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: Block randomization method was used for randomization. Eight blocks, including ten patients, were generated by the Online Randomizer website (www.sealesenvelop.com/ simple randomizer).” Comment: Allocation sequence random. Unclear allocation concealment (use of fixed block in an open label study). |
| Deviations from intervention |
Some concerns |
Registry: "Blinding (investigator's opinion): Not blinded" Comment: Unblinded study (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: biologics and corticosteroids. Antiviral administration was 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 low for the outcome: Mortality (D28). |
| Missing outcome data |
Low |
Comment: 84 participants randomized; 84 participants analyzed. Data available for all or nearly all participants randomized. Risk assessed to be low for the outcome: Mortality (D28). |
| 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) Mortality is an observer-reported outcome not involving judgement. Risk assessed to be low for the outcome: Mortality (D28). |
| Selection of the reported results |
Some concerns |
Comment: The protocol and statistical analysis plan were not available. The trial registry was available but it is unlikely that it was registered prospectively/before unblinded data was available for analysis. The report also did not included the actual start of recruitment date. Quote: "Registration timing: registered_while_recruiting" 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: Mortality (D28). |
| Overall risk of bias |
Some concerns |