Clinical Trials Register

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	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Austria - BASG

A.2

EudraCT number

2020-001206-35

A.3

Full 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.3.1

Title 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.4.1

Sponsor's protocol code number

ACEI-COVID-19

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Medizinische Universität Innsbruck
B.1.3.4	Country	Austria
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Medizinische Universität Innsbruck
B.4.2	Country	Austria
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Medizinische Universität Innsbruck, Univ.-Klinik für Innere Medizin III
B.5.2	Functional name of contact point	Univ.-Prof. Dr. Axel Bauer
B.5.3	Address:
B.5.3.1	Street Address	Anichstraße 35
B.5.3.2	Town/ city	Innsbruck
B.5.3.4	Country	Austria
B.5.4	Telephone number	+4351250425621
B.5.6	E-mail	kks-regulatory@i-med.ac.at

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another 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.1.1

Medical 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.1.1.1

Medical 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.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main 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.2.2

Secondary 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.2.3

Trial contains a sub-study

E.3

Principal 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.4

Principal 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.5.1

Primary 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.5.1.1

Timepoint(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.5.2

Secondary 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.5.2.1

Timepoint(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.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other 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.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator 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.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

160

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

638

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

648

F.4.2

For a multinational trial

F.4.2.1

In the EEA

150

F.4.2.2

In 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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-04-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-04-14

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-12-31

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