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: "Randomization was performed through a computer-generated list stratified by site. Treatments were assigned after confirming the correctness of the admission criteria. Neither the research performers nor the patients were aware of the treatment assignments."
Quote from the trial registry: "By trained professionals, numbered and grouped by random indicator method, in order to the patient number (according to the inclusion criteria and exclusion criteria, screening out do not conform to the requirements of cases), by the method of stochastic indicator of the group will arrange into the group of." Comment: Allocation sequence probably random. Unclear allocation concealment. |
Deviations from intervention |
Some concerns |
Quote: "Neither the research performers nor the patients
were aware of the treatment assignments."
Comment: Unclear blinding (participants blinded and unclear if personnel/carers blinded) No participant cross-over. No information of administration of co-interventions of interest: corticosteroids. Antivirals and biologics 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 outcomes: Adverse events. Serious adverse events. |
Missing outcome data |
Low |
Comment: 62 participants randomized, 62 participants analyzed.
Data available for all participants randomized. Risk assessed to be low for the outcomes: 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 (outcome assessor) 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: Neither the protocol nor the statistical analysis plan was available. The registry was available.
Adverse and serious adverse events were not mentioned in the registry 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: Adverse events. Serious adverse events. |
Overall risk of bias |
Some concerns |