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: “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.” In the protocol "The main investigator with the statistician had the randomization code, which was hidden from both the patients and treating doctors".
Comment: Allocation sequence random. Allocation concealed. |
| 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 carers were blinded as the frequency and duration of the treatments were different between groups. Hence probably not blinded (participants and personnel/carers) Deviations from intended intervention arising because of the study context: No information on participant cross-over (no flow chart). No information on administration of co-interventions of interest: Biologics. Corticosteroids and Antivirals were reported. Hence, no information on whether deviations arose because of the trial context. Risk assessed to be some concerns for outcome: Mortality (D28).Adverse events. Serious adverse events. |
| Missing outcome data |
Low |
Comment: 200 patients randomized; 200 patients analyzed.
Data available for all or nearly all participants. Risk assessed to be low for the outcome: Mortality (D28).Adverse events. Serious adverse events. |
| Measurement of the outcome |
Some concerns |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Unclear blinding of outcome assessor. Mortality is an observer-reported outcome not involving judgement. Risk assessed to be low for the outcome: Mortality (D28). The authors reported on adverse events and serious adverse events that may contain both clinically- and laboratory-detected events. All these outcomes can be influenced by knowledge of the intervention assignment, but is not likely in the context of the pandemic. Risk assessed to be some concerns for the outcomes: Adverse events. Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: The trial registry was available, but registration occurred after the study was completed.
No information on whether the results were selected from multiple outcome measurements or analyses of the data. No information on whether the trial was analyzed as pre-specified. Risk assessed to be some concerns for the outcome: Mortality (D28).Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |