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    The EU Clinical Trials Register currently displays   42567   clinical trials with a EudraCT protocol, of which   7008   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


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    Summary
    EudraCT Number:2020-001409-21
    Sponsor's Protocol Code Number:IMIB-DFC-2020-02
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-04-03
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2020-001409-21
    A.3Full title of the trial
    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.
    Ensayo clínico en fase IIb prospectivo, multicéntrico, aleatorizado, paralelo, doble ciego, controlado con placebo para evaluar la infusión intravenosa de Defibrotide en la prevención y tratamiento del distrés respiratorio y síndrome de liberación de citoquinas en pacientes con COVID-19.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    DEFIBROTIDE AS PREVENTION AND TREATMENT OF RESPIRATORY DISTRESS AND CYTOKINE RELEASE SYNDROME OF COVID-19
    DEFIBROTIDE COMO PREVENCIÓN Y TRATAMIENTO DEL DISTRÉS RESPIRATORIO Y SÍNDROME DE LIBERACIÓN DE CITOQUINAS DEL COVID-19
    A.3.2Name or abbreviated title of the trial where available
    DEFACOVID
    DEFACOVID
    A.4.1Sponsor's protocol code numberIMIB-DFC-2020-02
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFFIS
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportISCARLOS III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFFIS
    B.5.2Functional name of contact pointLOLA SERNA GUIRAO
    B.5.3 Address:
    B.5.3.1Street AddressLUIS FONTES PAGAN 9
    B.5.3.2Town/ cityMURCIA
    B.5.3.3Post code30003
    B.5.3.4CountrySpain
    B.5.6E-maillola.serna@carm.es
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name DEFITELIO
    D.2.1.1.2Name of the Marketing Authorisation holderJazz Pharmaceuticals
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/04/212
    D.3 Description of the IMP
    D.3.1Product nameDEFITELIO
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDEFIBROTIDE
    D.3.9.1CAS number 83712-60-1
    D.3.9.4EV Substance CodeSUB01572MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COVID-19
    COVID19
    E.1.1.1Medical condition in easily understood language
    COVID19
    COVID19
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    Determinar la eficacia de la infusión intravenosa de Defibrotide (Defitelio) para reducir la mortalidad en pacientes con infección por SARS-CoV-2 con estado clínico grado 4, 5 o 6 según clasificación de la OMS.
    E.2.2Secondary objectives of the trial
    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.
    Evaluar la seguridad de la infusión intravenosa de Defibrotide (Defitelio) en pacientes con infección por SARS-CoV-2 con estado clínico grado 4, 5 o 6 según clasificación de la OMS.
     Analizar los efectos de la infusión intravenosa de Defibrotide (Defitelio) en el estado clínico de los pacientes con infección por SARS-CoV-2 con estado clínico grado 4, 5 o 6 según clasificación de la OMS.
     Valorar la capacidad de la infusión intravenosa de Defibrotide (Defitelio) de mejorar la respuesta radiológica de los pacientes con infección por SARS-CoV-2 con estado clínico grado 4, 5 o 6 según clasificación de la OMS.
     Estudiar la acción de Defibrotide (Defitelio) sobre biomarcadores de riesgo en pacientes con infección por SARS-CoV-2 con estado clínico grado 4, 5 o 6 según clasificación de la OMS.
    E.2.3Trial contains a sub-study No
    E.3Principal 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
     Pacientes de ambos sexos con edad mayor o igual a 18 años.
     Pacientes con diagnóstico de infección por SARS-CoV-2 confirmado por RT-PCR.
     Pacientes con estado clínico grado 4, 5 o 6 según clasificación de la OMS.
    - Grado 4: Pacientes hospitalizados que requieren oxigenoterapia.
    - Grado 5: Pacientes hospitalizados que requieren oxigenoterapia de alto flujo, ventilación mecánica no invasiva o ambas.
    - Grado 6: Pacientes hospitalizados que requieren oxigenación por membrana extracorpórea o ventilación mecánica invasiva.
     Pacientes con niveles de IL-6 igual o superior a 3 veces el valor de la normalidad
     Pacientes potencialmente fértiles deberán tener una prueba de embarazo negativo en suero (beta-HCG) u orina (evaluada entre 2 y 1 días previos a la administración de la medicación del estudio).
     Pacientes que ofrezcan garantías suficientes de adhesión al protocolo.
     Pacientes que otorguen su consentimiento informado por escrito para participar en el estudio
    E.4Principal 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
     Pacientes con sangrado agudo.
     Pacientes con tratamiento trombolítico y tratamiento anticoagulante a dosis terapéuticas.
     Pacientes con tumor maligno activo.
     Pacientes con enfermedades sistémicas o neuropsiquiátricas graves.
     Pacientes con hipersensibilidad al principio activo o a alguno de los excipientes del fármaco en estudio.
     Pacientes que estén participando en otros ensayos clínicos.
     Pacientes con incapacidad para comprender el consentimiento informado.
     Pacientes embarazadasb, en periodo postparto o en periodo de lactancia activa.
     Pacientes físicamente fértilesa, A NO SER QUE estén utilizando un método anticonceptivo altamente efectivo
    E.5 End points
    E.5.1Primary end point(s)
    Mortality rate 30 days after starting treatment.
    Tasa de mortalidad a los 30 días de inicio de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    15, 30 ,60 days
    15, 30 y 60 dias
    E.5.2Secondary 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.
    Reacciones adversas observadas por clases de órganos y sistemas descritas en la ficha técnica de Defibrotide (Defitelio)
    - Proporción de sujetos con mejora clínica definida como disminución de al menos 1 categoría desde el inicio de tratamiento en la escala ordinal de 7 categorías de estado clínico.
    - Tiempo hasta la mejora clínica definida como disminución de al menos 1 categorías desde el inicio de tratamiento en la escala ordinal de 7 categorías de estado clínico (días).
    - Proporción de sujetos con estado clínico grados 4 y 5 según clasificación de la OMS que precisan de ventilación mecánica invasiva.
    - Tiempo hasta el inicio de ventilación mecánica invasiva (días).
    - Tiempo de la ventilación mecánica invasiva en pacientes con estado clínico grado 6 según clasificación de la OMS (días).
    - Tiempo de la estancia hospitalaria (días).
    - Proporción de sujetos con disminución de al menos 2 puntos en la escala NEWS2 mantenida durante 24 horas.
    - Tiempo hasta la disminución de al menos 2 puntos en la escala NEWS2 mantenida durante 24 horas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    0, +7,+15,+30, +60
    0, +7,+15,+30, +60
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    tratamiento convencional de eleccion
    conventional treatment
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLP
    LVLP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    NONE
    Ninguno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-31
    P. End of Trial
    P.End of Trial StatusOngoing
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