriers to
patients who are in hospital for other diseases. Nowadays a question that has not yet been
clarified by science has been arises: is hydroxychloroquine associated with zinc effective as
a prophylaxis for asymptomatic healthcare workers involved in the treatment of suspected or
confirmed cases of COVID-19?
|
| 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 |
Not yet recruiting |
Early Phase 1 |
2020-05-01 |
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 |
Not yet recruiting |
Phase 2 |
2020-06-03 |
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. We 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 |
2020-06-01 |
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, we 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. We 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 in COVID -19 |
Not yet recruiting |
Phase 2/Phase 3 |
2020-05-14 |
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 3 arms: hydroxychloroquine; favipiravir;
supportive 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 |
The NO-COVID Study |
Recruiting |
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 |
Not yet recruiting |
Phase 2/Phase 3 |
2020-05-01 |
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 2/Phase 3 |
2020-07-01 |
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. We 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 Efficacy of Lucinactant in Adults With COVID-19 |
Not yet recruiting |
Phase 1/Phase 2 |
2020-06-01 |
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 |
Recruiting |
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 |
Not yet recruiting |
Phase 2/Phase 3 |
2020-05-01 |
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 |
Not yet recruiting |
Phase 1/Phase 2 |
2020-06-01 |
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 |
2020-06-30 |
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 (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. 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.
Reference:
Gralinski and Baric 2015. Molecular pathology of emerging coronavirus infections. J Pathol
2015: 235: 185-195; DOI: 10.1002/path.4454
|
| NCT04390594 |
Efficacy and Safety Evaluation of Treatment Regimens in Adult COVID-19 Patients in Senegal |
Not yet recruiting |
Phase 3 |
2020-06-01 |
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).
Two therapeutic regimens have been eligible in the short term for SEN-CoV-Fadj:
Hydroxychloroquine (HCQ) on one hand, and the combination of Hydroxychloroquine and
Azithromycin (HCQ + AZM) on the other hand.
|
| 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 |
Recruiting |
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 |
Randomised, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Efficacy of Hydroxychloroquine and Azithromycine in Patients With COVID-19 and Hematological Malignancies |
Not yet recruiting |
Phase 2 |
2020-05-12 |
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 |
2020-05-01 |
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 immunomodulant 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 already
administered standard therapy: chloroquine/idrossichloroquine and low-molecular weight eparin
(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 enpoints 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 (TACTIC-E) |
Not yet recruiting |
Phase 2/Phase 3 |
2020-05-20 |
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.
Reference:
Gralinski and Baric 2015. Molecular pathology of emerging coronavirus infections. J Pathol
2015: 235: 185-195; DOI: 10.1002/path.4454
|
| NCT04393792 |
SINUS WASH Pilot Study in Adults Testing Positive for COVID-19 |
Recruiting |
Phase 1 |
2020-05-01 |
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 |
Not yet recruiting |
Phase 3 |
2020-06-01 |
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 |
Not yet recruiting |
Phase 4 |
2020-05-01 |
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 |
Not yet recruiting |
Phase 3 |
2020-05-20 |
This study is a randomized Double-Blind Placebo-Controlled Trial on the Safety and Efficacy
of Imatinib for Hospitalized Adults with COVID-19
|
| NCT04395170 |
Convalescent Plasma Compared to Anti-COVID-19 Human Immunoglobulin and Standard Treatment (TE) in Hospitalized Patients |
Not yet recruiting |
Phase 2/Phase 3 |
2020-06-01 |
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.
|
| NCT04395768 |
International ALLIANCE Study of Therapies to Prevent Progression of COVID-19 |
Not yet recruiting |
Phase 2 |
2020-05-25 |
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.
|
| 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 |
Not yet recruiting |
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
|
| NCT04398004 |
Anti-inflammatory Clarithromycin for Improving COVID-19 Infection Early |
Recruiting |
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 |
Not yet recruiting |
Phase 2 |
2020-06-01 |
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 |
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.
|
| NCT04400799 |
Enoxaparin for Primary Thromboprophylaxis in Ambulatory Patients With COVID-19 |
Not yet recruiting |
Phase 3 |
2020-06-01 |
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.
|
| NCT04400929 |
Using GM-CSF as a Host Directed Therapeutic Against COVID-19 |
Not yet recruiting |
Phase 2 |
2020-06-01 |
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 |
Not yet recruiting |
Phase 3 |
2020-06-01 |
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 |
Recruiting |
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
|
| NCT04401527 |
Treatment of Lung Injury From COVID-19 Infection With Intravenous Sodium Nitrite |
Not yet recruiting |
Phase 2 |
2020-06-01 |
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).
|
| NCT04402957 |
LSALT Peptide vs. Placebo to Prevent ARDS and Other Organ Injuries in Patients Infected With SARS-CoV-2 (COVID-19) |
Not yet recruiting |
Phase 2 |
2020-07-01 |
To evaluate the efficacy of intravenous LSALT peptide plus standard of care to prevent the
progression of COVID-19 to mild, moderate or severe ARDS, acute kidney injury,
cardiomyopathy, acute liver injury, coagulopathy, or death in patients infected with
SARS-CoV-2 compared with placebo plus standard of care.
