Clinical Trials Register

Summary
EudraCT Number:	2020-001303-16
Sponsor's Protocol Code Number:	7747
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2020-03-29
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

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A. Protocol Information

A.1

Member State Concerned

France - ANSM

A.2

EudraCT number

2020-001303-16

A.3

Full title of the trial

Efficacy of Hydroxychloroquine, Telmisartan and Azithromycin on Survival in Elderly Hospitalized Patients with VIDOC-19 : A Randomized, Multi-Centre, Adaptive, Blinded Study

Efficacité de l’Hydroxychloroquine, du Telmisartan et de l’Azithromycine sur la survie des patients âgés hospitalisés atteints de COVID-19 : une étude randomisée, multicentrique, adaptative, en aveugle

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Efficacy of Hydroxychloroquine, Telmisartan and Azithromycin on Survival in Elderly Hospitalized Patients with VIDOC-19 : A Randomized, Multi-Centre, Adaptive, Blinded Study

A.3.2

Name or abbreviated title of the trial where available

COVID-Aging

A.4.1

Sponsor's protocol code number

7747

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	Hôpitaux Universitaires de Strasbourg
B.1.3.4	Country	France
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	Hôpitaux universitaires de Strasbourg
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Hôpitaux Universitaires de Strasbourg
B.5.2	Functional name of contact point	Eric DEMONSANT
B.5.3	Address:
B.5.3.1	Street Address	1 place de l'hopital
B.5.3.2	Town/ city	STRASBOURG
B.5.3.3	Post code	67091
B.5.3.4	Country	France
B.5.4	Telephone number	0033388115266
B.5.5	Fax number	0033388115494
B.5.6	E-mail	dpidrci@chru-strasbourg.fr

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
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.2.1.1.1	Trade name	Plaquenil
D.2.1.1.2	Name of the Marketing Authorisation holder	SANOFI-AVENTIS FRANCE
D.2.1.2	Country which granted the Marketing Authorisation	France
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.3.1	Product name	Hydroxychloroquine
D.3.4	Pharmaceutical form	Tablet
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	Test
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.2.1.1.1	Trade name	Telmisartan EG
D.2.1.1.2	Name of the Marketing Authorisation holder	EG LABO
D.2.1.2	Country which granted the Marketing Authorisation	France
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.3.1	Product name	Telmisartan
D.3.4	Pharmaceutical form	Tablet
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	Test
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.2.1.1.1	Trade name	Azithromycine EG
D.2.1.1.2	Name of the Marketing Authorisation holder	EG LABO
D.2.1.2	Country which granted the Marketing Authorisation	France
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.3.1	Product name	Azithromycine
D.3.4	Pharmaceutical form	Tablet
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.2.1.1.1	Trade name	Curcumin C3
D.2.1.1.2	Name of the Marketing Authorisation holder	Prescription Nature
D.2.1.2	Country which granted the Marketing Authorisation	France
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.3.1	Product name	Curcumin
D.3.4	Pharmaceutical form	Capsule
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	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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

COVID-19 infection

Infection à COVID-19

E.1.1.1

Medical condition in easily understood language

COVID-19 infection

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

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

The main objective of this study is to evaluate the survival interest of Hydroxychloroquine 400 mg, Telmisartan 80 mg, Azithromycin 500 mg and Curcumin 800 mg daily on the survival of elderly patients with VIDOC-19 at 2 weeks from the start of treatment.

L’objectif principal de cette étude est d’évaluer l’intérêt sur la survie de l’Hydroxychloroquine 400 mg, du Telmisartan 80 mg, de l’Azithromycine 500 mg et de la Curcumine 800 mg par jour sur la survie des patients âgés atteints du COVID-19 à 2 semaines du début du traitement.

