FREEDOM – COVID-19

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):

1. Fever >38 degrees Celsius
2. O2 saturation ≤94
3. Abnormal laboratory marker (at least 1):
   1. d-dimer ≥1.0 μg /mL
   2. CRP >2 mg/L
   3. Ferritin >300 μg /L
   4. Lymphopenia <1500 cells /m3

• Patient or legal guardian provides written informed consent

NCT ID

NCT04512079