Efficacy of Favipiravir in Treatment of Mild & Moderate COVID-19 Infection in Nepal
Status:
Recruiting
Trial end date:
2021-05-31
Target enrollment:
Participant gender:
Summary
COVID-19 has affected almost all countries in the world. Every other country is constantly
working towards its treatment and development of vaccines, with little to no success so far.
Recently, several regimens have been tried as antiviral medicine. Among these medicines,
Favipiravir is considered a broad-spectrum antiviral with the spectrum of activity noted
against a wide range of RNA viruses & a good oral antiviral drug with > 97% bioavailability.
It has already proved its safety profile as it has received FDA indication for drug-resistant
Influenza. There has been increasing evidence of favorable outcome against COVID-19 in terms
of early viral clearance & quicker symptomatic relief however, most of these studies lack
strong statistical significance & are not peer-reviewed. Subjects will be categorized into
two arms based on the severity of infection due to COVID-19 defined by NMC guidelines. Each
arm will have respective two groups as the study drug group and control group. Based on the
sample size calculation, subjects will be stratified & randomly enrolled in the study after
checking the eligibility criteria at the screening visit. About 276 mild patients will be
recruited for this trial and 400 moderate patients (including 10% loss ). Study arm groups
will receive a Favipiravir treatment of 1800 mg PO BID on day 1, then 800 mg PO BID from day
2 onwards and control groups will receive the same quantity of Placebo. Treatment will be
continued till 5 days after for mild groups and 10 days for moderate groups. Eligible
patients will be randomly assigned (1:1) to either Favipiravir or Placebo among mild cases;
and Favipiravir or Remdesivir among moderate cases. Randomization will be stratified by age
group (18 to 40 years, 40 to 60 years and 60 to 80 years) and co-morbidity. The permuted
block (30 patients per block) randomization sequence, including stratification, will be
prepared by a statistician using STATA-15 software. Eligible patients will be allocated to
the respective arm and will receive individually numbered packs, according to the sequence
order as informed by the hotline. Informed written consent will be taken from the
participants before commencing the study. All safety data, patient's baseline, clinical
outcome data, data from endpoints and variables should be reported by the clinician and
his/her team in a pre-instructed case report form (CRF) via a designated website.
It is our assumption that if the study results come favorable, Favipiravir, when used in mild
or moderate cases, might prevent progression of the disease to higher severity, helps achieve
viral clearance early so as to positively impact disease transmission in the community,
increase the quality of life by quicker symptom recovery & decrease health burden by
shortening the length of stay at the hospital. These findings can also be useful in
international scenarios where the world is looking for innovative measures to curb COVID-19
infection. The study findings will be disseminated within and outside the country and will be
published in peer-reviewed journals.