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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:2020-001768-27
    Sponsor's Protocol Code Number:P20/07
    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:2020-04-16
    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 number2020-001768-27
    A.3Full title of the trial
    "STUDY OF THE EFFICIENCY OF NORMAL HUMAN IMMUNOGLOBULINS (IVIG) IN PATIENTS AGED 75 YEARS AND OVER COVID-19 WITH SEVERE ACUTE RESPIRATORY FAILURE" GERONIMO 19
    « ETUDE DE L’EFFICACITE DES IMMUNOGLOBULINES HUMAINES NORMALES (IGIV) CHEZ LES PATIENTS AGES DE 75 ANS ET PLUS COVID-19 PRESENTANT UNE INSUFFISANCE RESPIRATOIRE AIGUE SEVERE » GERONIMO 19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    "STUDY OF THE EFFICIENCY OF NORMAL HUMAN IMMUNOGLOBULINS (IVIG) IN PATIENTS AGED 75 YEARS AND OVER COVID-19 WITH SEVERE ACUTE RESPIRATORY FAILURE" GERONIMO 19
    « ETUDE DE L’EFFICACITE DES IMMUNOGLOBULINES HUMAINES NORMALES (IGIV) CHEZ LES PATIENTS AGES DE 75 ANS ET PLUS COVID-19 PRESENTANT UNE INSUFFISANCE RESPIRATOIRE AIGUE SEVERE » GERONIMO 19
    A.3.2Name or abbreviated title of the trial where available
    GERONIMO19
    A.4.1Sponsor's protocol code numberP20/07
    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 SponsorCH Versailles
    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 supportCH de Versailles
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCH de Versailles
    B.5.2Functional name of contact pointMélody FORT
    B.5.3 Address:
    B.5.3.1Street Address177 rue de Versailles
    B.5.3.2Town/ cityLE CHESNAY
    B.5.3.4CountryFrance
    B.5.4Telephone number+330139239776
    B.5.5Fax number+330139239773
    B.5.6E-mailmfort@ch-versailles.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 Immunoglobulines Humaines Normales
    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.3.4Pharmaceutical form Solution for injection/infusion
    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 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
    Patients aged 75 years and older with confirmed infection Covid19 and saturation SaO2≤ under 95% O2> 5 L / min disqualified from a care in the ICU
    Patients âgés de 75 ans et plus présentant une infection à Covid19 confirmée et une saturation SaO2≤ 95 % sous O2 > 5 L/min récusés pour une prise en charge en réanimation
    E.1.1.1Medical condition in easily understood language
    Patients aged 75 years and older with confirmed infection Covid19 and saturation SaO2≤ under 95% O2> 5 L / min disqualified from a care in the ICU
    Patients âgés de 75 ans et plus présentant une infection à Covid19 confirmée et une saturation SaO2≤ 95 % sous O2 > 5 L/min récusés pour une prise en charge en réanimation
    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
    Evaluation of the efficacy of polyvalent IVIg in combination with the standard management of patients aged 75 and over with SARSCov2 infection with acute respiratory failure (saturation ≤ 95%) requiring oxygen therapy> 5 L / min (i.e. patients considered as moderate to severe ARDS according to the Berlin definition, Pa02 / Fi02≤200)
    and disqualified from a care in the ICU.
    Evaluation de l’efficacité des IgIV polyvalentes en association avec la prise en charge standard des patients de 75 ans et plus présentant une infection à SARSCov2 avec une insuffisance respiratoire aigüe (saturation ≤ 95 %) nécessitant une oxygénothérapie > 5 L/min (soit des patients considérés en SDRA modéré à sévère selon la définition de Berlin, Pa02/Fi02≤200)
    et récusés d’une prise en charge en réanimation.
    E.2.2Secondary objectives of the trial
    Evaluate the consequences of treatment with immunoglobulins on
    - The length of hospital stay
    - The duration of oxygen therapy (oxygen dependence)
    - The evolution of the parameters of inflammation
    - Lung function and overall physical condition at 3 and 6 months
    - The quality of life at 3 and 6 months
    - The rate of death and re-hospitalization at 3 and 6 months
    Evaluer les conséquences du traitement par immunoglobulines sur
    - La durée d’hospitalisation
    - La durée d’oxygénothérapie (oxygéno-dépendance)
    - L’évolution des paramètres de l’inflammation
    - La fonction pulmonaire et l’état physique global à 3 et 6 mois
    - La qualité de vie à 3 et 6 mois
    - Le taux de décès et de ré-hospitalisation à 3 et 6 mois
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Man or woman aged 75 and over
    - SARS-coV2 infection confirmed by RT-PCR or thoraco-pulmonary CT
    - Hospitalized in the acute general geriatrics unit of the Versailles Hospital Center
    - Patient rejected from resuscitation
    - Saturation ≤ 95% under oxygen therapy> 5 L / min (i.e. PaO2 / FiO2≤200mmHg according to the Berlin definition of ARDS) by means of a nasal cannula, a high concentration facial mask or another device similar oxygen distribution
    - Homme ou femme de 75 ans et plus
    - Infection par le SARS-coV2 confirmée par RT-PCR ou par TDM thoraco-pulmonaire
    - Hospitalisé dans l’unité de gériatrie aigue polyvalente du Centre Hospitalier de Versailles
    - Patient récusé d’une prise en charge en réanimation
    - Saturation ≤ 95 % sous oxygénothérapie > 5 L/min (soit une PaO2/FiO2≤200mmHg selon la définition de Berlin du SDRA) au moyen d’une canule nasale, d’un masque facial haute concentration ou d’un autre dispositif de distribution d’oxygène similaire
    E.4Principal exclusion criteria
    - Patient under palliative care
    - Patient with contraindication to IV polyvalent Ig
    at. Hypersensitivity to the active substance or to any of the excipients (L-proline)
    b. Hypersensitivity to human immunoglobulins, especially when the patient has anti-IgA antibodies,
    vs. Patients with type I or II hyperprolinemia

    - Patient under guardianship or curatorship
    - Patient receiving another experimental treatment as part of an interventional study
    - Moderate to severe dementia known: it must have been diagnosed before hospitalization and is defined by an MMSE <20/30 or a neuropsychological assessment with a diagnosis made.
    - Patient not affiliated with a social security system in France
    - ADL patients <4/6 and / or IADL <6/8
    - Patient en situation de prise en charge palliative
    - Patient présentant une contre-indication aux Ig polyvalente IV
    a. Hypersensibilité à la substance active ou à l’un des excipients (L-proline)
    b. Hypersensibilité aux immunoglobulines humaines, particulièrement lorsque le patient présente des anticorps anti-IgA,
    c. Patients souffrant d’hyperprolinémie de type I ou II

    - Patient sous tutelle ou curatelle
    - Patient recevant un autre traitement expérimental dans le cadre d’une étude interventionnelle
    - Démence modérée à sévère connue : elle doit avoir été diagnostiquée avant l’hospitalisation et est définie par un MMSE<20/30 ou un bilan neuropsychologique avec un diagnostic posé.
    - Patient non affilié à un système de sécurité sociale en France
    - Patients ADL<4/6 et / ou IADL<6/8
    E.5 End points
    E.5.1Primary end point(s)
    Mortality
    Mortalité
    E.5.1.1Timepoint(s) of evaluation of this end point
    On D14 of treatment D1
    E.5.2Secondary end point(s)
    - Total number of days of full hospitalization,
    - Duration of oxygen therapy
    - Ferritin, CRP, LDH, lymphocyte, PNN, and platelet levels in the blood
    - WHO performance index, WHOQOL-OLD questionnaire at 3 and 6 months
    - Lung function by pulmonary computed tomography and EFR at 3 and 6 months
    - Mortality and re-hospitalization rates at 3 months and 6 months
    - Nombre total de jours d’hospitalisation complète,
    - Durée de l’oxygénothérapie
    - Taux de ferritine, CRP, LDH, taux de lymphocytes, PNN, et plaquettes dans le sang
    - Indice de performance OMS, questionnaire WHOQOL-OLD à 3 et 6 mois
    - Fonction pulmonaire par tomodensitométrie pulmonaire et EFR à 3 et 6 mois
    - Taux de mortalité et de Ré-hospitalisation à 3 mois et 6 mois
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 and 6 months
    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 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 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.8.5The 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
    last visit last patient
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months8
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 39
    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 No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state39
    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
    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 Decision2020-04-16
    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 StatusCompleted
    P.Date of the global end of the trial2021-11-05
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