Defibrotide for the Treatment of Severe COVID-19

What this study is

The goal of this study is to evaluate the safety and feasibility of defibrotide in COVID-19 pneumonia.

Official title: A Single-Arm Safety and Feasibility Study of Defibrotide for the Treatment of Severe COVID-19
Sponsor: Brigham and Women's Hospital
Conditions: Covid19
Enrolling: 42 people
Starts: 2021-01-01
Est. completion: 2027-01-01
Design: Open-label, single group, Phase 2
Record: View on ClinicalTrials.gov ↗

Age 18 Years – 100 YearsSex ALLHealthy volunteers Accepted

You may qualify if

Age ≥18 years.
Active COVID-19 infection confirmed by positive SARS-CoV-2 PCR.
Radiographic evidence of bilateral pulmonary infiltrates.
A life expectancy of at least 24 hours.
Score of 4-7 on the WHO ordinal scale.
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.
Patient or surrogate able to provide informed consent

You can't join if

Clinically significant acute bleeding.
Concomitant use of thrombolytic therapy (e.g. t-PA).
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
Known allergy or hypersensitivity to DF.
Pregnant or lactating.

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1

1 open

Brigham and Women's Hospital
Boston, Massachusetts, United States
- Paul G Richardson, MD · Contact617-632-2127 Paul_Richardson@dfci.harvard.edu
- Paul G Richardson, MD · Principal investigator
Recruiting

Sponsor

Study ID 2020P003203

Have questions? The record lists no central contact. Use Consider me and the site team can reach you, or find them through ClinicalTrials.gov ↗.

The sponsor hasn't published answers to common questions for this trial.