Trial NCT04411667
Publication Sakoulas G, medRxiv, 2020
Primary outcome on the report: respiratory failure requiring receipt of mechanical ventilation (a composite of either receiving ventilation or the subject status changed to a do not resuscitate/do not intubate resulting in progressive respiratory failure and death)
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. Hypertension at baseline favored the control arm, however, the difference appears to be compatible with chance.
Deviations from intervention
Some concerns 		Comment: Unblinded study. No information on antimalarial cointervention, however antivirals, glucocorticoids, and biologics were reported. One participant in the treatment arm excluded from the study with reasons. 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 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.
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: 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 recovery. Incidence of WHO score 7 and above. Adverse events. Serious adverse events.
Overall risk of bias
Some concerns