| Bias | Author's judgement | Support for judgement |
| Randomization |
Low |
Quote: "Patients were assigned to stratified randomized treatments based on a central, computer-generated randomization scheme coordinated by an independent third party."
Quote: “conducted centrally by an independent third party to avoid selection bias.” Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Some concerns |
Quote: "open-label"
Comment: Unblinded study. No participant cross-over. No information on administration of co-interventions of interest: corticosteroids, biologics. Other antiviral use was exclusion criterion. Data were analyzed using intention-to-treat analysis |
| Missing outcome data |
Low |
Comment:150 patients randomized, 147 analyzed
Data available for >95% of population. Risk assessed to be low for the outcomes: Mortality. Incidence of viral negative conversion. Time to viral negative conversion. Clinical improvement. Time to clinical improvement. Adverse events. Serious adverse events. |
| Measurement of the outcome |
Some concerns |
Comment: Unblinded study
Mortality and viral negative conversion are observer-reported outcomes not involving judgement. Risk assessed to be low for the outcomes: Mortality. Incidence of viral negative conversion. Time to viral negative conversion. Clinical improvement (defined as discharge) requires clinical judgement and could be affected by knowledge of intervention receipt. Also, the authors reported on adverse events and serious adverse events that may contain both clinically- and laboratory-detected outcomes. All these outcomes 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: Clinical improvement. Time to clinical improvement. Adverse events. Serious adverse events. |
| Selection of the reported results |
Low |
Comment: The trial registry was available, but not the protocol or statistical analysis plan.
Outcomes pre-specified as reported. Results were not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for outcomes: Mortality. Incidence of viral negative conversion. Time to viral negative conversion. Clinical improvement. Time to clinical improvement. Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |