| 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
|
| 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.
|
| 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).
|
| 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.
|
| 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.
|
| 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.
|
| 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.
|
| 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
|
