Covid-19 Living Data

Trial NCT04464408
Publication Bosaeed M, Clin Microbiol Infect (2022) (published paper)
Dates: 2020-07-23 to 2021-08-04
Funding: Public/non profit (King Abdullah International Medical Research Center (KAIMRC).)
Conflict of interest: No

Methods
	RCT Blinding: double blinding
	Location : Multicenter / Saudi Arabia Follow-up duration (days): 28
Inclusion criteria	18 years and above, from community settings diagnosed with mild COVID-19 (confirmed by positive PCR test for SARS2-CoV) enrolled within 5 days of disease onset (mild COVID-19 case defined as a patient with mild illness (with or without respiratory symptoms), oxygen saturation >94% at room air, and can be managed at home with appropriate therapy)
Exclusion criteria	hospitalized moderate or severe COVID-19 cases pregnant or breastfeeding females those who used favipiravir or participated in other interventional drugs clinical study within 30 days prior to the first dose of the study treatment hematologic malignancy, advanced (stage 4-5) chronic kidney disease (including dialysis therapy), severe liver damage (Child-Pugh score C or AST> 5 times the upper limit), HIV patients with history of gout or hyperuricemia (two times above the upper limit of normal) patients with sensitivity/allergy to favipiravir cases with clinical prognostic non-survival, palliative care, or in a deep coma
Interventions
	Treatment Favipiravir Initial dose: 1800 mg twice daily (9 tablets) Maintenance dose: 800 mg twice daily (4 tablets) for 5-7 days
	Control Placebo
Participants
	Randomized participants : Favipiravir=122 Placebo=123
	Characteristics of participants N= 245 Mean age : NR 155 males Severity : Mild: n= 245/ Asymptomatic: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register PCR negative [ Time Frame: 15 days ]
	In the report Time from start of treatment to viral clearance defined as the conversion of SARS-CoV-2 RT-PCR from positive to negative within 15 days
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, the registry and statistical plan were available for data extraction and risk of bias assessment. The trial (n = 245) did not achieve its target sample size (n = 576) because recruitment was terminated due to futility at the interim analysis. There is no change from the trial registration in the intervention and control treatments. The primary outcome indicated in registry reflects the primary outcome reported in the paper.