Actively Recruiting

Phase 2
Age: 18Years - 100Years
All Genders
Healthy Volunteers
NCT04652115

Defibrotide for the Treatment of Severe COVID-19

Led by Brigham and Women's Hospital · Updated on 2024-05-10

42

Participants Needed

1

Research Sites

217 weeks

Total Duration

On this page

Sponsors

B

Brigham and Women's Hospital

Lead Sponsor

J

Jazz Pharmaceuticals

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Defibrotide for the Treatment of Severe COVID-19

Who Can Participate

Age: 18Years - 100Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Active COVID-19 infection confirmed by positive SARS-CoV-2 PCR
  • Radiographic evidence of bilateral pulmonary infiltrates
  • Life expectancy of at least 24 hours
  • Score of 4 to 7 on the WHO ordinal scale
  • Prophylactic anticoagulation allowed for cohort 1
  • Therapeutic anticoagulation for active thrombosis, ECMO, or CRRT allowed for cohort 2 if no bleeding after 24 hours
  • Patient or surrogate able to provide informed consent
Not Eligible

You will not qualify if you...

  • Clinically significant acute bleeding
  • Use of thrombolytic therapy (e.g., t-PA)
  • Hemodynamic instability requiring more than 1 vasopressor agent for cohort 1
  • Hemodynamic instability requiring more than 2 vasopressor agents for cohort 2
  • Known allergy or hypersensitivity to defibrotide
  • Pregnant or lactating

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02214

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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