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: “The patients who successfully pass the screening tests and meet the eligibility criteria will be
enrolled in the study and will be randomized to one of the two treatment groups by IWRS.” IWRS - Interactive Web Response System
Comment: Allocation sequence random.
Allocation sequence concealed. Imbalances in baseline characteristics appear to be compatible with chance. |
| Deviations from intervention |
Low |
Quote: “double blind”
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). Time to clinical improvement. Adverse events. Serious adverse events. |
| Missing outcome data |
Low |
Comment: 353 participants randomized; 353 participants analyzed for mortality, clinical improvement, time to clinical improvement. 334 patients analyzed for adverse events and serious adverse events.
Data available for all or nearly all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28), Clinical improvement (D28). Time to clinical improvement. 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: Mortality (D28). Clinical improvement (D28). Time to clinical improvement. Adverse events. Serious adverse events. |
| Selection of the reported results |
Low |
Comment: The supplementary material and protocol (dated 7 days after the start of the study) were available. As the registry is retrospective by a small amount (consulted version dated Aug 26, 2020), we will still consider it as ‘before unblinded data was available for analysis’
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). Clinical improvement (D28) Time to clinical improvement. Adverse events. Serious adverse events. |
| Overall risk of bias |
Low |