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Anticoagulant

Defibrotide for COVID-19

Phase 2
Recruiting
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years
Radiographic evidence of bilateral pulmonary infiltrates
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 21 days
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial will test if the drug defibrotide is safe and effective in treating COVID-19 pneumonia.

Who is the study for?
This trial is for adults over 18 with severe COVID-19, showing lung complications on X-rays. They must expect to live at least another day and be able to consent. People already on blood thinners or certain therapies like ECMO or CRRT can join specific groups unless they're bleeding or unstable due to low blood pressure.
What is being tested?
The study tests the safety and effectiveness of a drug called Defibrotide in treating pneumonia caused by COVID-19. It aims to see if this treatment can help patients with serious symptoms.
What are the potential side effects?
Potential side effects of Defibrotide may include bleeding problems since it's used in conditions related to blood clots. Other side effects are not specified but could align with those seen in its use for other conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My lung scans show signs of infection in both lungs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently using medication to dissolve blood clots.
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I need more than one medication to maintain my blood pressure for cohort 1, and more than two for cohort 2.
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I am currently experiencing significant bleeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 21 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 21 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The rate of adverse event of special interest (bleeding and hypotension)

Side effects data

From 2018 Phase 4 trial • 20 Patients • NCT02876601
81%
Headache
38%
Flu-like Symptoms
19%
Chills
13%
Nausea
13%
Arthralgia
6%
Precollapse
6%
Dizziness
6%
Vertigo
100%
80%
60%
40%
20%
0%
Study treatment Arm
Defibrotide Plus LPS
Placebo Plus LPS
Defibrotide Plus Placebo
Placebo/Placebo

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: DefibrotideExperimental Treatment1 Intervention
Defibrotide IV
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Defibrotide
FDA approved

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,670 Previous Clinical Trials
11,878,224 Total Patients Enrolled
Jazz PharmaceuticalsIndustry Sponsor
251 Previous Clinical Trials
34,992 Total Patients Enrolled

Media Library

Defibrotide (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT04652115 — Phase 2
Coronavirus Research Study Groups: Defibrotide
Coronavirus Clinical Trial 2023: Defibrotide Highlights & Side Effects. Trial Name: NCT04652115 — Phase 2
Defibrotide (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04652115 — Phase 2
~9 spots leftby Dec 2025
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