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    Summary
    EudraCT Number:2020-001281-11
    Sponsor's Protocol Code Number:20CH065
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-03-26
    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 number2020-001281-11
    A.3Full title of the trial
    Evaluation of the concentration/viral effect relationship of hydroxychloroquine in COVID-19 patients in the intensive care unit.
    Évaluation de la relation concentration effet Virologique de l’HYdrOXychloroquine chez les patients COVID-19 en Réanimation
    Étude multicentrique
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the concentration/viral effect relationship of hydroxychloroquine in COVID-19 patients in the intensive care unit..
    Évaluation de la relation concentration effet virologique de l’hydroxychloroquine chez les patients infectés par SARS-CoV-2 en Réanimation
    A.4.1Sponsor's protocol code number20CH065
    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 SponsorCHU de Saint Etienne
    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 supportCHU de Saint Etienne
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationURCIP- CHU Saint Etienne
    B.5.2Functional name of contact pointproject manager
    B.5.3 Address:
    B.5.3.1Street AddressURCIP - Batiment Recherche - Hôpital Nord
    B.5.3.2Town/ citySAINT ETIENNE CEDEX 2
    B.5.3.3Post code42055
    B.5.3.4CountryFrance
    B.5.4Telephone number33(0)477120469
    B.5.5Fax number33(0)477127820
    B.5.6E-mailcarine.labruyere@chu-st-etienne.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 Plaquenil
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS FRANCE
    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 nameSulfate d'hydroxychloroquine
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 747-36-4
    D.3.9.3Other descriptive nameHYDROXYCHLOROQUINE SULFATE
    D.3.9.4EV Substance CodeSUB02587MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number400 to 800
    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
    covid-19
    covid-19
    E.1.1.1Medical condition in easily understood language
    covid 19
    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 10070267
    E.1.2Term SARS virus test positive
    E.1.2System Organ Class 100000004848
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10022519
    E.1.2Term Intensive care
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to describe the pharmacokinetics of hydroxychloroquine in resuscitation patients infected with SARS-CoV-2.
    décrire la pharmacocinétique de l’hydroxychloroquine chez les patients infectés par SARS-CoV-2 en réanimation.
    E.2.2Secondary objectives of the trial
    - Describe the relationship between HCQ concentration and cardiac toxicity.
    - To describe the pharmacokinetic (concentration) and pharmacodynamic (viral load) relationship of hydroxychloroquine in resuscitation patients infected with SARS-CoV-2.
    - To define the best modalities of administration of hydroxychloroquine in resuscitation patients infected with SARS-CoV-2 based on the PK/PD relationship.
    - Décrire la relation concentration HCQ et toxicité cardiaque
    - Décrire la relation pharmacocinétique (concentration) et pharmacodynamique (charge virale) de l’hydroxychloroquine chez les patients infectés par SARS-CoV-2 en réanimation.
    - Définir à partir de la relation PK/PD les meilleures modalités d’administration de l’hydroxychloroquine des patients infectés par SARS-CoV-2 en réanimation.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients hospitalized in the intensive care unit infected with SARS-CoV-2, for whom a diagnosis of respiratory SARS-CoV-2 infection was made by nasopharyngeal swab or deep respiratory sampling.
    - Patient receiving Hydroxychloroquine treatment
    - Patients hospitalisés dans les services de réanimation infectés par SARS-CoV-2, pour lesquels un diagnostic d’infection respiratoire à SARS-CoV-2 a été fait un écouvillon nasopharyngé ou un prélèvement respiratoire profond.
    - Patient recevant un traitement par hydroxychloroquine
    E.4Principal exclusion criteria
    - Hypersensitivity to the active substances or to any of the following excipients: lactose monohydrate, povidone, corn starch, magnesium stearate.
    - Retinopathies
    - Combination with citalopram, escitalopram, hydroxyzine, domperidone and piperazine due to increased risk of ventricular rhythm disturbances, including torsades de pointes.
    - Patient with known QT prolongation
    - Known deficit in G6PD
    - Hypersensibilité aux substances actives ou à l’un des excipients suivants : lactose monohydraté, povidone, amidon de maïs, stéarate de magnésium.
    - Rétinopathies
    - Association au citalopram, l’escitalopram, l'hydroxyzine, la dompéridone et la pipéraquine en raison du risque majoré de troubles du rythme ventriculaire, notamment de torsades de pointe
    - Patient avec un allongement connu du QT
    - Déficit connu en G6PD
    E.5 End points
    E.5.1Primary end point(s)
    determination of the blood concentration of hydroxychloroquine by liquid chromatography coupled with mass spectrometry.
    Mesure de la concentration sanguine d’hydroxychloroquine par chromatographie liquide couplée à la spectrométrie de masse.
    E.5.1.1Timepoint(s) of evaluation of this end point
    daily for 10 days
    tous les jours pendants 10 jours
    E.5.2Secondary end point(s)
    - QT measurement by ECG monitoring
    - Viral load measurement by SARS-Cov-2 specific RT PCR
    - Simulations from the PK/PD model
    - Mesure du QT par monitoring ECG
    - Mesure de la charge virale par RT PCR spécifique SARS-Cov-2
    - Simulations à partir du modèle PK/PD
    E.5.2.1Timepoint(s) of evaluation of this end point
    daily for 10 days
    tous les jours pendant 10 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 No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned12
    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
    Last visit last patient
    la dernière visite du dernier patient inclus
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months4
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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
    Upon admission to intensive care, patients will not be able to give consent. Consent will be obtained on discharge or as soon as the patient is able to give it.
    A leur admission en réanimation, les patients ne seront pas en mesure de donner leur consentement. Le consentement sera recueilli à la sortie du patient en réanimation ou dès qu’il sera en mesure de le donner.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    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 Decision2020-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-04-28
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