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 |
Low |
Quote: "The included patients were randomized using a computer random number generator" "Sequentially numbered, opaque, sealed envelopes were used to ensure concealment"
Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Some concerns |
Quote: “Open-label. Patients and physicians were aware of the assigned treatments.”
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. It was reported that antivirals and corticosteroids were part of standard care, but it was not reported how many participants received these. Hence, not sufficient 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 concern for the outcome: Mortality (D28). |
| Missing outcome data |
Low |
Comment: 164 participants randomized; 164 participants analyzed.
Data available for 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 trial registry was retrospective, dated May 27, 2020, and substantial changes were made to outcomes, follow up and interventions both during and after the conduct of the study.
Outcome not pre-specified. The primary outcome was changed from negative viral conversion at 6 months to improvement or mortality at 1 month during the conduct of the study. The outcomes reported in the article were specified after study completion (2021-03-03). No information on whether the result was selected from multiple outcome measurements or analyses of the data. Trial not analyzed as pre-specified. Risk assessed to be some concerns for the outcome: Mortality (D28). |
| Overall risk of bias |
Some concerns |