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    Summary
    EudraCT Number:2021-000504-37
    Sponsor's Protocol Code Number:2020PI215
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-03-26
    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 number2021-000504-37
    A.3Full title of the trial
    Characterization by PET-CT with 18F-FDG of brain lesions in young subjects with sequential psycho-cognitive disorders following severe COVID19
    Caractérisation par TEP-TDM au 18F-FDG des lésions cérébrales chez des sujets jeunes présentant des troubles psycho-cognitifs séquellaires dans les suites d’une COVID-19 grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Characterizing brain lesions using PET/CT imaging with glucose in young subjects with psycho-cognitive disorders following severe VIDOC-19
    Caractériser les lésions cérébrales grace à l'imagerie TEP/TDM au glucose chez des sujets jeunes présentant des troubles psycho-cognitifs suite à une COVID-19 grave
    A.3.2Name or abbreviated title of the trial where available
    TEPCOV
    TEPCOV
    A.4.1Sponsor's protocol code number2020PI215
    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 SponsorCHRU DE NANCY
    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 supportCHRU de nancy
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHRU DE NANCY
    B.5.2Functional name of contact pointRegulatory project manager
    B.5.3 Address:
    B.5.3.1Street Address5, rue du morvan
    B.5.3.2Town/ cityvandoeuvre les nancy
    B.5.3.3Post code54511
    B.5.3.4CountryFrance
    B.5.4Telephone number+33383153475
    B.5.5Fax number+33338155285
    B.5.6E-maildripromoteur@chru-nancy.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 FLUCIS
    D.2.1.1.2Name of the Marketing Authorisation holderCURIUM
    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 nameFLUCIS
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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 Yes
    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.IMP: 2
    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 GLUCOTEP
    D.2.1.1.2Name of the Marketing Authorisation holderCURIUM
    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 nameGLUCOTEP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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) 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 Yes
    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.IMP: 3
    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 GLUSCAN
    D.2.1.1.2Name of the Marketing Authorisation holderAAA
    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 nameGLUSCAN
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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) 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 Yes
    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.IMP: 4
    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 No
    D.2.1.1.1Trade name METATRACE fdg
    D.2.1.1.2Name of the Marketing Authorisation holderPETNET SOLUTION
    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 nameMETATRACE FDG
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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) 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 Yes
    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
    young subjects with sequential psycho-cognitive disorders in the aftermath of severe COVID-19
    sujets jeunes présentant des troubles psycho-cognitifs séquellaires dans les suites d’une COVID-19 grave
    E.1.1.1Medical condition in easily understood language
    young subjects with psycho-cognitive disorders in the aftermath of severe COVID-19
    sujets jeunes présentant des troubles psycho-cognitifs dans les suites d’une COVID-19 grave
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084547
    E.1.2Term Exposure to COVID-19
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10057668
    E.1.2Term Cognitive disorder
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To characterize the changes in brain metabolism observed in 18F-FDG PET-CT in the patient population included in the Neurocog-Covid study at the Nancy CHRU, compared to the brain metabolism of a control subject base.
    Caractériser les modifications du métabolisme cérébral observées en TEP-TDM au 18F-FDG, dans la population de patients inclus dans l’étude Neurocog-Covid au CHRU de Nancy, en comparaison au métabolisme cérébral d’une base de sujets contrôles.
    E.2.2Secondary objectives of the trial
    1) To compare the sensitivity of detection of abnormalities in cerebral MRI and PET-CT to 18F-FDG in the patient population included in the Neurocog-Covid study at the Nancy University Hospital.
    2) To correlate the brain functions impacted and objectified on the neuropsychological assessment (BNP) to the brain metabolism observed in 18F-FDG PET-CT in the patient population included in the Neurocog-Covid study at the Nancy University Hospital.
    3) Correlating brain metabolism to the volume of damage to the lung sequelae of Covid-19.
    1) Comparer la sensibilité de détection d’anomalies en IRM cérébrale et en TEP-TDM au 18F-FDG, dans la population de patients inclus dans l’étude Neurocog-Covid au CHRU de Nancy.
    2) Corréler les fonctions cérébrales impactées et objectivées sur le bilan neuropsychologique (BNP) au métabolisme cérébral observé en TEP-TDM au 18F-FDG dans la population de patients inclus dans l’étude Neurocog-Covid au CHRU de Nancy.
    3) Corréler le métabolisme cérébral au volume d’atteinte des lésions pulmonaires séquellaires de la Covid-19.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient included in the Neurocog-Covid study (i.e. presenting a cognitive disorder that has been objectified on the neuropsychological assessment and having to undergo a cerebral MRI),
    - Major patient who has received full information about the organization of the research and has given written informed consent (or a third person, independent of the investigator and the sponsor, in the event of a reading or writing disability),
    - Patient affiliated to or beneficiary of a social security plan
    • Patient inclus dans l’étude Neurocog-Covid (c’est-à-dire présentant un trouble cognitif objectivé sur le bilan neuropsychologique et devant passer une IRM cérébrale),
    • Patient majeure ayant reçu l’information complète sur l’organisation de la recherche et ayant donné son consentement éclairé sous forme écrite (ou une tierce personne, indépendante de l’investigateur et du promoteur, en cas d’incapacité de lecture ou d’écriture),
    • Patient affilié à un régime de sécurité sociale ou bénéficiaire d’un tel régime
    E.4Principal exclusion criteria
    - Contraindication for performing 18F-FDG PET-CT
    - Presence of pre-Covid-19 chronic neurological or psychiatric pathologies
    - Women of childbearing age who do not have effective contraception.
    - Pregnant woman or nursing mother.
    - Person referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code.
    - Persons deprived of liberty by a judicial or administrative decision, persons undergoing psychiatric care pursuant to articles L. 3212-1 and L. 3213-1
    - Persons referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code.
    • Contre-indication pour réaliser la TEP-TDM au 18F-FDG
    • Présence de pathologies neurologiques ou psychiatriques chroniques pré-Covid-19
    • Femme en âge de procréer ne disposant pas de moyen de contraception efficace.
    • Femme enceinte ou mère allaitante.
    • Personne visée aux articles L. 1121-5, L. 1121-7 et L1121-8 du code de la santé publique.
    • Les personnes privées de liberté par une décision judiciaire ou administrative, les personnes faisant l'objet de soins psychiatriques en vertu des articles L. 3212-1 et L. 3213-1
    • Personnes visées aux articles L. 1121-5, L. 1121-7 et L1121-8 du Code de la Santé Publique.
    E.5 End points
    E.5.1Primary end point(s)
    Volumes and topographies of brain regions (PMS-type quantitative analysis), defined as those presenting a decrease in glycolytic metabolism in 18F-FDG PET-CT in patients included in the Neurocog-Covid study at the Nancy University Hospital, compared to the control subjects.
    Volumes et topographies des régions cérébrales (analyse quantitative type SPM), définies comme celles présentant une diminution du métabolisme glycolytique en TEP-TDM au 18F-FDG chez les patients inclus dans l’étude Neurocog-Covid au CHRU de Nancy, en comparaison à la base de sujets contrôles
    E.5.1.1Timepoint(s) of evaluation of this end point
    at the end of the inlcusion
    à la fin des inclusions
    E.5.2Secondary end point(s)
    1) Number of abnormal 18F-FDG MRI and PET-CT scans in the patient population included in the Neurocog-Covid study at Nancy University Hospital.

