Defibrotide as Prevention and Treatment of Respiratory Distress and Cytokine Release Syndrome of Covid 19.
DEFACOVID
Phase IIb Prospective, Multi-center, Randomized, Parallel, Double Blind, Placebo Controlled Trial to Evaluate Defibrotide Intravenous Infusion in the Prevention and Treatment of COVID-19 Respiratory Distress and Cytokine Release Syndrome
1 other identifier
interventional
156
1 country
6
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 covid19
Started Apr 2020
Longer than P75 for phase_2 covid19
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2020
CompletedStudy Start
First participant enrolled
April 8, 2020
CompletedFirst Posted
Study publicly available on registry
April 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2023
CompletedJune 7, 2023
June 1, 2022
2.9 years
April 8, 2020
June 6, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
7,15, 30 day
Secondary Outcomes (15)
1. Mortality rate
: up to 30 days
Rate os serious adverse events .
7, 15, 30 and 60 Day
Clinical improvement by WHO
7, 15, 30 and 60 Day
Clinical improvement by NEWS2 scales
7, 15, 30 and 60 Day
Clinical improvement by NEWS2 scales
7, 15, 30 and 60 Day
- +10 more secondary outcomes
Study Arms (2)
Defibrotide + standard therapy
EXPERIMENTALDefibrotide + standard therapy
Placebo
PLACEBO COMPARATORPlacebo + standard therapy
Interventions
6.25 mg/kg every 6 hours in 2 hours infusion for 7 or 15 days
Eligibility Criteria
You may qualify if:
- Acceptance of participation in the study by the patient or legal representative.
- Patients of any gender, 18 years or older.
- Confirmed diagnosis by PCR+ of SARS-CoV-2 infection.
- 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.
- Levels of IL-6 ≥ 3 times the upper limit of normality
You may not qualify if:
- Acute bleeding.
- Thrombolytic treatment and anticoagulant treatment at therapeutic doses.
- Pregnancy or lactation.
- Patients with active malignant tumour, other serious systemic or neuropsychiatric diseases.
- Patients participating in other clinical trials in the last month.
- Inability to give informed consent or to accomplish the requirements of the diagnostic tests.
- Patients with hypersensitivity to Defibrotide.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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, 30120, Spain
Hospital General Universitario Morales Meseguer
Murcia, Spain
Hospital General Universitario Reina Sofía
Murcia, Spain
Hospital Universitario Salamanca
Salamanca, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- double blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2020
First Posted
April 16, 2020
Study Start
April 8, 2020
Primary Completion
February 28, 2023
Study Completion
February 28, 2023
Last Updated
June 7, 2023
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share