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: (protocol) "Randomization and treatment assignment will be via the Randomization Trial Supply Management System."
Comment: Allocation sequence random. Allocation sequence probably concealed. |
Deviations from intervention |
Low |
Quote: “triple blinding”
Comment: Blinded study (participants and personnel/carers) 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 low for the outcomes: Mortality (D28). Clinical improvement (D28). WHO score 7 and above (D28). Serious adverse events. |
Missing outcome data |
Low |
Comment: 210 participants randomized; 205 participants analyzed for mortality and safety; 202 participants analyzed for clinical improvement and WHO Score 7 and above.
Data available for nearly all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Clinical improvement (D28). WHO score 7 and above (D28). 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 outcomes: Mortality (D28). Clinical improvement (D28). WHO score 7 and above (D28). Serious adverse events. |
Selection of the reported results |
Some concerns |
Comment: The retrospective protocol and statistical analysis plan were available. The prospective registry (consulted up to version dated June 25, 2020) was utilized for assessement.
MORTALITY. CLINICAL IMPROVEMENT. 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 low for the outcome: Mortality (D28). Clinical improvement (D28). WHO SCORE 7 AND ABOVE. SERIOUS ADVERSE EVENTS. Outcomes not pre-specified. 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 outcomes: WHO score 7 and above. Serious adverse events. |
Overall risk of bias |
Some concerns |