Trial EudraCT number: 2020-001934-37
Publication Corral L, medRxiv, 2020
Primary outcome on the report: composite endpoint that included in-hospital all-cause mortality, escalation to ICU admission, or progression of respiratory insufficiency that required non-invasive ventilation (NIV).
Bias Author's judgement Support for judgement
Randomization
High 		Quote: "Patients were randomized (1:1) and allocated to the MP or control arm accordingly. Patients were randomized based on a spreadsheet that transformed every medical record number into a group allocation."
Comment: The allocation sequence was probably not concealed. The generation of the randomization sequence is inadequate.
Deviations from intervention
Some concerns 		Comment: Unblinded study.
3 patients in the control arm received a bolus of corticosteroids.
No information on n per arm of cointerventions of interest, biologics and anticioagulants, were reported. Antiviral administration via lopinavir/ritonavir was reported.
Trialists used ITT analyses.
Missing outcome data
Low 		Comment: 64 randomized; 64 analyzed.
Risk assessed to be low for the outcomes: Mortality. Score 6 and above. Score 7 and above. Adverse events. Serious adverse events.
Measurement of the outcome
Some concerns 		Comment: Open label trial. Mortality is an observer-reported outcome not involving judgement. For the outcome Score 6 or above although the assessment could possibly be influenced by knowledge of the intervention assignment we did not consider this likely to have happened in the context of a pandemic. For the outcome Score 7 or above we consider the assessment cannot possibly be influenced by knowledge of the intervention assignment. The outcomes Adverse events and Serious adverse events includes only observer-reported events not involving judgement (laboratory measures) so we consider that it cannot be influenced by knowledge of the intervention assignment.
Risk assessed to be low for outcomes: Mortality. Incidence of WHO score 7 and above. Adverse events. Serious adverse events.
Risk assessed to be some concerns for outcome: Incidence of WHO score 6 and above.
Selection of the reported results
Some concerns 		Comment: There is no protocol or statistical plan available.
Risk assessed to be some concerns for the outcomes: Mortality. Incidence of WHO score 6 and above. Incidence of WHO score 7 and above. Adverse events. Serious adverse events.
Overall risk of bias
High