COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
Platform trial comparing the effectiveness of anticoagulation agents against antiplatelet agents and a placebo control arm. Stage 1 study agents include anticoagulation with apixaban (1 arm for 2.5 mg dosage and 1 arm for 5 mg dosage), with low dose aspirin as the antiplatelet.
Anticoagulant Agent VS. Antiplatelet Agent VS. Placebo
Key Personnel
Jean M. Connors, MD
PI (Brigham and Women’s Hospital)jconnors@bwh.harvard.edu(617) 732-5190
Paul M. Ridker, MD
Trial Chair (Brigham and Women’s Hospital)pridker@bwh.harvard.edu(617) 732-8790
Primary Outcome(s)
Thrombotic Event
A composite endpoint of need for hospitalization for cardiovascular/pulmonary events, symptomatic deep venous thrombosis, pulmonary embolism, arterial thromboembolism, myocardial infarction, ischemic stroke, and all-cause mortality for up to 45 days after initiation of assigned treatment.
A composite endpoint of need for hospitalization for cardiovascular/pulmonary events, symptomatic deep venous thrombosis, pulmonary embolism, arterial thromboembolism, myocardial infarction, ischemic stroke, and all-cause mortality for up to 45 days after initiation of assigned treatment.
Population
Adults age between 40 and 80 years, COVID-19 positive, who do not require hospitalization.
Intervention
- Anticoagulation: apixaban 2.5 mg
- Anticoagulation: apixaban 5 mg
- Antiplatelet agent: low dose aspirin
- Placebo
Planned Enrollment
7,000 in total (1,750 to each treatment arm) for Stage 1
Power and Interim Assessments
80% power to detect a 30% relative reduced risk
90% power to detect a 34% relative reduced risk
For stage 1, considering apixaban 5.0mg superiority with 8.0% placebo rate.
Follow-up
Minimum of weekly follow-up through Day 75.