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: (registry) “Method of Generating Random Sequence: Computer generated randomization.Method of Concealment:Centralized ”
Comment: Allocation probably random. Allocation probably concealed. No information on baseline characteristics. |
| Deviations from intervention |
Some concerns |
Quote:"open label"
Comment: Unblinded study (participants and personnel/carers). No information on participant cross-over. In the outpatient setting, we consider no important cointerventions of interest. Hence, not enough information on whether deviations arose because of the trial context. 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 some concerns for the outcomes: Serious adverse events. |
| Missing outcome data |
Low |
Comment: 1218 participants randomized; 1218 participants analyzed.
Data available for all or nearly all participants randomized. Risk assessed to be low for the outcomes: Serious adverse events. |
| Measurement of the outcome |
Some concerns |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Unblinded study (outcome assessor). The authors reported on adverse events and serious adverse events that may contain both clinically- and laboratory-detected events, which can be influenced by knowledge of the intervention assignment, but is not likely in the context of the pandemic. Risk assessed to be some concerns for the outcomes: Serious adverse events. |
| Selection of the reported results |
Low |
Comment: The protocol and statistical analysis plan were not available. The prospective registry was available (dated June 1st, 2021).
Outcome pre-specified in the registry. 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: Serious adverse events. |
| Overall risk of bias |
Some concerns |