Defibrotide as Prevention and Treatment of Respiratory Distress and Cytokine Release Syndrome of Covid 19. (DEFACOVID)

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Status and phase: Completed; Phase 2

Conditions: COVID19

Treatments: Drug: Defibrotide; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04348383

IMIB-DFC-2020-02

Details and patient eligibility

About

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

Full 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 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

Enrollment: 156 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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156 participants in 2 patient groups, including a placebo group

Defibrotide + standard therapy

Experimental group

Description:

Defibrotide + standard therapy

Treatment:

Drug: Defibrotide

Placebo

Placebo Comparator group

Description:

Placebo + standard therapy

Treatment:

Drug: Placebo