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: "Patients were randomly assigned following simple randomization procedures (computerized random numbers) to one of two treatment groups."
Comment: Allocation sequence random. No information on allocation concealment. |
| Deviations from intervention |
Some concerns |
Comment: No information on blinding (participants and personnel/carers)
Deviations from intended intervention arising because of the study context: No participant cross-over. No information on administration of co-interventions of interest: antivirals, corticosteroids, biologics were reported. Hence, no information on whether deviations arose because of the trial context. Data for the outcome were analyzed using 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 outcome: Incidence of viral negative conversion (D7). |
| Missing outcome data |
Low |
Comment: 24 patients randomized; 24 patients analyzed.
Data available for all participants randomized. Risk assessed to be low 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 (outcome assessor) 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, protocol and the statistical analysis plan 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 |
Some concerns |