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: “A block randomization method was used to randomize the study participants into two groups that result in equal sample size. This method was used to ensure a balance in sample size across groups over the time and keep the number of participants in each group similar at all times.”
Comment: Allocation sequence random. No information on allocation concealment. |
Deviations from intervention |
Some concerns |
Quote: “double blind randomized controlled clinical trial”.
Comment: No detailed information reported on blinding of personnel. While the study says it was double blind, it is unclear how doctors and care providers were blinded as the frequency and duration of the treatments were different between groups. Unlikely there was impactful crossover No information on administration of co-interventions of interest: antivirals, corticosteroids and biologics. Analysis method was not reported. Hence, no information on whether deviations arose because of the trial context. Risk assessed as some concerns for the outcome: Mortality D28. |
Missing outcome data |
Low |
Comment: 200 patients randomized; 200 patients analyzed.
Data available for >95% of population. Risk assessed to be low for the outcome: Mortality D28. |
Measurement of the outcome |
Low |
Comment: Unclear blinding of 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 |
Some concerns |
Comment: The trial registry was available, but registration occurred after the study was completed.
Results were not selected from multiple outcome measurements or analyses of the data. Trial analysis method was not reported. Risk assessed to be some concerns for the outcome: Mortality D28. |
Overall risk of bias |
Some concerns |