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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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:2020-003125-39
    Sponsor's Protocol Code Number:TRI-08892
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-02-03
    Trial results View 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 ConcernedGermany - BfArM
    A.2EudraCT number2020-003125-39
    A.3Full title of the trial
    Early thromboprophylaxis in COVID-19 (ETHIC trial): an open label, randomized phase IIIb trial of community-based prophylactic low molecular-weight heparin (LMWH) versus standard of care (no enoxaparin) in COVID-19 positive patients
    Frühzeitige Thromboseprophylaxe bei COVID-19 (ETHIC-Studie): Eine offene, randomisierte Phase-IIIb-Studie zur Prophylaxe mit niedermolekularem Heparin (NMH) im Vergleich zur Standardversorgung (kein Enoxaparin) bei COVID-19-positiven Patienten im ambulanten Versorgungsbereich
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To study if giving a small dose of a blood-thinning drug (enoxaparin) at an early stage of the COVID-19 infection can prevent worsening of the illness and avoid the need for hospital admission
    A.3.2Name or abbreviated title of the trial where available
    ETHIC trial: Early LMWH in symptomatic COVID-19 positive patients
    A.4.1Sponsor's protocol code numberTRI-08892
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04492254
    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 SponsorThrombosis Research Institute
    B.1.3.4CountryUnited Kingdom
    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 supportThrombosis Research Institute
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportSanofi UK
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThrombosis Research Institute
    B.5.2Functional name of contact pointClinical Operations Lead
    B.5.3 Address:
    B.5.3.1Street AddressEmmanuel Kaye Building, 1b Manresa Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSW36LR
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number442031989898
    B.5.6E-mailafernandez@tri-london.ac.uk
    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 Clexane® 4.000 I. E. (40 mg)/0,4 ml Klinik Injektionslösung
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Confirmed diagnosis of SARS-CoV-2 with symptomatic infection
    Patienten aus ausgewählten Ländern mit bestätigtem COVID-19
    E.1.1.1Medical condition in easily understood language
    COVID-19 infection with symptoms and a positive test
    Patienten aus ausgewählten Ländern mit bestätigtem COVID-19 (d. h. Symptome + positiver Test auf SARS-CoV-2)
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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 demonstrate the superiority of prophylactic enoxaparin compared to the current standard of care (no enoxaparin) in reducing hospital admission and/or death within 21 days of randomisation in symptomatic individuals with COVID-19 in a community setting
    E.2.2Secondary objectives of the trial
    • Evaluate the bleeding risk of prophylactic enoxaparin in symptomatic individuals with COVID-19 in a community setting compared to the current standard of care (no enoxaparin), within 21 days of randomisation.
    • Assess whether prophylactic enoxaparin reduces the number of individuals admitted to hospital requiring supplemental oxygen within 21 days of randomisation.
    • Assess whether prophylactic enoxaparin reduces the incidence of venous thromboembolism (deep vein thrombosis and/or pulmonary embolism) or ischemic stroke within 21 days of randomisation
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Signed consent form
    • Confirmed COVID-19 (i.e. symptoms + positive PCR test for SARS-CoV-2)
    • Male or female, age ≥ 30 years
    • Negative pregnancy test for female patients of reproductive potential
    • At least one of the following additional risk factors:
    o Age ≥ 70 years
    o Body mass index > 25 kg/m2
    o Chronic obstructive pulmonary disease (COPD)*(chronic obstructive lung disease, chronic bronchitis, chronic obstructive asthma, interstitial lung disease)
    o Diabetes*
    o Cardiovascular disease*(coronary artery disease, PAD, heart valve disease, treated arrhythmia, heart failure, hypertension, congenital heart disease, prior stroke or TIA, carotid artery disease)
    o Previous venous thromboembolism (deep vein thrombosis or pulmonary embolism)
    o Liver disease* (alcoholic cirrhosis, non-alcoholic cirrhosis, chronic non-alcoholic liver disease, chronic hepatitis C, chronic hepatitis B, cryptogenic cirrhosis).
    o Immunocompromised state (due to blood or bone marrow transplant, immunodeficiencies, HIV infection, systemic corticosteroid use or other medication that weakens the immune system [e.g. active cancer treatment])
    o Anaemia of chronic disease or sickle cell disease

    *Defined as any disease requiring medical intervention or treatment.
    • Unterzeichnete Einverständniserklärung
    • Bestätigte COVID-19 (d.h. Symptome + positiver PCR SARS-CoV-2 Test)
    • Männlich oder weiblich, Alter ≥ 30 Jahre
    • Negativer Schwangerschaftstest für Patientinnen mit reproduktivem
    Potenzial
    • Mindestens 1 der nachfolgenden zusätzlichen Risikofaktoren:
    o Alter ≥ 70 Jahre
    o Body Mass Index > 25 kg/m2
    o Chronisch obstruktive Lungenerkrankung (COPD)*(chronisch obstruktive Lungenerkrankung, chronische Bronchitis, chronisch obstruktives Asthma, interstitielle Lungenerkrankung)
    o Diabetes*
    o Kardiovaskuläre Erkrankung*(Koronararterienerkrankung, PAD, Herzklappenerkrankung, behandelte Arrhythmie, Herzinsuffizienz, Hypertonie, angeborene Herzerkrankung, früherer Schlaganfall oder TIA, Karotiserkrankung)

    o venöse Thromboembolien (tiefe Venenthrombose oder Lungenembolie)
    Lebererkrankung * (alkoholische Zirrhose, alkoholfreie Zirrhose, chronische nichtalkoholische Lebererkrankung, chronische Hepatitis C, chronische Hepatitis B, kryptogene Zirrhose).
