FREEDOM COVID Anticoagulation Strategy Randomized Trial
Objective
This is a multi-center, open-label, randomized controlled comparative safety and effectiveness trial with objectives: 1. To determine the effectiveness of enoxaparin and apixaban in patients hospitalized (but not yet intubated) with confirmed COVID-19 and 2. To determine the safety of enoxaparin and apixaban in patients hospitalized (but not yet intubated) with confirmed COVID-19. Observational analyses have suggested potential benefit for in-hospital use of anticoagulation.
Study Arms
- Active Comparator: Prophylactic Enoxaparin
- Active Comparator: Full Dose Enoxaparin
- Experimental: Apixaban
Eligibility
- Hospitalization within the prior 24 hours for either confirmed (based on PCR or antigen positive test for SARS-CoV-2) or suspected COVID-19 based on 3 criteria (all 3 must be present for suspected cases):
- Fever >38 degrees Celsius
- O2 saturation ≤94
- Abnormal laboratory marker (at least 1):
- d-dimer ≥1.0 μg /mL
- CRP >2 mg/L
- Ferritin >300 μg /L
- Lymphopenia <1500 cells /m3
- Patient or legal guardian provides written informed consent
NCT ID
NCT04512079