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 randomization list was generated by an independent researcher with no involvement in the study. A software-based approach (www.sealedenvelope.com) was used to generate the allocation sequence. Sealed and sequentially numbered opaque envelopes, containing the allocation arms, were prepared in advance according to the randomization list. The project coordinator and investigators in each unit of the hospital enrolled the participants. Once the eligibility criteria were met, the envelope was opened, and the therapy was prescribed according to the arm specified in the envelope."
Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Some concerns |
Comment: Unblinded study (participants and personnel/carers).
Deviations from intended intervention arising because of the study context: No participant cross-over No information on review co-interventions of interest: antivirals, corticosteroids and biologics. 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: Mortality (D28). |
| Missing outcome data |
Low |
Comment: 30 participants randomized, 30 participants analyzed
Data available for all participants randomized. Risk assessed to be low for the outcomes: 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 |
Low |
Comment: No protocol or statistical plan available. The registry was available and utilized.
Outcomes reported as specified in the registry. Result was 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). |
| Overall risk of bias |
Some concerns |