Defibrotide for the Treatment of Severe COVID-19
ConditionCovid19
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorBrigham and Women's Hospital
About this trial
The goal of this study is to evaluate the safety and feasibility of defibrotide in COVID-19 pneumonia.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Defibrotide
DrugDeibrotide via IV
Treatment groups
42 Participants
are divided into 1 treatment groupGroup A: DefibrotideExperimental treatment 1 intervention
Trial outcomes
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)
Time frame
Up to 21 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Brigham and Women's Hospital
Lead sponsor
Jazz Pharmaceuticals
Collaborator
Source ClinicalTrials.gov