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    Summary
    EudraCT Number:2020-001188-96
    Sponsor's Protocol Code Number:20PH061
    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:2020-03-24
    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 number2020-001188-96
    A.3Full title of the trial
    Chemoprophylaxis of SARS-CoV-2 infection (COVID-19) in exposed healthcare workers: a randomized double-blind placebo-controlled clinical trial
    Essai de chimioprophylaxie de l’infection à SARS-CoV-2 (COVID-19) chez les soignants exposés : essai multicentrique randomisé contrôle versus placebo en double aveugle.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Chemoprophylaxis of SARS-CoV-2 infection (COVID-19) in exposed healthcare workers: a randomized double-blind placebo-controlled clinical trial
    Essai de chimioprophylaxie de l’infection à SARS-CoV-2 (COVID-19) chez les soignants exposés : essai multicentrique randomisé contrôle versus placebo en double aveugle.
    A.3.2Name or abbreviated title of the trial where available
    COVIDAXIS
    COVIDAXIS
    A.4.1Sponsor's protocol code number20PH061
    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 organisationCHU 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)477120286
    B.5.5Fax number33(0)477127820
    B.5.6E-mailarnauld.garcin@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 Lopinavir/Ritonavir
    D.2.1.1.2Name of the Marketing Authorisation holderMYLAN
    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 nameLopinavir/Ritonavir
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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.IMP: 2
    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 namehydroxychloroquine
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Healthcare workers
    Soignant
    E.1.1.1Medical condition in easily understood language
    Healthcare workers
    Soignants
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10008434
    E.1.2Term Chemoprophylaxis NOS
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10061986
    E.1.2Term SARS
    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 explore whether a 2-month treatment with either LPV/r or hydroxychloroquine may reduce the incidence of symptomatic or asymptomatic infection by SARS-CoV-2, as compared to their placebo in healthcare workers exposed to SARS-CoV-2.
    Déterminer si un traitement de deux mois par LPV/r ou hydroxychloroquine peut réduire l'incidence de l'infection symptomatique ou asymptomatique par le SARS-CoV-2, par rapport au placebo chez les soignants exposés au SARS-CoV-2.
    E.2.2Secondary objectives of the trial
    1. To evaluate the occurrence of adverse events in each arm,
    2. To evaluate the discontinuation rates of the investigational drug in each arm,
    3. To evaluate the adherence of participants to study drug,
    4. To evaluate the incidence of symptomatic cases of SARS-CoV-2 infection in each arm,
    5. To evaluate the incidence of asymptomatic cases of SARS-CoV-2 infection in each arm, at to 2,5 months after randomization,
    6. To evaluate the incidence of severe cases of SARS-CoV-2 infection in each arm.
    1. Évaluer l'occurrence des événements indésirables dans chaque bras,
    2. Évaluer les taux d'abandon du médicament expérimental dans chaque bras,
    3. Évaluer l'adhésion des participants à l'étude du médicament,
    4. Évaluer l'incidence des cas symptomatiques d'infection par le SARS-CoV-2 dans chaque bras,
    5. Évaluer l'incidence des cas asymptomatiques d'infection par le SARS-CoV-2 dans chaque bras, 2,5 mois après la randomisation,
    6. Évaluer l'incidence des cas graves d'infection par le SARS-CoV-2 dans chaque bras.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult Healthcare workers (HCWs) (physicians, nurses, assistant nurses, dentists, physiotherapists, and midwives)
    - HCWs involved at the time of enrolment in the care of patients with confirmed or suspected SARS-CoV-2 infection in hospital settings in outpatient care settings or in geriatric long-term care facilities
    - HCWs tested negative for HIV
    - HCW affiliated to the French health insurance system
    - HCW women of childbearing age with an effective contraception (ethinylestradiol-containing contraceptive pills are not regarded as effective in the context of LPV/r treatment)
    - Willing to comply to study design and the follow-up
    - Soignant adultes (médecins, infirmières, infirmières auxiliaires, dentistes, physiothérapeutes et sages-femmes)
    - Les soignants impliqués au moment de l'inscription dans la prise en charge des patients atteints d'une infection confirmée ou suspectée par le SRAS-CoV-2 en milieu hospitalier, en milieu de soins ambulatoires ou dans des établissements de soins de longue durée gériatriques
    - Test de dépistage du VIH négatifs
    - Affilié ou bénéficiaire d’un régime de sécurité sociale
    - Les femmes en âge de procréer ayant une contraception efficace (les pilules contraceptives contenant de l'éthinylestradiol ne sont pas considérées comme efficaces dans le cadre d'un traitement LPV/r)
    - La volonté de se conformer à la conception de l'étude et au suivi
    E.4Principal exclusion criteria
    - HCWs with positive SARS-CoV-2 RT-PCR of nasopharyngeal swab at the inclusion visit.
