Covid-19 Living Data

Trial CTRI/2020/05/025114
Publication Udwadia Z, Int J Infect Dis (2020) (published paper)

Funding: Private (Glenmark Pharmaceuticals Limited, India)
Conflict of interest: Yes

Methods
	RCT Blinding: Unblinded
	Location : Multicenter / India Follow-up duration (days): 28
Inclusion criteria	Age 18-75 years, infection with SARS-CoV-2 virus confirmed by RT-PCR within 48 hours prior to randomization, no participation in any other interventional clinical study, agreement to use effective contraception during the study and for ≥7 days following the last treatment, and, for female patients of child-bearing potential, a negative pre-treatment pregnancy test
Exclusion criteria	Severe infection (defined as need for invasive or non-invasive ventilator support, extracorporeal membrane oxygenation [ECMO] or shock requiring vasopressor support), oxygen saturation ≤93% or arterial oxygen partial pressure or fraction of inspired oxygen of ≤300 mmHg, requiring ICU care for management of ongoing clinical status, inability to take or tolerate oral medications, allergy or hypersensitivity to favipiravir, asthma or chronic obstructive lung disease, severe liver disease (underlying liver cirrhosis or alanine aminotransferase/aspartate aminotransferase elevated over 5 times the upper limit of normal [ULN]), history of gout or hyperuricemia (above the ULN), prolonged QT (defined as QTcF ≥450 msec for men and as QTcF ≥470 msec for women), severely reduced left ventricular function (ejection fraction <30%), or severe renal impairment (creatinine clearance <30 mL/min), or having received continuous renal replacement therapy, hemodialysis or peritoneal dialysis
Interventions
	Treatment Favipiravir Loading dose: 1800 mg twice on day 1 - Maintenance dose: 800 mg twice a day for up to 14 days.
	Control Standard care
Participants
	Randomized participants : Favipiravir=75 Standard care=75
	Characteristics of participants N= 150 Mean age : NR 108 males Severity : Mild: n=89 / Moderate: n=58 / Severe: n=0 Critical: n=0 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 a negative SARS-CoV2 RT-PCR result of both oropharyngeal swab and nasopharyngeal swab).
	In the report Time from randomization to cessation of oral shedding of the SARS-CoV-2 virus (28-days maximum; specified as a negative RT-PCR result for both oropharyngeal and nasopharyngeal swabs)
Documents available	Protocol NR Statistical plan NR Data-sharing willing stated in the publication: No
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 pre-proof article, the study's prospective registry was used for data extraction and assessment of risk of bias. Neither the study protocol nor statistical analysis plan were available at time of data extraction. There were no substantive differences between the published article and trial registry in population, procedures, treatment or outcomes. The study achieved its pre-stated sample size. This study was updated on February 1st, 2021 after contact with authors.