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    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   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:2020-001700-42
    Sponsor's Protocol Code Number:APHP200410
    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:2020-04-11
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-001700-42
    A.3Full title of the trial
    Efficacy of captopril nebulization in Covid-19 patients suffering of SARS-CoV-2 pneumonia.
    A randomized phase II study
    Etude d’efficacité de l’administration d’aérosols de captopril pour les patients atteints de pneumonie à SARS-CoV-2 dans le cadre de la maladie Covid-19. Etude randomisée de phase II
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of captopril in Covid-19 patients suffering of pneumonia
    Etude d’efficacité de l’administration de captopril pour les patients atteints de pneumonie dans le cadre de la maladie Covid-19
    A.3.2Name or abbreviated title of the trial where available
    CAPTOCOVID
    A.4.1Sponsor's protocol code numberAPHP200410
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    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 supportEthypharm
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportAerogen
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
    B.5.2Functional name of contact pointDRCI Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address1 av. Claude Vellefaux
    B.5.3.2Town/ cityParis
    B.5.3.4CountryFrance
    B.5.6E-mailfrance.guyot@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 nameCAPTOPRIL
    D.3.4Pharmaceutical form Concentrate for nebuliser solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation 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 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
    Patient ≥18 with SARS Cov 2 pneumonia requiring oxygen administration.
    Patients âgés de 18 et plus, atteints d’une pneumonie SARS-CoV-2, nécessitant une administration d'oxygène.
    E.1.1.1Medical condition in easily understood language
    Pneumonia in covid-19 patients
    Pneumonie chez les patients atteints de 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 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the efficacy of captopril nebulization addition to standard of care compared to standard of care in term of 14-day ventilation free survival
    Démontrer l’efficacité du captopril en aérosol associé à la prise en charge standard comparé à la prise en charge standard seule en termes de survie sans ventilation mécanique invasive (VMI) à J14
    E.2.2Secondary objectives of the trial
    To demonstrate the efficacy and safety of captopril nebulization:
    - Efficacy :
    • Mortality at 28 day
    • Need of invasive mechanical ventilation (IMV) at 28 days
    • Length of hospitalization
    • Length of stay in ICU
    • Length of mechanical ventilation
    - Safety :
    • Respiratory tolerance
    • Hemodynamic tolerance
    • Metabolic tolerance
    • Renal tolerance
    • Skin tolerance
    Démontrer l’efficacité et la sécurité du captopril aérosol :
    - l’efficacité sur :
    • la mortalité à 28 jours
    • le besoin en ventilation mécanique invasive à 28 jours
    • la durée d’hospitalisation
    • la durée de séjour en réanimation
    • la durée d’hospitalisation
    • la durée de ventilation mécanique invasive
    - la tolérance des aérosols de captopril :
    • sur le plan respiratoire
    • sur le plan hémodynamique
    • sur le plan métabolique
    • sur le plan rénal
    • sur le plan cutané
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1- Hospitalization for acute respiratory failure requiring oxygen administration ≥3L/mn
    2- Age > 18 years or older
    3- Presence of pneumonia
    4- PCR SARS-CoV-2 positive in any biological sample in the last 7 days
    5- Patient affiliated to social security regime
    6- Written informed consent provided by the patient or alternatively by next-of-kin, or in emergency situations, prior to any protocol-specific procedures
    1- Hospitalisation pour insuffisance respiratoire aiguë nécessitant une administration d'oxygène ≥ 3 L / mn
    2- Patient âgé de 18 ans ou plus
    3- Présence de pneumonie
    4- PCR SARS-CoV-2 positive sur n’importe quel fluide ou tissu biologique dans les 7 derniers jours
    5- Patient affilié à un régime de sécurité sociale
    6- Consentement éclairé écrit fourni par le patient ou alternativement par le plus proche parent ou procédure d’inclusion en urgence décrite avant toute procédure spécifique au protocole.
    E.4Principal exclusion criteria
    1- Decision of withholding invasive mechanical ventilation
    2- Shock requiring vasopressor infusion
    3- Co-infection with another respiratory pathogen which could be responsible of pneumonia
    4- Hypersensitivity to captopril, to any other angiotensin converting enzyme inhibitor or any of the excipients of the specialty used
    5- History of angio-oedema
    6- History of ACE-inhibitor allergy
    7- Known pregnancy or current lactation: Female subject of childbearing potential should have a negative serum
    pregnancy test prior to receiving the first dose of study medication.
