Trial NCT04346628
Publication Holubar M, Clin Infect Dis (2022) (published paper)
Dates: 2020-07-08 to 2021-03-23
Funding: Public/non profit (Anonymous donors to Stanford University)
Conflict of interest: No

Methods
RCT
Blinding: double blinding
Location : Single center / USA
Follow-up duration (days): 28
Inclusion criteria
  • Asymptomatic or symptomatic
  • adults
  • without respiratory distress
  • positive SARS-CoV-2 RT-PCR collected within 72 hours of enrollment
Exclusion criteria
  • Individuals who required renal replacement therapy
  • liver impairment
  • immunocompromised or taking immunosuppressing medications
  • pregnant or breast-feeding
Interventions
Treatment
Favipiravir
Initial dose: 1800 mg orally twice a day on day 1 - Maintenance dose: 800 mg orally twice a day on days 2-10.
Control
Placebo

Participants
Randomized
participants :
Favipiravir=75
Placebo=74
Characteristics of participants
N= 149
Mean age : NR
66 males
Severity : Mild: n= 135/ Asymptomatic: n=14
Number of vaccinated participants: NR
Primary outcome
In the register
Time until cessation of oral shedding of SARS-CoV-2 virus [ Time Frame: Up to 28 days ] Time in days from randomization to the first two negative results of nasal and/or oropharyngeal swab.
In the report
SARS-CoV-2 shedding cessation, defined as the time from enrollment to the first of two consecutive negative nasal RT-PCRs
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 preprint and published articles, the supplemental data and study registry were used in data extraction and risk of bias assessment. The protocol and statistical analysis plan were not available. The registry primary outcome reflects the reported primary outcome. Some outcomes (e.g. mortality, hospitalization, adverse events) are reported in the paper, but were not pre-specified in the trial registry. The trial (n = 149) achieved its original target sample size (n = 120), but with 116 PCR-positive patients (days 1-3) did not achieve the amended target sample size for PCR-positive patients (n = 120).
This study was updated on May 11th, 2022 with data extracted from the final published report.
This study was updated on August 8th, 2022 with data obtained from contact with authors.
This study was updated on November 4th, 2022 with data extracted from the registry.