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New treatment option for Covid19
Official title Defibrotide for the Treatment of Severe COVID-19
ClinicalTrials.gov ID: NCT04652115
What this study is testing
What is Defibrotide?
Defibrotide is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for covid19.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this study is to evaluate the safety and feasibility of defibrotide in COVID-19 pneumonia.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100. Healthy volunteers may be eligible.
You may be able to join 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.
You likely can't join 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...
- Known allergy or hypersensitivity to DF.
- Pregnant or lactating.
See the full eligibility criteria
- 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...
- Patient or surrogate able to provide informed consent
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.