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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-08

Study Completion Date

2023-02-28

Brief Summary

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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

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Detailed Description

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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

Conditions

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COVID19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Phase IIb prospective, multi-center, randomized, parallel, double blind, placebo controlled

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

double blind

Study Groups

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Defibrotide + standard therapy

Group Type EXPERIMENTAL

Defibrotide

Intervention Type DRUG

6.25 mg/kg every 6 hours in 2 hours infusion for 7 or 15 days

Placebo

Placebo + standard therapy

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo 250 cc every 6 hours for 7 or15 days

Interventions

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Defibrotide

6.25 mg/kg every 6 hours in 2 hours infusion for 7 or 15 days

Intervention Type DRUG

Placebo

Placebo 250 cc every 6 hours for 7 or15 days

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No