NCT04652115 Defibrotide for the Treatment of Severe COVID-19
| NCT ID | NCT04652115 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Brigham and Women's Hospital |
| Condition | Covid19 |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2021-01-01 |
| Primary Completion | 2026-12-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 42 participants in total. It began in 2021-01-01 with a primary completion date of 2026-12-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Frequently Asked Questions
Who can join the NCT04652115 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Covid19. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04652115 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04652115 currently recruiting?
Yes, NCT04652115 is actively recruiting participants. Visit ClinicalTrials.gov or contact Brigham and Women's Hospital to inquire about joining.
Where is the NCT04652115 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT04652115 clinical trial?
NCT04652115 is sponsored by Brigham and Women's Hospital. The trial plans to enroll 42 participants.
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