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: "Patients use randomized block-chain, which not only makes Randomization equal in two groups, but also allows patients to be assigned equally to both groups at each stage of the study. These small blocks keep the balance between the two groups and make the number of people in each group similar. In our study, considering that there are two groups, four patients are considered for each block. "
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: corticosteroids, biologics. Antivirals were 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 some concerns for the outcome: Mortality (D28). WHO score 7 and above (D28). |
| Missing outcome data |
Low |
Comment: 111 participants randomized; 111 participants analyzed.
Data available for all or nearly all participants randomized. Risk assessed to be low for the outcome: Mortality (D28). WHO score 7 and above (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 outcomes not involving judgement. Risk assessed to be low for the outcome: Mortality (D28). WHO SCORE 7 AND ABOVE For WHO score 7 and above, we consider that the assessment cannot possibly be influenced by knowledge of intervention assignment. Risk assessed to be low for the outcome: WHO score 7 and above (D28). |
| Selection of the reported results |
Some concerns |
Comment: Neither the protocol nor the statistical analysis plan was available. The trial registry was available and prospective (dated April 20th, 2020).
Outcomes not pre-specified. No information on whether the result was selected from multiple outcome measurements or analyses of the data. Trial probably not analyzed as pre-specified. Risk assessed to be some concerns for the outcomes: Mortality (D28). WHO score 7 and above (D28). |
| Overall risk of bias |
Some concerns |