| 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, were reported. Antiviral administration via lopinavir/ritonavir was reported. Trialists used ITT analysis. |
| Missing outcome data |
Low |
Comment: 64 randomized/64 analyzed.
Data available for all participants. Risk assessed to be low for the outcomes: Mortality. WHO score 6 and above. WHO 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 WHO 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. WHO score 7 and above. Adverse events. Serious adverse events. For the outcome WHO 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. Risk assessed to be some concerns for outcome: WHO score 6 and above. |
| Selection of the reported results |
Low |
Comment: The protocol and statistical plan were not available. The registry was available and utilized.
Safety outcomes were not listed in the registry nor specified as outcomes in the paper. All other outcomes related to those that were registered and also reported in the paper. Results were not selected from multiple outcome measurements nor analyses of the data. Trial analyzed as prespecified. Risk assessed to be low for the outcomes: Mortality. WHO score 6 and above. WHO score 7 and above. Adverse events. Serious adverse events. |
| Overall risk of bias |
High |