Note: The risk of bias by domain corresponds to the highest risk of bias among outcomes by domain.
The overall risk of bias corresponds to the overall highest risk of bias assessed among outcomes.
| 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: Allocation sequence probably random. The allocation sequence was probably not concealed. |
| Deviations from intervention |
Some concerns |
Quote: "open-label trial"
Comment: Unblinded study (participants and personnel/carers). Deviations from intended intervention arising because of the study context: 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. This deviation was not balanced and could affect the outcome. Nevertheless, this domain was rated as some concern as it is impossible to distinguish deviation because of trial context and deviation because of intervention effect. Data for the outcome were analyzed using intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention. Risk assessed to be some concerns for the outcomes: Mortality (D28). WHO score 7 and above (D28). Adverse events. Serious adverse events. |
| Missing outcome data |
Low |
Comment: 64 participants randomized, 64 participants analyzed.
Data available for all participants. Risk assessed to be low for the outcomes: Mortality (D28). WHO score 7 and above (D28). Adverse events. Serious adverse events. |
| Measurement of the outcome |
Low |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Unblinded study (outcome assessor) 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. Also, the authors reported on adverse events and serious adverse events that contain only laboratory-detected events so we consider that it cannot be influenced by knowledge of the intervention assignment. Risk assessed to be low for outcomes: Mortality (D28). WHO score 7 and above (D28). Adverse events. Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: Safety and WHO score 7 and above outcome data acquired from contact with authors.
Results were probably not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcomes: WHO score 7 and above (D28). Adverse events. Serious adverse events. The registry pre-specified mortality outcome. However, it was very retrospective. The protocol and statistical plan were not available. No information on whether the result was selected from multiple outcome measurements or analyses of the data. No information on whether the trial was analyzed as pre-specified. Risk assessed to be some concerns for the outcome: Mortality (D28). |
| Overall risk of bias |
High |