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: “Patients were randomized to one of three groups”
Comment: Allocation sequence probably random. No information on allocation concealment. |
| Deviations from intervention |
Low |
Quote: “double-blind”
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 low for the outcomes: Mortality (D28). Clinical improvement (D28). Time to WHO score 7 and above. Adverse effects. Serious adverse effects. |
| Missing outcome data |
Low |
Comment: 106 participants randomized; 106 participants analyzed.
Data available for all of the participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Clinical improvement (D28). Time to WHO score 7 and above. Adverse effect. Serious adverse effects. |
| Measurement of the outcome |
Low |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome does not differ between groups. Blinded study (outcome assessor). Risk assessed to be low for the outcomes: Mortality (D28). Clinical improvement (D28). Time to WHO score 7 and above. Adverse events. Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: The trial registry was available.
MORTALITY, CLINICAL IMPROVEMENT Outcomes not pre-specified in the registry. 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 outcomes: Mortality (D28). Clinical improvement (D28). TIME TO WHO SCORE 7 AND ABOVE. ADVERSE EVENTS. SERIOUS ADVERSE EVENTS. Outcome data acquired 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: Time to WHO score 7 and above. Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |