|Bias||Author's judgement||Support for judgement|
|Quote: "Patients were randomly assigned via computer-generated random numbering (1:1) to either start favipiravir on day 1 (early treatment group) or on day 6 of study participation (late treatment group)."
Comment: Allocation sequence random. No information on allocation concealment.
|Deviations from intervention||
|Quote: "An open-label design was adopted as placebo was not readily available at the time of study initiation"
Comment: Unblinded study.
No participant cross-over.
No information on administration of co-interventions of interest: biologics. Antivirals, corticosteroids, and anticoagulants were reported.
Data were analyzed using intention-to-treat analysis
|Missing outcome data||
|Comment: 89 patients randomized; 88 patients analyzed for outcomes mortality, clinical improvement and WHO score 7 and above
Data available for < 95% of population (1 patient withdrew form the study)
Risk assessed to be low for outcomes: Mortality. Time to clinical improvement. Incidence of WHO score 7 and above.
8 patients in the early favipiravir arm and 11 in the late favipiravir arm were excluded due to negative PCR on day 1. Quote: "According to the study protocol that was a priori planned before the data analysis, unless otherwise stated, analyses for virological endpoints were performed on the Infected ITT population. This was defined as all subjects who enrolled into the study except those for whom there was no efficacy data after randomization occurred and those whose first RT-PCR testing upon enrollment was already negative."
There is no evidence that the result is not biased since the decision was made before analysis and not before start of the study.
Missingness could depend on it's true value and is likely to since it is due to viral negative conversion status.
Risk assessed to be high for the outcome: Time to viral negative conversion.
|Measurement of the outcome||
|Comment: Unblinded study
Mortality and viral negative conversion are observer-reported outcomes not involving judgement. WHO score 7 and above cannot be influenced by knowledge of intervention assignment.
Risk assessed to be low for the outcomes: Mortality. Time to viral negative conversion. Incidence of WHO score 7 and above.
Clinical improvement (defined as hospital discharge) requires clinical judgement and could be affected by knowledge of intervention receipt, but is not likely in the context of the pandemic.
Risk assessed to be some concerns for the outcome: Time to clinical improvement.
|Selection of the reported results||
|Comment: The protocol and statistical analysis plan were available. The analysis plan was dated May 15 and recruitment ended May 18th. This was probably not before unblinded data were available to principal investigators, hence not pre-specified.
Result was not selected from multiple outcome measurements nor multiple analyses of the data.
Trial was probably not analyzed in accordance with a pre-specified plan.
Risk assessed to be some concerns for the outcomes: Mortality Time to viral negative conversion. Time to clinical improvement. Incidence of WHO score 7 and above.
|Overall risk of bias||