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: “Randomisation was done in a 1:1 ratio in permuted blocks of variable size, stratified according to clinical condition (stable or unstable), using a central, concealed, web-based, automated randomisation system.”
Comment: Allocation sequence random. Allocation sequence concealed. Imbalances in baseline characteristics appear to be compatible with chance |
| Deviations from intervention |
Some concerns |
Quote: “Open-label”
Comment: Unblinded study (participants and personnel/carers) Deviations from intended intervention arising because of the study context: The comparison was therapeutic-dose anticoagulation for 30 days versus usual care anticoagulation during hospitalization. Both arms received anticoagulation, but the majority of the intervention group (94.8%) received therapeutic dose anticoagulation while the majority of the control group received prophylactic dose anticoagulation during hospitalization (99.5%), while 13% were prescribed extended prophylaxis beyond hospital discharge. One participant in the prophylactic anticoagulation group received therapeutic anticoagulation but all were analyzed according to their randomized groups. No information on administration of biologics. Antivirals and corticosteroids were reported and balanced between groups. Hence, no information on whether deviations arose because of the trial context. 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 some concerns for the outcomes: Mortality (D28). Clinical improvement (D28). WHO score 7 and above (D28). |
| Missing outcome data |
Low |
Comment: 615 participants randomized; 614 participants analyzed.
Data available for nearly all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Clinical improvement (D28). WHO score 7 and above (D28). |
| 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). WHO score 7 and above (D28). |
| Selection of the reported results |
Low |
Comment: The protocol (from version dated June 4th, 2020), statistical analysis plan and registry were available and utilized.
Outcomes 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 outcomes: Mortality (D28). Clinical improvement (D28). WHO score 7 and above (D28). |
| Overall risk of bias |
Some concerns |