UNC is now a fully active clinical site for the ACTIV-4c Post-Hospital Thrombosis Prevention Study. This protocol is part of the larger ACTIV (Accelerating COVID-Therapeutic Interventions and Vaccine) study. This protocol focuses on preventing blood clots in patients discharged after being hospitalized with COVID-19. UNC is now enrolling participants in this adaptive, prospective, randomized, double-blinded trial to evaluation the efficacy and safety of antithrombotic strategies in patients with COVID-19 following hospital discharge.
The UNC ACTIV-4c Team is led by the site Principal Investigator, Raj Kasthuri, MBBS, Professor of Medicine. Other UNC faculty include, Nigel Key, MD, the Harold R. Roberts Distinguished Professor of Medicine, Stephan Moll, MD, Professor of Medicine, Micah Mooberry, MD, Assistant Professor of Medicine, and Yasmina Abajas, MD, Assistant Professor of Pediatrics. The study team also include staff in the UNC Blood Research Center, Brett Phillips, Laura Finerty, Amy Brightwood, and Kelly Kivette.
Patients infected with the SARS-CoV2 are at an increased risk of thrombotic events which contribute to overall morbidity and mortality. Recent hospitalization is associated with increased risk for VTE. The impact of COVID-19 on this increased risk for VTE after hospital discharge is unknown.
Study Population: Adults ≥ 18 years of age with COVID-19 hospitalized 48 hours or longer ready for discharge from the hospital without an indication for or contraindication to anticoagulant therapy.
Stage 1 intervention: prophylactic apixaban 2.5 mg bid vs. placebo
Primary Endpoint: Composite endpoint of venous thromboembolism, ischemic stroke, myocardial infarction, peripheral arterial thromboembolism, and all-cause mortality by 30 days after randomization
Anticoagulant therapy has been shown to reduce VTE risk in select, high-risk patients with a recent hospitalization for an acute medical illness; whether post-discharge anticoagulant therapy benefits patients with COVID-19 is also unknown.