    - HCW with past history of confirmed SARS-CoV-2 infection
    - HCW with positive SARS-CoV-2 serology at the inclusion visit (if the serology is available at inclusion time, if SARS-CoV-2 serology is not available, it will be a secondary exclusion criteria)
    - HCW with comorbidities such as chronic HCV infection treated by direct antiviral drugs or with hypothyroidism that need hormonal substitution, or retinopathy or known to have hypercholesterolemia hypertriglyceridemia
    - Pregnant HCW
    - Breastfeeding HCW
    - HCW taking comedications known to have interactions with LPV/r according to the official characteristics of the product
    See sessions 4.3 Contraindications and 4.5 Interaction with other medicinal products and other forms of interaction
    Lopinavir and ritonavir are both inhibitors of the P450 isoform CYP3A in vitro. Co-administration of LPV/r and medicinal products primarily metabolised by CYP3A may result in increased plasma concentrations of the other medicinal product, which could increase or prolong its therapeutic and adverse reactions. LPV/r does not inhibit CYP2D6, CYP2C9, CYP2C19, CYP2E1, CYP2B6 or CYP1A2 at clinically relevant concentrations (see section 4.3).
    LPV/r has been shown in vivo to induce its own metabolism and to increase the biotransformation of some medicinal products metabolised by cytochrome P450 enzymes (including CYP2C9 and CYP2C19) and by glucuronidation. This may result in lowered plasma concentrations and potential decrease of efficacy of co-administered medicinal products
    - HCW taking comedications known to have interactions with hydroxychloroquine according to the official characteristics of the product
    - Soignants avec un résultat positif à la RT-PCR du SRAS-CoV-2 de l'écouvillon nasopharyngé lors de la visite d’inclusion.
    - Soignants ayant des antécédents d'infection confirmée par le SRAS-CoV-2
    - Soignants avec une sérologie SRAS-CoV-2 positive lors de la visite d’inclusion (si la sérologie est disponible au moment de l'inclusion, si la sérologie SRAS-CoV-2 n'est pas disponible, elle constituera un critère d'exclusion secondaire)
    - Soignants avec des comorbidités telles qu'une infection chronique par le VHC traitée par des médicaments antiviraux directs ou une hypothyroïdie nécessitant une substitution hormonale, ou de rétinopathie ou connu pour avoir une hypercholestérolémie ou une hypertriglycéridémie
    - Femme enceinte
    - Femme en cours d'allaitement maternel
    - Soignants prenant des co médicaments connus pour avoir des interactions avec le LPV/r selon les caractéristiques officielles du produit
    - Les soignants prenant des co médicaments connus pour avoir des interactions avec l'hydroxychloroquine selon les caractéristiques officielles du produit
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the occurrence of an symptomatic or asymptomatic SARS-CoV-2 infection among healthcare workers (HCWs)
    An infection by SARS-CoV-2 is defined by either:
    • a positive specific RT-PCR on periodic systematic nasopharyngeal swab during follow-up
    OR
    • a positive specific RT-PCR on a respiratory sample in case of onset of symptoms consistent with COVID-19 during follow-up
    OR
    • a seroconversion to SARS-CoV-2 after randomization.
    Le principal critère d'évaluation est l'apparition d'une infection symptomatique ou asymptomatique par le SARS-CoV-2 chez les soignants exposés.
    Une infection par le SRAS-CoV-2 est définie par l'un ou l'autre :
    - une RT-PCR spécifique positive sur un prélèvement nasopharyngé périodique et systématique lors du suivi
    OU
    - une RT-PCR spécifique positive sur un échantillon respiratoire en cas d'apparition de symptômes compatibles avec le COVID-19 au cours du suivi
    OU
    - une séroconversion au SRAS-CoV-2 après randomisation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day: 7, 14, 21, 28, 35, 42, 49, 57, 71 after the start of the drug
    Jour: 7, 14, 21, 28, 35, 42, 49, 57, 71 après le début du traitement
    E.5.2Secondary end point(s)
    1. Number of adverse events expected or unexpected, related and unrelated to the treatment, notably grades 2, 3 and 4 (moderate, severe and lifethreatening, according to the Adverse National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0) in each arm.
