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: “Randomization was stratified by the statistician of the leading site, who produced computer-generated block randomization lists with a block size of 4 patients.”
Comment: Allocation sequence random. Unclear allocation concealment. |
| Deviations from intervention |
Some concerns |
Quote: "This was a single-blind trial; the physicians were aware of the treatment assignment, but the participants were blinded."
Quote: “During the whole study period, the data collection and end point judgement were blinded, and the statisticians were also blinded during the statistical analysis.”
Comment: Single blinded study (participants blinded; personnel/carers unblinded). Deviations from intended intervention arising because of the study context: No participant cross-over. Administration of co-interventions of interest, antivirals (31/43 vs 36/43) and biologics (3/43 vs 4/43) were reported. This deviation was not balanced and could affect the outcome. Nevertheless, this domain was rated as some concern as it is impossible to distinguish deviation because of trial context and deviation because of intervention effect. 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: Mortality (D28). Time to viral negative conversion. |
| Missing outcome data |
Low |
Comment: 86 participants randomized; 86 participants analyzed.
Data available for all or nearly all participants. Risk assessed to be low for the outcome: Mortality (D28). Time to viral negative conversion. |
| Measurement of the outcome |
Low |
Quote: “During the whole study period, the data collection and end point judgement were blinded, and the statisticians were also blinded during the statistical analysis.”
Comment: Method of measuring the outcome probably appropriate. Measurement or ascertainment of outcome probably does not differ between groups. Comment: Blinded study (outcome assessor). Risk assessed to be low for the outcome: Mortality (D28). Time to viral negative conversion. |
| Selection of the reported results |
Low |
Comment: The prospective trial registry was available (February 20th version).
Outcomes pre-specified. 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 outcome: Mortality (D28). Time to viral negative conversion. |
| Overall risk of bias |
Some concerns |