    o Immungeschwächter Zustand (aufgrund von Blut- oder , Immundefekten, HIV-Infektion, systemischer Verwendung von Kortikosteroiden oder anderen Medikamenten, die das Immunsystem schwächen [z. B. aktive Krebsbehandlung])
    o Anämie bei chronischen Erkrankungen oder Sichelzellenerkrankungen
    * Definiert als jede Erkrankung, die einen medizinischen Eingriff oder eine Behandlung erfordert.
    E.4Principal exclusion criteria
    • Contraindications to unfractionated heparin or LMWH (History of immune mediated heparin-induced thrombocytopenia, active clinically significant bleeding and conditions with a high risk of haemorrhage, including recent haemorrhagic stroke, gastrointestinal ulcer, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophthalmic surgery, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities; hypersensitivity, etc).
    • Received any COVID-19 vaccination
    • Recent (<48 hours) or planned spinal or epidural anesthesia or puncture, PCI or thrombolytic therapy within the preceding 24 hours
    • Increased risk for bleeding complications
    • Pregnant women
    • Severe renal impairment (GFR < 30 mL/min)
    • Receiving any antiplatelet therapy (with the exception of low dose (≤ 100mg) aspirin) or clopidogrel (≤75mg) monotherapy or anticoagulant therapy (e.g. VKA, DOAC)
    • Patients participating in an interventional study that is outside the purview of TRI sponsored studies.
    • Kontraindikationen gegen unfraktioniertes Heparin oder NMH (Anamnese einer immunvermittelten Heparin-induzierten Thrombozytopenie, aktiver klinisch signifikanter Blutungen und Erkrankungen mit hohem Blutungsrisiko, einschließlich kürzlich aufgetretenem hämorrhagischem Schlaganfall, Magen-Darm-Geschwür, Vorhandensein eines malignen Neoplasmas mit hohem Blutungsrisiko, kürzlich durchgeführter Gehirn-, Wirbelsäulen- oder Augenchirurgie, bekannt oder Verdacht auf Ösophagusvarizen, arteriovenöse Fehlbildungen, Gefäßaneurysmen oder schwerwiegende intraspinale oder intrazerebrale Gefäßanomalien; Überempfindlichkeit usw.).
    • eine COVID-19-Impfung
    • Kurz zurückliegende (<48 Stunden) oder geplante spinale oder epidurale Anästhesie oder Punktion, PCI oder thrombolytische Therapie innerhalb der letzten 24 Stunden
    • Erhöhtes Risiko für Blutungskomplikationen
    • Schwangere Frauen
    • Schwere Niereninsuffizienz (GFR < 30 mL/min)
    • Patienten, die eine Thrombozytenaggregationshemmer-Therapie (mit Ausnahme von niedrig dosiertem (≤100mg) Aspirin) oder eine Antikoagulanzien-Therapie (z. B. VKA, DOAK) erhalten
    • Patienten, die an einer interventionellen Studie teilnehmen, die nicht in den Bereich der von TRI gesponserten Studien fällt.
    E.5 End points
    E.5.1Primary end point(s)
    The composite of hospitalization or all-cause death within 21 days after randomization.
    E.5.1.1Timepoint(s) of evaluation of this end point
    21 Days
    E.5.2Secondary end point(s)
    Death (at 21, 50 and 90 days)
    • All-cause
    • Cardiovascular
    • Non-Cardiovascular
    • Specific causes
    • Fatal bleed
    • Hospital admission (at 21, 50 and 90 days)
    o Pneumonia
    o Acute Respiratory distress syndrome
    o Acute medical care or admission to intensive care unit (ICU)
    o Mechanical ventilation/ Extracorporeal membrane oxygenation
    (ECMO)
    o Non-invasive ventilation/high flow oxygen
    o Hospitalized on supplemental oxygen
    o Hospitalized not requiring supplemental oxygen
    o Hospitalized not requiring ongoing medical care
    • Bleeding (as defined by ISTH criteria [12, 13]) (at 21 and 50 days)
    o Frequency
    o Location
    o Treatment (transfusion and units of blood products transfused)
    o Severity (classified as major, clinically relevant non-major and minor
    • Diagnosis of VTE: Deep Vein Thrombosis (DVT) or Pulmonary
    Embolism (PE) (at 21, 50 and 90 days)
    • Diagnosis of Ischemic stroke (at 21, 50, and 90 days)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Death (at 21, 50 and 90 days)
    Bleeding (as defined by ISTH criteria [12, 13]) (at 21 and 50 days)
    Diagnosis of VTE: Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE) (at 21, 50 and 90 days)
    Diagnosis of Ischemic stroke (at 21, 50, and 90 days)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard of care treatment (No Enoxaparin)
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    India
    Russian Federation
    South Africa
    Belgium
    Spain
    United Kingdom
    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
    Last Visit Last Patient
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months8
    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: 50
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 50
    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 No
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 1370
    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
    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 Decision2021-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-11-29
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