Trial NCT04348305
Publication COVID STEROID - Munch MW, Acta Anaesthesiol Sc (2021) (published paper)
Primary outcome on the report: Days alive without the use of life support (i.e. invasive mechanical ventilation, circulatory support, or renal replacement therapy, including days in between intermittent renal replacement therapy) at day 28

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
Low 		Quote: "The randomisation was performed according to a computer-generated allocation sequence, stratification variables (trial site, use of invasive mechanical ventilation (y/n), age below 70 years (y/n)), and varying block sizes. The allocation sequence was only known by the data manager at the CTU." Comment: Comment: Allocation sequence random. Allocation sequence concealed
Deviations from intervention
Low 		Quote: “The Management Committee, investigators, trial site staff registering outcome data, trial statistician, clinical staff, relatives, and participants were all blinded to the allocation. Trial medication was prepared daily using shelf-medication by a dedicated team of unblinded trial site staff (medical students and/or research nurses and doctors). The unblinded trial site staff were not involved in the care of trial participants, outcome data entry, or statistical analyses.”
Comment: Blinded study (participants and personnel/carers)
Risk assessed to be low for the outcomes: Mortality (D28). Mortality (D60 or more). Serious adverse events.
Missing outcome data
Low 		Comment: 30 participants randomized; 30 participants analyzed.
Data available for all or nearly all participants randomized.
Risk assessed to be low for the outcomes: Mortality (D28). Mortality (D60 or more). 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.
Blinded study (outcome assessor).
Risk assessed to be low for the outcomes: Mortality (D28). Mortality (D60 or more). Serious adverse events
Selection of the reported results
Low 		Comment: The protocol, statistical analysis plan (retrospective, dated July 21st, 2020)and registry (prospective,dated April 14th, 2020) were available
Outcome pre-specified.
Results were not selected from multiple outcome measurements or analyses of the data.
Trial analyzed as pre-specified.
Risk assessed to be low for the outcome: Mortality (D28). Mortality (D60 or more). Serious adverse events.
Overall risk of bias
Low