Status:
COMPLETED
Defibrotide as Prevention and Treatment of Respiratory Distress and Cytokine Release Syndrome of Covid 19.
Lead Sponsor:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Conditions:
COVID19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Protection of endothelial dysfunction by intravenous infusion of Defibrotide (Defitelio), expected to decrease inflammation and expression of adhesion molecules in the endothelium, leukocyte tissue in...
Detailed Description
Protection of endothelial dysfunction by intravenous infusion of Defibrotide (Defitelio), expected to decrease inflammation and expression of adhesion molecules in the endothelium, leukocyte tissue in...
Eligibility Criteria
Inclusion
- Acceptance of participation in the study by the patient or legal representative.
- Patients of any gender, 18 years or older.
- Confirmed diagnosis by PCR+ of SARS-CoV-2 infection.
- COVID-19 positive patients WHO grades 4, 5 or 6.
- Grade 4: hospitalized requiring oxygen therapy.
- Grade 5: hospitalized requiring high-flow oxygen therapy, noninvasive mechanical ventilation, or both.
- Levels of IL-6 ≥ 3 times the upper limit of normality
Exclusion
- Acute bleeding.
- Thrombolytic treatment and anticoagulant treatment at therapeutic doses.
- Pregnancy or lactation.
- Patients with active malignant tumour, other serious systemic or neuropsychiatric diseases.
- Patients participating in other clinical trials in the last month.
- Inability to give informed consent or to accomplish the requirements of the diagnostic tests.
- Patients with hypersensitivity to Defibrotide.
Key Trial Info
Start Date :
April 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2023
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT04348383
Start Date
April 8 2020
End Date
February 28 2023
Last Update
June 7 2023
Active Locations (6)
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1
Hospital General Universitario Santa Lucía
Cartagena, Murcia, Spain
2
Hospital Clinico y Provincial de Barcelona
Barcelona, Spain
3
Virgen de la Arrixaca University Clinical Hospital
Murcia, Spain, 30120
4
Hospital General Universitario Morales Meseguer
Murcia, Spain