Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   40657   clinical trials with a EudraCT protocol, of which   6636   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-002060-31
    Sponsor's Protocol Code Number:WHOCOVID-19coreprotocol
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-05-26
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2020-002060-31
    A.3Full title of the trial
    An international randomised trial of additional treatments for COVID-19 in hospitalised patients who are all receiving the local standard of care
    Mezinárodní randomizovaná studie další léčby COVID-19 u hospitalizovaných pacientů, kteří jsou léčeni standardní péčí.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An international randomised trial of additional treatments for COVID-19 in hospitalised patients who are all receiving the local standard of care
    Mezinárodní randomizovaná studie další léčby COVID-19 u hospitalizovaných pacientů, kteří jsou léčeni standardní péčí.
    A.3.2Name or abbreviated title of the trial where available
    SOLIDARITY
    SOLIDARITY
    A.4.1Sponsor's protocol code numberWHOCOVID-19coreprotocol
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN83971151
    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 SponsorMasaryk University
    B.1.3.4CountryCzech Republic
    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 supportWorld Health Organisation
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportMasaryk University
    B.4.2CountryCzech Republic
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMasaryk University, Faculty of Medicine
    B.5.2Functional name of contact pointPharmacological Department
    B.5.3 Address:
    B.5.3.1Street AddressKamenice 5
    B.5.3.2Town/ cityBrno
    B.5.3.3Post code625 00
    B.5.3.4CountryCzech Republic
    B.5.4Telephone number00420549496526
    B.5.6E-maildemlova@med.muni.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 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 nameremdesivir
    D.3.4Pharmaceutical form Lyophilisate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNREMDESIVIR
    D.3.9.1CAS number 1809249-37-3
    D.3.9.4EV Substance CodeSUB195655
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Kaletra
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLOPINAVIR
    D.3.9.1CAS number 192725-17-0
    D.3.9.4EV Substance CodeSUB02970MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITONAVIR
    D.3.9.1CAS number 155213-67-5
    D.3.9.4EV Substance CodeSUB10342MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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: 3
    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 Rebif
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Powder and solution for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNinterferonum beta-1a
    D.3.9.1CAS number 220581-49-7
    D.3.9.3Other descriptive nameInterferon beta-1a
    D.3.9.4EV Substance CodeSUB12440MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number22 to 250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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: 4
    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 s. r. o.
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    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 Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHydroxychloroquine
    D.3.9.1CAS number 118-42-3
    D.3.9.4EV Substance CodeSUB08077MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COVID-19
    COVID-19
    E.1.1.1Medical condition in easily understood language
    COVID-19
    COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of the protocol is to compare the effect of standard care alone and standard care with using one of the four antiviral alternatives.

    The primary objective of this large international randomised trial is to provide reliable estimates on any effects of these anti-viral treatments on in-hospital mortality in moderate and in severe COVID-19.
    Účelem tohoto klinického hodnocení je porovnat výsledek lokální standardní péče a standardní péči s jedním ze čtyř alternativních virových léčiv.

    Primárním cílem tohoto rozsáhlého mezinárodního klinického hodnocení je zhodnotit všechny příčiny úmrtí, rozdělené dle závažnosti onemocnění v čase randomizace.

    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess any effects of these anti-viral treatments on hospital duration and receipt of ventilation or intensive care, and to identify any serious adverse reactions.

    Sekundárním cílem je zhodnotit efekt antivirotické léčby během trvání hospitalizace a připojení k ventilaci nebo přijetí na jednotku intenzivní péče s cílem identifikovat závažné nežádoucí reakce.




