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    Summary
    EudraCT Number:2020-005015-40
    Sponsor's Protocol Code Number:IVER-303
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-03-25
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2020-005015-40
    A.3Full title of the trial
    A multicentre, phase III, double-blind, randomised, parallel, placebo-controlled trial to assess efficacy and safety of early administration of Ivermectin during 3 consecutive days to prevent SARS CoV-2 (COVID-19) hospitalisation in adults older than 50 years of age
    Multicentrické, dvojito zaslepené, randomizované, paralelné, placebom kontrolované klinické skúšanie vo fáze III na vyhodnotenie účinnosti a bezpečnosti skorého podávania ivermektínu v priebehu troch po sebe nasledujúcich dní na prevenciu hospitalizácie z dôvodu ochorenia vírusom SARS-CoV-2 (COVID-19) u dospelých starších ako 50 rokov
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ivermectin to prevent SARS-CoV-2 (COVID-19) hospitalisation in subjects over 50
    Použitie ivermektínu na prevenciu hospitalizácie účastníkov so SARS-CoV-2 (COVID-19) vo veku nad 50 rokov
    A.3.2Name or abbreviated title of the trial where available
    Ivermectin to prevent SARS-CoV-2 (COVID-19) hospitalisation in subjects over 50
    Ivermektín na prevenciu hospitalizácie SARS-CoV-2 (COVID-19) u osôb starších ako 50 rokov
    A.4.1Sponsor's protocol code numberIVER-303
    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 SponsorChemo Research S.L.
    B.1.3.4CountrySpain
    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 supportChemo Research S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChemo Research S.L.
    B.5.2Functional name of contact pointMedical Director
    B.5.3 Address:
    B.5.3.1Street AddressManuel Pombo Angulo, 28
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28050
    B.5.3.4CountrySpain
    B.5.4Telephone number0034917711500
    B.5.5Fax number0034917668963
    B.5.6E-mailMaria.Perello@exeltis.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 No
    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 nameIvermectin 9 mg tablets
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNIvermectin
    D.3.9.1CAS number 70288-86-7
    D.3.9.3Other descriptive nameIVERMECTIN
    D.3.9.4EV Substance CodeSUB12089MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    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 No
    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 nameIvermectin 18 mg tablets
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNIvermectin
    D.3.9.1CAS number 70288-86-7
    D.3.9.3Other descriptive nameIVERMECTIN
    D.3.9.4EV Substance CodeSUB12089MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    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 placeboTablet
    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 placeboTablet
    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
    Coronavirus disease (COVID-19)
    Ochorenie koronavírusom (COVID-19)
    E.1.1.1Medical condition in easily understood language
    Coronavirus disease (COVID-19)
    Ochorenie koronavírusom (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 23.1
    E.1.2Level PT
    E.1.2Classification code 10084460
    E.1.2Term COVID-19 treatment
    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 assess the efficacy of early administration of Ivermectin for three consecutive days to prevent SARS-CoV-2 hospitalisation in adults older than 50 years of age.
    Vyhodnotiť účinnosť skorého podávania ivermektínu v priebehu troch po sebe nasledujúcich dní na prevenciu hospitalizácie z dôvodu ochorenia vírusom SARS-CoV-2 u dospelých starších ako 50 rokov
    E.2.2Secondary objectives of the trial
    1. To assess efficacy of an early administration of Ivermectin for three consecutive days to prevent SARS-CoV-2 disease progression in adults older than 50 years of age
    2. To evaluate the safety and tolerability of Ivermectin in SARS CoV 2 infected adults older than 50 years of age
    1. Vyhodnotiť účinnosť skorého podávania ivermektínu v priebehu troch po sebe nasledujúcich dní na prevenciu progresie ochorenia vírusom SARS-CoV-2 u dospelých starších ako 50 rokov
    2. Vyhodnotiť účinnosť a znášanlivosť ivermektínu u dospelých starších ako 50 rokov infikovaných vírusom SARS CoV 2
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female adult > 50 years of age
    2. SARS-CoV-2 infection diagnosed either through a rapid antigen-based test or an RNA based reverse-transcription polymerase chain reaction (RT-PCR) diagnostic test performed in nasopharyngeal sample
    3. Onset of COVID-19 symptoms < 120 hours prior to screening (Visit 1.1)
    4. Written informed consent
    5. For females of childbearing potential only: They must declare that they did not intend to become pregnant in the last month prior to screening and they do not intend to become pregnant for one month following the last IP administration. For males who have partners of childbearing potential: Willing to use condoms until 3 months after last IP intake.
