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 |
Some concerns |
Quote: “Consecutive patients were assigned to aviptadil + maximal Standard of Care (SOC) vs placebo + maximal SOC in a 2:1 randomization”
Comment: Allocation sequence probably random. No information on allocation concealment. |
Deviations from intervention |
Low |
Quote: "Randomized prospective double-blind placebo-controlled trial with 28 day and 60 day endpoints "
Comment: Blinded study (participants and personnel/carers) 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 outcomes: Mortality (D28). Mortality (D60 or more) Clinical improvement (D28). Clinical improvement (D60 or more) Adverse events. |
Missing outcome data |
Low |
Comment: 203 participants randomized; 196 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). Clinical improvement (D28). Clinical improvement (D60 or more). 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). Clinical improvement (D28). Clinical improvement (D60 or more). Adverse Events. |
Selection of the reported results |
Some concerns |
Comment: The protocol and statistical analysis plan were not available. The trial registry (prospective, up to the version dated May 15th, 2020) was available.
MORTALITY Different timepoint pre-specified in registry No information on whether the result was selected from multiple outcome measurements or analyses of the data. Trial probably not analyzed as pre-specified. Risk assessed to be some concerns for the outcome: Mortality (D28). Mortality (D60 or more) CLINICAL IMPROVEMENT, AE Outcome not pre-specified No information on whether the result was selected from multiple outcome measurements or analyses of the data. Trial probably not analyzed as pre-specified. Risk assessed to be some concerns for the outcome: Clinical improvement (D28). Clinical improvement (D60 or more). Adverse events. |
Overall risk of bias |
Some concerns |