|
| NCT04403100 |
Hydroxychloroquine and Lopinavir/ Ritonavir to Improve the Health of People With COVID-19: "The Hope Coalition - 1" |
Not yet recruiting |
Phase 3 |
2020-05-28 |
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 and Doxycycine in COVID-19 Treatment |
Not yet recruiting |
Phase 2/Phase 3 |
2020-06-01 |
Efficacy of Ivermectin and Doxycycline in COVID-19 treatment
|
| NCT04403685 |
Safety and Efficacy of Tocilizumab in COVID-19 and Inflammatory Markers: a Phase III Randomized Controlled Trial |
Recruiting |
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 Phase 3 Study in Hospitalized Patients With Severe COVID-19 With or Without Cancer |
Not yet recruiting |
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 |
2020-06-15 |
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 EIDD-2801 to Eliminate Infectious Virus Detection in Persons With COVID-19 |
Not yet recruiting |
Phase 2 |
2020-05-26 |
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
|
| NCT04405921 |
Hydroxychloroquine, Azithromycin in the Treatment of Covid-19 |
Not yet recruiting |
Phase 3 |
2020-05-01 |
This study investigates the efficay and tolerance of 5-days course of hydroxychloroquine or
hydroxychloroquine and azithromycin of patients with COVID-19 infection. We 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 |
Recruiting |
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 |
Recruiting |
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. |
Not yet recruiting |
Phase 2 |
2020-06-01 |
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 |
Recruiting |
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 and many governments
including USA and India have already endorse that due to lack of any other better alternative
drugs. Indian council of medical research (ICMR) has advised for HCQ prophylaxis for the
people who are at risk for developing SARS-CoV-2 infection, 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. As a
research institute of national as well as international interest, it is a great opportunity
for us to produce such a robust data which can be utilized in reforming national and
international guidelines for the battle against of COVID-19 pandemic. 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. If any asymptomatic individual become
symptomatic they will be admitted for SARS-Cov-2 testing and will be managed accordingly with
best possible care in the institute's communicable disease ward under isolation. Only the
symptomatic individual with RTPCR positive for SARS-CoV-2 will be defined as confirmed
COVID-19 case and negative symptomatic individual will be defined as probable COVID-19 case.
Incidence of confirmed or probable COVID-19 case in asymptomatic quarantined individuals will
be compared between the PEP and control groups.
|
| NCT04409327 |
Phase 3 Study to Determine if RTB101 Reduces the Severity of COVID-19 in Older Adults Residing in Nursing Homes |
Recruiting |
Phase 3 |
2020-05-01 |
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) |
Not yet recruiting |
Phase 2 |
2020-07-01 |
In this pilot trial, 120 confirmed COVID-19 individuals will be randomly assigned to 1 of 4
groups: distilled water, CloSYS (Rowpar Pharmaceutical Inc., USA), Oral-B Mouth Sore (Oral-B,
USA), or Crest Pro-Health Multi-Protection (Crest, USA).
Study participants will be asked to rinse/gargle with 10ml (2 teaspoons) of the assigned
solutions 4 times per day, for 15 seconds, for 4 weeks.
|
| NCT04409925 |
DISmantling COvid iNduced Neutrophil ExtraCellular Traps (DISCONNECT-1) |
Not yet recruiting |
Phase 1 |
2020-06-01 |
This is a pilot study to investigate the safety and tolerability of rhDNase1 and its impact
on neutrophil extracellular traps (NETs) in COVID-19 infected patients
|
| NCT04410328 |
Aggrenox To Treat Acute Covid-19 |
Not yet recruiting |
Phase 3 |
2020-06-21 |
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 |
Not yet recruiting |
Phase 2 |
2020-06-01 |
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 |
Randomized Double-blind Study in Subjects With SARS-Cov-2 (COVID-19) Virus Infection |
Not yet recruiting |
Phase 2/Phase 3 |
2020-06-01 |
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 |
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 |
Feasibility Study of Anti-SARS-CoV-2 Plasma Transfusions in COVID-19 Patients With SRD |
Recruiting |
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 Standard of Care Plus Intravenous Immunoglobulin (IVIG) Compared to Standard of Care Alone in the Treatment of COVID-19 Infection |
Recruiting |
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. He 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 |
Not yet recruiting |
Phase 2 |
2020-06-01 |
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 |
2020-06-01 |
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 |
Not yet recruiting |
Phase 3 |
2020-06-15 |
Around1 in 4 COVID-19 patients suffer lung failure needing 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 we give
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 you breathe 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 this illness depending on which type of sedation drug they
receive. We will 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 COVID-19 patients who need lifesaving treatments.
|
| NCT04415073 |
A Phase 2 Study to Evaluate Axatilimab for Hospitalized Patients With Respiratory Involvement Secondary to COVID-19 |
Recruiting |
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).
