Trial NCT04445467
Publication VIRCO - McMahon JH, EClinicalMedicine (2022) (published paper)
Dates: 2020-07-31 to 2021-09-19
Funding: Mixed (The study was supported in part by grants from the Commonwealth Bank Australia, the Lord Mayor’s Charitable Foundation, Melbourne Australia and the Orloff Family Charitable Trust, Melbourne, Australia. JHM is supported by the Medical Research Future Fund, AYP, JT are supported by the Australian National Health and Medical Research Council.)
Conflict of interest: No

Methods
RCT
Blinding: triple blinding
Location : Single center / Australia
Follow-up duration (days): 28
Inclusion criteria
  • adults ≥18 years old
  • with PCR confirmed COVID-19 on nasopharyngeal or combined nose and throat swab
  • onset of COVID-19 related symptoms (one or more of: fever, cough, sore throat, shortness of breath, fatigue, myalgia) in the prior 5 days.
Exclusion criteria
  • enrolled into another COVID-19 antiviral treatment trial
  • were pregnant or breastfeeding. Female participants of childbearing potential were required to have a negative pregnancy test prior to enrolment
  • chronic liver disease (Child-Pugh C)
  • renal impairment requiring dialysis.
Interventions
Treatment
Favipiravir
Initial dose: 1800 mg orally on day 1 -Maintenance dose: 800 mg orally 2 times a day for 14 days
Control
Placebo

Participants
Randomized
participants :
Favipiravir=99
Placebo=100
Characteristics of participants
N= 199
Mean age : NR
109 males
Severity : Mild: n= 198/ Asymptomatic: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Time to virological cure [Time Frame: 14 days]: Time to 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing.
In the report
time to virological cure as defined by 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by PCR.
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing willing stated in the publication:

Yes
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 In addition to the published article, its supplement and the preprint, the study registry and protocol were used in data extraction and risk of bias assessment. The study achieved the target sample size specified in the trial registry and protocol. There is no change from the trial registration in the intervention and control treatments. The registry primary outcome reflects the reported primary outcome.