| Bias | Author's judgement | Support for judgement |
| Randomization |
Some concerns |
Quote: "SAS software was used to generate the random number and the treatment group corresponding to the random number. After the subjects passed screening, the researchers assigned the random number according to the order of enrollment, removed the random envelope according to the random number, and treated the subjects according to the random envelope group and treatment plan. The blind method is not suitable for this trial." Comment: unclear reporting of allocation concealment. |
| Deviations from intervention |
Some concerns |
Comment: Unblinded study.
No participant cross-over. No information of administration of co-interventions of interest: glucocorticoids and anticoagulants, antivirals (in the control arm) and biologics were reported. Appropriate analysis method was used; participants were analyzed according to their assigned intervention. |
| Missing outcome data |
Low |
Comment: 30 randomized/29 analyzed. Risk assessed to be low for the outcomes: Time to clinical improvement. Clinical improvement incidence. Time to negative viral conversion. Negative viral conversion incidence. Mortality. WHO clinical progression scale Score 6 and above. WHO clinical progression scale Score 7 and above. Serious adverse events. |
| Measurement of the outcome |
Some concerns |
Quote: "The blind method is not suitable for this trial." Comment: the trial was not blinded. The outcomes that concern clinical improvement/progression are observer-measured outcomes that involve clinical decision-making, and the assessment could theoretically be influenced by knowledge of the intervention assignment, though we do not consider this likely in the context of the pandemic. The outcomes in question do not seem to differ significantly between-groups. We consider that the outcome WHO clinical progression scale score 7 or above cannot be influenced by knowledge of the intervention assignment. Some adverse events were patient-reported or involved assessor judgment. The remaining outcomes are observer-measured and do not involve clinical decision-making. Risk assessed to be "low" for the outcomes: Mortality. Viral Negative Conversion incidence. Time to viral negative conversion. WHO Clinical progression scale score 7 or above. Risk assessed to be "some concerns" for the outcomes: WHO Clinical progression scale score 6 or above. Time to Clinical Improvement. Clinical improvement incidence. Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: There is no protocol, or pre-specified analysis plan in the appendix. Risk assessed to be "some concerns" for the outcomes: Time to clinical improvement. Clinical improvement incidence. Time to negative viral conversion. Negative viral conversion incidence. Mortality. WHO clinical progression scale Score 6 and above. WHO clinical progression scale Score 7 and above. Serious adverse events. |
| Overall risk of bias |
Some concerns |