|
| NCT04416334 |
PREEMPTIVE THERAPY WITH COLCHICINE IN PATIENTS OLDER THAN 70 YEARS WITH HIGH RISK OF SEVERE PNEUMONIAE DUE TO CORONAVIRUS SARS-CoV2 (COVID-19) |
Not yet recruiting |
Phase 3 |
2020-05-25 |
This is a phase 3 clinical trial, randomized, single-center, opened, controlled, to evaluate
efficacy and safety of early administration of colchicines in patients older than 70 years,
with high risk of pulmonary complications due to coronavirus SARS-CoV2 (COVID-19). An
approximately number of 1000 subjects meeting all inclusion and none exclusion criteria will
be randomized either to receive colchicines or symptomatic treatment with paracetamol during
21 days.
|
| NCT04417257 |
Study of LAU-7b for the Treatment of COVID-19 Disease in Adults |
Not yet recruiting |
Phase 2 |
2020-06-08 |
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 |
2020-05-25 |
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 |
Not yet recruiting |
Phase 2 |
2020-06-01 |
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) |
Recruiting |
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 TID for the Treatment of Hospitalized Patients With COVID-19 |
Not yet recruiting |
Phase 2 |
2020-07-01 |
This is a proof of concept study to evaluate the efficacy of nitazoxanide (600 mg TID) to
treat hospitalized patients with non-critical COVID-19.
|
| NCT04425031 |
Handling Oxygenation Targets in COVID-19 |
Not yet recruiting |
Phase 4 |
2020-08-01 |
Patient 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 adults COVID-19 patients with hypoxaemic
respiratory failure at ICU admission.
|
| NCT04425538 |
A Phase 2 Trial of Infliximab in Coronavirus Disease 2019 (COVID-19). |
Recruiting |
Phase 2 |
2020-06-01 |
We 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 Elderly Renal Dialysis Patients |
Not yet recruiting |
Early Phase 1 |
2020-06-01 |
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 |
Not yet 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 |
Not yet recruiting |
Phase 2 |
2020-07-31 |
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 |
Phase 2 Study of the Efficacy and Safety of Intravenous Pamrevlumab, in Hospitalized Patients With Acute COVID-19 Disease |
Not yet recruiting |
Phase 2 |
2020-06-01 |
This is a Phase 2 trial to evaluate the efficacy and safety of intravenous (IV) infusions of
pamrevlumab as compared to placebo in hospitalized subjects 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 |
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). |
Not yet recruiting |
Phase 2 |
2020-06-26 |
This is a multicenter, randomized, double-blind, parallel group study to investigate the
efficacy of PB1046 by improving the clinical outcomes and increasing days alive and free of
respiratory failure 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 |
Not yet recruiting |
Phase 2 |
2020-06-01 |
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 |
Not yet recruiting |
Phase 2 |
2020-06-01 |
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) |
Recruiting |
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 3 |
2020-07-01 |
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, we 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.
Our 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: A Randomized-Controlled Trial |
Not yet recruiting |
N/A |
2020-06-01 |
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 |
Not yet recruiting |
Phase 2 |
2020-06-15 |
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) With SOC Versus SOC in Subjects With COVID-19 |
Not yet recruiting |
Phase 2 |
2020-08-01 |
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). |
Not yet 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 |
2020-06-22 |
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.
|
| 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 |
Recruiting |
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. We considered prasugrel 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 |
Protection of Health Workers Against COVID-19 |
Not yet recruiting |
Phase 2/Phase 3 |
2020-07-30 |
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 |
Not yet recruiting |
Phase 2 |
2020-07-01 |
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 |
Not yet recruiting |
Phase 2 |
2020-06-01 |
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). |
Not yet recruiting |
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 (Inhaled Epoprostenol Delivered Via Dedicated Delivery System) in Subjects With COVID-19 Requiring Mechanical Ventilation |
Not yet recruiting |
Phase 2 |
2020-07-31 |
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) |
Not yet recruiting |
Phase 3 |
2020-07-01 |
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 |
Afety and Efficacy of Tramadol 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 |
A Randomized Placebo-controlled Study to Evaluate STI-1499 (COVI-GUARD) in Hospitalized Patients With COVID-19 |
Not yet recruiting |
Phase 1 |
2020-08-01 |
Randomized, placebo-controlled study to evaluate the safety, pharmacokinetics, preliminary
efficacy of three dose levels of a single dose of STI-1499 (COVI-GUARD), a COVID-19 targeting
monoclonal antibody, in hospitalized patients with 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 But Are Able to Stay at Home |
Not yet recruiting |
Phase 2/Phase 3 |
2020-06-22 |
This is a phase II/III randomised, multi-centre, prospective, open label, community-based
clinical trial. The trial aims to recruit patients who test positive for COVID-19 but who
have mild disease and therefore can treat their symptoms in the community. Patients who seek
testing and have a confirmed positive test result will be invited to enrol in the trial.
|
| NCT04456153 |
Atovaquone for Treatment of COVID-19 |
Not yet recruiting |
Phase 2 |
2020-07-01 |
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 |
Recruiting |
Early Phase 1 |
2020-07-01 |
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 |
Recruiting |
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 |
Not yet recruiting |
Phase 2 |
2020-08-01 |
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 group. The 49 patients
in group 1 will receive the standard of care determined by their primary care providers while
the 49 patients 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 |
Not yet recruiting |
Phase 2/Phase 3 |
2020-07-06 |
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 With and Without Ribavirin in Treatment of COVID 19 |
Not yet recruiting |
Phase 2/Phase 3 |
2020-08-01 |
Sofosbuvir with and without ribavirin in treatment of COVID 19 Egyptian patients
|
| NCT04461340 |
Efficacy and Safety of Sirolimus in COVID-19 Infection |
Not yet recruiting |
Phase 2 |
2020-07-25 |
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 |
Recruiting |
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 |
Recruiting |
Phase 2 |
2020-08-01 |
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 |
Not yet recruiting |
Phase 2 |
2020-07-15 |
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) |
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 |
Not yet recruiting |
Phase 2 |
2020-08-01 |
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.
|
| 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 |
Not yet recruiting |
Phase 2 |
2020-08-07 |
Tofacitinib suppresses pro-inflammatory signaling that may be important pathogenetically to
progression to more severe lung disease and 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.
We 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 |
Active, not 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. 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 and Hazard
Regression 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
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 and Nigella Sativa in COVID-19 Patients |
Recruiting |
Phase 1/Phase 2 |
2020-07-14 |
To measure the effect of Ivermectin (sub-cutaneous) with or without zinc and Nigella sativa
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 |
Rapid Experimental Medicine for COVID-19 |
Recruiting |
Phase 2/Phase 3 |
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 |
Not yet recruiting |
Phase 2 |
2020-08-11 |
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 vs Standard Therapy in Severe-non Critical COVID-19 Adults |
Not yet recruiting |
Phase 2 |
2020-07-01 |
Phase 2, randomized, open-label study to compare the safety and efficacy of maraviroc,
favipiravir, and both drugs combined versus standard treatment in hospitalized patients with
pulmonary SARS-CoV-2 infection (COVID-19)
|
| NCT04476992 |
Nitric Oxide Therapy for COVID-19 Patients With Oxygen Requirement |
Not yet recruiting |
Phase 1/Phase 2 |
2020-07-17 |
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) |
Not yet recruiting |
Phase 2 |
2020-08-05 |
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 |
2020-07-29 |
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 |
2020-07-20 |
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 |
Not yet recruiting |
Phase 1/Phase 2 |
2020-10-01 |
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 |
Recruiting |
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
|
| NCT04484493 |
Corticosteroid Nasal Spray in COVID-19 Anosmia |
Not yet recruiting |
Phase 3 |
2020-08-01 |
The aim of this study is to evaluate the role of the topical corticosteroids nasal spray
(momentasonefuratenasal spray) in improving anosmia in patients recovered from COVID-19
infection.
|
| NCT04485130 |
DISulfiram for COvid-19 (DISCO) Trial |
Not yet recruiting |
Phase 2 |
2020-09-01 |
Disulfiram 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 test disulfiram 2000 mg/day for
3 consecutive days (doses shown to be well tolerated and safe in a recent phase 2b trial) in
60 symptomatic COVID PCR+ individuals in a randomized (1:1) clinical trial evaluating the
effect on COVID symptoms severity, SARS-CoV-2 viral load, and biomarkers of inflammation over
31 days.
|
| NCT04486313 |
Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19 |
Not yet recruiting |
Phase 3 |
2020-07-30 |
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 |
Not yet recruiting |
Phase 3 |
2020-07-30 |
In a 2x2 factorial design randomized controlled trial, we aim to investigate 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. We 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 |
Not yet recruiting |
Phase 2 |
2020-07-01 |
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 |
Not yet recruiting |
Phase 3 |
2020-07-01 |
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.
|
| NCT04488081 |
I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients |
Not yet recruiting |
Phase 2 |
2020-07-25 |
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 |
N/A |
2020-04-10 |
Beyond supportive care, there are currently no proven treatment options for coronavirus
disease (COVID-19). As mortality in patients with critical category is quite substantial,
hence every effort has to be made to intervene early and aggressively in order to prevent
progression of disease. Globally, approximately eight million confirmed cases of Covid-19
have been reported with an outcome based overall mortality of 5.51% In Pakistan, there is
exponential rise in Covid-19 cases in last few months. Nevertheless, data from various
international studies shows that 81% of patients have had mild to moderate disease, which
includes non-pneumonia and pneumonia cases. Management of mild disease is equally important
as this is the main bulk involved in transmission of disease to others. It is well known fact
that asymptomatic carriers and patients with mild disease are also the main sources of
disease transmissibility. Therefore, it is a matter of utmost importance to detect mild cases
earlier and start some investigational treatment in carefully selected hospitalized patients.
Different investigational treatment options have been tried in different severity categories
of COVID-19. Out of many therapeutic off-label options, HCQ seems more suitable owing to its
known safety profile, side effects, posology and drug interactions6. HCQ has been found to
have good in vitro activity against SARS-CoV-2and better safety profile than chloroquine. A
small study on 36 patients shows that hydroxychloroquine (HCQ) treatment is significantly
associated with viral load reduction/disappearance in COVID-19 patients. Similarly, it has
been hypothesized that HCQ might inhibit cytokine storm by reducing CD154 expression in T
cells, thus reducing chances of disease progression.
|
| NCT04492254 |
Early Prophylactic Low-molecular-weight Heparin (LMWH) in Symptomatic COVID-19 Positive Patients |
Not yet recruiting |
Phase 3 |
2020-07-01 |
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(+) |
Not yet recruiting |
Phase 2 |
2020-08-20 |
Phase IIa clinical trial in which 75 non-ICU hospital inpatients will be randomized 2:1 to 7
days of Neoral (2.5mg/kg PO BID) + standard of care (SOC) or no CSA + 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.
|
| NCT04494646 |
BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19) |
Not yet recruiting |
Phase 2/Phase 3 |
2020-08-01 |
This multi-center, double-blind, placebo-controlled, randomized Phase 2/3 trial will study
the safety, tolerability, and efficacy of bardoxolone methyl in approximately 400-440
patients hospitalized with confirmed COVID-19. The Phase 2 portion of the trial will include
approximately 40 patients and is designed to provide an early interim analysis of safety. The
Phase 3 portion of the trial will include approximately 360-400 additional patients, and is
designed to determine whether bardoxolone methyl increases the probability of recovery at Day
29 when compared with matching placebo. Patients will be randomized using permuted block
randomization in a 1:1 fashion to either once-daily administration of bardoxolone methyl (20
mg) or matching placebo and treatment will be administered for the duration of
hospitalization (until recovery), with a maximum treatment duration of 29 days.
|
| 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 |
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 |
Not yet recruiting |
Phase 1 |
2020-07-31 |
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 40-79 |
Not yet recruiting |
Phase 3 |
2020-08-01 |
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 |
Recruiting |
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 |
Recruiting |
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 |
2020-08-01 |
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 |
Not yet recruiting |
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 |
Not yet recruiting |
Phase 3 |
2020-08-30 |
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 |
Recruiting |
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 |
Not yet recruiting |
Phase 2 |
2020-08-01 |
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 |
Anti-thrombotics for Adults Hospitalized With COVID-19 |
Not yet recruiting |
Phase 4 |
2020-08-01 |
This is a randomized, open label, adaptive platform trial to compare the effectiveness of
antithrombotic 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 |
Not yet recruiting |
Phase 3 |
2020-08-17 |
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 |
Not yet recruiting |
Phase 2/Phase 3 |
2020-09-01 |
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 |
Not yet recruiting |
Phase 3 |
2020-08-01 |
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 Anticoagulation Strategy Randomized Trial |
Not yet recruiting |
Phase 4 |
2020-09-01 |
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. (1) 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 (2). 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 |
A Practical, Pilot, Randomized, Controlled Trial of Valproate Alone or in Combination With Quetiapine for Severe COVID-19 Pneumonia With Agitated Delirium |
Not yet recruiting |
Phase 4 |
2020-09-01 |
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.
|
| NCT04514302 |
Safety and Efficacy of Anti-SARS-CoV-2 Equine Antibody Fragments (INOSARS) for Hospitalized Patients With COVID-19 |
Not yet recruiting |
Phase 1/Phase 2 |
2020-10-20 |
This is a two-center, randomized, placebo-controlled pilot study of anti-SARS-CoV-2 equine
immunoglobulin fragments F(ab')2 (INOSARS) to evaluate safety and preliminary efficacy in the
treatment of hospitalized COVID-19 patients. Clinical improvement at 28 days from the start
of treatment will be evaluated.
|
| NCT04516759 |
AZD1656 in Diabetic Patients Hospitalised With Suspected or Confirmed COVID-19 |
Not yet recruiting |
Phase 2 |
2020-08-01 |
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) |
Not yet recruiting |
Phase 2 |
2020-08-01 |
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)
|
| 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.
|
| 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 |
Not yet recruiting |
Phase 2/Phase 3 |
2020-08-19 |
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, antidiabetics drugs, antiretroviral agents, steroids or commonly prescribed
analgesics / anti-inflammatory agents.
