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    Summary
    EudraCT Number:2020-001287-28
    Sponsor's Protocol Code Number:APHP200395
    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:2020-03-30
    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 number2020-001287-28
    A.3Full title of the trial
    NA
    Thérapie cellulaire par cellules stromales mésenchymateuses issues de cordon ombilical dans le syndrome de détresse respiratoire aiguë (SDRA) associé au SARS-CoV-2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Non applicable
    Non applicable
    A.3.2Name or abbreviated title of the trial where available
    STROMA-COV2
    A.4.1Sponsor's protocol code numberAPHP200395
    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 SponsorAssitance Publique-Hôpitaux de Paris
    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 supportPHRC
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAssistance Publique-Hôpitaux de Paris
    B.5.2Functional name of contact pointChef de Projet
    B.5.3 Address:
    B.5.3.1Street Address1 Avenue Claude VELLEFAUX
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number+330144841742
    B.5.5Fax number+330144841701
    B.5.6E-mailkarine.seymour@aphp.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 nameCellules souches/stromales mésenchymateuses (CSM) allogéniques
    D.3.4Pharmaceutical form Suspension 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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    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
    D.8.3Pharmaceutical form of the placeboSuspension for injection
    D.8.4Route of administration of the placeboIntravenous drip use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non applicable
    Patient testé positif (PCR positive) pour le nouveau coronavirus 2019-nCOV
    E.1.1.1Medical condition in easily understood language
    Non applicable
    Syndrome de détresse respiratoire aiguë (SDRA) associé au nouveau coronavirus 2019-nCOV
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    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
    Non applicable
    L’objectif principal de l’étude est de démontrer que l’administration intraveineuse de cellules stromales mésenchymateuses issues de cordon ombilical, ajoutée à une prise en charge standard, améliore la résolution du syndrome de détresse respiratoire aiguë lié au nouveau coronavirus, en comparaison à l’administration d’un placebo ajouté à la prise en charge standard.
    E.2.2Secondary objectives of the trial
    Non applicable
    • La sécurité et la tolérance de CSM-CO
    • L’effet de CSM-CO sur :
    o la mortalité et le nombre de jours sans ventilation
    o le nombre de jours sans hospitalisation en réanimation
    o les échanges gazeux et la mécanique ventilatoire
    o le nombre de séances de décubitus ventral pratiqué en réanimation
    o la survenue de défaillance d’organes
    o les biomarqueurs inflammatoires
    o l’état de santé et la qualité de vie à 1 an
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Non applicable
    - homme ou femme de plus de 18 ans
    - Intubé et ventilé
    - infection par le SARS-coV2 confirmée par RT-PCR
    - présentant un syndrome de détresse respiratoire aiguë (SDRA) datant de moins de 96 heures, défini selon les critères de BERLIN*
    - obtention du consentement écrit du patient ou d’un parent/proche/personne de confiance. En cas d’absence du parent/proche/personne de confiance, le patient peut être inclus en procédure d’urgence par le médecin investigateur en charge du patient.
    - bénéficiaire d’un régime français de sécurité sociale (hormis AME)
    * Critères de BERLIN définis en page 32, chapitre : 6.1 Critères d’inclusion
    E.4Principal exclusion criteria
    Non applicable
    Les critères de non inclusion sont :
    - Cancer évolutif, ou traité depuis moins de 2 ans
    - Fibrose pulmonaire
    - Hypertension artérielle pulmonaire de classe III ou IV (classification de l’OMS)
    - Antécédent d’allergie ayant nécessité un traitement désensibilisant spécifique
    - Embolie pulmonaire datant de moins de 3 mois
    - Assistance de type ECMO veino-veineuse ou veino-artérielle
    - Immunodépression (immunosuppresseurs ou corticoïdes à dose immunosuppressive: ≥ 10mg/j équivalent prednisolone)
    - Présence de toute tumeur maligne active (autre qu’un cancer de la peau non-mélanome) qui a nécessité un traitement au cours des 2 dernières années
    - Toute autre maladie ou affection irréversible pour laquelle la mortalité à 6 mois est estimée à plus de 50%
    - Insuffisance hépatique modérée à sévère (score de Child-Pugh> 12)
    - Maladie respiratoire chronique sévère avec une PaCO2> 50 mm Hg ou l'utilisation d'oxygène à domicile
    - Patient transplanté pulmonaire
    - Patient avec limitations thérapeutiques actives
    - Patient moribond avec décès prévisible dans les 48 heures
    - Aucune intention / réticence à suivre une stratégie de ventilation protectrice des poumons ou un protocole de gestion des fluides
    - Enceinte ou allaitante
    - Patient inclus dans une autre étude COVID-19 de catégorie Jardé 1 et 2
    - Patient sous tutelle ou curatelle
    - Patient privé de liberté par une décision judiciaire ou administrative
    E.5 End points
    E.5.1Primary end point(s)
    Non applicable
    Le critère de jugement principal est l’évolution du rapport PaO2/FiO2 entre le début du traitement et J7.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Non applicable
    Le critère d’évaluation principal est l’efficacité respiratoire des cellules stromales mésenchymateuses dans le syndrome de détresse respiratoire aiguë associé au nouveau coronavirus.
    L’efficacité respiratoire sera jugée prioritairement sur l’évolution du rapport PaO2/FiO2 au 7ème jour après le début du traitement.
    E.5.2Secondary end point(s)
    Non applicable


    Biomarqueurs spécifiques à J0, J2, J4, J7 et J14 :
    - taux plasmatiques des cytokines pro-inflammatoires : interleukine (IL)-1, IL2, IL-6, IL-8, TNF-alpha,
    - taux plasmatiques des cytokines anti-inflammatoires : IL-10, IL1Ra, TGF-bêta
    - taux plasmatiques de marqueurs de lésions épithéliales pulmonaires : sRAGE, SP-A, SP-D
    - taux plasmatiques de marqueurs de lésions endothéliales : angiopoïétine 2, facteur von Willebrand
    Anticorps anti-HLA des cellules injectées à J0 et J14
    E.5.2.1Timepoint(s) of evaluation of this end point
    Non applicable
    Non applicable
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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
    Non applicable
    Dans un contexte d’urgence vitale, certains patients seront inclus dans ce protocole avec l’accord d’un proche ou d’une personne de confiance désignée au préalable. Le consentement du patient sera récupéré dès que son état de santé le permettra.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    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
    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 Decision2020-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-10-26
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