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    Summary
    EudraCT Number:2020-001570-30
    Sponsor's Protocol Code Number:D20-P013
    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:2020-04-06
    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 number2020-001570-30
    A.3Full title of the trial
    Interest of early treatment with polyvalent immunoglobulins in the management of respiratory distress syndrome associated with SARS-CoV-2 infections_COVID-19
    Intérêt d’un traitement précoce par immunoglobulines polyvalentes dans la prise en charge du syndrome de détresse respiratoire associé aux infections par SARS-CoV-2_COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ICAR (IgIV in Covid-related ARds)
    ICAR (IgIV in Covid-related ARds)
    A.3.2Name or abbreviated title of the trial where available
    ICAR (IgIV in Covid-related ARds)
    ICAR (IgIV in Covid-related ARds)
    A.4.1Sponsor's protocol code numberD20-P013
    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 SponsorGHU PARIS PSYCHIATRIE ET NEUROSCIENCES
    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 supportMINISTERE SANTE
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGHU PARIS PSYCHIATRIE ET NEUROSCIENCES
    B.5.2Functional name of contact pointAWASSI
    B.5.3 Address:
    B.5.3.1Street Address1 RUE CABANIS
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75104
    B.5.3.4CountryFrance
    B.5.4Telephone number33145657401
    B.5.5Fax number33145 65 76 09
    B.5.6E-mailv.awassi@ghu-paris.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 Clairyg 50mg/ml, Solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderLFB BIOMEDICAMENTS
    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 nameClairyg 50mg/ml, Solution for infusion
    D.3.2Product code J06BA02
    D.3.4Pharmaceutical form 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 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) No
    D.3.11.7Plasma derived medicinal product Yes
    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 placeboInfusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cov-2 SARS Disease
    Maladie du Covid-19
    E.1.1.1Medical condition in easily understood language
    Associated respiratory Distress syndrome with Cov-2 SARS
    Syndrome de détresse respiratyoire aigu lié à l'infection au Covid-19
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    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 determine if the administration of IVIG at a dose of 2 g / kg over 4 consecutive days (i.e. 0.5 g / Kg / D) started during the first 24 to 120 hours of invasive mechanical ventilation (VM) of a patient suffering from d 'A post-SARS-CoV-2 ARDS improves the number of days living without VM on D28.
    déterminer si l’administration d’IgIV à la dose de 2g/kg sur 4 jours consécutifs (soit 0.5g/Kg/J) débutée au cours des 24 à 120 premières heures de ventilation mécanique invasive (VM) d’un patient atteint d’un SDRA post-SARS-CoV-2 permet d’améliorer le nombre de jours vivant sans VM à J28.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess the impact of IVIg on mortality, organ failure, complications of resuscitation and the functional and psychological sequelae at D28 as well as their side effects.
    Les objectifs secondaires sont d’évaluer l’impact des IgIV sur la mortalité, les défaillances d’organe, les complications de la réanimation et les séquelles fonctionnelles et psychologiques à J28 ainsi que leurs effets secondaires.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) VM (mechanical ventilation) invasive for less than 36 hours
    2) ARDS meeting the Berlin criteria (Ref)
    3) SARS-CoV-2 infection proven by PCR
    4) Consent of the patient, a relative or relative or deferred (emergency clause).
    1) VM (ventilation mécanique) invasive depuis moins de 36 heures
    2) SDRA répondant aux critères de Berlin (Ref)
    3) Infection à SARS-CoV-2 prouvée par une PCR
    4) Consentement du patient, d’un proche ou parent ou différé (clause d’urgence).
    E.4Principal exclusion criteria
    - Allergy to polyvalent immunoglobulins.
    - Pregnant woman or minor patient
    - Known IgA deficiency.
    - Patient with renal failure on admission defined by a 3-fold increase in baseline creatinine or serum creatinine> 354 micromol / L or a diuresis of less than 0.3 mL / Kg for 24 hours or anuria for 12 hours.
    - Participation in another interventional trial
    - Allergie aux immunoglobulines polyvalentes.
    - Femme enceinte ou patient mineur
    - Déficit en IgA connu.
    - Patient présentant une insuffisance rénale à l’admission définie par une augmentation de 3 fois de la créatininémie de base ou une créatininémie >354 micromol/L ou une diurèse de moins de 0,3 mL/Kg pendant 24 heures ou une anurie pendant 12 heures.
    - Participation à un autre essai interventionnel
    E.5 End points
    E.5.1Primary end point(s)
    Survival without invasive ventilatory assistance (i.e. ventilator-free days) until D28. The score is calculated by summing the days on which the patient has not had a VM; but in the event of death before D28, the score is zero. The 28-day delay was recommended because the average duration of VM for post-SARS-CoV-2 ARDS patients is 20 days.
