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, stratified by study site, was based on a computer-generated allocation sequence; the 1:1 allocation sequence used permuted, random block sizes of four. The investigators who were responsible for assessing the primary outcomes and the patients were blinded to the study group assignment."
"The drug and placebo needed for the study were repackaged in identical bottles with the same labels at a Chinese pharmaceutical factory." Comment: Allocation sequence random. No information on allocation sequence concealment. |
| Deviations from intervention |
Some concerns |
Quote: "The investigators who were responsible for assessing the primary outcomes and the patients were blinded to the study group assignment."
Comment: Unclear blinding (participants blinded and unclear if personnel/carers blinded). Deviations from intended intervention arising because of the study context: No participant cross-over Administration of co-interventions of interest, antivirals, corticosteroids were reported. No information on biologics. 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: Mortality (D28). Adverse events. Serious adverse events. |
| Missing outcome data |
Low |
Comment: 52 participants randomized; 52 participants analyzed.
Data available for all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Adverse events. Serious adverse events. |
| Measurement of the outcome |
Low |
Quote: "The investigators who were responsible for assessing the primary outcomes and the patients were blinded to the study group assignment."
Comment: Method of measuring the outcome probably appropriate. Measurement or ascertainment of outcome probably does not differ between groups. Blinded study (outcome assessor). Risk assessed to be low for the outcomes: Mortality (D28). Adverse events. Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: The statistical analysis plan was not available. The protocol and registry were available. The protocol was retrospective (dated October 2020) and although the registry was prospective (dated February 19th, 2020), it had since been updated (June 17th, 2020) and it is unclear if the outcomes were changed.
No information on whether the result was 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 |