    8- Patient who is currently enrolled in other investigational study;
    9- Persons deprived of their liberty by judicial or administrative decision,
    10- Persons under legal protection/safeguard of justice,
    11- Patients under duress psychiatric care,
    12- Persons admitted to a health or social institution
    13- Patient on AME (state medical aid)
    1- Patient pour lequel une décision de non-recours à l’intubation a été statuée avant son inclusion
    2- Etat de choc justifiant de l’administration d’amines vasopressives
    3- Co-infection avec un autre pathogène respiratoire possiblement responsable de la pneumonie
    4- Hypersensibilité au captopril, ou à tout autre inhibiteur d’enzymes de conversion d’angiotensine ou à l’un des excipients de la spécialité utilisée
    5- Antécédent d’angiooedeme
    6- Allergie connue aux inhibiteurs de l’enzyme de conversion
    7- Grossesse ou allaitement en cours : Les femmes en âge de procréer doivent avoir un test de grossesse sanguin négatif avant de recevoir la première dose du médicament à l'étude.
    8- Patient inclus dans une autre étude interventionnelle
    9- Personnes privées de liberté par décision judiciaire ou administrative
    10- Personnes sous mesure de protection légale/sauvegarde de justice
    11- Patient faisant l’objet de soins psychiatriques sous contrainte,
    12- Personnes admises dans un établissement sanitaire ou social
    13- Patient sous AME (aide médicale d'Etat)
    E.5 End points
    E.5.1Primary end point(s)
    14-day invasive mechanical ventilation free survival: defined as the proportion of patients requiring IMV or dying between randomization and Day 14
    Survie sans ventilation mécanique invasive (VMI) à J14 : définie comme la proportion de patients nécessitant une VMI ou décédant entre la randomisation et J14
    E.5.1.1Timepoint(s) of evaluation of this end point
    14 days
    14 jours
    E.5.2Secondary end point(s)
    - Efficacy :
    • Overall 28-day mortality
    • Number of days alive without IMV at 28 days
    • Length of stay in ICU in days (restricted to 28 days)
    • Length of hospitalization (restricted to 28 days).
    • Length of mechanical ventilation (restricted to 28 days).
    - Safety :
    • Respiratory tolerance:
    - Unstoppable cough requiring nebulization interruption
    - Increasing of O2 flow more than 3L/mn
    • Hemodynamic tolerance:
    - Hypotension requiring nebulization interruption
    - Hypotension requiring vasopressor infusion in the 24h after nebulization
    • Metabolic tolerance:
    Hyperkaliemia requiring calcium gluconate administration or renal replacement therapy (RRT) in the 72h after nebulization
    • Renal tolerance:
    Creatinine level increasing of more 50% or renal replacement therapy in the 72h after nebulization
    • Skin tolerance:
    Angiooedemea in the 72h after nebulization
    - Pour l’efficacité :
    • Survie globale à J28
    • Nombre de jours vivant sans ventilation mécanique invasive à J28
    • La durée de séjour en réanimation (bornée à 28 jours)
    • La durée d’hospitalisation (bornée à 28 jours)
    • La durée sous ventilation mécanique invasive (bornée à 28 jours)
    - Pour la sécurité :
    • sur le plan respiratoire :
    Toux inarrêtable nécessitant une interruption de la nébulisation
    majoration du débit d’O2 de 3L/mn
    • sur le plan hémodynamique :
    Hypotension nécessitant l’arrêt de la nébulisation
    Hypotension nécessitant la perfusion d’un vasopresseur dans les 24h suivant la nébulisation
    • sur le plan métabolique :
    Hyperkaliémie nécessitant l'administration de gluconate de calcium ou une expuration extra-rénale dans les 72 heures suivant la nébulisation
    • sur le plan rénal :
    Majoration de plus de 50% de la créatininémie ou recours à une épuration extrarénale dans les 72h suivants la nébulisation.
    • sur le plan cutané :
    Apparition d’un angiooedème dans les 72h suivants la nébulisation
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 days
    28 jours
    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 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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Soin Courant selon les recommandations Covid-Sepsis-Campaign en vigueur
    Standard of care according to Surviving-Covid-campaign
    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 concerned18
    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
    LVLS
    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 months4
    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: 115
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 115
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state230
    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 Decision2020-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-27
    P. End of Trial
    P.End of Trial StatusOngoing
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