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. 2021 Mar 18;2021(3):CD013881. doi: 10.1002/14651858.CD013881

9. ROB table: tocilizumab vs standard care(SC)/placebo. Time to death.

Study 1.Randomisation 2.Deviations from
intervention
3.Missing outcome
data
4.Measurement
of the outcome
5.Selection of the
reported results
Overall risk of bias
Gordon REMAP‐CAP 2021 Low Some concerns 1 Low Low Low Some concerns
Hermine CORIMUNO‐19 2020 Low Some concerns 2 Low Low Low Some concerns
Stone 2020 Low Low Low Low Low Low

1 Quote: “open‐label” Comment: unblinded study. Deviations from intended intervention arising because of the study context: No participant cross‐over. Administration of co‐interventions of interest: antivirals (Remdesivir, 32.8%) and corticosteroids (> 80%) were administered, but numbers per group were not reported. Hence, this domain was rated as some concern as not enough information on deviations that arose because of the trial context were reported. Participants were analysed according to their randomised groups for the outcome. Of note, 13 vs 10 participants were excluded from the analysis post‐randomisation for reasons related to missing data. This method was considered appropriate to estimate the effect of assignment to intervention.

2 Quote: “Open‐label study” Comment: unblinded study.

Deviations from intended intervention arising because of the study context: three participants in the treatment group did not receive study drug. Administration of co‐interventions of interest (antivirals, corticosteroids and biologics) were reported. The proportions of participants receiving antivirals and steroids were imbalanced between 2 arms (> 10% absolute difference between the 2 arms) for steroids. This deviation could affect the outcome and was not balanced. Nevertheless, this domain was rated as Some Concerns as it is impossible to distinguish deviation because of trial context and deviation because of intervention effect. Participants were analysed according to their randomised groups for the outcome. Of note, 1 vs 0 participants were excluded from the analysis because of consent withdrawal. Nevertheless, we consider the analysis appropriate to estimate the effect of assignment to intervention.