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    Summary
    EudraCT Number:2021-002024-21
    Sponsor's Protocol Code Number:IVER-FNUSA-21
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-04-28
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2021-002024-21
    A.3Full title of the trial
    Randomized placebo controlled clinical trial evaluating the safety and efficacy of ivermectin in hospitalized patients with Covid-19 disease
    Randomizované, placebem kontrolované klinické hodnocení hodnotící bezpečnost a účinnost ivermektinu u hospitalizovaných pacientů s onemocněním Covid-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized placebo controlled clinical trial evaluating the safety and efficacy of ivermectin in hospitalized patients with Covid-19 disease
    Randomizované, placebem kontrolované klinické hodnocení hodnotící bezpečnost a účinnost ivermektinu u hospitalizovaných pacientů s onemocněním Covid-19
    A.4.1Sponsor's protocol code numberIVER-FNUSA-21
    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 SponsorFakultní nemocnice u sv. Anny v Brně
    B.1.3.4CountryCzechia
    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 supportFakultní nemocnice u sv. Anny v Brně
    B.4.2CountryCzechia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFakultní nemocnice u sv. Anny v Brně
    B.5.2Functional name of contact pointOddělení klinických studií
    B.5.3 Address:
    B.5.3.1Street AddressPekarska 53
    B.5.3.2Town/ cityBrno
    B.5.3.3Post code65691
    B.5.3.4CountryCzechia
    B.5.4Telephone number00420731692781
    B.5.6E-mailtrials.icrc@fnusa.cz
    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.2.1.2Country which granted the Marketing AuthorisationBulgaria
    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.3.4Pharmaceutical 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 INNivermectin
    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 number3
    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 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
    Covid-19 disease
    onemocnění Covid-19
    E.1.1.1Medical condition in easily understood language
    Covid-19 disease
    onemocnění 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 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084270
    E.1.2Term SARS-CoV-2 acute respiratory disease
    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
    Evaluation of the clinical safety of ivermectin versus placebo as an add-on therapy to the standard treatment of COVID-19 disease in both treatment arms.
    Hodnocení klinické bezpečnosti ivermektinu oproti placebu jako add-on terapie ke standardní léčbě onemocnění COVID-19 v obou léčebných ramenech.
    E.2.2Secondary objectives of the trial
    - Evaluation of the condition of patients at the level of 8-level Ordinal Scale S1 on individual days of the clinical trial
    - Time to first improvement by 1 category compared to Day 1 on the 8-degree Ordinal Scale S1
    - Time to first deterioration by 1 category compared to Day 1 on the 8-degree Ordinal Scale S1
    - Duration (days) of need for oxygen therapy
    - Length (days) of the need for non-invasive ventilation or high flow oxygenation
    - Duration (days) of need for intubation and mechanical ventilation or organ support by vasopressors, dialysis or extracorporeal membrane oxygenation (ECMO)
    - Mortality
    - Length (days) of need for hospitalization
    - change of X-ray findings on the lungs during the 10th day - upon the invetigator's decision and the length of hospitalization (control X-ray on the 10th day or on the day of discharge - in case of a clinical reason)
    - Evaluation of concomitant treatment in both arms
    - Evaluation of the change in viral load as a function of time
    – Vyhodnocení stavu pacientů na úrovni 8stupňové Ordinal Scale S1 v jednotlivých dnech klinického hodnocení (do dne 28)
    – Doba do prvního zlepšení o 1 kategorii ve srovnání s Den 1 na 8stupňové Ordinal Scale S1 (do dne 28)
    – Doba do prvního zhoršení o 1 kategorii ve srovnání s Den 1 na 8stupňové Ordinal Scale S1 (do dne 28)
    – Délka (dny) nutnosti oxygenoterapie (do dne 28)
    – Délka (dny) nutnosti neinvazivní ventilace či high flow oxygenace (do dne 28)
    – Délka (dny) nutnosti intubace a mechanické ventilace či orgánové podpory vazopresory, dialýza nebo extrakorporální membránová oxygenace (ECMO) (do dne 28)
    – Mortalita (do dne 28)
    – Délka (dny) nutnosti hospitalizace (do dne 28)
    – změna RTG nálezu na plicích během 10.dne – dle rozhodnutí lékaře a dle délky hospitalizace (provedení kontrolního RTG 10. den či v den propuštění bude provedeno pokud k tomu bude klinický důvod)
    – Hodnocení souběžné léčby v obou ramenech
    – Hodnocení změny virové nálože v závislosti na čase (Den 1 a Den 7)

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Age ≥ 18 years
    2) Willingness to participate in the clinical trial expressed by signing the informed consent form
    3) Patients with confirmed Covid-19 disease requiring hospitalization with at least one of the following symptoms:
    a. febrile illness above 38.5 ° C;
    b. shortness of breath at rest or with minimal exertion,
    c. oxygen-free saturation below 93 % SpO2,
    d. inability to self-service, general exhaustion and more
    4) Laboratory PCR confirmed positivity SARS-CoV-2 (nasopharyngeal swab) or positive antigen test not older than 5 days.