    2. Number of treatment discontinuations in each arm
    3. Treatment adherence rate, which will be assessed by:
    • measurement of LPV and HCQ plasma concentrations using LC-MS/MS or LC-Fluorimetric detection
    • the count of returned drugs at each visit.
    4. Number of incident cases of symptomatic SARS-CoV-2 infections among HCWs in each arm. Symptomatic infection is defined as :
    • a positive specific RT-PCR on a respiratory or non respiratory sample
    OR
    • a thoracic CT scan with imaging abnormalities consistent with COVID-19.
    These investigations being performed in case of signs/symptoms consistent with COVID-19 during follow-up.
    5. Number of incident cases of asymptomatic SARS-CoV-2 infection among HCWs in each randomization arm. Asymptomatic infection is defined as :
    • a positive specific RT-PCR on periodic systematic nasopharyngeal swab during clinical follow-up without consistent clinical signs/symptoms during follow-up
    OR
    • a seroconversion to SARS-CoV-2 between start and end of the study in HCWs that did not reported any consistent clinical symptoms during follow-up.
    6. Number of incident cases of severe SARS-CoV-2 infections among HCWs in each randomization arm, defined as :
    • a positive specific RT-PCR on a respiratory sample
    OR
    • a thoracic CT scan with imaging abnormalities consistent with COVID-19 performed in case of onset of symptoms consistent with COVID-19 during follow-up in a participant who need to be hospitalized for respiratory distress. Respiratory distress defined as dyspnea with a respiratory frequency > 30/min, blood oxygen saturation <93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300 and/or lung infiltrates >50 %.
    1. Nombre d'événements indésirables attendus ou inattendus, liés ou non au traitement, notamment les grades 2, 3 et 4 (modérés, graves et mettant la vie en danger, selon les critères communs de terminologie des événements indésirables de l'Institut national du cancer, version 5.0) dans chaque bras.
    2. Nombre d'interruptions de traitement dans chaque bras
    3. Le taux d'adhésion au traitement, qui sera évalué par :
    • la mesure des concentrations plasmatiques de LPV et de HCQ par la méthode LC-MS/MS ou par la LC détection fluorimétrique
    • le décompte des drogues retournées à chaque visite.
    4. Nombre de cas incidents d'infections symptomatiques par le SRAS-CoV-2 parmi les soignants exposés dans chaque bras. L'infection symptomatique est définie comme :
    - une RT-PCR spécifique positive sur un échantillon respiratoire ou non respiratoire
    OU
    - un scanner thoracique avec des anomalies d'imagerie conformes au COVID-19.
    Ces examens sont effectués en cas de signes/symptômes compatibles avec le COVID-19 lors du suivi.
    5. Nombre de cas incidents d'infection asymptomatique par le SRAS-CoV-2 parmi les soignants exposés dans chaque groupe de randomisation. L'infection asymptomatique est définie comme :
    - une RT-PCR spécifique positive sur un prélèvement nasopharyngé systématique périodique au cours du suivi clinique sans signes/symptômes cliniques cohérents au cours du suivi
    OU
    - une séroconversion au SARS-CoV-2 entre le début et la fin de l'étude chez les soignants exposés qui n'ont pas signalé de symptômes cliniques constants pendant le suivi.
    6. Nombre de cas incidents d'infections graves par le SARS-CoV-2 parmi les soignants dans chaque groupe de randomisation, défini comme :
    - une RT-PCR spécifique positive sur un échantillon respiratoire
    OU
    - un scanner thoracique avec des anomalies d'imagerie conformes au COVID-19 effectué en cas d'apparition de symptômes conformes au COVID-19 lors du suivi d'un patient qui doit être hospitalisé pour détresse respiratoire. La détresse respiratoire est définie comme une dyspnée avec une fréquence respiratoire > 30/min, une saturation en oxygène du sang <93 %, une pression partielle de l'oxygène artériel par rapport à la fraction d'oxygène inspiré <300 et/ou des infiltrations pulmonaires >50 %.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day: 7, 14, 21, 28, 35, 42, 49, 57, 71 after the start of the drug
    Jour: 7, 14, 21, 28, 35, 42, 49, 57, 71 après le début du traitement
    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 No
    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 No
    E.8.1.4Double blind Yes
    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 trial4
    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 concerned14
    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
    The end of the trial is different from the anticipated last visit of the last participant, in order to performed all the centralized analyses and to complete all the statistical analyses.
    La fin de l'essai est différente de la dernière visite prévue du dernier participant, afin d'effectuer toutes les analyses centralisées et de compléter toutes les analyses statistiques.
    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 months8
    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: 1200
    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 Yes
    F.3.2Patients No
    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 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state1200
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-07
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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