Table 1.
PICOT element | Eligibility criteria | |
Population | Adults with laboratory-confirmed COVID-19, receiving care in any clinical setting (outpatient or inpatient, including non-ICU and ICU-level care) | |
Intervention and comparator/exposure | Intermediate-dose prophylactic anticoagulation vs standard low-dose prophylaxisTherapeutic anticoagulation vs standard low-dose prophylaxis | |
Outcomes | Primary | All-cause mortality at 30 days, death, or dischargea |
Secondary | At 30 days, death, or discharge, rates of: | |
1. Venous thromboembolism | ||
2. Pulmonary embolism | ||
3. Deep venous thrombosis | ||
4. Any arterial thrombosis | ||
5. Any thrombosis | ||
6. Composite outcome of thrombosis or death | ||
7. Days requiring organ support | ||
8. Any requirement for respiratory support (IMV or ECMO) | ||
9. Major bleeding | ||
10. Clinically relevant nonmajor bleeding | ||
11. Major or clinically relevant nonmajor bleeding | ||
12. Any bleeding |
Abbreviations: COVID-19, coronavirus disease 2019; ECMO, extracorporeal membrane oxygenation; ICU, intensive care unit; IMV, invasive mechanical ventilation; PICOT, population, intervention, comparator, outcomes and timing criteria.
Study deviations from these predefined timepoints have been described in the analysis.