← Back to all trials
Recruiting
NCT04652115
Defibrotide for the Treatment of Severe COVID-19
Conditions: Covid19
Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: Yes
Phase: PHASE2
Enrollment: 42
Sponsor: Brigham and Women's Hospital
Location: Brigham and Women's Hospital Boston Massachusetts
Summary
The goal of this study is to evaluate the safety and feasibility of defibrotide in COVID-19 pneumonia.
Eligibility 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.
Source: ClinicalTrials.gov (NCT04652115). StuddyBuddy aggregates publicly available trial information.