| 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. Administration of co-interventions of interest : antivirals and biologics were reported and balanced between groups. |
| Missing outcome data |
Low |
Comment: 19 patients randomized; 19 patients analyzed.
Risk assessed to be low for the outcomes: Mortality. |
| Measurement of the outcome |
Low |
Comment: Unblinded study
Mortality is an observer-reported outcome not involving judgement. Risk assessed to be low for the outcomes: Mortality. |
| 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 outcomes: Mortality. |
| Overall risk of bias |
Low |