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: "Random allocation using the block randomization method was performed in all four branches of the strata, based on two prognostic factors such as age (< 55 and ≥55) and disease severity based on O2 saturation (<85 and ≥85). During the procedure, the allocation remained concealed. The patient, assessor, and analyzer in the two groups did not have access to the randomization list and type of administered drug (Triple blind)."
Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Low |
Quote: "The patient, assessor, and analyzer in the two groups did not have access to the randomization list and type of administered drug (Triple blind)."
Contact with author confirmed blinding of personnel/carers. Comment: Blinded study (participants and personnel/carers). 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 outcome: Mortality (D28).Adverse events. Serious adverse events. |
| Missing outcome data |
Some concerns |
Comment: 93 participants randomized; 86 participants analyzed for Mortality.Unclear how many patients were analysed for Adverse events and Serious adverse events.
Data not available for all or nearly all participants. Reasons: Stopped treatment early (1 vs 1), Adverse event (1 vs 1), Protocol violation (1 vs 2). Missingness could depend on the true value of the outcome Not likely that missingness depended on the true value of the outcome (No important difference in proportion of missing data and reasons for missing outcome data between arms). Risk assessed to be some concerns for the outcome: Mortality (D28).Adverse events. Serious adverse events. |
| 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 outcome: Mortality (D28).Adverse events. Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: Protocol and statistical analysis plan were not available. Trial registry was substantially changed after the trial was completed.
Mortality outcome not pre-specificed in original trial registry. No information on whether the result was selected from multiple outcome measurements or analyses of the data. Trial probably not analyzed as pre-specified. Risk assessed to be some concerns for the outcome: Mortality (D28). Outcome data for Adverse events and Serious adverse eventsacquired from contact with authors. Results were probably not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcome: Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |