Defibrotide for the Treatment of Severe COVID-19

NCT04652115 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2020P003203
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• The rate of adverse event of special interest (bleeding and hypotension)

  The rate of adverse event of special interest (bleeding and hypotension)

  Up to 21 days

Study Arms (1)

Defibrotide

EXPERIMENTAL

Defibrotide IV

Drug: Defibrotide

Interventions

Defibrotide DRUG

Deibrotide via IV

Defibrotide

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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 may not qualify 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Jazz Pharmaceuticals: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02214, United States

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

defibrotide

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, single arm, two cohort clinical trial.

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 3, 2020
• Study Start: January 1, 2021
• Primary Completion: September 1, 2024
• Study Completion: March 1, 2025
• Last Updated: May 10, 2024

Record last verified: 2024-05

Locations

US (1)