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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2020-005827-35
    Sponsor's Protocol Code Number:RC31/20/0441
    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:2020-12-11
    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 number2020-005827-35
    A.3Full title of the trial
    SARS-CoV-2 neurotropism, micRoglial ActivatioN and cytokine dySregulaTiOn in COVID-19 patients with delirium
    Neurotropisme viral, activation microgliale et dysfonction cytokinique chez les patients COVID-19 atteints de delirium
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Neurotropism and neuroinflammation in COVID-19 patients with delirium
    A.3.2Name or abbreviated title of the trial where available
    BRAINSTORM
    A.4.1Sponsor's protocol code numberRC31/20/0441
    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 SponsorUniversity Hospital of Toulouse
    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 supportANR
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital of Toulouse
    B.5.2Functional name of contact pointDRI
    B.5.3 Address:
    B.5.3.1Street Address2 rue Viguerie
    B.5.3.2Town/ cityToulouse
    B.5.3.3Post code31059
    B.5.3.4CountryFrance
    B.5.4Telephone number330561777032
    B.5.5Fax number330561778411
    B.5.6E-mailbelloc.a@chu-toulouse.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 No
    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 name [18F]N,N-diethyl-2-[2-(4-(2fluoroethoxy)phenyl)-5,7dimethylpyrazolo[1,5-a]pyrimidin-3yl]acetamide
    D.3.2Product code [18F]DPA-71
    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.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
    delirium
    délirium
    E.1.1.1Medical condition in easily understood language
    Delirium is defined by acute change in mental status or a fluctuating mental status, inattention, altered level of consciousness and disorganized thinking
    Le délirium est défini par un changement aigu de l'état mental ou un état mental fluctuant, l'inattention, un niveau de conscience altéré et une pensée désorganisée
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    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
    o describe whole-brain changes in microglial activity in patients with Covid-19 and delirium during the acute phase of delirium.
    Décrire, à l’échelle du cerveau entier, les modifications de l’activité microgliale des patients atteints par la Covid-19 et présentant un delirium, pendant la phase aigüe du delirium
    E.2.2Secondary objectives of the trial
    - Identification of structural and functional abnormalities of the whole brain in magnetic resonance imaging (MRI) in patients at V1 and 3 months after (V2).
    - Study of the cerebral neurotropism of CoV-2-CoV-SARS quasispecies at V1 and V2
    - Description of the central and peripheral immune response to V1 and V2
    - Simple (V1) and multidimensional (V2) neurocognitive assessment to explore patient outcomes and cognitive impact of delirium
    - Comparison between the parameters evaluated at V1 and V2 (microglial activation, structural and functional cerebral modifications, neurotropism, central and peripheral immune response, neuropsychological evaluation) to characterize the impact of delirium on the evolution and fate of patients
    - Identification des anomalies structurelles et fonctionnelles cérébrales à l'échelle du cerveau entier, en imagerie par résonance magnétique (IRM) chez les patients à V1 et 3 mois après ( V2)
    - Étude du neurotropisme cérébral des quasi-espèces de SARS-CoV-2, à V1 et V2
    - Description de la réponse immunitaire centrale et périphérique à V1 et V2
    - Évaluation neurocognitive simple (V1) et multidimensionnelle (V2) pour explorer le devenir des patients et les répercussions du delirium sur le plan cognitif
    - Comparaison entre les paramètres évalués à V1 et V2 (activation microgliale, modifications structurelles et fonctionnelles cérébrales, neurotropisme, réponse immunitaire centrale et périphérique, évaluation neuropsychologique) pour caractériser l’impact du delirium sur l’évolution et le devenir des patients
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult patients (male or female > or = 18 years)
    - COVID-19 (positive respiratory track PCR test < 30 days)
    - Delirium (CAM-ICU criteria)
    - informed and written consent to participate in the study by patient’s surrogate
    - Homme ou Femme d’âge > ou = 18 ans.
    - Maladie COVID-19 (PCR voies respiratoires < 30 jours).
    - Delirium (selon critères CAM-ICU).
    - Consentement de la personne de confiance / membre de la famille.
