Protection of endothelial dysfunction by intravenous infusion of Defibrotide (Defitelio), expected to decrease inflammation and expression of adhesion molecules in the endothelium, leukocyte tissue infiltration and epithelial destruction, and to promote immune tolerance through a change in the Cytokine balance, which is decisive in preventing multiorgan failure and death in patients with SARS-CoV-2 infection with clinical status grade 4 or 5 according to the WHO classification
Protection of endothelial dysfunction by intravenous infusion of Defibrotide (Defitelio),
expected to decrease inflammation and expression of adhesion molecules in the endothelium,
leukocyte tissue infiltration and epithelial destruction, and to promote immune tolerance
through a change in the Cytokine balance, which is decisive in preventing multiorgan failure
and death in patients with SARS-CoV-2 infection with clinical status grade 4 or 5 according
to the WHO classification
Drug: Defibrotide
6.25 mg/kg every 6 hours in 2 hours infusion for 7 or 15 days
Drug: Placebo
Placebo 250 cc every 6 hours for 7 or15 days
Inclusion Criteria:
1. Acceptance of participation in the study by the patient or legal representative.
2. Patients of any gender, 18 years or older.
3. Confirmed diagnosis by PCR+ of SARS-CoV-2 infection.
4. 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.
5. Levels of IL-6 ≥ 3 times the upper limit of normality
Exclusion Criteria:
1. Acute bleeding.
2. Thrombolytic treatment and anticoagulant treatment at therapeutic doses.
3. Pregnancy or lactation.
4. Patients with active malignant tumour, other serious systemic or neuropsychiatric
diseases.
5. Patients participating in other clinical trials in the last month.
6. Inability to give informed consent or to accomplish the requirements of the diagnostic
tests.
7. Patients with hypersensitivity to Defibrotide.
Hospital General Universitario Santa Lucía
Cartagena, Murcia, Spain
Hospital Clinico y Provincial de Barcelona
Barcelona, Spain
Virgen de la Arrixaca University Clinical Hospital
Murcia, Spain
Hospital General Universitario Morales Meseguer
Murcia, Spain
Hospital General Universitario Reina Sofía
Murcia, Spain
Hospital Universitario Salamanca
Salamanca, Spain