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: “Computer-generated randomization codes were enclosed in sequentially numbered opaque sealed envelopes containing treatment allocation. After meeting study eligibility criteria, the study nurse assigned the next envelope to the participant, opened the envelope and assigned treatment allocation.”
Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Low |
Quote: “Open-label. Participants and the trial team were not blinded.”
Comment: Unblinded study (participants and personnel/carers) Deviations from intended intervention arising because of the study context: No participant cross-over. In the outpatient setting, we consider no important cointerventions of interest. Hence, no deviation arose because of the trial context. Our analysis for the 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: Incidence of viral negative conversion (D7). Time to viral negative conversion. Adverse events. Serious adverse events. |
| Missing outcome data |
Low |
Comment: 105 participants randomized; 105 participants analyzed.
Data available for all participants randomized. Risk assessed to be low for the outcomes: Incidence of viral negative conversion (D7). Time to viral negative conversion. Adverse events. 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) VIRAL NEGATIVE CONVERSION Viral negative conversion is an observer-reported outcome not involving judgement. Risk assessed to be low for the outcomes: Incidence of viral negative conversion (D7). Time to viral negative conversion. ADVERSE and SERIOUS ADVERSE EVENTS 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: Adverse events. Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: The registry was retrospective.
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: Incidence of viral negative conversion (D7). Time to viral negative conversion. Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |