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:"Randomization was performed using a secure web application and was stratified based on noncritical care (non–intensive care unit [ICU]) or critical care (ICU) status at the time of randomization."
Comment: Allocation sequence random. Allocation sequence concealed |
Deviations from intervention |
Some concerns |
Quote: “Partial blinding”
Comment: Partially blinded study (participants and site principal investigators, but not carers). Deviations from intended intervention arising because of the study context: Participant cross-over from prophylactic/intermediate anticoagulation to therapeutic was permitted in the event of reduced kidney function but no occurrence is reported. No information on administration of co-intervention of interest: corticosteroids, biologics and antivirals. Hence, no information on whether deviations arose because of the trial context. 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. Of note, 1 (therapeutic) vs 3 (prophylactic) participants were excluded from the analysis post-randomization because they did not receive the drug. Risk assessed to be some concerns for the outcome: Mortality (D28). Clinical improvement (D28). Serious adverse events. |
Missing outcome data |
Low |
Comment: 257 participants randomized; 253 participants analyzed.
Data available for all or nearly all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Clinical improvement (D28). Serious adverse events. |
Measurement of the outcome |
Low |
Quote from contact with authors: "The staff that assessed the outcomes: Yes, blinded"
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 outcome: Mortality (D28). Clinical improvement (D28). Serious adverse events. |
Selection of the reported results |
Low |
Comment: The prospective protocol and statistical analysis plan were available (dated April 26, 2020). The registry was dated May 21, 2020.
MORTALITY 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, SERIOUS ADVERSE EVENTS Outcome data acquired from contact with authors. 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: Clinical improvement (D28). Serious adverse events. |
Overall risk of bias |
Some concerns |