drugset / Trial / NCT04512079

FREEDOM COVID-19 Anticoagulation Strategy

NCT04512079

Phase 4 Completed 3460 enrolled Valentin Fuster
RandomizedParallel-groupOpen-labelTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
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

Indications