We 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 > 50 years and/ or
with comorbidity). We will perform a randomised controlled trial enrolling 960 patients with
mild disease. The primary outcome measure will be the proportion progressing to severe
disease (hospitalisation) based on the WHO clinical progression scale (progression to 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 |
A Phase 2 Randomized, Double-blind, Placebo-controlled, Proof of Concept Study to Evaluate the Safety and Efficacy of Antroquinonol in Hospitalized Patients With Mild to Moderate Pneumonia Due to COVID-19 |
Not yet recruiting |
Phase 2 |
2020-09-07 |
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.
|
| NCT04523831 |
Clinical Trial of Ivermectin Plus Doxycycline for the Treatment of Confirmed Covid-19 Infection |
Recruiting |
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 |
Not yet recruiting |
N/A |
2020-09-01 |
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.
|
| 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 |
Not yet recruiting |
Phase 2 |
2020-08-01 |
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 |
Not yet recruiting |
Phase 2 |
2020-09-01 |
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 |
Not yet recruiting |
Phase 3 |
2020-09-01 |
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 |
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.
|
| NCT04530617 |
Camostat and Artemisia Annua vs Placebo in COVID-19 Outpatients |
Not yet recruiting |
Phase 2 |
2020-08-01 |
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 |
Not yet recruiting |
Phase 2 |
2020-09-01 |
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 |
Not yet recruiting |
Phase 1/Phase 2 |
2020-09-18 |
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 |
Not yet recruiting |
Phase 4 |
2020-08-26 |
The use of growth hormone in obese cases with COVID-19 may help them to recover earlier.
|
| NCT04533347 |
A Double-blind Placebo-controlled Study to Assess the Efficacy and Safety of Oral Tafenoquine Versus Placebo in Patients With Mild to Moderate COVID-19 Disease |
Not yet recruiting |
Phase 2 |
2020-10-01 |
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) |
Not yet recruiting |
Phase 3 |
2020-09-01 |
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 |
Not yet recruiting |
Phase 4 |
2020-09-07 |
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 |
Not yet recruiting |
Phase 1 |
2020-09-11 |
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) |
Not yet recruiting |
Phase 3 |
2020-09-04 |
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 |
2020-11-01 |
This is an open-label, randomized, multi-centre pilot 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 Prevention of COVID-19 Related ARDS |
Not yet recruiting |
Phase 1 |
2020-09-01 |
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) |
Not yet recruiting |
Phase 3 |
2020-09-21 |
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 |
Not yet 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 |
2020-09-01 |
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 |
Not yet recruiting |
Phase 2 |
2020-09-01 |
The purpose of this study is to assess the safety and efficacy of orally-administered
dapansutrile capsules for the treatment of moderate COVID-19 symptoms and evidence of early
cytokine release syndrome.
|
| 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 |
Not yet recruiting |
Phase 3 |
2020-09-01 |
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 |
Open-label Randomized 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.
|
| 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 |
Not yet recruiting |
Phase 2 |
2020-10-01 |
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 |
Not yet recruiting |
Phase 3 |
2020-12-01 |
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: 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: nitazoxanide 500mg 8 / 8 hours for 5 days. Control group: 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 |
2020-09-28 |
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 |
Active, not recruiting |
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.
- We plan to 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. We believe that acute PE in the setting of active COVID-19
infections likely portend a poor prognosis.
- Prospective, multicenter, randomized two-arm trial enrolling consecutive patients who
meet enrollment criteria.
- We hope to 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 |
Not yet recruiting |
Phase 4 |
2020-09-30 |
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) |
Not yet recruiting |
Phase 2 |
2020-12-01 |
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 |
Active, not recruiting |
Phase 2 |
2020-04-19 |
Multicenter, randomized, placebo-controlled, parallel, blinded, interventional, treatment
clinical trial with two arms.
Population: 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.
|
| 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 |
Recruiting |
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 |
Not yet recruiting |
Phase 2 |
2020-09-28 |
Prospective, Randomized, Double-Blind, Placebo-Controlled Phase II Trial of 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-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 |
Not yet recruiting |
Phase 3 |
2020-11-01 |
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.
|
| 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) |
Not yet recruiting |
Phase 2 |
2020-10-10 |
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.
|
| NCT04576312 |
Study to Assess the Safety of Ascending Doses of UNI911 INHALATION in Healthy Volunteers in Preparation for Evaluation in Adults With COVID-19 |
Recruiting |
Phase 1 |
2020-06-29 |
This is a Phase 1 Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to
Assess the Safety of Ascending Doses of UNI911 INHALATION in Healthy Volunteers in
Preparation for Evaluation in Adults with COVID-19
|
| NCT04576728 |
Efficacy and Safety of Trimodulin in Subjects With Severe COVID-19 |
Not yet recruiting |
Phase 2 |
2020-10-01 |
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.
