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    Summary
    EudraCT Number:2020-001206-35
    Sponsor's Protocol Code Number:ACEI-COVID-19
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-03-26
    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 ConcernedAustria - BASG
    A.2EudraCT number2020-001206-35
    A.3Full title of the trial
    Stopping ACE-inhibitors in COVID-19 - a randomized, controlled clinical trial
    Stopp von ACE-Hemmern bei Patienten mit COVID 19 - eine randomisierte, kontrollierte klinische Prüfung
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Discontinuation of ACE inhibitors in patients with COVID-19 infection
    Absetzen von ACE-hemmende Arzneimittel bei Patienten mit COVID-19 Infektion
    A.4.1Sponsor's protocol code numberACEI-COVID-19
    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 SponsorMedizinische Universität Innsbruck
    B.1.3.4CountryAustria
    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 supportMedizinische Universität Innsbruck
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Universität Innsbruck, Univ.-Klinik für Innere Medizin III
    B.5.2Functional name of contact pointUniv.-Prof. Dr. Axel Bauer
    B.5.3 Address:
    B.5.3.1Street AddressAnichstraße 35
    B.5.3.2Town/ cityInnsbruck
    B.5.3.4CountryAustria
    B.5.4Telephone number+4351250425621
    B.5.6E-mailkks-regulatory@i-med.ac.at
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 AuthorisationEuropean Union
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 AuthorisationEuropean Union
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 AuthorisationEuropean Union
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 AuthorisationEuropean Union
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The study will investigate infections with the new SARS-CoV2 virus. Current studies show that the SARS-CoV2 virus penetrates human cells via the angiotensin converting enzyme II (ACE2) receptor 2. Experimental studies show that ACE inhibitors (ACEI) and angiotensin receptor blockers (ARB) can increase the expression of ACE2 and thus could facilitate virus uptake. This study will investigate the effect of stopping chronic ACEI or ARB therapy in patients with proven SARS-CoV2 infection.
    Diese Studie untersucht Infektionen mit dem neuen SARS-CoV2 Virus. Untersuchungen zeigen, dass das SARS-CoV2 Virus über den Angiotensin Converting Enzyme II (ACE2)-Rezeptor 2 in menschliche Zellen eindringt. Studien belegen, dass ACE-Hemmer (ACEI) und Angiotensin-Rezeptorblocker (ARB) die Expression von ACE2 steigern können und dadurch womöglich die Virusaufnahme erleichtern. Diese Studie erforscht den Effekt des Absetzens der chronischen ACEI- oder ARB-Therapie bei SARS-CoV2 Infizierten.
    E.1.1.1Medical condition in easily understood language
    This study will investigate the effect of stopping chronic ACEI or ARB therapy in patients with proven SARS-CoV2 coronavirus infection.
    In dieser Studie wird untersucht, wie sich ein Absetzen der chronischen ACEI- oder ARB-Therapie bei Patienten mit nachgewiesener SARS-CoV2-Coronavirus-Infektion auswirkt.
    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
    Patients with coronary artery disease, arterial hypertension or diabetes are often treated with angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB). Treatment with ACEI and ARB may be of great relevance for the course of COVID-19: Similar to SARS-CoV (epidemic 2002-2003), the novel SARS-CoV2 is also absorbed into human cells via angiotensin converting enzyme 2 (ACE2). Treatment with ACEI and ARB leads to a significant upregulation of the SARS-CoV2 receptor ACE2. An increased expression of ACE2 in turn correlates with a higher intake of SARS-CoV2 and possibly promotes a faster spread of the virus in the organism of infected patients.
    The primary aim of the study is to test whether discontinuing chronic ACEI or ARB therapy in patients with proven SARS-CoV2 infection leads to a more favorable course of the disease of COVID-19 than the continuation of the ACEI or ARB therapy.
    Patienten mit koronarer Herzerkrankung, arterieller Hypertonie oder Diabetes werden häufig mit Angiotensin Converting Enzyme-Inhibitoren (ACEI) oder Angiotensin Rezeptor Blockern (ARB) behandelt. Die Behandlung mit ACEI und ARB ist möglicherweise für den Verlauf von COVID-19 von grosser Relevanz: Ähnlich wie SARS-CoV (Epidemie 2002-2003) wird auch das neuartige SARS-CoV2 über Angiotensin Converting Enzyme 2 (ACE2) in humane Zellen aufgenommen. Die Behandlung mit ACEI und ARB führt zu einer deutlichen Hochregulation des SARS-CoV2 Rezeptors ACE2. Eine gesteigerte Expression von ACE2 wiederum korreliert mit einer stärkeren Aufnahme von SARS-CoV 2 und fördert möglicherweise eine raschere Ausbreitung des Virus im Organismus infizierter Patienten.
