| Bias | Author's judgement | Support for judgement |
| Randomization |
Some concerns |
Quote: "After informed consent was obtained, subjects were
randomized 1:1 into treatment arm or standard of care (SOC) control arm." Comment: There was no information on the allocation sequence and its concealment. |
| Deviations from intervention |
Some concerns |
Comment: Unblinded study.
No participant cross-over. Administration of all co-interventions of interest were reported: antivirals, glucocorticoids, anticoagulants and biologics. Imbalance in glucocorticoid administraiton: 94.1% vs. 58.8% in the intervention vs control arms. Outcome data were analyzed using intention-to-treat analysis. |
| Missing outcome data |
Low |
34 randomized; 33 analyzed. Data unavailable in <5% of population. Risk assessed to be low for outcomes: Mortality. Incidence of clinical improvement. Incidence of WHO score 6 and above. Incidence of WHO score 7 and above. Adverse events. Serious adverse events. |
| Measurement of the outcome |
Low |
Comment: Mortality is an observer-reported outcome not involving judgement. Death was the only serious adverse event reported, therefore no judgement was involved. Incidence of WHO score 7 and above is an outcome that reflects decisions made by the intervention provider. However, we consider that the assessment of these outcomes cannot possibly be influenced by knowledge of the intervention assignment. Risk assessed to be low for outcomes: Mortality. Incidence of WHO score 7 and above. Serious adverse events. Clinical improvement (definition is discharged from hospital on room air/no O2) reflects a decision made by the intervention provider where the assessment could possibly be influenced by knowledge of the intervention assignment however we did not consider this likely in the context of a pandemic. For WHO score 6 and above, although the assessment could also possibly be influenced by knowledge of the intervention assignment, we also did not consider this likely to have happened in the context of a pandemic. Adverse events may contain both clinically- and laboratory-detected outcomes, therefore it can be influenced by knowledge of the intervention assignment, but is not likely to. Risk assessed to be some concerns for outcomes: Incidence of clinical improvement. Incidence of WHO score 6 and above. Adverse events. |
| Selection of the reported results |
Some concerns |
Comment: The protocol and statistical analysis plan were not available. Risk assessed to be some concerns for the outcomes: Mortality. Incidence of clinical improvement. Incidence of WHO score 6 and above. Incidence of WHO score 7 and above. Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |