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 |
High |
Quote: “Randomisation was done using an odd-even methodology applied to registration numbers, in a consecutive fashion of 1:1 ratio” Comment: Allocation sequence random. Allocation sequence probably not concealed. |
| Deviations from intervention |
Low |
Quote: “open-label”
Comment: Unblinded study. 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. Participants were analyzed according to their randomized groups for the outcome. Of note, 42 participants were excluded from the analysis post-randomization for unknown reason. Nevertheless, we considered the analysis to be probably appropriate to estimate the effect of assignment to intervention. Risk assessed to be low for outcome: Incidence of viral negative conversion (D7). |
| Missing outcome data |
Some concerns |
Comment: 82 patients randomized; 40 patients analyzed for outcome of interest. Data not available for all or nearly all participants. No evidence that the result is not biased: only 20 patients in each arm tested for viral negative conversion with no information on how they were selected and reason for missingness, hence no evidence that the result is not biased. No information on whether missingness could depend on its true value, but it is not considered likely to owing to the equal proportion of missingness between groups. Risk assessed to be some concerns for the outcome: Incidence of viral negative conversion (D7). |
| Measurement of the outcome |
Low |
Comment: Method of measuring the outcome probably appropriate. Measurement or ascertainment of outcome probably does not differ between groups. Unblinded study Viral negative conversion is an observer-reported outcome not involving judgement. Risk assessed to be low for the outcome: Incidence of viral negative conversion (D7). |
| Selection of the reported results |
Some concerns |
Comment: The protocol, statistical analysis plan and registry were not available. 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 outcome: Incidence of viral negative conversion (D7). |
| Overall risk of bias |
High |