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    Summary
    EudraCT Number:2020-003125-39
    Sponsor's Protocol Code Number:TRI-08892
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-10-19
    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 ConcernedUK - MHRA
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Early treatment of patients with symptoms and confirmed COVID-19 with medication to prevent the disease becoming worse
    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 Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCYTE Global
    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 pointAlice Fernandez
    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 number02031989898
    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
    D.2.1.1.2Name of the Marketing Authorisation holderAventis Pharma Limited Trading as Sanofi
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameClexane
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.4EV Substance CodeAS2
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Low Molecular Weight Heparin (LMWH) thromboprophylaxis in patients with COVID-19
    E.1.1.1Medical condition in easily understood language
    Prevention of blood clots in patients with a COVID-19 infection
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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
    We want to find out if giving a small dose of blood-thinning drug (enoxaparin) in an early stage of the COVID-19 disease can prevent the individuals being admitted to hospital and/or death.

    Half the patients in the study will receive enoxaparin for three weeks in addition to standard of care, and half will receive only standard of care treatment (no enoxaparin). Individuals will be randomly allocated to one of these groups. After 21 days, the number of patients in each group who were either admitted to hospital, or died, will be compared.
    E.2.2Secondary objectives of the trial
    We want to find out if giving a small dose of blood-thinning drug (enoxaparin) in an early stage of the COVID-19 disease can prevent patients being given extra oxygen as treatment for the disease, developing a blood clot or having a stroke within 21 days after receiving the drug. The two groups will be compared again at 50 and 90 days.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Signed Informed consent
    Confirmed COVID-19 (i.e. symptoms + positive test for SARS-CoV-2)
    Male or female, age ≥ 55 years
    At least two of the following additional risk factors:
    o Age ≥ 70 years
    o Body mass index > 25 kg/m2
    o Chronic obstructive pulmonary disease (COPD)*
    o Diabetes*
    o Cardiovascular disease*
    o Corticosteroid use
    *Defined as any disease requiring medical intervention or treatment
    E.4Principal exclusion criteria
    Contraindications to unfractionated heparin or LMWH
    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 anticoagulant therapy (e.g. VKA, DOAC)
    Patients participating in an interventional study that is outside the purview of TRI sponsored studies.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study will be the composite of hospitalization or all-cause death within 21,50 and 90 days after randomization.
    • Death
    • All-cause
    • Cardiovascular
    • Non-Cardiovascular
    • Specific causes
    • Fatal bleed
    • Hospital admission
    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
    E.5.1.1Timepoint(s) of evaluation of this end point
    21,50 and 90 days after randomization
    E.5.2Secondary end point(s)

    • Bleeding (as defined by ISTH criteria) (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
    Bleeding (as defined by ISTH criteria) (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 not mandated by protocol
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Belgium
    Brazil
    India
    South Africa
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 state200
    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)
    All patients will receive standard of care of treatment for the duration of the trial.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-10-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-15
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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