RecruitingPhase 2NCT04652115

Defibrotide for the Treatment of Severe COVID-19

A Single-Arm Safety and Feasibility Study of Defibrotide for the Treatment of Severe COVID-19

Sponsor

Brigham and Women's Hospital

Enrollment

42 participants

Start Date

Jan 1, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 100 Years

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

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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