Using defibrotide to treat severe COVID-19 pneumonia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Investigating olfactory dysfunction after COVID-19 infection

  This study is trying to understand why some people still have trouble smelling after recovering from COVID-19 by looking at samples from their noses.

  Recruiting at 6 sites Universitaire Ziekenhuizen KU Leuven · Brussels, Brussels Capital and 6 other locations · NCT06482138

• Registry to evaluate pregnancy outcomes in women treated for COVID-19

  This study is trying to see how treatments for COVID-19, like certain medications, affect the health of pregnant women and their babies.

  Recruiting Pregistry · Los Angeles, California · NCT05013632

• Collecting COVID-19 virus secretions and serum for developing treatments

  This study is collecting samples from people with COVID-19 to learn more about how the virus behaves and how it affects recovery, with the goal of improving treatments for those at higher risk.

  Recruiting at 2 sites Tulane University · New Orleans, Louisiana and 1 other locations · NCT04956445

• Using donor-derived T cells to treat mild to moderate COVID-19

  This study is testing whether T cells from family members who have recovered from COVID-19 can help treat hospitalized patients with mild to moderate COVID-19.

  Recruiting Phase 1/2 New York Medical College · Valhalla, New York and 3 other locations · NCT04896606

• Observational study on the biology of COVID-19 in Saarland

  This study looks at how COVID-19 affects people in different ways, including those with long-term symptoms, to learn more about the disease and its progression.

  Recruiting Universität des Saarlandes · Homburg, Saarland · NCT04837755

• Imaging immune activation in COVID-19 patients

  This study is testing a special imaging technique to see how the immune system is working in people who have recently recovered from COVID-19.

  Recruiting Phase 2 CellSight Technologies, Inc. · San Francisco, California · NCT04815096

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.