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    Summary
    EudraCT Number:2020-003936-25
    Sponsor's Protocol Code Number:RLX0120
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-11-23
    Trial results View 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-003936-25
    A.3Full title of the trial
    Multicenter, adaptive, randomized, placebo-controlled, double blind, parallel-group Phase 2/3 trial, to study efficacy and safety of two doses of raloxifene in adult paucisymptomatic COVID-19 patients.
    Studio clinico di fase 2/3, multicentrico, adattativo, randomizzato, controllato con placebo, in doppio cieco, a gruppi paralleli, per valutare l’efficacia e la sicurezza di due differenti dosi di raloxifene in pazienti adulti paucisintomatici affetti da COVID-19.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial to study efficacy and safety of two doses of raloxifene in adult paucisymptomatic COVID-19 patients
    Studio clinico per valutare l’efficacia e la sicurezza di due differenti dosi di raloxifene in pazienti adulti paucisintomatici affetti da COVID-19.
    A.3.2Name or abbreviated title of the trial where available
    RLX0120
    RLX0120
    A.4.1Sponsor's protocol code numberRLX0120
    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 SponsorDOMPé FARMACEUTICI S.P.A.
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDompé farmaceutici S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDompé farmaceutici S.p.A.
    B.5.2Functional name of contact pointFlavio Mantelli
    B.5.3 Address:
    B.5.3.1Street AddressVia Santa Lucia, 6
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20122
    B.5.3.4CountryItaly
    B.5.4Telephone number02583831
    B.5.6E-mailFlavio.Mantelli@dompe.com
    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 RALOXIFENE SANDOZ - 60 MG COMPRESSE RIVESTITE CON FILM 14 COMPRESSE IN BLISTER PVC/PE/PVDC/AL
    D.2.1.1.2Name of the Marketing Authorisation holderSANDOZ S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameRaloxifene
    D.3.2Product code [Raloxifene]
    D.3.4Pharmaceutical form Capsule, hard
    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.3.8INN - Proposed INNRALOXIFENE CLORIDRATO
    D.3.9.1CAS number 84449-90-1
    D.3.9.2Current sponsor coderaloxifene cloridrato
    D.3.9.4EV Substance CodeSUB12568MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 placeboCapsule, hard
    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
    Adult paucisymptomatic COVID-19 patients
    Pazienti adulti paucisintomatici affetti da COVID-19
    E.1.1.1Medical condition in easily understood language
    Adult COVID-19 patients with mild symptomps
    Pazienti adulti affetti da COVID-19 con sintomi lievi
    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 HLGT
    E.1.2Classification code 10047438
    E.1.2Term Viral infectious disorders
    E.1.2System Organ Class 10021881 - Infections and infestations
    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 effectiveness of therapy in reducing the proportion of subjects who still have viruses in the upper airways after 7 days of therapy;
    - evaluation of the effectiveness of therapy in reducing the proportion of subjects who requires supplemental oxygen therapy and/or mechanical ventilation within 14 days of starting therapy.
    - valutazione dell’efficacia della terapia nel ridurre la proporzione di soggetti che hanno ancora virus nelle vie aeree superiori dopo 7 giorni di terapia;
    - valutazione dell’efficacia della terapia nel ridurre la proporzione di soggetti che richiedono ossigeno-terapia supplementare e/o ventilazione meccanica entro 14 giorni dall’inizio della terapia.
    E.2.2Secondary objectives of the trial
    - evaluation of the effectiveness of therapy in reducing the proportion of subjects who still have viruses in the upper airways after 14 and 28 days of therapy;
    - evaluation of the effectiveness of therapy in reducing the proportion of subject patients who requires supplemental oxygen therapy and/or mechanical ventilation within 7 or 28 days of starting therapy;
    - 7, 14 and 28 days drug safety and tolerability profile;
    - Assessment of body temperature, blood and biochemical parameters between T0 and T28.
    - valutazione dell’efficacia della terapia nel ridurre la proporzione di soggetti che hanno ancora virus nelle vie aeree superiori dopo 14 e 28 giorni di terapia;
    - valutazione dell’efficacia della terapia nel ridurre la proporzione di soggetti che richiedono ossigeno-terapia supplementare e/o ventilazione meccanica entro 7 o 28 giorni dall’inizio della terapia;
    - profilo di sicurezza e tollerabilità del farmaco a 7, 14 e 28 giorni;
    - valutazione della temperatura corporea, parametri sanguigni e biochimici tra T0 e T28.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject (or legally authorized representative) provides igormed consent prior to initiation of any study procedures;
    2. Males and females >= 50 years old at time of enrolment;
    3. Understands and agrees to comply with planned study procedures, has the availability of an email address as well as an Internet connection at domicile location
    4. Agrees to the collection of nasopharyngeal swabs and venous blood samples per protocol;
    5. Has laboratory-confirmed SARS-CoV-2 infection as determined by an approved molecular test (PCR) in Italy within 7 days of randomization;
    6. Complains since less than 7 days before positive result to swab, at least one of the following symptoms with mild to moderate intensity: fever, dyspnea, headache, cough, dysgeusia, conjunctivitis, vomiting, diarrhea, anosmia, muscle or body aches;
    7. No need of supplemental oxygen therapy, mechanical ventilation;
    8. Females of child-bearing potential and with an active sexual life must not wish to get pregnant within 30 days after the end of the study and must be using at least one of the following reliable methods of contraception:
    a. Systemic, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit until 30 days after final visit
    b. A non-hormonal intrauterine device [IUD] or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit until 30 days after final visit
    c. A male sexual partner who agrees to use a male condom with spermicide
    d. A sterile sexual partner
    Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted. For all female subjects, with child-bearing potential, pregnancy test result must be negative before first drug intake on T7 and T14.
    1. Firma del modulo di consenso informato, da parte del soggetto (o suo rappresentante legale autorizzato) prima di iniziare qualsiasi procedura legata allo studio clinico;
    2. Uomini e donne >= 50 anni al momento dell’arruolamento;
    3. Il soggetto comprende e si impegna a rispettare le procedure di studio previste abbia disponibilità di un indirizzo email nonché di una connessione internet nel luogo di domicilio;
    4. Il soggetto acconsente alla raccolta di tamponi nasofaringei e di campioni sanguigni come previsto dal protocollo di studio;
    5. In laboratorio ha confermato l'infezione da SARS-CoV-2 come determinato da un test molecolare (PCR) approvato in Italia;
    6. Il soggetto lamenta da meno di 7 giorni prima del risultato positivo al tampone, almeno uno dei seguenti sintomi, con intensità da lieve a moderata: febbre, dispnea, mal di testa, tosse, disgeusia, congiuntivite, vomito, diarrea, anosmia, dolori muscolari o corporei.
    7. Il soggetto non necessita di ossigeno-terapia supplementare, ventilazione meccanica;
    8. Donne in età fertile e con vita sessuale attiva non devono desiderare di rimanere incinte entro 30 giorni dalla fine dello studio e devono utilizzare almeno uno dei seguenti metodi affidabili di contraccezione:
    a. Contraccettivi sistemici, impiantabili, transdermici o iniettabili da almeno 2 mesi prima della visita di screening e fino a 30 giorni dopo la visita finale.
    b. Un dispositivo intrauterino al rame [IUD] o preservativo femminile con spermicida o spugna contraccettiva con spermicida o diaframma con spermicida o cappuccio cervicale con spermicida da almeno 2 mesi prima della visita di screening e fino a 30 giorni dopo la visita finale.
    c. Partner di sesso maschile che acconsente all’utilizzo di preservativi con spermicida.
    d. Partner sterile
    Le partecipanti donna non fertili o in stato di menopausa da almeno 1 anno, potranno essere ammesse a partecipare allo studio. Per tutte le partecipanti di sesso femminile in età fertile il test di gravidanza dovrà risultare negativo prima della prima assunzione del farmaco sperimentale, alla visita T7 e T14.
    E.4Principal exclusion criteria
    Patients who meet any of the following criteria are NOT eligible for inclusion in the study.
    1. Being totally asymptomatic for less than 7 days before positive result to swab
    2. Requires supplemental oxygen therapy or mechanical ventilation;
    3. Being already under raloxifene or other SERM treatment for another medical condition at the time of randomization;
    4. Being concurrently involved in another trial or participation in any clinical trial for 1 months before this study. The 1-month interval is calculated as the time between the last visit of the previous study and the first day of the present study (date of the electronic informed consent signature);
    5. Clinically significant abnormal physical findings which could interfere with the objectives of the study;
    6. Diseases:
    a) HIV infection (based on the anamnesis),
    b) history of stroke and/or venous thromboembolism,
    c) known severe renal impairment: Chronic Kidney Disease (CKD) stage 3 or higher (eGFR <60 ml/min/m2), or CKD stage 4 or higher (eGFR <15 ml/min/m2),
    d) known liver injury (Child-Pugh Class A or higher);
    e) signs or symptoms of endometrial cancer;
    f) presence of hypoalbuminemia (albumin < 3.5 g/dL) that may interfere with the aim of the study.
    7. Autoimmune diseases receiving therapy at the time of randomization;
    8. Risk of venous thrombosis or any condition/disease that could bring to an extended period of immobilization;
    9. Ascertained or presumptive hypersensitivity to the active principles (raloxifene) and/or excipients or allergic reactions in general, which the Investigator considers may affect the outcome of the study;
    10. Medications: in particular cholestyramine (or any ion exchange resin), medications used in treatment of early or advanced breast cancer (including adjuvant therapy), warfarin, use of any antiretroviral medication, any drug that cannot be co-administered with the experimental compound.
    11. Pregnancy: positive or missing pregnancy test at screening visit or day 1, pregnant or lactating women;
    12. Women of childbearing potential and fertile men who doesn’t agree to use at least one primary form of contraception for the duration of the study.
    1. Il soggetto è totalmente asintomatico per meno di 7 giorni prima del risultato positivo al tampone;
    2. Il soggetto richiede ossigeno-terapia supplementare o ventilazione meccanica;
    3. Il soggetto al momento della randomizzazione è già in trattamento con raloxifene o altri SERMs per altre condizioni mediche
    4. Il soggetto sta partecipando ad un altro studio clinico o ha partecipato a qualsiasi studio 1 mese prima dell’inizio di questo trial. L’intervallo di 1 mese è calcolato come il tempo che intercorre tra l’ultima visita del precedente studio e il primo giorno del presente studio (data di firma del modulo di consenso informato);
    5. Anormalità all’esame fisico, clinicamente significative, che potrebbero interferire con gli obiettivi dello studio;
    6. Malattie:
    - infezione da HIV (sulla base dell’anamnesi),
    - storia clinica di ictus e/o tromboembolismo venoso,
    - insufficienza renale grave: Malattia Renale Cronica (CKD) stadio 3 o maggiore (eGFR <60 ml/min/m2), o CKD stadio 4 o maggiore (eGFR <15 ml/min/m2),
    - insufficenza epatica (Child-Pugh classe A o maggiore);
    - segni o sintomi di cancro endometriale;
    - presenza di ipoalbuminemia (albumina < 3.5 g/dL) che potrebbe interferire con lo scopo dello studio.
    7. Malattie autoimmuni in terapia al momento della randomizzazione;
    8. Rischio di trombosi venosa o qualsiasi condizione/patologia che potrebbe portare ad estendere il periodo di immobilità;
    9. Ipersensibilità accertata o presunta al principio attivo (raloxifene) e/o agli eccipienti o reazioni allergiche in generale, che lo Sperimentatore ritiene possano influenzare l’esito dello studio;
    10. Farmaci: in particolare colestiramine (o qualsiasi resina a scambio ionico), farmaci utilizzati per il trattamento del cancro al seno, precoce o avanzato (inclusa la terapia adiuvante), warfarin, uso di qualsiasi farmaco antiretrovirale, qualsiasi farmaco che non può esser co-somministrato con il composto sperimentale.
    11. Gravidanza: test di gravidanza positivo o mancante prima della prima assunzione del farmaco sperimentale o al giorno 1, donne gravide o che allattano;
    12. Donne e uomini fertili devono acconsentire all’utilizzo di almeno una delle forme primarie di contraccezione per tutta la durata dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    Virologic outcome. Proportion of participants with undetectable SARS-CoV-2at PCR at day 7 after randomization.
    Clinical outcome. Proportion of participants who not requires supplemental oxygen therapy (NEWS <=2) and/or mechanical ventilation at day 14 after randomization.
    Outcome virologico. Proporzione di partecipanti con infezione da SARS-CoV-2 non rilevabile mediante PCR al giorno 7 dopo la randomizzazione.
    Outcome clinico. Proporzione di partecipanti che non richiedono ossigeno-terapia supplementare (NEWS <=2) e/o ventilazione meccanica al giorno 14 dopo la randomizzazione.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Virologic outcome: at day 7 after randomization.
    Clinical outcome: at day 14 after randomization.
    Outcome virologico: al giorno 7 dopo la randomizzazione.
    Outcome clinico: al giorno 14 dopo la randomizzazione.
    E.5.2Secondary end point(s)
    Proportion of participants with undetectable SARS-CoV-2 at PCR at day 14 after randomization and at day 28 after randomization;; Proportion of participants who doesn't requires supplemental oxygen therapy (NEWS <=2) and/or mechanical ventilation at day 7 and 28 after randomization;; Proportion of patients in each category at time 0, 7, 14 and 28 after randomization;; Mean value of category at time 0,7,14 and 28 after randomization;; Proportion of participants with any adverse event (grade = 2 according to CTCAE) at day 7, 14 and 28 after randomization;; Proportion of participants with severe adverse events (grade = 3 according to CTCAE) at day 7, 14 and 28 after randomization; Proportion of participants admitted to intensive care at day 7, 14 and 28 after randomization;; Proportion of survivors at day 7, 14 and 28 after randomization;; Mean variation of value of the following biomarker parameters, from base line to day 7, 14, 21 and 28 after randomization:
    o Complete blood cell counts;
    o Hepatic function (ALT, AST and bilirubin);
    o Coagulation (PT, aPTT and INR);
    o Other marker including (D-dimer, CPK, LDH).; Quality of life questionnaire 3 months after the randomization.
    Proporzione di partecipanti con infezione da SARS-CoV-2 non rilevabile mediante PCR al giorno 14 dopo la randomizzazione e al giorno 28 dopo la randomizzazione;; Proporzione di partecipanti che non richiedono ossigeno-terapia supplementare (NEWS =<2) e/o ventilazione meccanica ai giorni 7, 28 dopo la randomizzazione;; Proporzione di pazienti in ogni categoria ai tempi 0, 7, 14 e 28 dopo la randomizzazione;; Valore medio della categoria ai tempi 0, 7, 14 e 28 dopo la randomizzazione;; Proporzione di partecipanti con qualsiasi evento avverso (grado < 2 in accordo alla classificazione CTCAE) ai giorni 7, 14 e 28 dopo la randomizzazione;; Proporzione di partecipanti con eventi avversi severi (grado > 3 in accordo alla classificazione CTCAE) ai giorni 7, 14 e 28 dopo la randomizzazione;; Proporzione di partecipanti ammessi in terapia intensive ai giorni 7, 14 e 28 dopo la randomizzazione; Proporzione di partecipanti sopravvissuti ai giorni 7, 14 e 28 dopo la randomizzazione;; Variazione media del valore dei seguenti biomarkers, dal basale ai giorni 7, 14, 21 e 28 dopo la randomizzazione:
    o Emocromo completo con formula;
    o Funzione epatica (ALT, AST e bilirubina);
    o Coagulazione completa (PT, aPTT e INR);
    o Altri marcatori (D-dimero, CPK, LDH).; Questionario sulla qualità di vita a 3 mesi dalla randomizzazione.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At day 14 and 28 after randomization;; At day 7 and 28 after randomization; At time 0, 7, 14 and 28 after randomization; At time 0,7,14 and 28 after randomization;; At day 7, 14 and 28 after randomization;; At day 7, 14 and 28 after randomization; At day 7, 14 and 28 after randomization;; At day 7, 14 and 28 after randomization; From base line to day 7, 14, 21 and 28 after randomization; 3 months after the randomization.
    Al giorno 14 e 28 dopo la randomizzazione.; Ai giorni 7, 28 dopo la randomizzazione; Ai tempi 0, 7, 14 e 28 dopo la randomizzazione; Ai tempi 0, 7, 14 e 28 dopo la randomizzazione;; Ai giorni 7, 14 e 28 dopo la randomizzazione;; Ai giorni 7, 14 e 28 dopo la randomizzazione;; Ai giorni 7, 14 e 28 dopo la randomizzazione; Ai giorni 7, 14 e 28 dopo la randomizzazione;; Sal basale ai giorni 7, 14, 21 e 28 dopo la randomizzazione:; A 3 mesi dalla randomizzazione
    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 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) Yes
    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 trial3
    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 concerned2
    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 Information not present in EudraCT
    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
    LVLS
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial 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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 135
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects with legally authorized representative
    Soggetti con rappresentante legale autorizzato
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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)
    -
    -
    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 Decision2020-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-31
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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