    E.4Principal exclusion criteria
    - medical decision of withdrawal of life sustaining treatments previous to patients recruitment
    - former neurological or psychiatric disability
    - MRI or PET scan contraindication
    - pregnancy or breastfeeding
    - hemodynamic or respiratory failure precluding patient’s transport / MRI or PET scanning
    Critères standards :
    - Antécédent de maladie neurologique ou psychiatrique.
    - Décision d’arrêt des soins avant recrutement
    - Sujet non affilié à un régime de sécurité sociale.
    - Personnes bénéficiant d’un système de protection juridique.
    - Femme enceinte ou allaitante.
    Critères liés à l'IRM :
    - État clinique incompatible avec le transport vers un centre d’imagerie ou la réalisation de l’examen.
    - Porteur de stimulateur cardiaque ou de tout autre matériel susceptible d’interférer avec le champ magnétique de l’IRM.
    - Refus d’être informé d’une anomalie détectée lors de l’examen d’IRM

    Critères liés à la TEP :
    - État clinique incompatible avec le transport vers un centre d’imagerie ou la réalisation de l’examen.
    - Réaction allergique connue au marqueur radiopharmaceutique TEP ([18F]DPA-714), ou à un de ses excipients.
    E.5 End points
    E.5.1Primary end point(s)
    Intensity and topography of microglial activation, marked in vivo by [18F]DPA-714 during PET imaging examination during the acute phase of delirium (V1).
    The phenotype of TSPO will be taken into account in the analyses of the PET scan results.
    Intensité et de topographie de l’activation microgliale, marquée in vivo par le [18F]DPA-714 lors de l'examen en imagerie par TEP réalisé pendant la phase aigüe du delirium (V1).
    Le phénotype de la TSPO sera pris en compte dans les analyses des résultats de l’examen TEP
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 1: Within 8 days after inclusion, during the acute phase of delirium.
    Visite 1: Dans les 8 jours après l'inclusion, durant la phase aigüe de delirium
    E.5.2Secondary end point(s)
    - Structural and functional brain abnormalities in patients at V1 and V2 in terms of whole-brain structural-functional disconnects (multimodal MRI)
    - Cerebral neurotropism of CoV-2-SARS-SRAS at V1 and V2 through the identification of viral quasispecies and characterization of serological profiles related to CoV-2-SARS infection (blood and CSF)
    - The central and peripheral immune response at V1 and V2
    - The evolution of patients and the impact of delirium on the cognitive level thanks to the performance of patients during the simple neurocognitive evaluation at V1 and multidomain evaluation at V2, using global and specific scales of major cognitive functions.
    - Anomalies structurelles et fonctionnelles cérébrales chez les patients, à V1 et V2, en termes de déconnexions structuro-fonctionnelles à l’échelle du cerveau entier (IRM multimodale)
    - Neurotropisme cérébral des quasi-espèces de SARS-CoV-2 à V1 et V2 grâce à l’identification des quasi-espèces virales et la caractérisation des profils sérologiques liés à l’infection par le SARS-CoV-2 (sang et LCR)
    - La réponse immunitaire centrale et périphérique à V1 et V2
    - L’évolution des patients et les répercussions du delirium sur le plan cognitif grâce aux performances des patients lors de l’évaluation neurocognitive simple à V1 et multidomaine à V2, à l’aide d’échelles globales et spécifiques des grandes fonctions cognitives
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 1: Within 8 days after inclusion, during the acute phase of delirium.
    Visite 1: Dans les 8 jours après l'inclusion, durant la phase aigüe de delirium
    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 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 Yes
    E.6.13.1Other scope of the trial description
    physiopathology
    physiopathologie
    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.8.3 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 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
    The last visit of the last subject undergoing the trial
    Date de la dernière visite de la dernière personne participant à l'essai
    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 months15
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial months15
    E.8.9.2In all countries concerned by the trial days15
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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.3.3.6.1Details of subjects incapable of giving consent
    Patients with delirium
    Patients avec un délirium
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    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 Decision2021-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-25
    P. End of Trial
    P.End of Trial StatusCompleted
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