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”. Comment: Allocation sequence probably random. No information on allocation concealment. |
Deviations from intervention |
Low |
Quote: “double-blinded”.
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: Hospitalization or Death. Mortality (D28). Incidence of viral negative conversion (D7). WHO score 7 and above (D28). Adverse events. Serious adverse events. |
Missing outcome data |
Low |
Comment: 130 participants randomized; 87 participants analyzed.
Data not available for all or nearly all participants No evidence that the result is not biased. Reasons for missing data: insufficient biochemical data due to budget limitations (balanced across arms). Missingness could not depend on the true value of the outcome (due to documented reasons unrelated to the outcome). Risk assessed to be low for the outcomes: Hospitalization or Death. Mortality (D28). Incidence of viral negative conversion (D7). WHO score 7 and above (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 outcomes: Hospitalization or Death. Mortality (D28). Incidence of viral negative conversion (D7). WHO score 7 and above (D28). Adverse events. Serious adverse events. |
Selection of the reported results |
Some concerns |
Comment: The protocol and statistical analysis plan were not available. The trial registry was retrospective and only available after the study had been completed.
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: Hospitalization or Death. Mortality (D28). Incidence of viral negative conversion (D7). WHO score 7 and above (D28). Adverse events. Serious adverse events. |
Overall risk of bias |
Some concerns |