| 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, anticoagulants, 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 |
Some concerns |
Comment: The protocol was available but was not pre-specified. The statistical analysis plan was not available. The registry was retrospective.
Risk assessed to be some concerns for the outcomes: Mortality. Incidence of viral negative conversion. Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |