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 were randomized in 1:1 allocation in two groups (group-A and group-B) which contains 50 patients"
Comment: No information on allocation sequence. No information on allocation concealment. Allocation sequence probably random. |
| Deviations from intervention |
Some concerns |
Quote: "prospective, open-label, randomized and double blind clinical trial"; "The participants of the placebo group were received a similar tablet without therapeutic effects"
Comment: Blinding unclear as no description provided and contradictory descriptions used in study. Deviations from intended intervention arising because of the study context: No information on cross-over (no flow chart) No information on administration of co-intervention of interest: antivirals. biologics, corticosteroids. 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 outcome: Mortality (D28). |
| Missing outcome data |
Low |
Comment:100 patients randomized; 100 patients analyzed.
Data available for all participants. 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. Unclear blinding. 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: Neither the protocol nor the statistical analysis plan was available. The prospective registry was available and utilized
Mortality outcome was not pre-specified. However, we considered the reporting of this outcome acceptable as mortality should be reported even if not planned. Results were not selected from multiple outcome measurements or analyses of the data. Trial probably analyzed as pre-specified. Risk assessed to be low for the outcome: Mortality (D28). |
| Overall risk of bias |
Some concerns |