    6. Negative result for urine pregnancy test (women of childbearing potential only)
    1. Dospelí muži alebo dospelé ženy vo veku > 50 rokov
    2. Infekcia vírusom SARS-CoV-2 diagnostikovaná na základe rýchleho antigénového testu alebo diagnostického testu na RNA založenej polymerázovej reťazovej reakcii s reverznou transkriptázou (RT-PCR) vykonaného z nazofaryngeálnej vzorky
    3. Nástup príznakov ochorenia COVID-19 < 120 hodín (5 dní) pred skríningom (návšteva V1.1)
    4. Písomný informovaný súhlas
    5. Iba pre ženy v plodnom veku: musia prehlásiť, že nemali v úmysle otehotnieť posledný mesiac pred skríningom a že nebudú mať v úmysle otehotnieť v priebehu jedného mesiaca po poslednom podaní skúšaného lieku. Pre mužov, ktorí majú partnerky v plodnom veku: ochotní používať kondómy až do 3 mesiacov po poslednom užití skúšaného lieku
    6. Negatívny výsledok tehotenského testu z moču (iba ženy v plodnom veku)
    E.4Principal exclusion criteria
    1. Intake of Ivermectin within 30 days before screening (Visit 1.1)
    2. Routine intake of antivirals, including antiretroviral treatment
    3. Allergy, hypersensitivity or contraindication to Ivermectin, metabolites or excipients
    4. Subjects with symptoms of disease severity (dyspnoea, SpO2 ≤ 94%)
    5. Subjects requiring hospitalisation for any reason
    6. Epidemiological risk or suspicion of being infected by Loa loa or other filariases
    7. Previous enrolment in this trial or participation in any other drug investigational trial within the past 30 days (or five half-lives of investigational product [IP] whichever is longer) prior to screening (Visit 1.1)
    8. Weight < 50 kg
    9. Pregnancy or lactation
    10. Inability to take oral medications
    11. At least one of the following acute/chronic disease or deficiency:
    a. History of bone marrow transplant or haematopoietic systems diseases
    b. Moderate or severe liver disease (Child Pugh score ≥ B or ALT [alanine transaminase] or AST [aspartate transaminase] > 3 times upper limit as determined at screening (Visit 1.2), severe cholestasis, cirrhosis or severe hepatic failure
    c. Transplanted patient under immunosuppressive treatment, disease that may need immunosuppressive treatments or other medical conditions that under the judgement of investigator would not benefit the patient to be included (including but not limited to psoriasis, G6PD (glucose-6-phosphate dehydrogenase) deficiency, porphyria, history of diverticulosis, seizure disorder, concurrent malignancy requiring chemotherapy, ongoing skin infection (e.g. pyodermitis) or evidence of current tuberculosis including latent untreated tuberculosis)
    d. Ophthalmological or recent/ongoing neurological diseases
    12. Active cardiac disease or a history of cardiac dysfunction including any of the following:
    a. History of angina pectoris, symptomatic pericarditis, or myocardial infarction within 12 months prior to screening
    b. History of congestive heart failure (New York Heart Association functional classification III-IV)
    13. Concomitant use of barbiturates, sodium oxybate, valproic acid or warfarin
    14. Laboratory abnormalities relevant for the trial, including but not limited to: neutropenia < 500/mm3, thrombocytopenia < 100 000/mm3
    15. Any other significant disease, disorder or finding which, in the opinion of the investigator, may significantly increase the risk to the subject because of participation in the study, affect the ability of the subject to participate in the study or impair interpretation of the study data
    16. Employees of the investigator or clinical trial site, with direct involvement in the proposed trial or other studies under the direction of that investigator or clinical trial site, as well as family members of the employees or the principal investigator
    17. Persons committed to an institution by virtue of an order issued either by the judicial or other authorities
    1. Užívanie ivermektínu do 30 dní pred skríningom (návšteva 1.1)
    2. Rutinné užívanie antivirotík vrátane antiretrovirotík
    3. Alergia, precitlivenosť alebo kontraindikácia týkajúca sa ivermektínu, metabolitov alebo pomocných látok
    4. Účastníci s príznakmi závažnosti ochorenia (dyspnoe, SpO2 ≤ 94 %)
    5. Účastníci vyžadujúci hospitalizáciu z akéhokoľvek dôvodu
    6. Epidemiologické riziko alebo podozrenie na infekciu Loa loa alebo inými filáriami
    7. Predchádzajúce zaradenie do tohto klinického skúšania alebo účasť v akomkoľvek inom klinickom skúšaní lieku počas posledných 30 dní (alebo piatich polčasov rozpadu skúšaného lieku, podľa toho, čo je dlhšie) pred skríningom (návšteva V1.1)
    8. Telesná hmotnosť < 50 kg
    9. Tehotenstvo alebo dojčenie
    10. Neschopnosť užívať perorálne lieky
    11. Aspoň jedno z nasledujúcich akútnych/chronických ochorení alebo deficitov:
    a. Anamnéza transplantácie kostnej drene alebo ochorenia hematopoetických systémov
    b. Stredné alebo závažné ochorenie pečene (skóre podľa Childa-Pugha ≥ B alebo hladina ALT [alaníntransamináza] alebo AST [aspartáttransamináza] > 3-krát vyššia ako horný limit stanovená pri skríningu (návšteva V1.2)), závažná cholestáza, cirhóza alebo závažné zlyhanie pečene
    c. Pacient po transplantácii s imunosupresívnou liečbou, ochorením, ktoré môže vyžadovať imunosupresívnu liečbu, alebo iné zdravotné stavy, na základe ktorých by podľa posúdenia skúšajúceho lekára účasť pre pacienta nebola prínosná (zahŕňajúc okrem iného psoriázu, deficit G6PD (glukóza-6-fosfátdehydrogenáza), porfýriu, anamnézu divertikulózy, záchvatové ochorenie, súbežnú malignitu vyžadujúcu chemoterapiu, súčasné kožné ochorenie (napr. pyodermitída) alebo dôkazy o súčasnej tuberkulóze vrátane latentnej neliečenej tuberkulózy)
    d. Oftalmologické alebo nedávne/súčasné neurologické poruchy
    12. Aktívne srdcové ochorenie alebo anamnéza poruchy funkcie srdca vrátane čohokoľvek z nasledujúceho:
    a. Anamnéza angíny pectoris, symptomatická perikarditída alebo infarkt myokardu do 12 mesiacov pred skríningom
    b. Anamnéza kongestívneho srdcového zlyhávania (funkčná klasifikácia podľa NYHA (New York Heart Association) III – IV)
    13. Súčasné užívanie barbiturátov, oxybátu sodného, kyseliny valproovej alebo warfarínu
    14. Laboratórne abnormality relevantné pre klinické skúšanie zahŕňajúc okrem iného neutropéniu < 500/mm3, trombocytopéniu < 100 000/mm3
    15. Každé iné významné ochorenia, poruchy alebo nálezy, ktoré môžu podľa názoru skúšajúceho lekára významne zvýšiť riziko pre účastníka z dôvodu účasti v klinickom skúšaní, ovplyvňujú schopnosť účastníka zúčastniť sa na klinickom skúšaní alebo narušia interpretáciu údajov z klinického skúšania
    16. Zamestnanci skúšajúceho lekára alebo pracoviska klinického skúšania, ktorí sú priamo zapojení do navrhovaného skúšania alebo iných skúšaní pod vedením skúšajúceho lekára alebo pracoviska klinického skúšania, ako aj rodinní príslušníci zamestnancov alebo hlavného skúšajúceho lekára
    17. Osoby vo vzťahu k inštitúcii na základe uznesenia vydaného súdnymi alebo inými orgánmi
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of subjects requiring SARS-CoV-2 hospitalisation during 28 days after first IP administration
    Percento účastníkov vyžadujúcich hospitalizáciu z dôvodu ochorenia vírusom SARS-CoV-2 počas 28 dní po prvom podaní skúšaného lieku
    E.5.1.1Timepoint(s) of evaluation of this end point
    Data recorded on day 1, 2, 3, 4, 6, 8, 10, 12, 14, 21, 28. Final evaluation on day 28.
    Údaje zaznamenané v 1., 2., 3., 4., 6., 8., 10., 12., 14., 21., 28. deň. Záverečné vyhodnotenie v 28. deň.
    E.5.2Secondary end point(s)
    1. Change in subjects’ clinical status on Day 28
    2. The occurrence of any adverse event related to Ivermectin treatment
    1. Zmena klinického stavu účastníkov v deň 28
    2. Výskyt akýchkoľvek nežiaducich udalostí súvisiacich s liečbou Ivermectinom
    E.5.2.1Timepoint(s) of evaluation of this end point
    Data recorded on day 1, 2, 3, 4, 6, 8, 10, 12, 14, 21, 28. Final evaluation on day 28.
    Údaje zaznamenané v 1., 2., 3., 4., 6., 8., 10., 12., 14., 21., 28. deň. Záverečné vyhodnotenie v 28. deň.
    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 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 trial2
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA46
    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
    LVLS
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months4
    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: 208
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 624
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-03-25. Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state250
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 832
    F.4.2.2In the whole clinical trial 832
    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 Decision2021-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-06-21
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