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

NCT04348383 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2023-06-07

No results posted yet for this study

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 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

  • COVID19

Interventions

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

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-08
Primary Completion
2023-02-28
Completion
2023-02-28

Countries

  • Spain

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04348383 on ClinicalTrials.gov