Risk of bias for analysis 7.2 All‐cause mortality up to 120 days.
| Study | Bias | |||||||||||
| Randomisation process | Deviations from intended interventions | Missing outcome data | Measurement of the outcome | Selection of the reported results | Overall | |||||||
| Authors' judgement | Support for judgement | Authors' judgement | Support for judgement | Authors' judgement | Support for judgement | Authors' judgement | Support for judgement | Authors' judgement | Support for judgement | Authors' judgement | Support for judgement | |
| Subgroup 7.2.1 High‐income countries | ||||||||||||
| Munch 2021a | Low risk of bias | No issues with randomisation process. | Low risk of bias | Withdrawals with consecutive open‐label steroids may have affected the outcome, but withdrawals and non‐compliance was rather balanced after all. | Low risk of bias | No missing data. | Low risk of bias | No issues with measurement. | Low risk of bias | No relevant issues with the reported result. | Low risk of bias | Withdrawals because of the experimental context lead to some concerns (but it is less than 10% of all patients). |
| Subgroup 7.2.2 Low‐ and middle‐income countries | ||||||||||||
| Edalatifard 2020 | Some concerns | No information about the allocation concealment. | Some concerns | 6 patients in the control group received the intervention drug and were excluded from the analyses (17%). | Low risk of bias | The data were requested from the authors because the follow‐up time was not clearly visible from the publication. | Low risk of bias | The measurements were similar between groups. | Some concerns | Neither the protocol nor the SAP were available | Some concerns | Overall judged some concerns due to the randomisation process, protocol deviations and the selection of the reported results. |
| Jeronimo 2020 | Low risk of bias | An independent statistician prepared an electronically generated randomisation list with 14 blocks of 30 participants per block, generated via R software version 3.6.1 (blockrand package). The list was accessible only to non‐blinded pharmacists in the study. Participants were randomised by the study pharmacist to their designated treatment regimen at the time of inclusion and were subsequently identified throughout the study only by their allocated study number. There were no major differences in baseline characteristics between the intervention and placebo groups |
Some concerns | Intervention group: 14 excluded before starting treatment, 1 excluded after starting treatment Control group: 5 excluded before starting treatment, 3 excluded after starting treatment |
Low risk of bias | 416 participants randomised and 416 participants analysed. | Low risk of bias | The measurements were similar between groups | Low risk of bias | Protocol and statistical plan available. Data analysed and presented according to a pre‐specified plan. | Some concerns | Overall judged some concerns due to protocol deviations. |