A Single-Arm Safety and Feasibility Study of Defibrotide for the Treatment of Severe COVID-19
Brigham and Women's Hospital
Summary
The goal of this study is to evaluate the safety and feasibility of defibrotide in COVID-19 pneumonia.
Description
This study is a prospective, single-arm, two-cohort, phase 2 pilot study that will evaluate the safety and efficacy of defibrotide in clinically severe COVID-19. The defibrotide dose that is approved by the FDA for the treatment of post-HSCT VOD/SOS (6.25 mg/kg IV q6 hours) will be used. Cohort 1 will consist of patients with COVID-19 pneumonia confirmed by PCR and radiography, who are hospitalized with an oxygen requirement (either supplemental O2 or mechanical ventilation), are not on therapeutic dose anticoagulation, and require no more than one vasopressive agent to maintain hemodynamic s…
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- Yes
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 provi…
Interventions
- DrugDefibrotide
Deibrotide via IV
Location
- Brigham and Women's HospitalBoston, Massachusetts