No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 100
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
42 (estimated)
Sponsor
Brigham and Women's Hospital · Other
Who this trial is looking for
This trial is looking for adults with severe COVID-19 who have pneumonia. Participants will receive defibrotide to see if it's safe and helpful for this condition.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have a confirmed active COVID-19 infection.
I have lung issues shown on my imaging tests.
I can expect to live for at least 24 more hours.
I have a score of 4-7 on the WHO scale.
I can provide consent or have someone who can.
I may be taking certain anticoagulants.
You may not be able to join if
I have significant bleeding.
I am receiving thrombolytic therapy.
I am unstable and need more than one vasopressor.
I am allergic to defibrotide.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The goal of this study is to evaluate the safety and feasibility of defibrotide in COVID-19 pneumonia.
Trial Locations
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Facility
City
State
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Status
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 …
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.
Contacts
No contact information available.
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