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: "Randomisation was performed at the Alfred Hospital Clinical Trials Pharmacy using computer generated block-randomisation lists". Protocol adds, "Each study participant is provided with a participant randomisation
number, which is recorded on the electronic case report form (eCRF). The randomisation
code containing information on randomisation numbers and corresponding treatment
allocation will be provided to the clinical trials pharmacy at the Alfred Hospital and
maintained by an investigator independent of all study staff at Alfred Health."
Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Low |
Quote: "blinded" participants and study staff.
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). Hospitalization or death. WHO score 7 and above (D28). Adverse events. Serious adverse events. |
| Missing outcome data |
Low |
Comment: 200 participants randomized; at least 190 participants analyzed, depending on the review outcome.
Data available for nearly all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Hospitalization or death. 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: Mortality (D28). Hospitalization or death. WHO score 7 and above (D28). Adverse events. Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: The protocol, statistical analysis plan, and registry were available (dated June 24, 2020).
MORTALTIY, HOSPITALIZATION OR DEATH, ADVERSE AND SERIOUS ADVERSE EVENTS 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). Hospitalization or death. Adverse events. Serious adverse events. WHO SCORE 7 AND ABOVE 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: WHO score 7 and above (D28). |
| Overall risk of bias |
Some concerns |