    Survie sans assistance ventilatoire invasive (i.e. ventilator-free days) jusqu’à J28. Le score est calculé en faisant la somme des jours où le patient n’a pas bénéficié d’une VM; mais en cas de décès avant J28, le score est de zéro. Le délai de 28 jours a été préconisé du fait que la durée moyenne de VM des patients en SDRA post-SARS-CoV-2 est de 20 jours.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 day delay
    Délai de 28 jours
    E.5.2Secondary end point(s)
    ● Mortality at D28 and D90
    ● Organ failures according to the SOFA score performed on D1, D3 and D7, D14, D21 and D28.
    ● Clinical efficacy criteria: Radiological score, P / F ratio value, pulmonary compliance on D1, D3 and D7, D14, D21 and D28
    ● Biological efficacy criteria: inflammatory syndrome on D1, D3 and D7, D14, D21 and D28: perhaps specify on what: CRP, fibrinognene, d.dimers, dosages of complement C3, C4, CH50, proteinuria of 24 hours
    ● Immunological profile: quantity of CD4 HLA-DR + and CD38 +, CD8 lymphocytes strongly expressing perforin for a subgroup of 10 patients. If a bronchiolo-alveolar lavage, the formula will be studied.
    ● Administration of other treatments (corticosteroids, antiretrovirals, plaquenil)
    ● Occurrence of deep vein thrombosis of a pulmonary embolism detected clinically and proven by a Doppler ultrasound of the lower limbs. Occurrence of pulmonary embolism evidenced by a pulmonary angiogram.
    ● Total duration of mechanical ventilation, ventilatory withdrawal, curarization
    ● KDIGO score and need to resort to extrarenal purification (Annex 2)
    ● Occurrence of an adverse event linked to immunoglobulins (renal insufficiency, hypersensitivity manifestations with skin or hemodynamic manifestations, aseptic meningitis, hemolytic anemia, leuko-neutropenia, post-transfusion respiratory distress syndrome (TRALI)
    ● Occurrence of an NMAR will be evaluated by the MRC sum score on waking (Annex 3).
    ● Onset of pneumonia acquired under mechanical ventilation defined by an evocative radio-clinical context associated with a bacteriological sample by culture of tracheal secretions, bronchiolo-alveolar lavage or a protected distal sample.
    ●Mortalité à J28 et J90
    ●Défaillances d’organe selon le score SOFA réalisé à J1, J3 et J7, J14, J21 et J28.
    ●Critères cliniques d’efficacité : Score radiologique, valeur du rapport P/F, compliance pulmonaire à J1, J3 et J7, J14, J21 et J28
    ●Critères biologiques d’efficacité : syndrome inflammatoire à J1, J3 et J7, J14, J21 et J28 : peut-être préciser sur quoi : CRP, fibrinognène, d.dimers, dosages du complément C3, C4, CH50, protéinurie des 24 heures
    ●Profil immunologique: quantité de lymphocytes CD4 HLA-DR+ et CD38+, CD8 exprimant fortement la perforine pour un sous-groupe de 10 patients. Si un lavage bronchiolo-alvéolaire, la formule en sera étudiée.
    ●Administrations d’autres traitements (corticoïdes, antirétroviraux, plaquenil)
    ●Survenue d’une thrombose veineuse profonde d’une embolie pulmonaire détectée cliniquement et prouvée par une echographie-doppler des membres inférieurs. Survenue d’une embolie pulmonaire mise en évidence par un angioscanner pulmonaire.
    ●Durée totale de ventilation de mécanique, de sevrage ventilatoire, de curarisation
    ●Score KDIGO et nécessité de recourir à une épuration extrarénale (Annexe 2)
    ●Survenue d’un événement indésirable lié aux immunoglobulines (Insuffisance rénale, manifestations d’hypersensibilité avec manifestations cutanés ou hémodynamiques, méningite aseptique, anémie hémolytique, leuco-neutropénie, syndrome de détresse respiratoire post-transfusionnel (TRALI)
    ●Survenue d’une NMAR sera évaluée par le MRC sum score au réveil (Annexe 3).
    ●Survenue d’une pneumopathie acquise sous ventilation mécanique définie par un contexte radio-clinique évocateur associé à un prélèvement bactériologique par mise en culture des sécrétions trachéales, un lavage bronchiolo-alvéolaire ou un prélèvement distal protégé.
    E.5.2.1Timepoint(s) of evaluation of this end point
    J28 and J90
    J28 et J90
    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) 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 No
    E.8.1.4Double blind Yes
    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 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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned17
    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
    yes
    oui
    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 months
    E.8.9.1In the Member State concerned days4
    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: 126
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Intubated patient in reanmation
    Patient intubé en Réa
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state126
    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
    non applicable
    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 Decision2020-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-08
    P. End of Trial
    P.End of Trial StatusOngoing
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