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 |
Low |
Quote: “Eligible patients were randomly assigned to intervention or control group using block randomization (using a web service www.sealedenvelope.com).”
Comment: Allocation sequence random. Allocation sequence concealed |
Deviations from intervention |
Some concerns |
Quote: “In this trial, the analyzer and care givers were blind to patients’ allocation group.” “we missed the opportunity of strengthening our methodology by using placebos and blinding.”
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 and corticosteroids. Antivirals were reported as an intervention. Hence, no information on whether deviations arose 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. Risk assessed to be some concerns for the outcomes: Mortality (D28). WHO score 7 and above (D28). |
Missing outcome data |
Some concerns |
Comment: 106 participants randomized; 100 participants analyzed.
Data not available for all or nearly all participants randomized. No evidence that the result is not biased. Reasons: 3 vs 3 participants were excluded from each arm post-randomization as they didn't meet inclusion criteria. Missingness could depend on the true value of the outcome. Not likely that missingness depended on the true value of the outcome due to same numbers missing between arms. Risk assessed to be some concerns for the outcomes: Mortality (D28). WHO score 7 and above (D28). |
Measurement of the outcome |
Low |
Comment: Method of measuring the outcome probably appropriate. Measurement or ascertainment of outcome probably does not differ between groups. Blinded study (outcome assessor). Risk assessed to be low for the outcomes: Mortality (D28). WHO score 7 and above (D28). |
Selection of the reported results |
Low |
Comment: The prospective registry was available.
Outcomes pre-specified. 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 (D28). WHO score 7 and above (D28). |
Overall risk of bias |
Some concerns |