COVID-19 Thrombosis Prevention Trials: Post-hospital Thromboprophylaxis

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

A multicenter, adaptive, randomized platform trial evaluating the efficacy and safety of antithrombotic strategies in patients with COVID-19 following hospital discharge

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas L. Ortel; Thomas Ortel, M.D., Ph.D.
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Apixaban

Criteria

Inclusion Criteria:

• • Age ≥ 18 years

• PCR-positive COVID-19 infection

• Hospitalized for two or more days

Exclusion Criteria:

• Pre-existing indication for anticoagulation (e.g., pulmonary embolism or deep vein thrombosis; atrial fibrillation; mechanical cardiac valve)

• Contraindication to antithrombotic therapy (e.g., known bleeding within the last 30 days requiring emergency room presentation or hospitalization; major surgery within 14 days; ischemic stroke, intracranial bleed or neurosurgery within 3 months.

• Platelet count < 50,000/mcL

• Hemoglobin <8 gm/dL

• Renal insufficiency (eGFR < 30 mL/min/1.73 m2)

• Pregnancy

• Prison inmate

• Life expectancy less than 90 days

• Unwilling or unable to provide informed consent/unwilling or unable to complete the study protocol

• Dual antiplatelet therapy that cannot be discontinued

• Concomitant need for strong inducers/inhibitors of p-gp or CYP3A4