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 |
Some concerns |
Quote: "A block-randomization scheme was generated by computer software; patients were randomized between favipiravir and HCQ based therapy in a 1:1 ratio"
Comment: Allocation sequence random. No information on allocation concealment. |
| Deviations from intervention |
Some concerns |
Quote: “open label study”
Comment: Unblinded study. No participant cross-over. No information on administration of co-interventions of interest: antivirals, corticosteroids, biologics. Anticoagulants were reported. Data for mortality were analyzed using intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention. For the incidence of viral negative conversion participants were analyzed according to their randomized groups for the outcome. Risk assessed to be some concerns for the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). |
| Missing outcome data |
Low |
Comment: 100 patients randomized; 100 patients analyzed for mortality outcome.
For incidence of viral negative conversion, one patient was missing from Day 7 negative conversion analysis. Possibly the patient who died on Day 8 due to acute heart failure resulting from myocarditis, but unclear. Data available for nearly all participants. Risk assessed to be low for the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). |
| Measurement of the outcome |
Low |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Comment: Unblinded study (outcome assessor) Mortality and viral negative conversion are observer-reported outcomes not involving judgement. Risk assessed to be low for the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). |
| Selection of the reported results |
Low |
Comment: Neither the protocol nor the statistical analysis plan was available. The registry was prospective and the primary outcome listed was "Viral clearance [Time Frame: 14 days]- two successive negative COVID-19 PCR analysis tests 48-72 hours apart". The report did not give a timepoint for this primary endpoint in the section labelled 'Endpoints'. It stated, "The primary endpoints were achievement of two successive negative SARS-CoV-2 PCR analysis tests 48
hours apart by nasopharyngeal swab, normalization of body temperature for 48 hours, improvement of
radiological abnormalities at day 14 and discharge rate out of the hospital." However, in the primary objective, timepoints of days 3, 7 and 14 were specified.
Mortality was not specified in the registry not stated as a primary or secondary outcome in the report. The result was probably not selected from multiple outcome measurements or analyses of the data. Trial was analyzed as pre-specified. Risk assessed to be low for the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). |
| Overall risk of bias |
Some concerns |