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: "Randomization (1:1) with a computerized system was stratified according to disease severity."
Comment: Allocation sequence random. No information on allocation concealment. |
| Deviations from intervention |
Some concerns |
Quote: “The study was open label without blinding for patients, healthcare workers or investigators”
Comment: Unblinded study. No information on participant cross-over (no flow chart). Administration of co-interventions of interest (antivirals, biologics, and corticosteroids) were reported and were balanced between groups. Data were analyzed appropriately; participants analyzed according to their randomized assignment |
| Missing outcome data |
Low |
Comment: 68 patients randomized; 65 patients analyzed.
Data available for >95% of population. Risk assessed to be low for the outcomes: Mortality. Time to clinical improvement. WHO score 6 and above. WHO score 7 and above. |
| Measurement of the outcome |
Some concerns |
Comment: Unblinded study
Mortality is an observer-reported outcome not involving judgement. For WHO score 7 and above, we consider that the assessment cannot possibly be influenced by knowledge of intervention assignment. Risk assessed to be low for the outcomes: Mortality. WHO score 7 and above. Clinical improvement (defined as a sustained 2-category clinical improvement on a WHO scale, or discharge) and WHO score 6 and above require clinical judgement and could be affected by knowledge of intervention receipt. Risk assessed to be some concerns for the outcomes: Time to clinical improvement. WHO score 6 and above. |
| Selection of the reported results |
Some concerns |
Comment: The trial registry was available.
Mortality and WHO scale severity outcomes were registered as reported in the paper. Results were not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcomes: Mortality. WHO score 6 and above. WHO score 7 and above. Clinical improvement was not pre-specified in the registry. No information on whether the result for time to clinical improvement was selected from multiple outcome measurements or analyses of the data. Risk assessed to be some concerns for the outcome: Time to clinical improvement. |
| Overall risk of bias |
Some concerns |