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: "Central randomization will be done within theREDCap system. Local investigators in participating ICUs are the only authorized personnel to interact withthe web-response system through a username and pass-word. Once eligibility is confirmed in the eCRF, the nextavailable treatment group is assigned by the system ac-cording to a randomization schedule prepared by a stat-istician and uploaded as a look-up table to the REDCapsystem. The computer-generated randomization sched-ule will use random permuted blocks of varying sizes tofurther ensure allocation concealment and is unavailableto those who enroll patients or assign interventions."
Comment: Allocation sequence random. Allocation sequence concealed |
| Deviations from intervention |
Low |
Quote: “Open Label”
Comment: Unblinded study (participants and personnel/carers). Deviations from intended intervention arising because of the study context: No participant cross-over. Administration of co-interventions of interest: antivirals and biologics were reported and balanced between groups. Hence, deviations did not arise because of the trial context. 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 low for the outcome: Mortality (D28). |
| Missing outcome data |
Low |
Comment: 19 participants randomized; 19 participants analyzed.
Data available for all participants randomized. Risk assessed to be low for the outcome: Mortality (D28). |
| 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. Risk assessed to be low for the outcome: Mortality (D28). |
| Selection of the reported results |
Low |
Comment: The protocol, statistical analysis plan, registry were available.
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). |
| Overall risk of bias |
Low |