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 |
Some concerns |
Quote: "The patients were randomized in a 1:1 ratio via a lottery method."
Comment: Allocation sequence random. No information on allocation concealment. |
| Deviations from intervention |
Some concerns |
Quote: “There was no blinding”
Comment: Unblinded study. No participant cross-over. No information on administration of co-interventions of interest: antivirals, biologics, corticosteroids. Hence, no information on whether deviations arose because of the trial context. Data for were analyzed using intention-to-treat analysis (available cases). This method was considered appropriate to estimate the effect of assignment to intervention. Risk assessed to be some concerns for the outcome: Incidence of viral negative conversion (D7). |
| Missing outcome data |
Some concerns |
Comment: 100 patients randomized; 86 patients analyzed.
>5% missing data. Reasons for missing data: Left against medical advice before day 14. No evidence that the result is not biased. Missingness may depend on the true value of the outcome. 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 trial registry was available.
The timepoints at which viral conversion is reported differ from the registry. The results could have been 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: Incidence of viral negative conversion (D7). |
| Overall risk of bias |
High |