COVID-19 Clinical Trial
Official title:
Efficacy and Safety of Favipiravir Compared to the Base Therapeutic Regiment in Moderate to Severe COVID-19: A Randomized, Controlled, Double-Blind, Clinical Trial
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.
Favipiravir, previously known as T-705, is a prodrug of a purine nucleotide, favipiravir
ribofuranosyl-5'-triphosphate. The active agent inhibits the RNA polymerase, halting viral
replication. Most of favipiravir's preclinical data are derived from its influenza and Ebola
activity; however, the agent also demonstrated broad activity against other RNA viruses. In
vitro, the 50% effective concentration (EC50) of favipiravir against severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) was 61.88 μM/L in Vero E6 cells.
Limited clinical experience has been reported supporting the use of favipiravir for COVID-19.
In a prospective, randomized, multicenter study, favipiravir (n = 120) was compared with
Arbidol (n = 120) for the treatment of moderate and severe COVID-19 infections. Differences
in clinical recovery at day 7 were observed in patients with moderate infections (71.4%
favipiravir and 55.9% Arbidol, P = .019). No significant differences were observed in the
severe or severe and moderate (combined) arms.73 These data support further investigation
with randomized clinical trials (RCTs) of the efficacy of favipiravir for the treatment of
COVID-19.
Chloroquine has been a broadly-utilized anti-malaria agent which back in 2006, had been
proved to be a powerful wide-spectrum antiviral. Moreover, Chloroquine has the
characteristics of anti-inflammatory and immune-modulatory by inhibiting the production of
tumor necrosis factor alpha (TNF-α) along with interleukin 6 (IL-6). In the first half of
February, a study illustrated puissant inhibition of SARS-CoV-2 by Chloroquine, when taking
two 500-mg tablets of it by mouth per day; similar to some clinical studies in China through
this outbreak. According to the news briefing of a study, it was indicated that chloroquine
phosphate actually outdo the control treatment in inhibition of pneumonia exacerbation,
improving lung imaging findings, and curtailing the disease course. Another study evaluated
the possible doses of chloroquine (CQ) and hydroxychloroquine (HCQ) to find the optimized
dose in treatment of COVID-19. They revealed that while within in-vitro settings
Hydroxychloroquine is more potent than chloroquine. As a conclusion, they suggested a 800 mg
daily dose of hydroxychloroquine, followed by an overall maintenance dose of 400 mg per day
divided in two separate doses, which was three-fold more potent compared to the 500 mg twice
daily administration of chloroquine in 5 days. The new study published in 16th March, pointed
out that hydroxychloroquine was notably effectual in eradicating SARS-CoV-2 from the
nasopharynx. Currently the evidence is quite inconclusive about the effectiveness or
comparative effectiveness of either HCQ or CQ. Moreover, CQ has recently become scarce and
even unavailable for ordering due to a huge demand for it, all because of a significant
interest gained as a potential medicinal alternative for the management of COVID-19. In spite
of all, the primary experience in China and France is propitious for the potential role of
chloroquine, or alternatively hydroxychloroquine, for managing COVID-19.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT06065033 -
Exercise Interventions in Post-acute Sequelae of Covid-19
|
N/A | |
Completed |
NCT06267534 -
Mindfulness-based Mobile Applications Program
|
N/A | |
Completed |
NCT05047601 -
A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection
|
Phase 2/Phase 3 | |
Recruiting |
NCT04481633 -
Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection
|
N/A | |
Recruiting |
NCT05323760 -
Functional Capacity in Patients Post Mild COVID-19
|
N/A | |
Completed |
NCT04537949 -
A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults
|
Phase 1/Phase 2 | |
Completed |
NCT04612972 -
Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru
|
Phase 3 | |
Recruiting |
NCT05494424 -
Cognitive Rehabilitation in Post-COVID-19 Condition
|
N/A | |
Active, not recruiting |
NCT06039449 -
A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2
|
Phase 3 | |
Enrolling by invitation |
NCT05589376 -
You and Me Healthy
|
||
Completed |
NCT05158816 -
Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
|
||
Recruiting |
NCT04341506 -
Non-contact ECG Sensor System for COVID19
|
||
Completed |
NCT04384445 -
Zofin (Organicell Flow) for Patients With COVID-19
|
Phase 1/Phase 2 | |
Completed |
NCT04512079 -
FREEDOM COVID-19 Anticoagulation Strategy
|
Phase 4 | |
Completed |
NCT05975060 -
A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT05542862 -
Booster Study of SpikoGen COVID-19 Vaccine
|
Phase 3 | |
Terminated |
NCT05487040 -
A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
|
Phase 1 | |
Withdrawn |
NCT05621967 -
Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation
|
N/A | |
Terminated |
NCT04498273 -
COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
|
Phase 3 | |
Active, not recruiting |
NCT06033560 -
The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure
|