    2) Volumes and topographies of brain regions (PMS-type quantitative analysis), defined as those presenting a decrease in glycolytic metabolism in 18F-FDG PET-CT in relation to cognitive profiles identified as defective.

    3) Volumes of brain regions (PMS type quantitative analysis), defined as those showing a decrease in glycolytic metabolism in 18F-FDG PET-CT in relation to the volumes of lung damage, objectively measured in 18F-FDG PET-CT.
    1) Nombre d’examens IRM et TEP-TDM au 18F-FDG anormaux dans la population de patients inclus dans l’étude Neurocog-Covid au CHRU de Nancy.

    2) Volumes et topographies des régions cérébrales (analyse quantitative type SPM), définies comme celles présentant une diminution du métabolisme glycolytique en TEP-TDM au 18F-FDG en lien avec les profils cognitifs identifiés comme défaillants.


    3) Volumes des régions cérébrales (analyse quantitative type SPM), définies comme celles présentant une diminution du métabolisme glycolytique en TEP-TDM au 18F-FDG en lien avec les volumes d’atteinte pulmonaire, objectivés en TEP-TDM au 18F-FDG.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at the end of the inclusion
    à la fin des inclusions
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    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 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.8.3 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.8.4.1Number of sites anticipated in Member State concerned1
    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
    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 months
    E.8.9.1In the Member State concerned days
    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.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 state50
    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 Decision2021-03-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-08-01
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