E.2.2

Secondary objectives of the trial

To evaluate adverse events, and particulary serious adverse avent.
ToEvaluate the effectiveness of different treatments on :
- SARS-Cov-2
- Survival to 4 weeks
- Inflammation
- The confusion
- Walking
- Functional capabilities
- Breathing rate
-Oxygen therapy
- Pulse rate
- Systolic and diastolic blood pressure
- Temperature
- Pneumonia
- Discharge
- Transfer to a convalescent hospital (SSR or equivalent)
- Necessity of add-on coritcosteroids or other immunomodulator or immunosuppressor
- Oxygen therapy
- The impulse rate
- Systolic and diastolic blood pressure
- The temperature
- Pneumonia
- The return home
- Disclaimer
- Transfer to a convalescent hospital (RHS or equivalent)
- The need for treatment with complementary, immonumodulating or immunosuppressive corticosteroids.

• Evènements indésirables et en particulier les évènements indésirables graves
• Evaluer l’efficacité des différents traitements sur :
-Le SRAS-Cov-2
-La survie à 4 semaines
-L’inflammation
-La confusion
-La marche
-Les capacités fonctionnelles
-Le taux de respiration
-L’oxygénothérapie
-Le taux d'impulsion
-La pression artérielle systolique et diastolique
-La température
-Pneumonie
-Le retour à domicile
-Décharge
-Le transfert vers un hôpital de convalescence (SSR ou équivalent)
-La nécessité d’un traitement par corticostéroïdes complémentaires, immonumodulateurs ou immunosuppresseurs.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Subject Male or female age ≥ 75, or ≥ 60 if dementia
- Subject infected with COVID 19 (confirmed by RT-PCR SARS-CoV-2 detectable less than 5 days old and clinical picture)
- Clinical manifestation of COVID 19 requiring hospitalization
- Subject affiliated to a social health insurance scheme
- Subject capable of understanding the objectives and risks of the research and of giving dated and signed informed consent, or agreement given by a trusted person, guardian or trustee.
- Subject who has been informed of the results of the prior medical examination

-Sujet Homme ou femme d’âge ≥ 75 ans, ou ≥ 60 ans si démence
-Sujet infecté par le COVID 19 (confirmé par RT-PCR SARS-CoV-2 détectable de moins de 5 jours et tableau clinique)
-Manifestation clinique du COVID 19 requérant une hospitalisation
-Sujet affilié à un régime de protection sociale d’assurance maladie
-Sujet apte à comprendre les objectifs et les risques liés à la recherche et à donner un consentement éclairé daté et signé, ou accord donné par la personne de confiance, le tuteur ou le curateur.
-Sujet ayant été informé des résultats de la visite médicale préalable

E.4

Principal exclusion criteria

Patients with a negative RT-PCR SARS-CoV-2 result
- Patients with COVID19 pneumopathy requiring resuscitative breathing support
- Patient on Sartan (Telmisartan, Candesartan, Valsartan, etc...), another antihypertensive, Hydroxychloroquine or Chloroquine, or macrolides (Azithromycin, Clarythromycyin...) within the last 24 hours.
- Patient with a contraindication to one of the treatments proposed in the study
- Contraindication Hydroxychloroquine: citalopram, escitalopram, hydroxyzine, domperidone, piperaquine, QT prolongation (>470ms for men and >480 ms for women), retinopathy, hypersensitivity to the active substances or to one of the excipients.
- Contraindication Azithromycin: combination with ergot derivatives, combination with colchicine, patients at risk of developing cardiac arrhythmia (diagnosis of QT interval prolongation (>470ms for men and >480 ms for women), severe hepatic impairment, history of allergy to macrolides or any of the excipients used in this study.
- Contraindication Telmisartan: Combination with drugs containing aliskiren, severe hepatic impairment, biliary obstruction, hypersensitivity to the active substance or to any of the excipients used in this study.
- Subject under safeguard of justice

