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:"Block randomization was done using an online random number generator with varying block sizes with the unique subject or patient code generated against the block sequence number."
Comment: Allocation sequence random No information on allocation concealment. |
| Deviations from intervention |
Some concerns |
Quote: "This is an open-label study, and after randomization, there was no masking. The investigators, treating clinical teams, and participants were not blinded, whereas the research personnel compiling and analyzing the outcome data were blinded to the group allotment."
Comment: Unblinded study (participants and personnel/carers) Deviations from intended intervention arising because of the study context: No participant cross-over. No information on administration of co-interventions of interest: biologics and antivirals. Corticosteroids were part of the intervention in both arms. Hence, deviations did not arise because of the trial context. Our analysis for the binary outcome is an intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention. No participants were missing for time to event analyses. Risk assessed to be low for the outcomes: Mortality (D28). Time to death. Time to clinical improvement. |
| Missing outcome data |
Low |
Comment: 42 participants randomized; 42 participants analyzed.
Data available for all or nearly all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Time to death. Time to clinical improvement. |
| 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, TIME TO DEATH Observer-reported outcome not involving judgement. Risk assessed to be low for the outcomes: Mortality (D28). Time to death. TIME TO CLINICAL IMPROVEMENT Clinical improvement (defined as 1 point improvement in the WHO CPS score) 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 |
Low |
Comment: The registry was available (dated: 30-04-2021)
Outcome pre-specified. Results were not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be some concerns for the outcome: Mortality (D28). Time to death. Time to clinical improvement. |
| Overall risk of bias |
Some concerns |