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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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:2020-001823-15
    Sponsor's Protocol Code Number:20CH089
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-04-15
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-001823-15
    A.3Full title of the trial
    Evaluation of the concentration-effect relationship of enoxaparin for thromboembolic prevention in COVID-19 resuscitation patients. COV-ENOX study
    Évaluation de la relation concentration effet de l’enoxaparine pour la prévention thromboembolique chez les patients COVID-19 en Réanimation. Etude COV-ENOX
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the concentration-effect relationship of enoxaparin for thromboembolic prevention in COVID-19 resuscitation patients. COV-ENOX study
    Évaluation de la relation concentration effet de l’enoxaparine pour la prévention thromboembolique chez les patients COVID-19 en Réanimation. Etude COV-ENOX
    A.3.2Name or abbreviated title of the trial where available
    COV-ENOX
    COV-ENOX
    A.4.1Sponsor's protocol code number20CH089
    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 SponsorCHU de Saint Etienne
    B.1.3.4CountryFrance
    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 supportCHU de Saint Etienne
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationURCIP- CHU Saint Etienne
    B.5.2Functional name of contact pointproject manager
    B.5.3 Address:
    B.5.3.1Street AddressURCIP - Batiment Recherche - Hôpital Nord
    B.5.3.2Town/ citySAINT ETIENNE CEDEX 2
    B.5.3.3Post code42055
    B.5.3.4CountryFrance
    B.5.4Telephone number33(0)477120469
    B.5.5Fax number33(0)477127820
    B.5.6E-mailcarine.labruyere@chu-st-etienne.fr
    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 Enoxaparine sodique
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS FRANCE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameenoxaparine sodique
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNENOXAPARIN SODIUM
    D.3.9.1CAS number 9041-08-1
    D.3.9.4EV Substance CodeSUB11933MIG
    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
    covid-19
    covid-19
    E.1.1.1Medical condition in easily understood language
    covid-19
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10070267
    E.1.2Term SARS virus test positive
    E.1.2System Organ Class 100000004848
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10022519
    E.1.2Term Intensive care
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To describe the pharmacokinetics of enoxaparin in resuscitation patients infected with CoV-2-SARS.
    Décrire la pharmacocinétique de l’enoxaparine chez les patients infectés par SARS-CoV-2 en réanimation.
    E.2.2Secondary objectives of the trial
    - To describe the relationship between enoxaparin concentration and bleeding risk in resuscitation patients with CoV-2-SARS.

    - To describe the relationship between enoxaparin concentration and thrombotic risk in resuscitation patients with CoV-2-SARS.

    - To propose optimal enoxaparin administration regimens tailored to individual patient characteristics.
    • Décrire la relation entre la concentration d’enoxaparine et le risque hémorragique chez les patients infectés par SARS-CoV-2 en réanimation.

    • Décrire la relation entre la concentration d’enoxaparine et le risque thrombotique chez les patients infectés par SARS-CoV-2 en réanimation.

