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    The EU Clinical Trials Register currently displays   39572   clinical trials with a EudraCT protocol, of which   6487   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-001678-31
    Sponsor's Protocol Code Number:APHP200462
    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:2020-04-17
    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 number2020-001678-31
    A.3Full title of the trial
    Randomized controlled trial evaluating the efficacy of vaccination with Bacillus Calmette and Guérin (BCG) in the Prevention of COVID-19 via the strengthening of innate immunity in Health Care Workers.”
    COVID-BCG
    Essai prospectif randomisé évaluant l’efficacité d’une vaccination BCG dans la prévention du COVID 19 via le renforcement de l’immunité innée chez le personnel soignant
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized controlled trial evaluating the efficacy of vaccination with Bacillus Calmette and Guérin (BCG) in the Prevention of COVID-19 via the strengthening of innate immunity in Health Care Workers.”
    COVID-BCG
    Essai prospectif randomisé évaluant l’efficacité d’une vaccination BCG dans la prévention du COVID 19 via le renforcement de l’immunité innée chez le personnel soignant
    A.3.2Name or abbreviated title of the trial where available
    COVID BCG
    COVID BCG
    A.4.1Sponsor's protocol code numberAPHP200462
    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
    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 supportMinistère de la Santé
    B.4.2CountryFrance
    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 pointmoufida.dabbech@aphp.fr
    B.5.3 Address:
    B.5.3.1Street Address1 avenue Claude Vellefaux, Hopital Saint Louis
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number3301 44 84 17 37
    B.5.5Fax number3301 44 84 17 01
    B.5.6E-mailmoufida.dabbech@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 Yes
    D.2.1.1.1Trade name VACCIN BCG AJVaccines
    D.2.1.1.2Name of the Marketing Authorisation holderAJVACCINES
    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 nameVACCIN BCG AJVaccines
    D.3.4Pharmaceutical form Powder and solvent for dispersion for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameBCG VACCINE, FREEZE-DRIED
    D.3.9.4EV Substance CodeSUB11734MIG
    D.3.10 Strength
    D.3.10.1Concentration unit CFU/ml colony forming unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2 to 8
    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) 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) Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntradermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COVID 19
    Health care workers (medical or non-medical) in French hospitals in direct contact with COVID-19 patients, including nurses, medical doctors and other personnel working in wards in charge of COVID-19 patients (emergency, intensive care units, infectious diseases, pneumology, geriatrics …).
    Personnel soignant (médical ou non médical) des hôpitaux de France en contact direct avec les patients COVID-19, incluant des aide soignants, infirmières/infirmiers, médecins, étudiants en santé et autres personnes travaillant dans les services prenant en charge ces patients (urgence, réanimation, soins intensifs, maladies infectieuses, pneumologie, gériatrie……) accueillant des patients COVID-19.
    E.1.1.1Medical condition in easily understood language
    COVID19
    COVID19
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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
    To evaluate among health care workers exposed to SARS CoV2 protection mediated by BCG against documented COVID-19.
    Evaluer chez des personnels de santé exposés au SARS CoV-2 la protection conférée par une revaccination BCG contre le COVID-19 documentée.
    E.2.2Secondary objectives of the trial
    - To evaluate protection mediated by BCG revaccination against :
    a. Severe forms of COVID-19
    b. Asymptomatic forms of SARS CoV2 infection
    c. Respiratory infections
    d. Absenteeism.
    - To evaluate safety of BCG revaccination among health care workers.
    - To evaluate the impact of COVID-19 on innate immunity in the context of BCG revaccination versus controls.
    - Evaluer la protection conférée par la revaccination BCG sur :
    a. les formes sévères de COVID -19
    b. les formes asymptomatiques d’infection à SARS COV-2
    c. les infections respiratoires
    d. l’absentéisme des personnels de santé
    - Evaluer la sécurité de la revaccination BCG parmi le personnel soignants
    - Evaluer l’impact du COVID-19 sur l’immunité innée dans le contexte de revaccination BCG vs contrôles.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A nested study will be carried out on blood samples of 72 study subjects in order to evaluate the impact of COVID-19 on innate immunity. These blood samples will be collected at M6 among 6 groups, each containing 12 study subjects:
    - One group of subjects vaccinated with BCG that have remained sero-negative for SARS CoV2
    - One group of subjects having received placebo that have remained sero-negative for SARS CoV2
    - One group of symptomatic subjects vaccinated with BCG
    - One group of symptomatic subjects having received placebo.
    - One group without symptoms but sero-positive for SARS CoV2 vaccinated with BCG
    - One group without symptoms but sero-positive for SARS CoV2 vaccinated with placebo
    Une sous étude de prélèvements sanguins sera réalisée sur 72 sujets pour évaluer l’impact du COVID-19 sur l’immunité innée. Ces prélèvements seront effectués dans 6 groupes de 12 sujets chacun:
    - 1 groupe vacciné avec le BCG et qui est resté séronégatifs au SRAS-CoV-2
    - 1 groupe ayant reçu le placebo et qui est resté séronégatifs au SRAS-CoV-2
    - 1 groupe symptomatique vacciné avec le BCG
    - 1 groupe symptomatique vacciné avec le placebo
    - 1 groupe sans symptômes mais séro-positif au SARS CoV-2 vacciné avec le BCG
    - 1 groupe sans symptômes mais séro-positif au SARS CoV-2 ayant reçu le placebo
    E.3Principal inclusion criteria
    -Individual (Male and female) aged 18 or over.
