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:"Patients were electronically randomized (using online application giving random numbers) into two groups"
Comment: Allocation sequence random
No information on allocation concealment
|Deviations from intervention||
|Comment: Unclear blinding
Deviations from intended intervention arising because of the study context:
No participant cross-over.
No information on administration of co-interventions of interest: biologics, antivirals (other than in the intervention).
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). Incidence of viral negative conversion (D7). Clinical improvement (D28).
|Missing outcome data||
|Comment: 174 participants randomized; 174 participants analyzed.
Data available for all or nearly all participants randomized.
Risk assessed to be low for the outcomes: Mortality (D28). Negative viral conversion (D7). Clinical Improvement (D28).
|Measurement of the outcome||
|Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups.
Unclear blinding (outcome assessor).
MORTALITY, VIRAL NEGATIVE CONVERSION
Observer-reported outcome not involving judgement.
Risk assessed to be low for the outcomes: Mortality (D28). Incidence of viral negative conversion (D7).
Clinical improvement (defined as improvement in WHO ordinal scale) 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: Clinical improvement (D28).
|Selection of the reported results||
|Comment: The protocol, statistical analysis plan and registry were not available
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). Incidence of viral negative conversion (D7). Clinical improvement (D28).
|Overall risk of bias||