-Patients ayant un résultat RT-PCR SARS-CoV-2 négatif
-Patients atteints de pneumopathie COVID19 nécessitant une assistance respiratoire en réanimation
-Patient sous Sartan (Telmisartan, Candesartan, Valsartan, etc…) sous un autre anti-hypertenseur, sous Hydroxychloroquine ou Chloroquine, ou sous macrolides (Azithromycine, Clarythromycyine…) dans les dernières 24 heures
-Patient présentant une contre-indication à l’un des traitements proposés dans l’étude
-Contre-indication Hydroxychloroquine : citalopram, escitalopram, hydroxyzine, domperidone, piperaquine, allongement du QT (>470ms pour les hommes et >480 ms pour les femmes), rétinopathie, hypersensibilité aux substances actives ou à l’un des excipients
-Contre-indication Azithromycine : l’association avec les dérivés de l’ergot de seigle, l’association avec la colchicine, patients à risque de survenue d’arythmie cardiaque (diagnostic d’un allongement de l’intervalle QT (>470ms pour les hommes et >480 ms pour les femmes), l’insuffisance hépatique sévère, les antécédents d'allergie aux macrolides ou à l’un des excipients utilisés pour cette étude
-Contre-indication Telmisartan : L’association à des médicaments contenant de l’aliskiren, insuffisance hépatique sévère, obstruction biliaire, hypersensibilité à la substance active ou à l’un des excipients utilisés pour cette étude
-Sujet sous sauvegarde de justice

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint will be two-weeks survival rate.

Le taux de survie à 2 semaines de traitements

E.5.1.1

Timepoint(s) of evaluation of this end point

14 days

14 jours

E.5.2

Secondary end point(s)

The secondary endpoints will be:
- Serious adverse events rate
- SARS RT-PCR-Cov-2 at 7 and 14 days
- The 28-day death rate
- The evolution of the CRP at 7 and 14 days
- Blood count evolution at 7 and 14 days of age
- And on a 7 and 14 day frame
o Hypotensive systolic or diastolic blood pressure Temperature <35 ° C or >40 ° C
o Pneumonia Severity Index (PSI) (Hung et al 2017),
o Non-cough rate,
o The rate of absence of dyspnea
o Rate of absence of fever
o The rate of non-requirement of supplementary oxygen
- The rate of SARS-Cov-2 undetectable at 7 and 14 days
- Recovery time
- Critical care admission rate
- The mechanical ventilation rate.
At regular intervals of 3 days:
- The evolution of the 4-meter walking test,
- Changes in Activity of Daily Living (ADL) and IADL (Instrumental Activity of Daily Living)
- The evolution of the 4AT confusion scale
- The number and dose of added corticosteroids, immonumodulators or immunosuppressants.

-Les événements indésirables et en particulier les évènements indésirables graves
-RT-PCR du SRAS-Cov-2 à 7 et 14 jours
-Le taux de décès à 28 jours
-L’évolution de la CRP à 7 et 14 jours
-L’évolution de la numération formule sanguine à 7 et 14 jours
-Et sur un cadre de 7 et 14 jours
oHypotension artérielle systolique ou diastolique La température <35 ° C ou >40 ° C
oL’indice de gravité de la pneumonie (PSI) (Hung et al 2017),
oLe taux de non-toux,
oLe taux d'absence de dyspnée
oLe taux d'absence de fièvre
oLe taux de non-besoin d'oxygène supplémentaire
-Le taux de SRAS-Cov-2 indétectable à 7 et 14 jours
-Le temps de récupération
-Le taux d'admission en soins intensifs
-Le taux de ventilation mécanique.
A intervalle régulier de 3 jours :
-L’évolution du test de marche sur 4 mètres,
-L’évolution de l'activité de la vie quotidienne (ADL) et IADL (Activité instrumentale de la vie quotidienne)
-L’évolution de l’échelle de confusion 4AT
-Le nombre et la dose de corticostéroïdes ajoutés, d’immonumodulateurs ou d’immunosuppresseurs.

E.5.2.1

Timepoint(s) of evaluation of this end point

7, 14 and 28 days

7, 14 et 28 jours

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

E.6.4

Safety

E.6.5

Efficacy

Yes

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

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)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

Yes

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Adaptatif

Adaptive

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

Phytothérapie

Herbal Medicine

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

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

last visit of the last subject undergoing the trial

dernière visite du dernier sujet

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 months

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:

500

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

1100

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

Yes

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

- people with dementia
- confused age person

- personne atteinte de démence
- personne âgé confuse

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

1600

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-04-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-04-11

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2021-06-02

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