COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-79

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 prophylactic dosage and 1 arm for therapeutic 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.

Population

Adults age between 40 and 80 years, COVID-19 positive, elevated D-dimer and hsCRP, who do not require hospitalization.

Intervention

  1. Anticoagulation: prophylactic dose apixaban
  2. Anticoagulation: therapeutic dose apixaban
  3. Antiplatelet agent: low dose aspirin
  4. 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.