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: "Participants were randomly assigned in a 2:2:1 ratio. Randomization was stratified by ARDS severity (severe vs mild/moderate at the time of randomization) and investigative site [REGISTRY RESULTS]. All participants will be centrally assigned to study treatment using an IRT system. The randomization schedule will be generated by a sponsor-independent statistician and sent directly to the IRT vendor without being provided to the Sponsor [PROTOCOL]."
Comment: Allocation sequence random Allocation sequence concealed |
Deviations from intervention |
Low |
Quote: “Double (Participant, Investigator) [REGISTRY]. Participants, investigator staff, persons performing the assessments, and the Incyte study team will remain blind to the identity of the treatment from the time of randomization until database lock [PROTOCOL]. ”
Comment: Blinded study (participants and personnel/carers) Our analysis for the binary outcome is an intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention. Risk assessed to be low for the outcomes: Mortality (D28). Clinical improvement (D28). Adverse events. Serious adverse events. |
Missing outcome data |
Low |
Comment: 211 participants randomized; 211 participants analyzed for efficacy; 209 participants analyzed for safety; 204 participants analyzed for clinical improvement.
Data available for all or nearly all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Clinical improvement (D28). Adverse events. 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). Clinical improvement (D28). Adverse events. Serious adverse events. |
Selection of the reported results |
Low |
Comment: The protocol, statistical analysis plan, prospective registry were available (dated May 6, 2020).
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). Clinical improvement (D28). Adverse events. Serious adverse events. |
Overall risk of bias |
Low |