Using defibrotide to treat severe COVID-19 pneumonia
A Single-Arm Safety and Feasibility Study of Defibrotide for the Treatment of Severe COVID-19
This study is testing if the drug defibrotide can safely help hospitalized patients with severe COVID-19 pneumonia who need oxygen support.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04652115 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of defibrotide in patients with clinically severe COVID-19 pneumonia. It is a prospective, single-arm, two-cohort, phase 2 pilot study that includes hospitalized patients requiring oxygen support. The study will utilize a dose de-escalation design in one of the cohorts to assess the drug's safety profile and potential effectiveness in this patient population. The FDA-approved dosing regimen for defibrotide will be administered to participants.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed COVID-19 pneumonia requiring hospitalization and oxygen support.
Not a fit: Patients with clinically significant acute bleeding or those requiring multiple vasopressors for hemodynamic stability may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from severe COVID-19 pneumonia.
How similar studies have performed: While this approach is novel in the context of COVID-19, similar studies using defibrotide for other conditions have shown promise.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.