RecruitingAccepts healthy volunteersPhase 2

Defibrotide for the Treatment of Severe COVID-19

Brigham and Women's Hospital · with Jazz Pharmaceuticals · NCT04652115

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Status re-checked against ClinicalTrials.gov within the last 12 hours.

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

Being studied: Defibrotide

Conditions: Covid19

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

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

Exclusion Criteria

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.

Brigham and Women's Hospital
Boston, MA 02214
Site contact: Paul G Richardson, MD · 617-632-2127 · Paul_Richardson@dfci.harvard.edu