    • Proposer des schémas d’administration optimale d’enoxaparine adaptés aux caractéristiques individuelles des patients
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult patients at least 18 years of age
    - Patients hospitalized in the intensive care unit infected with SARS-CoV-
    2, for whom a diagnosis of respiratory SARS-CoV-2 infection was made
    by nasopharyngeal swab or deep respiratory sampling (patients on HDON or artificial ventilation)
    - Patient receiving enoxaparin therapy as part of care or as part of a clinical trial for the prevention or treatment of thromboembolic venous disease.
    - Patient affiliated or entitled to a social security scheme
    • Patients adultes âgés d’au moins 18 ans
    • Patients hospitalisés dans les services de réanimation infectés par SARS-CoV-2 réanimation (patients sous ONHD ou ventilation artificielle) et ayant un diagnostic d’infection respiratoire à SARS-CoV-2 a été fait un écouvillon nasopharyngé ou un prélèvement respiratoire profond.
    • Patient recevant un traitement par enoxaparine dans le cadre du soin ou dans le cadre d’un essai clinique dans la prévention ou du traitement de la maladie veineuse thromboembolique.
    • Patient affilié ou ayant droit d’un régime de sécurité sociale
    E.4Principal exclusion criteria
    - Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWHs)
    - History of immune-mediated heparin-induced thrombocytopenia (HIT) in the last 100 days or in the presence of circulating antibodies
    - Active clinically significant bleeding or a condition associated with a high risk of bleeding, such as a recent hemorrhagic stroke, gastrointestinal ulcer, the presence of a malignant tumour at high risk of bleeding, recent brain, spinal or ophthalmologic surgery, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysm or major intrarachid or intracerebral vascular abnormalities.
    - Spinal, epidural or locoregional anaesthesia or anaesthesia when enoxaparin sodium is used for curative treatment within the previous 24 hours
    • Hypersensibilité à l’enoxaparine sodique, à l’héparine ou à ses dérivés, y compris à d’autres héparines de bas poids moléculaire (HBPM)
    • Antécédent de thrombopénie induite par héparine (TIH) à médiation immunitaire au cours des 100 derniers jours ou en présence d’anticorps circulants
    • Saignement actif cliniquement significatif ou une affection associée à un risque élevé d’hémorragie, telle qu’ un accident vasculaire cérébral hémorragique récent, un ulcère gastro-intestinal, la présence d’une tumeur maligne à risque élevé de saignement, une intervention chirurgicale récente du cerveau, du rachis ou ophtalmologique, des varices oesophagiennes connues ou suspectées, des malformations artérioveineuses, un anévrysme vasculaire ou des anomalies vasculaires intrarachidiennes ou intracérébrales majeures.
    • Rachianesthésie ou anesthésie péridurale ou locorégionale lorsque l’énoxaparine sodique est utilisée pour un traitement curatif dans les 24 heures précédentes
    E.5 End points
    E.5.1Primary end point(s)
    Measurement of the anti-Xa activity of enoxaparin by chromogenic method.
    Mesure de l’activité anti-Xa de l’enoxaparine par méthode chromogénique.
    E.5.1.1Timepoint(s) of evaluation of this end point
    daily for 30 days or until the complete decrease of drug
    tous les jours pendants 30 jours ou jusqu'à la décroissance complète du médicament
    E.5.2Secondary end point(s)
    Hemorrhage:
    - major hemorrhage as defined by the ISTH.
    - clinically "significant" but not major hemorrhage as defined by ISTH

    Venous thromboembolic events:
    - asymptomatic or symptomatic proximal deep vein thrombosis
    - asymptomatic or symptomatic pulmonary embolism

    Individual patient characteristics will be assessed by
    - Biological markers
    -Kidney function: creatininemia
    -Inflammation: CRP, inflammatory cytokines
    -Coagulation: fibrinogen, D-Dimers
    -Demographic characteristics Weight, age, sex, height, presence of a high thrombotic risk factor (history of venous thrombotics, active cancer, invasive mechanical ventilation)

    Translated with www.DeepL.com/Translator (free version)
    Hémorragie :
    - hémorragie majeure selon la définition de l’ISTH
    - hémorragie cliniquement « significative » mais non majeure selon la définition de l’ISTH

    Evènements thromboemboliques veineux :
    - thrombose veineuses profondes proximales asymptomatique ou symptomatique
    - embolie pulmonaire asymptomatique ou symptomatique

    Les caractéristiques individuelles des patients seront évalués par
    - Marqueurs biologiques
    •Fonction rénale : créatininémie
    •Inflammation : CRP, cytokines inflammatoires
    •Coagulation : fibrinogène, D-Dimères
    •Caractéristiques démographiques Poids, âge, sexe, taille, présence d’un facteur de risque thrombotique élevé (antécédent thrombotique veineux, cancer actif, ventilation mécanique invasive)
    E.5.2.1Timepoint(s) of evaluation of this end point
    daily for 30 days or until the complete decrease of drug
    tous les jours pendants 30 jours ou jusqu'à la décroissance complète du médicament
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 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 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
    Last visit last patient
    la dernière visite du dernier patient inclus
    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 months5
    E.8.9.1In the Member State concerned 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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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.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
    Aucun
    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 Decision2020-04-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-16
    P. End of Trial
    P.End of Trial StatusOngoing
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