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 |
Published Manuscript: "Trial procedures
were minimal but rigorous, with data entry through
a cloud-based Good Clinical Practice–compliant
clinical data management system that recorded
demographic characteristics, respiratory support,
coexisting illnesses, and local availability of trial
drugs before generating the treatment assignment."
Preprint: "Online randomization of consented patients (via a cloud-based GCP-compliant clinical data management system)" Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Low |
Comment: Unblinded study (patients and physicians)
Crossover: "for other drugs adherence midway was 94% to 95%, and crossover was 2 to 6%." Antivirals, corticosteroids and biologics were reported and balanced. Data were analyzed using intention-to-treat analysis. |
| Missing outcome data |
Low |
Comment: 4127 patients randomized, 4100 patients analyzed.
Data available for >95% of population. Risk assessed to be low for the outcome: Mortality. |
| Measurement of the outcome |
Low |
Comment: Unblinded study (outcome assessor)
Mortality is an observer-reported outcome, not involving judgement. Risk assessed to be low for the outcome: Mortality. |
| Selection of the reported results |
Low |
Comment: The prospective registry and protocol are available.
Mortality is specified in the protocol as reported in the paper. No timepoint of measurement is provided in the protocol but for this outcome, we do not suspect selective reporting of the results. Results were probably not selected from multiple outcome measurements not analyses of the data. Trial probably analyzed as pre-specified. Risk assessed to be Low for the outcome: Mortality. |
| Overall risk of bias |
Low |