    5) Clinical trial subjects of childbearing potential must agree to the use of the following methods of contraception for the duration of clinical trial and 3 months after the end of clinical trial.
    a. For women of childbearing potential using one of the following methods:
    i. highly reliable contraceptive methods within 3 months after end of clinical trial: combined hormonal contraception (oral, vaginal, transdermal), progesterone-containing contraceptives with ovulation inhibition (oral, injection), intrauterine non-hormonal or hormonal body, bilateral tubal occlusion or partner vasectomy
    OR
    ii. sexual abstinence if it is consistent with the lifestyle of the subject.
    b. For men, use one of the following methods: observance of sexual abstinence (if it is consistent with the lifestyle of the subject) or use of an adequate contraceptive method (ie condom) in the case of sexual intercourse within 3 months after the end of clinical trial.
    1) Věk ≥ 18 let
    2) Ochota účastnit se KH vyjádřená podpisem formuláře informovaného souhlasu
    3) Pacienti s potvrzeným onemocněním Covid-19 vyžadující hospitalizaci s alespoň jedním z příznaků:
    a. febrilie nad 38,5 °C,
    b. dušnost v klidu či při minimální námaze,
    c. saturace bez kyslíku pod 93 % SpO2,
    d. neschopnost sebeobsluhy, celková vyčerpanost a další
    4) Laboratorně PCR potvrzená pozitivita SARS-CoV-2 (stěr z nosohltanu) nebo pozitivní antigenní test ne starší než 5 dní.
    5) Subjekty KH v plodném věku musí souhlasit s používáním níže uvedených metod antikoncepce po dobu trvání KH a 3 měsíce po ukončení KH.
    a. Pro ženy v plodném věku použití jedné z následujících metod:
    i. vysoce spolehlivé antikoncepční metody do 3 měsíců po ukončení KH: kombinovaná hormonální antikoncepce (orální, vaginální, transdermální), antikoncepce obsahující progesteron s inhibicí ovulace (orální podán, injekce), nitroděložní tělísko nehormonální nebo hormonální, bilaterální tubární okluze nebo vasektomie partnera
    NEBO
    ii. sexuální abstinence pokud je v souladu se životním stylem subjektu
    b. Pro muže použití jedné z následujících metod: dodržování sexuální abstinence, pokud je v souladu se životním stylem nebo použití adekvátní antikoncepční metody (tj. kondomu) v případě pohlavního styku do 3 měsíců po ukončení KH.
    E.4Principal exclusion criteria
    1) Pregnancy, breastfeeding, positive chorionic gonadotropin (hCG)
    2) Inadequacy of classification of the subject on the basis of individual assessment of the examining physician
    3) Age <18 years
    4) Outpatient treatment of patients with Covid-19 disease
    5) Hepatic impairment - alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST)> 3x ULN detected before IP administration
    6) Known hypersensitivity to the components of the preparation
    7) Eating and fluid intake disorders and conditions limiting the bioavailability of the drug
    8) Participation in another clinical trial
    9) BMI > 35
    10) Inability to swallow drugs
    11) Current use of potent CYP3A4 inhibitors: fluconazole, fluoxetine, indinavir, itraconazole, clarithromycin, nifedipine, ritomavir, verapamil, voriconazole
    12) Use of ivermectin 1 month before inclusion in CT
    13) Bone marrow transplantation, history of hematopoietic disorders
    14) Neurological disorders such as epilepsy that are treated with GABA agonists, such as baclofen, or past suicidal ideation or attempts
    1) Těhotenství, kojení, pozitivní choriový gonadotropin (hCG)
    2) Nevhodnost zařazení subjektu na základě individuálního posouzení zkoušejícího lékaře
    3) Věk < 18 let
    4) Ambulantně léčení pacienti s Covid-19
    5) Postižení jater – alaninaminotransferáza (ALT) a/nebo aspartátaminotransferáza (AST)> 3x ULN detekované před podáním HLP
    6) Známá přecitlivělost na složky přípravku
    7) Porucha příjmu potravy a tekutin a stavy omezující biologickou dostupnost léčiva
    8) Účast v jiném KH
    9) BMI > 35
    10) Neschopnost polykat léky
    11) Aktuální užívání silných inhibitorů CYP3A4: flukonazol, fluoxetin, indinavir, itrakonazol, klaritromycin, nifedipin, ritomavir, verapamil, vorikonazol
    12) Užívání ivermektinu 1 měsíc před zařazením do KH
    13) Transplantace kostní dřeně, poruchy krvetvorby v anamnéze
    14) Neurologické poruchy typu epilepsie, které jsou léčeny GABA agonisty, jako např. baklofen, anebo suicidiální úmysly či pokusy v minulosti
    E.5 End points
    E.5.1Primary end point(s)
    1. Severity, expectations, intensity AE and association with IP and placebo
    2. Nature of AE, duration
    3. Improvement by at least one grade at the 8-level Ordinal Scale S1 assessment level, assessed on day 10 after the first IP / placebo administration
    1. Závažnost, očekávanost, intenzita nežádoucích příhod a souvislost s HLP a placebem
    2. Charakter AE, délka trvání
    3. Zlepšení stavu o nejméně jeden stupeň na úrovni hodnocení 8stupňové Ordinal Scale S1, hodnocený v 10. den po aplikaci první dávky HLP/placeba
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 28
    2. Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 28
    3. Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 28
    1. Den 1, Den 2, Den 3, Den 4, Den 5, Den 7, Den 10, Den 28
    2. Den 1, Den 2, Den 3, Den 4, Den 5, Den 7, Den 10, Den 28
    3. Den 1, Den 2, Den 3, Den 4, Den 5, Den 7, Den 10, Den 28
    E.5.2Secondary end point(s)
    1. Evaluation of the condition of patients at the level of 8-level Ordinal Scale S1 on individual days of clinical trial (until day 28)
    2. Time to first improvement by 1 category compared to Day 1 on the 8-speed Ordinal Scale S1 (until day 28)
    3. Time to first deterioration by 1 category compared to Day 1 on the 8-degree Ordinal Scale S1 (until day 28)
    4. Duration (days) of necessity of oxygen therapy (until day 28)
    5. Duration (days) of the need for non-invasive ventilation or high flow oxygenation (until day 28)
    6. Duration (days) of need for intubation and mechanical ventilation or organ support by vasopressors, dialysis or extracorporeal membrane oxygenation (ECMO) (until day 28)
    7. Mortality (until day 28)
    8. Length (days) of need for hospitalization (until day 28)
    9. Change of X-ray findings on the lungs during the 10th day - according to the doctor's decision and according to the length of hospitalization (control X-ray on 10th day or on the day of discharge will be performed if there is a clinical reason for this - f.e. listening findings)
    10. Evaluation of concomitant treatment in both arms
    11. Evaluation of the change in viral load over time
    12. Serum concentration of C-Reactive Protein (CRP)
    13. Number of subjects with increased alanine aminotransferase ALT and / or AST aspartate aminotransferase> 3x ULN
    1. Vyhodnocení stavu pacientů na úrovni 8stupňové Ordinal Scale S1 v jednotlivých dnech KH (do dne 28)
    2. Doba do prvního zlepšení o 1 kategorii ve srovnání s Den 1 na 8stupňové Ordinal Scale S1 (do dne 28)
    3. Doba do prvního zhoršení o 1 kategorii ve srovnání s Den 1 na 8stupňové Ordinal Scale S1 (do dne 28)
    4. Délka (dny) nutnosti oxygenoterapie (do dne 28)
    5. Délka (dny) nutnosti neinvazivní ventilace či high flow oxygenace (do dne 28)
    6. Délka (dny) nutnosti intubace a mechanické ventilace či orgánové podpory vazopresory, dialýza nebo extrakorporální membránovou oxygenace (ECMO) (do dne 28)
    7. Mortalita (do dne 28)
    8. Délka (dny) nutnosti hospitalizace (do dne 28)
    9. Změna RTG nálezu na plicích během 10. dne – dle rozhodnutí lékaře a dle délky hospitalizace (provedení kontrolního RTG 10. den či v den propuštění bude provedeno pokud k tomu bude klinický důvod - např. poslechový nález)
    10. Hodnocení souběžné léčby v obou ramenech
    11. Hodnocení změny virové nálože v závislosti na čase
    12. Sérová koncentrace C-Reaktivního Proteinu (CRP)
    13. Počet subjektů s výskytem zvýšení alaninaminotransferázy ALT a/nebo AST aspartátaminotransferázy > 3x ULN
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 28
    2. Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 28
    3. Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 28
    4.Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 28
    5. Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 28
    6. Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 28
    7. Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 28
    8. Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 28
    9. Day 1 (Day 10)
    10. Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 28
    11. Day 1, Day 7
    12. Day 1, Day 3, Day 5, Day 7
    13. Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 28
    1. Den 1, Den 2, Den 3, Den 4, Den 5, Den 7, Den 10, Den 28
    2. Den 1, Den 2, Den 3, Den 4, Den 5, Den 7, Den 10, Den 28
    3. Den 1, Den 2, Den 3, Den 4, Den 5, Den 7, Den 10, Den 28
    4. Den 1, Den 2, Den 3, Den 4, Den 5, Den 7, Den 10, Den 28
    5. Den 1, Den 2, Den 3, Den 4, Den 5, Den 7, Den 10, Den 28
    6. Den 1, Den 2, Den 3, Den 4, Den 5, Den 7, Den 10, Den 28
    7. Den 1, Den 2, Den 3, Den 4, Den 5, Den 7, Den 10, Den 28
    8. Den 1, Den 2, Den 3, Den 4, Den 5, Den 7, Den 10, Den 28
    9. Den 1 (Den 10)
    10. Den 1, Den 2, Den 3, Den 4, Den 5, Den 7, Den 10, Den 28
    11. Den 1, Den 7
    12. Den 1, Den 3, Den 5, Den 7
    13. Den 1, Den 2, Den 3, Den 4, Den 5, Den 7, Den 10, Den 28
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 concerned3
    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
    LVLS
    Poslední návštěva posledního pacienta
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state136
    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
    žádné
    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 Decision2021-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-09
    P. End of Trial
    P.End of Trial StatusOngoing
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