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:"assigned with randomized numbers, the random allocation sequence was generated through the website https://www.randomizer.org/#randomize”, and then sorted into either experimental group or control group."
Comment: Allocation sequence random. No information on allocation concealment. |
| Deviations from intervention |
Some concerns |
Quote: “open-label study”
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: antivirals and corticosteroids, 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: 80 participants randomized; 80 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 outcomes: Mortality (D28). |
| Selection of the reported results |
Low |
Comment: The protocol and statistical analysis plan were available.
Mortality was not specified in the protocol and not stated as a primary or secondary outcome in the publication. The result was probably not selected from multiple outcome measurements or analyses of the data. Trial was analyzed as pre-specified. Risk assessed to be low for the outcomes: Mortality (D28). |
| Overall risk of bias |
Some concerns |