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Defibrotide for the Treatment of Severe COVID-19

NCT04652115

RecruitingPhase 2

Sponsor: Brigham and Women's Hospital

Conditions: Covid19

Interventions: Defibrotide

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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.

Locations (1)

Boston, Massachusetts, United States