    -Healthcare Worker (medical or non-medical) from hospitals in direct -contact with COVID-19 patients.
    -Participants must give their written consent before any trial procedure.
    -Participants covered by social security regimen (excepting AME).
    -Healthy according to the opinion of the investigator.
    1. Homme ou femme âgé(e) de 18 ans ou plus
    2. Personnel soignant (médical ou non médical) en contact direct avec les patients COVID-19
    3. Ayant donné leur consentement écrit avant toute procédure d'essai.
    4. Couverture par un régime de sécurité sociale ou équivalent.
    5. En bonne santé selon l’opinion de l’investigateur
    E.4Principal exclusion criteria
    -Has any BCG vaccine contraindication, known allergy to the BCG vaccine or SAE to prior BCG vaccination.
    -History of tuberculosis
    -People with acquired or innate immunodeficiency.
    -People have already been infected with SARS Cov-2 (virological documentation or TDM or seropositive if serology available).
    -People who could not commit to follow-up for 6 months.
    -People not in good general condition, as assessed by the investigator.
    -People included in other therapeutic clinical trials assessing treatment
    -Pregnant or breastfeeding at enrolment visit.
    -BCG vaccine given within the last year.
    -Another live vaccine administered in the month prior to randomization.
    -History of anaphylaxis following vaccination.
    -Receiving medical treatment that affects the immune response or other immunosuppressive therapy in the last year. These therapies include systemic corticosteroids (more than or equal to 10 mg for more than or equal to 2 weeks), immunosuppressant, biological agents (such as monoclonal antibodies against tumour necrosis factor (TNF)-alpha).
    -Another vaccine administered in the month prior to inclusion and randomization.
    - Fever > 38°C within the past 24 hours
    - People under legal protection measure (tutorship)
    1. Antécédents de contre-indication au BCG, allergie connue au BCG ou EIG à une vaccination BCG préalable.
    2. ATCD de tuberculose.
    3. Personnes présentant une immuno-déficience acquise ou innée
    4. Personnes ayant déjà été infectées par le SARS Cov-2 (documentation virologique ou TDM ou sérologie positive quand la sérologie sera faisable)
    5. Personnes qui ne pourraient pas s’engager sur le suivi de 6 mois
    6. Personnes n’étant pas en bonne condition générale, jugé par l’investigateur
    7. Personnes incluses dans d’autres essais cliniques évaluant des traitements
    8. Grossesse, allaitement ou test de grossesse positif le jour de l'inclusion.
    9. Vacciné avec le BCG dans l’année précédente
    10. Vacciné avec un autre vaccin vivant dans le mois avant la randomisation
    11. Antécédents d'anaphylaxie après une vaccination.
    12. Ayant reçu un traitement médical qui affecte la réponse immune ou autre thérapie immunosuppressive dans l’année précédente. Ces thérapies incluent des corticostéroïdes systémiques (supérieurs ou égaux à 10 mg pendant 2 semaines ou plus), des immunosuppresseurs, des agents biologiques (tels que des anticorps monoclonaux contre le facteur de nécrose tumorale (TNF) -alpha).
    13. Ayant reçu un autre vaccin dans les 4 semaines précédentes
    14. Fièvre> 38 ° C au cours des dernières 24 heures.
    15. Personne sous mesure de protection juridique (tutelle)
    E.5 End points
    E.5.1Primary end point(s)
    Documented COVID-19, i.e.
    - symptomatic COVID-19 confirmed by either positive nasopharyngeal tests for SARS CoV2 and/or by thoracic tomodensitometry compatible with the diagnosis.
    - and/or SARS CoV2 seroconversion during the study period of 6 months.
    Proportion des participants ayant un diagnostic de COVID 19 cliniquement symptomatique et confirmé par prélèvement nasopharyngé positif pour le SARS Cov-2 et/ou un prélèvement sanguin positif et /ou un TDM thorax compatible avec le diagnostic et/ou une séroconversion SARS Cov-2 durant la période de suivi de 6 mois.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 mois
    E.5.2Secondary end point(s)
    -participants having developed a severe form of COVID-19, as defined by the necessity for hospitalization in ICU and O2 or artificial ventilation, or extracorporeal membrane oxygenation, or death;
    -Participants with seroconversion during the study, without symptoms related to COVID-19
    -participants presenting any kind of respiratory infection due to any cause;
    -local and general events following BCG revaccination up to 30 days after BCG revaccination
    -Numbers of sick days and number of sick leaves
    -Identify and measure potentially modified markers of innate immunity upon SARS CoV2 infection by comparing BCG vaccinated and non-vaccinated controls.
    - Proportion des participants ayant une forme sévère de COVID-19 définie par la nécessite d’une hospitalisation en réanimation avec recours à l’O2 ou ventilation artificielle ou ECMO ou le décès ;
    - Participants avec séroconversion au cours de l'étude, sans symptômes liés à COVID-19
    - Proportion des participants ayant présenté une infection respiratoire toutes causes confondues ;
    - Proportion des effets locaux et généraux survenus dans les 30 jours suivant la revaccination par le BCG ;
    - Nombre de jours d’arrêts de travail dans les deux groupes.
    - Identifier et mesurer les marqueurs modifiés de l’immunité innée
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months
    6 mois
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    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 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 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 months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    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.1.3Elderly (>=65 years) Yes
    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 Yes
    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 state1120
    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 Decision2020-04-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-28
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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