Note: The risk of bias by domain corresponds to the highest risk of bias among outcomes by domain.
The overall risk of bias corresponds to the overall highest risk of bias assessed among outcomes.
| Bias | Author's judgement | Support for judgement |
| Randomization |
Low |
Quote: “Patients were randomized at a ratio of 1:1 to either intervention group receiving favipiravir or control group without favipiravir. REDCap is a secure, web-based software platform designed to support data capture for research studies. Subjects were randomized based on a central, computer-generated randomization scheme coordinated by REDCap.”
Comment: Allocation sequence random. Allocation sequence concealed. Imbalances in baseline characteristics appear to be compatible with chance. |
| Deviations from intervention |
Low |
Quote: “Open-label”
Comment: Unblinded study (participants and personnel/carers) Deviations from intended intervention arising because of the study context: No participant cross-over. Administration of co-interventions of interest - biologics, antivirals and corticosteroids - was reported and balanced between groups. Hence, deviations did not arise because of the trial context. Our analysis for the binary outcomes is an intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention. Risk assessed to be low for the outcomes: Clinical improvement (D28). WHO score 7 and above (D28). Mortality (D28). Adverse events. |
| Missing outcome data |
Low |
Comment: 500 participants randomized; 500 participants analyzed.
Of note, 12 vs 1 participants discontinued intervention. Data available for all or nearly participants randomized. Risk assessed to be low for the outcomes: Clinical improvement (D28). WHO score 7 and above (D28). Mortality (D28). Adverse events. |
| Measurement of the outcome |
Some concerns |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Unblinded study (outcome assessor) MORTALITY Mortality is an observer-reported outcome not involving judgement. Risk assessed to be low for the outcomes: Mortality (D28). ADVERSE EVENTS The authors reported on adverse events that may contain both clinically- and laboratory-detected events, which can be influenced by knowledge of the intervention assignment, but is not likely in the context of the pandemic. Risk assessed to be some concerns for the outcomes: Adverse events. WHO SCORE 7 AND ABOVE For this outcome, we consider that the assessment cannot possibly be influenced by knowledge of intervention assignment. Risk assessed to be low for the outcomes: WHO score 7 and above (D28). CLINICAL IMPROVEMENT Clinical improvement (defined as hospital discharge) requires clinical judgement and could be affected by knowledge of intervention receipt, but it not considered likely to in the context of a pandemic. Risk assessed to be some concerns for the outcomes: Clinical improvement (D28). |
| Selection of the reported results |
Some concerns |
Comment: The protocol and registry were retrospective.
MORTALITY, ADVERSE EVENTS No information on whether the result was selected from multiple outcome measurements or analyses of the data. No information on whether the trial was analyzed as pre-specified. Risk assessed to be some concerns for the outcome: Mortality (D28). Adverse events. CLINICAL IMPROVEMENT, WHO SCORE 7 AND ABOVE Outcome acquired from direct contact with authors Analysis performed by the COVID-NMA Risk assessed to be low for the outcome: Clinical improvement (D28). WHO score 7 and above (D28). |
| Overall risk of bias |
Some concerns |