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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 21 days
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am 18 years old or older.
Select...
My lung scans show signs of infection in both lungs.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

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
1,615 Previous Clinical Trials
11,470,788 Total Patients Enrolled
Jazz PharmaceuticalsIndustry Sponsor
248 Previous Clinical Trials
34,243 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

May I partake in this research endeavor?

"This research seeks 42 individuals with COVID-19 between 18 and 100 years old. To qualify, applicants must have a WHO ordinal score of 4 to 7; an allowance for prophylactic anticoagulation in cohort 1; therapeutic dose anticoagulation without evidence of bleeding after 24 hours' time in cohort 2; age over the legal limit of consent; and a life expectancy that exceeds one day."

Answered by AI

Does the protocol for this clinical trial encompass individuals aged 75 and above?

"The parameters for admission to this trial require applicants aged between 18 and 100. There are 141 trials accessible to those under the age of majority, while 906 studies cater towards individuals over 65 years old."

Answered by AI

What prior research has been performed on Defibrotide?

"Currently, there are 4 clinical trials exploring Defibrotide with 0 of them in Phase 3. Of the 9 total sites that host these studies, the majority are located in Boston, Massachusetts."

Answered by AI

Are there any vacancies left for participants in this examination?

"Affirmative. Clinicaltrials.gov data reveals that this research protocol is actively enrolling participants since its initial posting on January 1st 2021, with the most recent edit happening on July 23rd 2021; 42 people are needed across one medical facility."

Answered by AI

How many individuals are currently taking part in this examination?

"Affirmative, clinicaltrials.gov data suggests that this trial is now open to applicants. The protocol was initially publicized on January first 2021 and has been recently revised on July twenty-third 2021. There are 42 openings at a single location."

Answered by AI

What potential risks does Defibrotide pose to individuals?

"There is limited evidence to suggest defibrotide's safety, so it was awarded a score of 2."

Answered by AI
~0 spots leftby May 2024