Defibrotide for the Treatment of Severe COVID-19

• Status: Recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this study is to evaluate the safety and feasibility of defibrotide in COVID-19 pneumonia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: Jazz Pharmaceuticals
• Treatments: Defibrotide

Criteria

Inclusion Criteria:

1. Age ≥18 years.

2. Active COVID-19 infection confirmed by positive SARS-CoV-2 PCR.

3. Radiographic evidence of bilateral pulmonary infiltrates.

4. A life expectancy of at least 24 hours.

5. Score of 4-7 on the WHO ordinal scale.

6. Prophylactic dose anticoagulation is allowed for enrollment into cohort 1. Therapeutic dose anticoagulation for active thrombosis, ECMO, and/or continuous renal replacement therapy (CRRT) is allowed for enrollment into cohort 2 if there is no evidence of bleeding after at least 24 hours of anticoagulation.

7. Patient or surrogate able to provide informed consent

Exclusion Criteria:

1. Clinically significant acute bleeding.

2. Concomitant use of thrombolytic therapy (e.g. t-PA).

3. Hemodynamic instability, defined as a requirement for >1 vasopressor agent for enrollment into cohort 1, and a requirement for >2 vasopressor agents for enrollment into cohort 2

4. Known allergy or hypersensitivity to DF.

5. Pregnant or lactating.