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|
|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||
|Quote: “The study was open label without blinding for patients, healthcare workers or investigators”
Comment: Unblinded study (participants and personnel/carers).
Administration of co-interventions of interest (antivirals, biologics, and corticosteroids) were reported and were balanced between groups.
No information on participant cross-over (no flow chart).
Hence, no information on whether deviations arose because of the trial context.
Data for the outcome were analyzed using intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention.
Risk assessed to be some concerns for the outcomes: Mortality (D28). Time to clinical improvement. WHO score 7 and above (D28).
|Missing outcome data||
|Comment: 68 participants randomized; 65 participants analyzed.
Data available for nearly all participants randomized.
Risk assessed to be low for the outcomes: Mortality (D28). Time to clinical improvement. WHO score 7 and above (D28).
|Measurement of the outcome||
|Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups.
Unblinded study (outcome assessor).
Mortality is an observer-reported outcome not involving judgement.
Risk assessed to be low for the outcomes: Mortality (D28).
WHO SCORE 7 AND ABOVE
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: WHO score 7 and above (D28).
TIME TO CLINICAL IMPROVEMENT
Clinical improvement (defined as a sustained 2-category clinical improvement on a WHO scale, or 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: Time to clinical improvement.
|Selection of the reported results||
|Comment: The trial registry was available but retrospective (dated March 27th, 2020).
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). Time to clinical improvement. WHO score 7 and above (D28).
|Overall risk of bias||