Covid-19 Living Data

Trial NCT04358549
Publication Finberg RW, Open Forum Infect Dis (2021) (published paper)
Dates: 2020-04-17 to 2020-10-30
Funding: Mixed (US Army Medical Research and Development Command (USAMRDC); FUJIFULM Pharmaceuticals USA, Inc)
Conflict of interest: Yes

Methods
	RCT Blinding: Unblinded
	Location : Multicenter / USA Follow-up duration (days): 60
Inclusion criteria	Hospitalized adults (age 18–80 years) with a SARS-CoV-2 PCR-positive nasopharyngeal or oropharyngeal test (within 72 hours of their hospitalization and within 7 days of the first positive PCR for SARS-CoV-2) later addition to the protocol specified that patients needed to have symptom onset within 10 days of presentation
Exclusion criteria	Taking other antivirals (including remdesivir) taking steroids (except for a topical or inhaled preparation or the equivalent of >10mg of prednisone) - Beginning in July 2020 with the report of the results of the Randomized Evaluation of COVID-19 Therapy (RECOVERY) trial, dexamethasone at 6mg daily was permitted receiving immune plasma or taking immunosuppressive or immunomodulatory drugs (including anticancer drugs, interleukins, interleukin antagonists, or interleukin receptor blockers) serious chronic diseases, including moderate or severe hepatic disease, and/or unstable renal, cardiac, pulmonary, neurologic, vascular, or endocrinologic diseases requiring medication dose changes within the last 30 days patients with glomerular filtration rates >20mL/min or requiring hemodialysis/continuous ambulatory peritoneal dialysis, liver impairment greater than Child-Pugh A uncontrolled psychiatric disease or a history of alcohol or drug abuse in the previous 6 months requiring mechanical ventilators at entry
Interventions
	Treatment Favipiravir Initial dose 1800 mg orally twice daily - Maintenance dose 1000 mg orally twice daily days 2-14 (800mg twice daily for patients with child-pugh-A liver disease)
	Control Standard care
Participants
	Randomized participants : Favipiravir=25 Standard care=25
	Characteristics of participants N= 50 Mean age : NR 30 males Severity : Mild: n=15 / Moderate: n=31 / Severe: n=4 Critical: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register Time to viral clearance [ Time Frame: Day 29 ]
	In the report Time to viral clearance
Documents available	Protocol Yes. In English Statistical plan Yes 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	In addition to the published article, the trial registry, protocol, statistical analysis plan and supplementary appendices were used in data extraction and assessment of risk of bias. The primary outcome in the published article reflected that in the registry and protocol. Several secondary outcomes reported in the article were not included in the registry, but were in the protocol. The trial achieved its target sample size. Incidence of viral negative conversion was a cumulative outcome reported by authors until day 8. The study was updated on April 13th, 2022 with data acquired after contact with authors. On November 4th, 2022, this study was updated with the results published on CT.gov.