|
| 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 |
Recruiting |
Phase 2 |
2020-10-12 |
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 (like the flip of a coin), to take either fostamatinib
pills or a placebo (sugar pill) 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 |
Big Effect Trial (BET-A) for the Treatment of COVID-19 |
Not yet recruiting |
Phase 2 |
2020-10-30 |
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 40 sites throughout the US. 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 100 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 |
Big Effect Trial (BET-B) for the Treatment of COVID-19 |
Not yet recruiting |
Phase 2 |
2020-10-30 |
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 40 sites throughout the US. 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 100 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 |
Not yet recruiting |
Phase 2 |
2020-10-01 |
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 |
Not yet recruiting |
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 |
Not yet recruiting |
Phase 2 |
2020-10-01 |
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 |
Not yet recruiting |
Phase 2/Phase 3 |
2020-10-30 |
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 |
Not yet recruiting |
Phase 2/Phase 3 |
2020-10-19 |
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 |
Not yet recruiting |
Phase 2 |
2020-10-01 |
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 |
A Randomized, Double-blind, Placebo-controlled Safety and Clinical Outcomes Study of Disulfiram in Subjects With Moderate COVID-19 |
Not yet recruiting |
Phase 2 |
2020-10-01 |
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 |
Not yet recruiting |
Phase 3 |
2020-11-15 |
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. We
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 Hospitalized Coronavirus-19 (COVID-19) Patients |
Recruiting |
Phase 2/Phase 3 |
2020-10-07 |
Study of ANA001 in Moderate COVID-19 Patients
|
| NCT04604223 |
Effect of Pioglitazone on T2DM Patients With COVID-19 |
Not yet recruiting |
Phase 4 |
2020-11-15 |
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 |
2020-11-01 |
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 |
Not yet recruiting |
Phase 2 |
2020-11-01 |
Pilot study into low dose naltrexone (LDN) and NAD+ for treatment of patients with
post-COVID-19 syndrome.
|
| NCT04606069 |
Treat COVID-19 Patients With Regadenoson |
Not yet recruiting |
Phase 1/Phase 2 |
2020-11-01 |
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 |
Randomized, Double-Blind, Placebo-Controlled Study of ZnAg to Treat COVID-19 Symptomatic Participants |
Not yet recruiting |
Phase 2 |
2020-12-01 |
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.
|
| 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, the REHSCU Study |
Not yet recruiting |
Phase 2 |
2020-11-01 |
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 |
CardiolRx™ in Patients With COVID-19 and Cardiovascular Disease or Risk Factors |
Not yet recruiting |
Phase 2/Phase 3 |
2020-12-01 |
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 Will Evaluate the Use of Nintedanib in Slowing Lung Fibrosis in Patients With Pulmonary Infiltrates Related to COVID |
Recruiting |
Phase 4 |
2020-11-01 |
This is a collaborative study between Icahn School of Medicine at Mount Sinai and Boehringer
Ingelheim Pharmaceuticals to determine the effect of Nintedanib on slowing the rate of lung
fibrosis 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 |
Not yet recruiting |
Phase 2 |
2020-11-09 |
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 |
Hydroxychloroquine, Azithromycin and Zinc for the Treatment of COVID-19 in the Outpatient Setting |
Not yet recruiting |
Phase 4 |
2020-11-01 |
This is a randomized, double-blind, placebo-controlled trial to assess the safety and
efficacy of hydroxychloroquine, azithromycin and 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. |
Not yet recruiting |
Phase 3 |
2020-11-17 |
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 |
Not yet recruiting |
Phase 3 |
2020-11-16 |
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 |
Not yet recruiting |
Phase 2 |
2020-11-20 |
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
|
| NCT04631536 |
Managing Endothelial Dysfunction in COVID-19 : A Randomized Controlled Trial at LAUMC |
Not yet recruiting |
Early Phase 1 |
2020-11-10 |
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 |
Not yet recruiting |
Phase 1 |
2020-11-16 |
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 |
Not yet recruiting |
Phase 3 |
2020-11-01 |
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 |
Phase I/II for the Use of Angiotensin-(1-7) in COVID-19 |
Recruiting |
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 |
2020-11-16 |
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 Infection |
Recruiting |
Phase 1 |
2020-11-10 |
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 infection.
COVID-19 infection 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 |
2020-11-01 |
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 and kidneys 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) |
Not yet recruiting |
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.
|
| NCT04646603 |
MRG-001 as an Immunoregulatory and Regenerative Therapy for COVID-19 Patients |
Not yet recruiting |
Phase 1/Phase 2 |
2021-01-05 |
The Study is Designed as A Combined Phase I Double-Blind Randomized Placebo controlled/IIa,
Randomized, Double-blind, Placebo controlled, Multi-center Study to Assess the Safety,
Pharmacokinetics, Pharmacodynamics and Efficacy of MRG-001 in Subjects Infected with
SARS-CoV-2.
Part A: To determine the safety and tolerability, pharmacokinetics (PK) and pharmacodynamics
(PD) profiles of MRG-001 in asymptomatic SARS-CoV-2 infected subjects.
