Recruiting
Phase 2

Defibrotide

Sponsor:

Brigham and Women's Hospital

Code:

NCT04652115

Conditions

Covid19

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Defibrotide

Study Details

Brief summary:

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

Conditions

Covid19

Study ID

NCT04652115

Start date

Jan 1, 2021

Status verified date

Jul, 2026

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Dec 24, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

42 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Defibrotide

Defibrotide IV

Interventions

Defibrotide

Deibrotide via IV

Primary outcome measure

  • The rate of adverse event of special interest (bleeding and hypotension) [ Time Frame: Up to 21 days ]

Central Contacts and Locations

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02214

Contacts

Paul G Richardson, MD

617-632-2127Paul_Richardson@dfci.harvard.edu

Principal Investigator:

Paul G Richardson, MD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-07-20.