Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.

    The EU Clinical Trials Register currently displays   38596   clinical trials with a EudraCT protocol, of which   6341   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).
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools

    < Back to search results

    Print Download

    EudraCT Number:2020-001513-20
    Sponsor's Protocol Code Number:DEFI-VID19
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-06-24
    Trial results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-001513-20
    A.3Full title of the trial
    Use of Defibrotide to reduce progression of acute respiratory failure rate in
    patients with COVID-19 pneumonia
    Uso di Defibrotide in infusione intravenosa per ridurre la progressione dell'insufficienza respiratoria in pazienti con polmonite severa da COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Use of Defibrotide to reduce progression of acute respiratory failure rate in
    patients with COVID-19 pneumonia
    Uso di Defibrotide in infusione intravenosa per ridurre la progressione dell'insufficienza respiratoria in pazienti con polmonite severa da COVID-19
    A.3.2Name or abbreviated title of the trial where available
    Defibrotide in COVID19
    Defibrotide in COVID19
    A.4.1Sponsor's protocol code numberDEFI-VID19
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04335201
    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 SponsorOSPEDALE SAN RAFFAELE
    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 support
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS Ospedale San Raffaele
    B.5.2Functional name of contact pointURC-SCP
    B.5.3 Address:
    B.5.3.1Street AddressVia Olgettina, 60
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20132
    B.5.4Telephone number0226434289
    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. of the Marketing Authorisation holderGENTIUM S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDefibrotide
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Concentrate for 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.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe COVID-19 pneumonia
    Polmonite severa da COVID-19
    E.1.1.1Medical condition in easily understood language
    Severe COVID-19 pneumonia
    Polmonite severa da COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10035737
    E.1.2Term Pneumonia viral
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that the treatment with Defibrotide administered intravenously in addition to the best available therapy according to institutional guidelines is able to reduce the progression of acute respiratory failure, the need of mechanical ventilation, the transfer to the intensive care unit or death, in patients with severe COVID-19 pneumonia
    Dimostrare che la somministrazione di Defibrotide per via endovenosa in pazienti con polmonite da COVID-19 é in grado di ridurre la progressione della insufficienza respiratoria, l’evoluzione verso intubazione orotracheale e ventilazione meccanica
    E.2.2Secondary objectives of the trial
    • To evaluate the safety of Defibrotide in the cohort of patients treated (incidence of adverse events)
    • To evaluate the duration of hospitalization for patients enrolled
    • To evaluate the overall survival at day+28 after start treatment with Defibrotide
    • To evaluate the change in biological features of systemic inflammation (PCR, LDH, ferritin, IL-10, IL-6, TNF-alpha, IFN-gamma, PTX3) at day +7 and +14 after start of treatment with Defibrotide
    • Valutare la safety di Defibrotide e l’incidenza di reazioni avverse
    • Valutare la sopravvivenza globale a giorno+28 e dall'inizio del trattamento
    • Valutare la durata complessiva del ricovero
    • Valutare l’evoluzione dei parametri biologici di infiammazione sistemica a giorno+7 e +14 dall'inizio del trattamento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Documented COVID-19 pneumonia: defined as upper respiratory tract swab positive for COVID-19 and/or imaging at computed tomography scan
    suggestive of COVID-19 pneumonia
    • SaO2 of 92% or less without oxygen support, or reduction of 3% from basal value of SaO2, or a ratio of PaO2/FiO2 below 300.
    • Any gender
    • Age >= 18 years
    • Written informed consent or as per Ethical Committee indication in case of patients not able to express written informed consent
    • Diagnosi di polmonite COVID-19: tampone virale positivo e/o imaging e clinica compatibile in assenza di altre documentate diagnosi
    • SpO2 <=92% in aria ambiente o variazione SpO2 di 3 punti percentuali in meno rispetto al basale o P/F = 300
    • Età>=18 anni
    • Consenso informato o come da indicazioni del CE in caso di pazienti sedati o con sensorio obnubilato
    E.4Principal exclusion criteria
    • Onset of COVID-19 pneumonia >14 days
    • Orotracheal intubation
    • Uncontrolled systemic infection (other than COVID-19)
    • Concomitant use of thrombolytic therapy or systemic anticoagulant therapy
    • Haemodynamic instability, defined as inability to maintain mean arterial pressure with single pressor support
    • Hypersensitivity to the active substance or to any of the excipients of the experimental drug
    • Patients who, based on the investigator's clinical judgement, are not able to receive the treatment
    • Pregnancy or breastfeeding patient
    • Polmonite da COVID-19 insorta da oltre 14 giorni
    • Paziente intubato
    • Evidenza di infezione non controllata (esclusa l’infezione da SARS-CoV-2)
    • Terapia anticoagulante o antitrombotica in corso
    • Altra controindicazione medica/di opportunità espressa dal curante
    • Ipersensibilità al farmaco in studio o ai suoi eccipienti
    • Intabilità emodinamica, necessitante supporto farmacologico
    • Gravidanza o allattamento
    E.5 End points
    E.5.1Primary end point(s)
    Respiratory-failure rate (RFR)
    Riduzione della progressione dell’insufficienza respiratoria acuta
    E.5.1.1Timepoint(s) of evaluation of this end point
    14 days from treatment start
    14 giorni dall'inizio del trattamento
    E.5.2Secondary end point(s)
    Adverse event; Duration of hospitalization; Systemic inflammation; Overall survival
    Eventi avversi; Durata del ricovero; Infiammazione sistemica; Sopravvivenza globale
    E.5.2.1Timepoint(s) of evaluation of this end point
    7 days from treatment start; 14 days from treatment start; 7 days and 14 days from treatment start; 28 days from treatment start
    7 giorni dall'inizio del trattamento; 14 giorni dall'inizio del trattamento; 7 e 14 giorni dall'inizio del trattamento; 28 giorni dall'inizio del trattamento
    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 Yes
    E.6.4Safety No
    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. 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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E. trial design description
    Con coorte osservazionale di riferimento
    With a parallel retrospective collection of data on not treated patients
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned2
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F. of subjects incapable of giving consent
    Sedated patients
    Pazienti sedati o con sensorio obnubilato
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    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)
    Normal clinical practice
    Normale pratica clinica
    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 Decision2020-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-06
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice