Trial NCT04529499; IND148286
Publication Shenoy S, medRxiv (2021) (preprint)
Dates: 2020-08-22 to 2020-01-27
Funding: Private (Dr. Reddys Laboratories Ltd. and Global Response Aid )
Conflict of interest: Yes

Methods
RCT
Blinding: double blinding
Location : Multicenter / Kuwait
Follow-up duration (days): 60
Inclusion criteria
  • Patients of either sex
  • aged between 21 (age of giving informed consent in Kuwait) and 80 years (both inclusive)
  • positive for SARS-CoV-2 by real-time Reverse Transcriptase Polymerase Chain Reaction (rRT-PCR) assay on a nasopharyngeal or oropharyngeal swab
  • clinically assessed to have moderate or severe COVID-19 and were hospitalized for management
Exclusion criteria
  • Critically ill patients
  • patients who had first onset of symptoms/signs suggestive of COVID-19 illness >10 days before randomization
  • patients who had allergy or contraindication to the drug, pregnant and lactating mothers
  • patients with congestive cardiac failure, moderate to severe hepatic dysfunction or renal failure, alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels > 5 times upper limit of normal (ULN) at screening evaluation, serum uric acid higher than the ULN at screening evaluation, those with history of gout or were on current treatment for gout
Interventions
Treatment
Favipiravir
Initial dose: 1800 mg BID (200 mg, 9 tablets BID) - Maintenance dose: 800 mg BID (200 mg, 4 tablets BID)
Control
Placebo

Participants
Randomized
participants :
Favipiravir=175
Placebo=178
Characteristics of participants
N= 353
Mean age : NR
238 males
Severity : Mild: n=38 / Moderate: n=312 / Severe: n=2 Critical: n=1
Number of vaccinated participants: NR
Primary outcome
In the register
Time to resolution of hypoxia (Stage I) [ Time Frame: 1-28 days ]
In the report
Time to resolution of hypoxia
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
Low
General comment In addition to the preprint article, the supplemental material and the study registry (registered 7 days after the start of the study) were used in data extraction and risk of bias assessment. The study (n=353) did not achieve the target sample size (n=780) specified in the trial registry and was terminated early due to futility and lack of evidence in the primary and some secondary endpoints. 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. Some outcomes from the registry are not reported in the preprint (e.g time to negative conversion, percentage of patients showing negative conversion).
On October 20th, 2022 this study was updated with information published in the registry.