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: "Patients who met the criteria for inclusion and did
not meet the criteria for exclusion were randomized 1:1 into a group receiving oral
administration of enisamium and a group receiving oral administration of placebo"
Comment: Allocation sequence probably random. No information on allocation concealment. No information on baseline characteristics for all randomized patients. |
| Deviations from intervention |
Low |
Quote: (report) "double-blind" (registry) "quadruple masking: Participant, Care Provider, Investigator, Outcomes Assessor"
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). Adverse events. Serious adverse events. |
| Missing outcome data |
Some concerns |
Comment: 592 randomized; 285 analyzed for mortality; 582 analyzed for safety.
MORTALITY Data not available for all or nearly all participants randomized. No evidence that the result is not biased. Reasons: 151 vs 147 were excluded from the analysis because they did not meet eligibility criteria. Missingness could depend on the true value of the outcome. Not likely that missingness depended on the true value of the outcome: same reason between arms. Risk assessed to be some concerns for the outcomes: Mortality (D28). ADVERSE AND SERIOUS ADVERSE EVENTS Data available for all or nearly all participants randomized. Risk assessed to be low for the outcomes: 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). Adverse events. Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: The protocol and statistical analysis plan were not available. The registry was retrospective (dated December 4th, 2020).
MORTALITY Mortality outcome was not pre-specified, however, we do not consider the reporting of this outcome to be selective since mortality should be reported even if not planned. Results were probably 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). ADVERSE AND SERIOUS ADVERSE EVENTS No information on whether the result was selected from multiple outcome measurements or analyses of the data. No information on whether the trial was analyzed as pre-specified. Risk assessed to be some concerns for the outcome: Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |