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: "In a computer-generated randomization (1:1), in blocks of four, patients
in the TP received either “tablet IP 50 mg kg−1 body weight/day rounded
to the nearest 500 mg dose (max 4 mg day−1) with DSC” (IP group) or
“matching placebo with DSC” (placebo group) for 10 days. Each group
included hospitalized and NHP... From registry: Pre-numbered or coded identical Containers."
Comment: Allocation sequence random. Allocation sequence probably concealed. Imbalances in baseline characteristics appear to be compatible with chance. |
| Deviations from intervention |
Low |
Quote: "double-blind" trial.
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). Adverse events. |
| Missing outcome data |
Low |
Comment: 416 participants randomized; at least 414 participants analyzed; 21 (5%) missing data (17 lost to follow up + 4 withdrawals).
Data available for all or nearly all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Clinical improvement (D28). 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). Adverse events. |
| Selection of the reported results |
Some concerns |
Comment: The prospective registry was available (dated February 1, 2021).
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 outcomes: Mortality (D28) and Clinical improvement (D28). ADVERSE EVENTS Outcome 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 outcome: Adverse events. |
| Overall risk of bias |
Some concerns |