Trial NCT04694612
Publication Adhikari P, Int J Infect Dis (2022)

Funding: Not reported/unclear
Conflict of interest: *

Methods
RCT
Blinding: Unblinded
Location : Multicenter / Nepal
Follow-up duration (days): *
Inclusion criteria
  • 18-80 years old
  • RT-PCR confirmed patients with mild COVID-19 infection (If a patient is COVID19 positive based on Antigen test, they can participate in the trial while awaiting result form PCR test with Ct-value)
  • Within 6 days of onset of symptoms
  • Signed informed consent provided by patient's or patient's healthcare proxy
  • Willing to practice celibacy OR take contraception during the study & within 7 days after treatment
  • Mild clinical condition with at least 3 of these of these symptoms: fever, cough, malaise/headache
Exclusion criteria
  • Pregnant (female of childbearing age with positive urine pregnancy test) or miscarriage or within 2 weeks after delivery
  • Severe or critical clinical condition as per NMC clinical guideline for COVID19
  • Chronic liver with ALT/AST increased 5 times higher than the upper limit of normal or with Child Pugh C
  • Creatinine clearance (Cockcroft-Gault Equation) < 30 ml/min or having hemodialysis/peritoneal dialysis
  • Known allergy or hypersensitivity to Favipiravir
  • Gout or history of gout or hyperuricemia two times the upper limit of normal
  • If using Remdesivir, Lopinavir-ritonavir, Hydroxychloroquine or any other antiviral drug with potential effect against SARS-CoV-2 virus
  • Lactating female
  • Asymptomatic COVID-19 cases
  • Mild COVID-19 cases not meeting the inclusion criteria symptoms
Interventions
Treatment
Favipiravir
Initial dose: 1800 mg orally twice on day 1 -Maintenance dose: 800 mg orally 2 times a day from day 2 until day 5.
Control
Placebo

Participants
Randomized
participants :
Favipiravir=38
Placebo=32
Characteristics of participants
N= 70
Mean age : NR
0 males
Severity : Mild: n=70 / Moderate: n=0 / Severe: n=0 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Clinical improvements in mild cases [Time Frame: 5 day]: Time to clinical improvements is defined as recovery in two out of the three common symptoms that includes fever (body temperature more than 99.5 degrees F), cough, and headache/malaise (scored more than 3 in a pain likert scale of 1 to 10).
In the report
Clinical improvement
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

Not reported
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment Only the published abstract and registry were used in data extraction and risk of bias assessment. There was no protocol or statistical analysis plan available. This was a preliminary data analysis.