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

June 6, 2023 updated by: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
156

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: José M. Moraleda, MD
  • Phone Number: +34 968369532
  • Email: jmoraled@um.es

Study Locations

  • Spain
      • Barcelona, Spain
        • Hospital Clínico y Provincial de Barcelona
      • Murcia, Spain, 30120
        • Virgen de la Arrixaca University Clinical Hospital
      • Murcia, Spain
        • Hospital General Universitario Morales Meseguer
      • Murcia, Spain
        • Hospital General Universitario Reina Sofía
      • Salamanca, Spain
        • Hospital Universitario Salamanca
    • Murcia
      • Cartagena, Murcia, Spain
        • Hospital General Universitario Santa Lucía

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Defibrotide + standard therapy
Drug: Defibrotide
6.25 mg/kg every 6 hours in 2 hours infusion for 7 or 15 days
Placebo Comparator: Placebo
Placebo + standard therapy
Drug: Placebo
Placebo 250 cc every 6 hours for 7 or15 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical improvement.
Time Frame: 7,15, 30 day
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
1. Mortality rate
Time Frame: : up to 30 days
All cause mortality
: up to 30 days
Rate os serious adverse events .
Time Frame: 7, 15, 30 and 60 Day
Number of adverse events with possible, probable or definite relationship with the study.
7, 15, 30 and 60 Day
Clinical improvement by WHO
Time Frame: 7, 15, 30 and 60 Day
Decrease ventilation days in grade 6 patients
7, 15, 30 and 60 Day
Clinical improvement by NEWS2 scales
Time Frame: 7, 15, 30 and 60 Day
Decrease the rate of grades 4-5 patients requiring mechanical ventilation.
7, 15, 30 and 60 Day
Clinical improvement by NEWS2 scales
Time Frame: 7, 15, 30 and 60 Day
Decrease ventilation days in grade 6 patients
7, 15, 30 and 60 Day
Biologic response
Time Frame: 7, 15, 30 and 60 Day
Decrease of IL-6 levels with respect to the basal ones > 50%.
7, 15, 30 and 60 Day
Biologic response
Time Frame: 7, 15, 30 and 60 Day
Absolute lymphocytes count: 50% increase with respect to the baseline
7, 15, 30 and 60 Day
Biologic response
Time Frame: 7, 15, 30 and 60 Day
Normal D-dimer (DD) or decrease of 50% with respect to the baseline
7, 15, 30 and 60 Day
Biologic response
Time Frame: 7, 15, 30 and 60 Day
Normal CRP or decrease of 50% with respect to the baseline
7, 15, 30 and 60 Day
Biologic response
Time Frame: 7, 15, 30 and 60 Day
Normal LDH or decrease of 50% with respect to the baseline
7, 15, 30 and 60 Day
Biologic response
Time Frame: 7, 15, 30 and 60 Day
Normal CPK or decrease of 50% with respect to the baseline
7, 15, 30 and 60 Day
Biologic response
Time Frame: 7, 15, 30 and 60 Day
Normal Ferritin or decrease of 50% with respect to the baseline
7, 15, 30 and 60 Day
Radiological response
Time Frame: 7, 15, 30 and 60 Day
Improvement of radiological images by conventional radiology
7, 15, 30 and 60 Day
Collection and storage of biological samples
Time Frame: 15,30 days
improve the knowledge of the disease at the inclusion of the patients
15,30 days
Clinical improvement by WHO
Time Frame: 7, 15, 30 and 60 Day
Decrease the rate of grades 4-5 patients requiring mechanical ventilation.
7, 15, 30 and 60 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IMIB-DFC-2020-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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