FREEDOM COVID-19 Anticoagulation Strategy
Summary
Coronavirus Disease (COVID-19), caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), has led to unprecedented morbidity and mortality in the modern era. To date, nearly 13 million people have contracted COVID-19, leading to more than 550,000 deaths worldwide. As the number of affected individuals continues to climb, effective strategies for treatment and prevention of the disease are of paramount importance. SARS-CoV-2 is understood to directly invade cells via the human angiotensin-converting enzyme 2 (ACE2) receptor, which is expressed predominantly in the lungs but also throughout the cardiovascular system. Thus, while acute respiratory distress syndrome remains a feared complication, new thromboembolic disease has emerged as a common and potentially catastrophic manifestation of COVID-19.
Timeline
- Start
- 2020-09-08
- Primary completion
- 2022-12-30
- Completion
- 2022-12-30
Publications
- Stone GW, Farkouh ME, Lala A, Tinuoye E, Dressler O, Moreno PR, Palacios IF, Goodman SG, Esper RB, Abizaid A, Varade D, Betancur JF, Ricalde A, Payro G, Castellano JM, Hung IFN, Nadkarni GN, Giustino G, Godoy LC, Feinman J, Camaj A, Bienstock SW, Furtado RHM, Granada C, Bustamante J, Peyra C, Contreras J, Owen R, Bhatt DL, Pocock SJ, Fuster V; FREEDOM COVID Anticoagulation Strategy Randomized Trial Investigators. Randomized Trial of Anticoagulation Strategies for Noncritically Ill Patients Hospitalized With COVID-19. J Am Coll Cardiol. 2023 May 9;81(18):1747-1762. doi: 10.1016/j.jacc.2023.02.041. Epub 2023 Mar 6.
- Farkouh ME, Stone GW, Lala A, Bagiella E, Moreno PR, Nadkarni GN, Ben-Yehuda O, Granada JF, Dressler O, Tinuoye EO, Granada C, Bustamante J, Peyra C, Godoy LC, Palacios IF, Fuster V. Anticoagulation in Patients With COVID-19: JACC Review Topic of the Week. J Am Coll Cardiol. 2022 Mar 8;79(9):917-928. doi: 10.1016/j.jacc.2021.12.023.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Apixaban | Small molecule | 2.5 mg | Oral |
| Subject | Apixaban | Small molecule | 5 mg | Oral |
| Comparator | Enoxaparin sodium | Other / unclassified | 1 mg/kg | Subcutaneous |
| Comparator | Enoxaparin sodium | Other / unclassified | 30 mg | Subcutaneous |
| Comparator | Enoxaparin sodium | Other / unclassified | 40 mg | Subcutaneous |