    Primäres Ziel der Studie ist es zu testen, ob das Absetzen einer chronischen ACEI- oder ARB-Therapie bei Patienten mit nachgewiesener SARS-CoV2-Infektion zu einem günstigeren Krankheitsverlauf von COVID-19 führt als die Weitergabe der Therapie.
    E.2.2Secondary objectives of the trial
    Secondarily, the effect of discontinuation on clinical and laboratory parameters of SARS-CoV2 therapy is examined.
    Sekundär wird der Effekt des Absetzens auf klinische und laborchemische Parameter einer SARS-CoV2-Therapie untersucht.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written, signed and dated informed consent form to participate in the clinical trial after prior written and oral information
    2. Male and female patients ≥ 18 years capable of making decisions
    3. Confirmed symptomatic SARS-CoV2 infection (throat swab) ≤ 5 days
    4. Chronic (≥1 month) pretreatment with medicinal products from the ATC groups C09A, C09B, C09C, C09D due to arterial hypertension, diabetes mellitus, heart failure or coronary heart disease.
    5. Stable circulatory conditions with not more than four antihypertensive drugs, which allow discontinuation of the therapy with a medicinal product from the ATC groups C09A, C09B, C09C, C09D (systolic arterial blood pressure ≤180mmHg).
    1. Schriftliche, unterschriebene und datierte Einverständniserklärung zur Teilnahme an der klinischen Prüfung nach vorheriger schriftlicher und mündlicher Aufklärung
    2. Entscheidungsfähige männliche und weibliche Patienten ≥ 18 Jahre
    3. Nachgewiesene symptomatische SARS-CoV2-Infektion (Rachenabstrich) ≤ 5 Tage
    4. Chronische (≥1 Monat) Vorbehandlung mit einem Präparate der ATC Gruppen C09A, C09B, C09C, C09D aufgrund von arterieller Hypertonie, Diabetes mellitus, Herzinsuffizienz oder koronarer Herzerkrankung.
    5. Stabile Kreislaufverhältnisse unter nicht mehr als vier antihypertensiven Medikamenten, die ein Absetzen der Therapie mit einem Präparat der ATC Gruppen C09A, C09B, C09C, C09D erlauben (systolischer arterieller Blutdruck ≤180mmHg).
    E.4Principal exclusion criteria
    1. Women of childbearing potential including pregnant women and breastfeeding mothers
    2. Participation in another interventional study
    3. At the time of study inclusion oral medication is not possible
    4. Acute coronary syndrome ≤3 months
    5. Heart failure in stages NYHA III and IV
    6. Restriction of left ventricular ejection fraction <30% or NTproBNP increase ≥600pg/mL in the case of clinical signs of heart failure
    7. Hospitalization due to cardiac decompensation ≤3 months
    8. Lung failure requiring intubation
    9. Severe arterial hypertension with maximum antihypertensive therapy (taking >4 antihypertensive drugs)
    10. Therapy-refractory arterial hypertension (systolic arterial blood pressure >180mmHg despite multiple therapy)
    11. Patients who cannot be switched to alternative therapy.
    12. Patients who cannot perform a blood pressure self-measurement under ambulant conditions
    1. Gebärfähige Frauen inkl. Schwangere und stillende Mütter
    2. Teilnahme an einer anderen interventionellen Studie
    3. Zum Studieneinschluss keine orale Medikationseinnahme möglich
    4. Akutes Koronarsyndrom ≤3 Monate
    5. Herzinsuffizienz im Stadium NYHA III und IV
    6. Einschränkung linksventrikuläre Ejektionsfraktion <30% oder NTproBNP-Erhöhung ≥600pg/mL bei klinischen Zeichen der Herzinsuffizienz
    7. Hospitalisierung aufgrund kardialer Dekompensation ≤3 Monate
    8. Intubationspflichtiges Lungenversagen
    9. Schwere arterielle Hypertonie mit maximaler antihypertensiver Therapie (Einnahme von >4 antihypertensiven Medikamenten)
    10. Therapierefraktäre arterielle Hypertonie (systolischer arterieller Blutdruck >180mmHg trotz Mehrfachtherapie)
    11. Patienten, die nicht auf eine alternative Therapie umgestellt werden können.
    12. Patienten, die unter ambulanten Bedingungen keine Blutdruckselbstmessung durchführen können
    E.5 End points
    E.5.1Primary end point(s)
    Two primary endpoints are tested hierarchically:
    Primary endpoint 1 is the combination of the maximum SOFA scores measured during the course of the disease (≤30 days) and death. The minimum SOFA score is 0 and the maximum is 24. In the event of death, the patient receives the maximum value of 24 points. Patients in the ambulant setting receive a value of 0. Patients in the stationaire setting who are not ventilated receive 0 points for the parameter "Respiration" (variable PaO2 / FiO2). Clinical trials have demonstrated that the maximum SOFA score correlates with mortality.
    Primary endpoint 2 is the combination of a combination of intensive care admission, intubation and death.
    Es werden 2 primäre Endpunkte hierarchisch getestet:
    Primärerer Endpunkt 1 ist die Kombination aus dem maximalen, während des Krankheitsverlaufs gemessenen SOFA-Scores während des Krankheitsverlaufs (≤30 Tage) und Tod. Der SOFA-Score kann minimal 0 und maximal 24 betragen. Bei Tod erhält der Patient den maximalen Wert von 24 Punkten. Patienten im ambulanten Setting erhalten einen Wert von 0. Patienten im stationären Setting, die nicht beatmet sind, erhalten für den Parameter „Respiration" (Variable PaO2/FiO2) 0 Punkte. Klinische Studien haben gezeigt, dass der maximale SOFA-Score mit der Mortalität korreliert.
    Primärer Endpunkt 2 ist die Kombination aus Kombination aus Aufnahme auf Intensivstation, Intubation und Tod.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the course of the disease (≤30 days ±2 days)
    Während des Krankheitsverlaufs (≤30 Tage ±2 Tage)
    E.5.2Secondary end point(s)
    1. Maximum and medium SOFA score
    2. Area under the SOFA curve (AUC)
    3. Death
    4. Hospitalization
    5. Intensive care admission
    6. Intubation
    7. Combination of intensive care admission, intubation and death
    8. Non-invasive ventilation (CPAP, high-flow etc.)
    9. ECMO treatment
    10. Renal replacement therapy
    11. Quality of Life (EQ-5D-3L)
    12. Change in viral load (only if clinically determined)
    13. C-reactive protein (CRP), D-dimer, IL-6, highly sensitive troponin (hsTN), NT-pro-BNP, lymphocytes, eosinophil and platelet count, ferritin, transferrin, LDH, procalcitonin, neopterin
    14. Identification of biomarkers (cellular immune status, soluble biomarkers, CHIP, transcription patterns at single cell level)
    15. Seroconversion
    1. Maximaler und mittlerer SOFA-Score
    2. Fläche unter der SOFA-Kurve (AUC)
    3. Tod
    4. Hospitalisierung
    5. Aufnahme auf Intensivstation
    6. Intubation
    7. Kombination aus Aufnahme auf Intensivstation, Intubation und Tod
    8. Nicht-invasive Beatmung (CPAP, high-flow etc.)
    9. ECMO-Behandlung
    10. Nierenersatztherapie
    11. Quality of Life (EQ-5D-3L)
    12. Veränderung Viruslast (nur falls klinisch erhoben)
    13. C-reaktives Protein (CRP), D-Dimer, IL-6, hochsensitives Troponin (hsTN), NT-pro-BNP, Lymphozyten, Eosinophilen- und Thrombozytezahl, Ferritin, Transferrin, LDH, Procalcitonin, Neopterin
    14. Identifikation von Biomarkern (zellulärer Immunstatus, lösliche Biomarker, CHIP, Transkriptionsmuster auf Einzelzellebene)
    15. Serokonversion
    E.5.2.1Timepoint(s) of evaluation of this end point
    After the last visit at day 30 (±2 days)
    Nach der letzten Visite am Tag 30 (±2 Tage)
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Evidence that discontinuing chronic ACEI/ARB medication has a positive impact on the clinical course of COVID-19 disease.
    Nachweis, ob das Absetzen einer chronischen ACEI/ARB-Medikation den klinischen Verlauf einer COVID-19-Erkrankung positiv beeinflusst
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Weiterführen versus Absetzen von bereits verschriebener chronischen ACEI/ARB-Medikation
    Continuation of prescribed ACEI/ARB-medication vs. discontinuation of prescribed ACEI/ARB-medication
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    The clinical trial is deemed to have ended when the last subject has completed his last visit as scheduled.
    The sponsor is entitled to end the clinical trial early at any time. This can be due to medical or ethical concerns, or if the clinical trial cannot be performed properly. The reasons for the termination will be documented in detail.
    Die klinische Prüfung gilt als beendet, wenn der letzte Proband seine prüfplangemäße letzte Visite absolviert hat.
    Der Sponsor ist jederzeit berechtigt, die klinische Prüfung vorzeitig zu beenden. Dies kann auf Grund medizinischer oder ethischer Bedenken erfolgen, oder falls die klinische Prüfung nicht sinnvoll durchgeführt werden kann. Die Gründe der Beendigung werden im Detail zu dokumentieren.
    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 months0
    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: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 638
    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 state648
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 798
    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)
    As planned in routine
    wie in Routine vorgesehen
    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 Decision2020-04-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-12-31
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