    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adults ≥ 18 years of age at the time of enrolment who has given informed consent.
    2. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR.
    3. Hospitalized patients with illness of any duration and at least one of the following:
    a. Moderate disease: Clinical assessment (evidence of rales/crackles on examination); shortness of breath AND SpO2 ≤ 94% on room air, OR
    b. Severe disease: Acute respiratory failure requiring supplemental oxygen administration by nasal cannula, simple face mask or other high flow oxygen delivery devices, invasive or non-invasive ventilation, or ECMO.
    4. For women of childbearing potential, sexual abstinence during the treatment period and 1 month after the last dose of study drug, OR use of the following highly effective contraception: combined hormonal contraception (oral, vaginal, transdermal), progestogen-only contraception associated with inhibition of ovulation (oral, injectable),non-hormonal intrauterine device, or intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner.
    1. Dospělý ≥18let v době zařazení do klinického hodnocení, kteří podepsali informovaný souhlas.
    2. Laboratorně potvrzená infekce SARS-CoV-2 za pomocí PCR.
    3. Hospitalizovaní pacienti s onemocněním jakéhokoliv trvání a s nejméně jednou z následujících podmínek:
    a.) Středně těžké onemocnění: klinické zhodnocení, dýchavičnost a SpO2 ≤ 94% nebo b.)těžké onemocnění: akutní respirační syndrom vyžadující dodatečné podání kyslíku nosní kanylou, jednoduchou obličejovou maskou nebo vyžadující podání kyslíku při vysokém průtoku, invazivní nebo neinvazivní ventilací nebo připojení na ECMO.
    4. Pro ženy v plodném věku: Sexuální abstinence během léčby a nejméně 1 měsíc od podání poslední dávky studijní medikace nebo použití následující vysoce spolehlivé antikoncepční metody kombinovaná hormonální antikoncepce (orální, vaginální, transdermální), antikoncepce obsahující progesteron s inhibicí ovulace (orální podán, injekce), nitroděložní tělísko nehormonální nebo hormonální, bilaterální tubulární okluze, vasektomie partnera.
    E.4Principal exclusion criteria
    1. Known hypersensitivity to lopinavir, ritonavir, natural or recombinant interferon beta, or hydroxychloroquine
    2. Know history of heart failure, prolonged QTc interval, torsade de pointes, or current need for treatment with drugs prolonging QTc interval or inducing arrhythmias
    (e.g. amiodarone, sotalol, hydroxyzine, domperidone, antipsychotics, citalopram, escitalopram, tricyclic antidepressants, macrolides, fluoroquinolones)
    3. Uncompensated epilepsy, diabetes mellitus, moderate or severe psoriasis
    4. Malignant cancer disease or ongoing oncological treatment incl. chemotherapy, radiotherapy or targeted therapy
    5. Pre-existing ocular maculopathy or retinopathy
    6. History of moderate or severe depression, suicidal ideations or attempt(s) or current depressive episode
    7. Stage 4 chronic kidney disease or need for dialysis (i.e. eGFR < 30 mL/min)
    8. Spontaneous blood ALT/AST levels > 5 times the upper limit of normal
    9. Uncorrected hypo- or hyperkalemia, or hypercholesterolemia with LDL > 4,9 mmol/L
    10. Human immunodeficiency virus infection under highly active antiretroviral therapy (HAART)
    11. Need for treatment with drugs with narrow therapeutic range highly dependent on CYP3A metabolism (e.g. amiodarone, dronedarone, colchicine, simvastatin, lovastatin, midazolam, sildenafil, ergot derivatives)
    12. Previous treatment with remdesivir, interferon β-1a, lopinavir/ritonavir, or hydroxychloroquine
    13. Pregnancy or breast-feeding
    14. Anticipated transfer to another hospital, which is not a trial site within 72 h
    15. Prior participation in any other clinical trial within 30 days before the enrolment and during this trial
    1. Známá přecitlivost na lopinavir, ritonavir, přírodní nebo rekombinantní interferon beta nebo hydroxychloroquine.
    2. Známá historie srdečního selhání, prodlouženého QT intervalu, torsade de pointes nebo momentální potřeba léčby léčivy prodlužující QT interval, nebo indukující arytmie (např. amiodarone, sotalol, hydroxyzine, domperidone, antipsychotics, citalopram, escitalopram, tricyclic antidepressants, macrolides, fluoroquinolones).
    3. Neléčená epilepsie, diabetes mellitus, středně těžká nebo těžká psoriáza.
    4. Maligní onkologické onemocnění nebo probíhající onkologické léčba zahrnující chemoterapii, radioterapii nebo cílenou terapii.
    5. Již existující makulopatie nebo retininopatie.
    6. Historie středně těžké nebo těžké deprese, sebevražedné myšlenky nebo pokusy nebo momentální depresivní epizody.
    7. Stádium 4 chronického onemocnění ledvin nebo potřeba dialýzy
    (např.. eGFR < 30 mL/min).
    8. Spontální hodnoty krve ALT/AST levels > 5 x vyšší než je horní limit
    9. Nekorigovaná hypo nebo hyperkalemie nebo hypercholesterolemie s LDL > 4,9 mmol/L.
    10. HIV infekce léčena dle postupu HAART.
    11. Potřeba léčby léky s úzkým terapeutickým rozhraním vysoce závislých na CYP3A metabolismu (např. amiodarone, dronedarone, colchicine, simvastatin, lovastatin, midazolam, sildenafil, ergotové deriváty).
    12. Předchozí léčba remdesivirem, interferon β-1a, lopinavir/ritonavir nebo hydroxychloroquine.
    13. Těhotenství nebo kojení.
    14. Očekávaný transfer do jiné nemocnice, která není studijním centrem během 72 hodin.
    15. Předchozí účast v jiném klinickém hodnocení během 30 dní před vstupem do tohoto klinického tohoto hodnocení a během průběhu tohoto klinického hodnocení.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is all-cause mortality, subdivided by severity of disease at the time of randomisation.
    Primárním cílem je zhodnotit všechny příčiny úmrtí, rozdělené dle závažnosti onemocnění v čase randomizace.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At discharge or death
    Při propuštění nebo úmrtí
    E.5.2Secondary end point(s)
    The secondary objectives are to assess any effects of these anti-viral treatments on hospital duration and receipt of ventilation or intensive care, and to identify any serious adverse reactions.
    Sekundárním cílem je zhodnotit efekt antivirotické léčby během trvání hospitalizace a připojení k ventilaci nebo přijetí na jednotku intenzivní péče s cílem identifikovat závažné nežádoucí reakce.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At discharge or death.
    Při propuštění nebo úmrtí.
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Lokální standardní péče
    Local standard of care
    E.8.2.4Number of treatment arms in the trial5
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    LPLV
    Poslední vizita posledního pacienta
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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: 7
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 13
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10000
    F.4.2.2In the whole clinical trial 100000
    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 Decision2020-05-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA