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

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia156 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

156

Conditions

COVID19

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

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

Outcomes

Primary Outcomes

Clinical improvement.

Number of days that the patient maintains the clinical improvement. The patient achieves a change of al least 1 category on WHO scale.

Time frame: 7,15, 30 day

Secondary Outcomes

1. Mortality rate

All cause mortality

Time frame: : up to 30 days

Rate os serious adverse events .

Number of adverse events with possible, probable or definite relationship with the study.