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: Blinded study (patients). Unclear if physicians and those administering treatment were blinded. No patient cross-over Administration of co-interventions of interest, antivirals, corticosteroids were reported. No information on biologics. Data were analyzed using intention-to-treat analysis. |
| Missing outcome data |
Low |
Comment: 52 patients randomized; 52 patients analyzed.
data available for all participants Risk assessed to be low for the outcomes: Mortality. Incidence of viral negative conversion. 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: Blinded study (outcome assessor). Risk assessed to be low for the outcomes: Mortality. Incidence of viral negative conversion. Adverse events. Serious adverse events. |
| Selection of the reported results |
Low |
Comment: The protocol and registry were available. The statistical analysis plan was not available.
All outcomes were registered and reported as such in the paper. Results were not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcomes: Mortality. Incidence of viral negative conversion. Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |