DEFIBROTIDE AS PREVENTION AND TREATMENT OF RESPIRATORY DISTRESS AND CYTOKINE RELEASE SYNDROME OF COVID-19

A prospective, multicenter, randomized, parallel, double-blind, placebo-controlled phase IIb clinical trial to evaluate intravenous infusion of Defibrotide in the prevention and treatment of respiratory distress and cytokine release syndrome in patients with COVID-19. - DEFACOVID

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001409-21-ES

Enrollment

120

Registered

2020-04-03

Start date

2020-04-01

Completion date

Unknown

Last updated

2020-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Interventions

Trade Name: DEFITELIO Product Name: DEFITELIO Pharmaceutical Form: Solution for infusion INN or Proposed INN: DEFIBROTIDE CAS Number: 83712-60-1 Concentration unit: mg/kg milligram(s)/kilogram Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Patients of both sexes with an age greater than or equal to 18 years. ? Patients with a diagnosis of SARS-CoV-2 infection confirmed by RT-PCR. ? Patients with grade 4, 5 or 6 clinical status according to the WHO classification. - Grade 4: Hospitalized patients requiring oxygen therapy. - Grade 5: Hospitalized patients requiring high-flow oxygen therapy, non-invasive mechanical ventilation, or both. - Grade 6: Hospitalized patients requiring extracorporeal membrane oxygenation or invasive mechanical ventilation. ? Patients with IL-6 levels equal to or greater than 3 times the value of normality ? Potentially fertile patients should have a negative pregnancy test in serum (beta-HCG) or urine (evaluated between 2 and 1 days prior to administration of the study medication). ? Patients who offer sufficient guarantees of adherence to the protocol. ? Patients who give their written informed consent to participate in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: ? Patients with acute bleeding. ? Patients with thrombolytic treatment and anticoagulant treatment at therapeutic doses. ? Patients with an active malignant tumor. ? Patients with severe systemic or neuropsychiatric diseases. ? Patients with hypersensitivity to the active substance or to any of the excipients of the study drug. ? Patients who are participating in other clinical trials. ? Patients with an inability to understand informed consent. ? Pregnant patientsb, in the postpartum period or in the period of active lactation. Physically fertile patients, UNLESS they are using a highly effective contraceptive method

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the efficacy of the intravenous infusion of Defibrotide (Defitelio) to reduce mortality in patients with SARS-CoV-2 infection with clinical status grade 4, 5 or 6 according to the WHO classification.;Secondary Objective: To assess the safety of intravenous Defibrotide (Defitelio) infusion in patients with SARS-CoV-2 infection with clinical status grade 4, 5 or 6 according to the WHO classification. ? To analyze the effects of the intravenous infusion of Defibrotide (Defitelio) on the clinical state of patients with SARS-CoV-2 infection with clinical status grade 4, 5 or 6 according to the WHO classification. ? Assess the capacity of intravenous infusion of Defibrotide (Defitelio) to improve the radiological response of patients with SARS-CoV-2 infection with clinical status grade 4, 5 or 6 according to the WHO classification. ? Study the action of Defibrotide (Defitelio) on risk biomarkers in patients with SARS-CoV-2 infection with grade 4, 5 or 6 clinical status according to the WHO classification.;Primary end point(s): Mortality rate 30 days after starting treatment.;Timepoint(s) of evaluation of this end point: 15, 30 ,60 days	—

Measure

Time frame

Main Objective: To determine the efficacy of the intravenous infusion of Defibrotide (Defitelio) to reduce mortality in patients with SARS-CoV-2 infection with clinical status grade 4, 5 or 6 according to the WHO classification.;Secondary Objective: To assess the safety of intravenous Defibrotide (Defitelio) infusion in patients with SARS-CoV-2 infection with clinical status grade 4, 5 or 6 according to the WHO classification. ? To analyze the effects of the intravenous infusion of Defibrotide (Defitelio) on the clinical state of patients with SARS-CoV-2 infection with clinical status grade 4, 5 or 6 according to the WHO classification. ? Assess the capacity of intravenous infusion of Defibrotide (Defitelio) to improve the radiological response of patients with SARS-CoV-2 infection with clinical status grade 4, 5 or 6 according to the WHO classification. ? Study the action of Defibrotide (Defitelio) on risk biomarkers in patients with SARS-CoV-2 infection with grade 4, 5 or 6 clinical status according to the WHO classification.;Primary end point(s): Mortality rate 30 days after starting treatment.;Timepoint(s) of evaluation of this end point: 15, 30 ,60 days

—

Secondary

Measure	Time frame
Secondary end point(s): Adverse reactions observed by organ classes and systems described in the Defibrotide (Defitelio) data sheet - Proportion of subjects with clinical improvement defined as a decrease of at least 1 category from the start of treatment on the ordinal scale of 7 categories of clinical status. - Time to clinical improvement defined as a decrease of at least 1 categories from the start of treatment on the ordinal scale of 7 categories of clinical status (days). - Proportion of subjects with clinical status grades 4 and 5 according to the WHO classification who require invasive mechanical ventilation. - Time until the start of invasive mechanical ventilation (days). - Invasive mechanical ventilation time in patients with clinical status grade 6 according to the WHO classification (days). - Length of hospital stay (days). - Proportion of subjects with a decrease of at least 2 points on the NEWS2 scale maintained for 24 hours. - Time to decrease of at least 2 points on the NEWS2 scale maintained for 24 hours.;Timepoint(s) of evaluation of this end point: 0, +7,+15,+30, +60	—

Measure

Time frame

Secondary end point(s): Adverse reactions observed by organ classes and systems described in the Defibrotide (Defitelio) data sheet - Proportion of subjects with clinical improvement defined as a decrease of at least 1 category from the start of treatment on the ordinal scale of 7 categories of clinical status. - Time to clinical improvement defined as a decrease of at least 1 categories from the start of treatment on the ordinal scale of 7 categories of clinical status (days). - Proportion of subjects with clinical status grades 4 and 5 according to the WHO classification who require invasive mechanical ventilation. - Time until the start of invasive mechanical ventilation (days). - Invasive mechanical ventilation time in patients with clinical status grade 6 according to the WHO classification (days). - Length of hospital stay (days). - Proportion of subjects with a decrease of at least 2 points on the NEWS2 scale maintained for 24 hours. - Time to decrease of at least 2 points on the NEWS2 scale maintained for 24 hours.;Timepoint(s) of evaluation of this end point: 0, +7,+15,+30, +60

—

Countries

Spain

Contacts

Public ContactLOLA SERNA GUIRAO

FFIS

lola.serna@carm.es

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026