Part B: To determine the safety and efficacy profile of MRG-001 in patients with
moderate-to-severe COVID-19. A total of 132 subjects will be enrolled and randomized in 1:1
ratio to receive MRG-001 or placebo. All subjects will be treated with the best available
treatment. The follow-up period is up to 28 days.
|
| 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 |
Not yet recruiting |
Phase 3 |
2020-12-01 |
A multicenter, adaptive, randomized platform trial evaluating the efficacy and safety of
antithrombotic strategies in patients with COVID-19 following hospital discharge
|
| NCT04652115 |
A Single-Arm Safety and Feasibility Study of Defibrotide for the Treatment of Severe COVID-19 |
Not yet 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 |
PureTech Phase 2 Study of LYT-100 in Post-acute COVID-19 Respiratory Disease |
Not yet recruiting |
Phase 2 |
2020-12-01 |
This study 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
|
| 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 |
Not yet recruiting |
Phase 2/Phase 3 |
2020-12-04 |
Sequential randomized, multicenter, active comparator study to evaluate the hypothesis that
rNAPc2, 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 Diffuse Lung Disease |
Recruiting |
N/A |
2020-12-10 |
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, we 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, Tolerability and Efficacy of Allocetra-OTS in Patients With COVID-19 |
Not yet recruiting |
Phase 1 |
2021-03-01 |
Phase 1b, multi-center, single-blinded, randomized, placebo-controlled study, evaluating
safety, tolerability and efficacy of different doses and regimens of Allocetra-OTS, in up to
50 adult patients with critical COVID-19.
|
| NCT04659707 |
Hyperpolarized 129Xe MRI of Survivors of COVID-19 |
Not yet recruiting |
Phase 1 |
2021-01-01 |
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 |
Not yet recruiting |
Phase 2 |
2021-01-01 |
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 |
Not yet recruiting |
Phase 2 |
2021-01-01 |
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 |
Not yet recruiting |
Phase 2 |
2021-01-01 |
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 |
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 |
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 |
2020-12-31 |
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 |
Recruiting |
Phase 3 |
2020-12-10 |
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 |
2020-12-15 |
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.
|
| NCT04668235 |
Study on Safety and Clinical Efficacy of AZVUDINE in COVID-19 Patients (SARS-CoV-2 Infected) |
Not yet recruiting |
Phase 3 |
2020-12-01 |
Estimated number of participants: 342 participants with COVID-19 Design: Phase III,
single-center, randomized, double-blind, parallel, placebo-controlled clinical study.
|
| 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, a Randomized Clinical Trial |
Recruiting |
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
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| NCT04678830 |
COVID-19 Long-Haulers Study |
Not yet recruiting |
Phase 2 |
2020-12-21 |
The purpose of this study is to assess the safety and efficacy of leronlimab (PRO 140)
administered as weekly subcutaneous injection in subjects experiencing prolonged symptoms (>
6 weeks) of COVID-19.
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| NCT04680949 |
suPAR-Guided Anakinra Treatment for Management of Severe Respiratory Failure by COVID-19 |
Not yet recruiting |
Phase 3 |
2020-12-21 |
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).
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| NCT04681430 |
Reconvalescent Plasma/Camostat Mesylate Early in SARS-CoV-2 Q-PCR (COVID-19) Positive High-risk Individuals |
Not yet recruiting |
Phase 2 |
2021-01-01 |
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.
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| 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.
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| 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.
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| NCT04695197 |
Malaria as a Risk Factor for COVID-19 in Western Kenya and Burkina Faso |
Not yet 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.
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| NCT04705597 |
Study to Evaluate the Safety, Tolerability, and Efficacy of BGE-175 in Participants ≥ 60 Years of Age and Hospitalized With Coronavirus Disease 2019 (COVID-19) That Are Not in Respiratory Failure |
Not yet recruiting |
Phase 2 |
2021-02-01 |
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy
of BGE-175 in participants ≥ 60 years of age hospitalized with documented COVID-19.
|
| NCT04707534 |
Dexamethasone for COVID-19 |
Not yet recruiting |
Phase 4 |
2021-01-11 |
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.
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| NCT04707664 |
Sargramostim Use in COVID-19 to Recover Patient Health (SCOPE) |
Not yet recruiting |
Phase 2 |
2021-02-01 |
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 and hospitalization related to COVID-19 or death.
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| NCT04707703 |
Isavuconazole for the Prevention of COVID-19-associated Pulmonary Aspergillosis |
Not yet recruiting |
Phase 3 |
2021-01-01 |
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).
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| NCT04708340 |
Tolerability and Efficacy of RJX in Patients With COVID-19 |
Not yet recruiting |
Phase 1/Phase 2 |
2021-02-01 |
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.
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| NCT04709172 |
Pilot Study of Cefditoren Pivoxil in COVID-19 Patients With Mild to Moderate Pneumonia |
Recruiting |
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.
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| NCT04710199 |
Trial to Evaluate the Safety and Efficacy of Maraviroc in Patients Hospitalized for Coronavirus Disease 2019 (COVID-19) |
Not yet recruiting |
Phase 2 |
2021-02-01 |
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 |
Not yet recruiting |
Phase 2 |
2021-01-15 |
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.
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| 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.
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| 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.
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| NCT04715932 |
Study of Hesperidin Therapy on COVID-19 Symptoms (HESPERIDIN) |
Not yet recruiting |
Phase 2 |
2021-01-21 |
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.
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| 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 |
Not yet recruiting |
N/A |
2021-01-01 |
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.
APT™ T3X is an FDA Registered, Over-the-Counter (non-prescription) ointment. 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.
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