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 patients were randomly divided into two groups by blocked randomization, and the sample size of each block was decided to be six. The randomization list was prepared using random allocation software. Implementation of the sequence was performed by a person who wasn't aware of the study design and content of the interventions.”
Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Some concerns |
Quote: “Groups that have been masked: Participant, Data analyser." "It is possible that because health-care providers were not blinded, some may have communicated the assigned treatment to patients."
Comment: Partially blinded study (participants blinded and personnel/carers unblinded). Deviations from intended intervention arising because of the study context: No participant cross-over. No information on administration of co-interventions of interest: biologics. Antivirals reported. All received corticosteroids. Hence, no information on whether deviations arose because of the trial context. Our analysis for the binary outcomes is an intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention. Of note, it is unclear if participants were excluded from the analysis post-randomization. According to the study methods, participants were excluded in the event of "discharge from hospital before recovery, death within the first 24 hours, or acute myocardial ischemia during the hospital stay". Risk assessed to be some concerns for the outcomes: Mortality (D28). |
| Missing outcome data |
Low |
Comment: 143 participants randomized; 143 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 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 prospective registry was available (dated March 27, 2021).
Outcome 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). |
| Overall risk of bias |
Some concerns |