Clinical Trials Register

Summary
EudraCT Number:	2020-005015-40
Sponsor's Protocol Code Number:	IVER-303
National Competent Authority:	Slovakia - SIDC (Slovak)
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2021-03-25
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

Slovakia - SIDC (Slovak)

A.2

EudraCT number

2020-005015-40

A.3

Full title of the trial

A multicentre, phase III, double-blind, randomised, parallel, placebo-controlled trial to assess efficacy and safety of early administration of Ivermectin during 3 consecutive days to prevent SARS CoV-2 (COVID-19) hospitalisation in adults older than 50 years of age

Multicentrické, dvojito zaslepené, randomizované, paralelné, placebom kontrolované klinické skúšanie vo fáze III na vyhodnotenie účinnosti a bezpečnosti skorého podávania ivermektínu v priebehu troch po sebe nasledujúcich dní na prevenciu hospitalizácie z dôvodu ochorenia vírusom SARS-CoV-2 (COVID-19) u dospelých starších ako 50 rokov

A.3.1

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

Ivermectin to prevent SARS-CoV-2 (COVID-19) hospitalisation in subjects over 50

Použitie ivermektínu na prevenciu hospitalizácie účastníkov so SARS-CoV-2 (COVID-19) vo veku nad 50 rokov

A.3.2

Name or abbreviated title of the trial where available

Ivermectin to prevent SARS-CoV-2 (COVID-19) hospitalisation in subjects over 50

Ivermektín na prevenciu hospitalizácie SARS-CoV-2 (COVID-19) u osôb starších ako 50 rokov

A.4.1

Sponsor's protocol code number

IVER-303

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	Chemo Research S.L.
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Chemo Research S.L.
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Chemo Research S.L.
B.5.2	Functional name of contact point	Medical Director
B.5.3	Address:
B.5.3.1	Street Address	Manuel Pombo Angulo, 28
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28050
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034917711500
B.5.5	Fax number	0034917668963
B.5.6	E-mail	Maria.Perello@exeltis.com

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	No
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	Ivermectin 9 mg tablets
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Ivermectin
D.3.9.1	CAS number	70288-86-7
D.3.9.3	Other descriptive name	IVERMECTIN
D.3.9.4	EV Substance Code	SUB12089MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	9
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	No
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	Ivermectin 18 mg tablets
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Ivermectin
D.3.9.1	CAS number	70288-86-7
D.3.9.3	Other descriptive name	IVERMECTIN
D.3.9.4	EV Substance Code	SUB12089MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	18
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Coronavirus disease (COVID-19)

Ochorenie koronavírusom (COVID-19)

E.1.1.1

Medical condition in easily understood language

Coronavirus disease (COVID-19)

Ochorenie koronavírusom (COVID-19)

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	23.1
E.1.2	Level	PT
E.1.2	Classification code	10084460
E.1.2	Term	COVID-19 treatment
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To assess the efficacy of early administration of Ivermectin for three consecutive days to prevent SARS-CoV-2 hospitalisation in adults older than 50 years of age.

Vyhodnotiť účinnosť skorého podávania ivermektínu v priebehu troch po sebe nasledujúcich dní na prevenciu hospitalizácie z dôvodu ochorenia vírusom SARS-CoV-2 u dospelých starších ako 50 rokov

E.2.2

Secondary objectives of the trial

1. To assess efficacy of an early administration of Ivermectin for three consecutive days to prevent SARS-CoV-2 disease progression in adults older than 50 years of age
2. To evaluate the safety and tolerability of Ivermectin in SARS CoV 2 infected adults older than 50 years of age

1. Vyhodnotiť účinnosť skorého podávania ivermektínu v priebehu troch po sebe nasledujúcich dní na prevenciu progresie ochorenia vírusom SARS-CoV-2 u dospelých starších ako 50 rokov
2. Vyhodnotiť účinnosť a znášanlivosť ivermektínu u dospelých starších ako 50 rokov infikovaných vírusom SARS CoV 2

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female adult > 50 years of age
2. SARS-CoV-2 infection diagnosed either through a rapid antigen-based test or an RNA based reverse-transcription polymerase chain reaction (RT-PCR) diagnostic test performed in nasopharyngeal sample
3. Onset of COVID-19 symptoms < 120 hours prior to screening (Visit 1.1)
4. Written informed consent
5. For females of childbearing potential only: They must declare that they did not intend to become pregnant in the last month prior to screening and they do not intend to become pregnant for one month following the last IP administration. For males who have partners of childbearing potential: Willing to use condoms until 3 months after last IP intake.
6. Negative result for urine pregnancy test (women of childbearing potential only)

1. Dospelí muži alebo dospelé ženy vo veku > 50 rokov
2. Infekcia vírusom SARS-CoV-2 diagnostikovaná na základe rýchleho antigénového testu alebo diagnostického testu na RNA založenej polymerázovej reťazovej reakcii s reverznou transkriptázou (RT-PCR) vykonaného z nazofaryngeálnej vzorky
3. Nástup príznakov ochorenia COVID-19 < 120 hodín (5 dní) pred skríningom (návšteva V1.1)
4. Písomný informovaný súhlas
5. Iba pre ženy v plodnom veku: musia prehlásiť, že nemali v úmysle otehotnieť posledný mesiac pred skríningom a že nebudú mať v úmysle otehotnieť v priebehu jedného mesiaca po poslednom podaní skúšaného lieku. Pre mužov, ktorí majú partnerky v plodnom veku: ochotní používať kondómy až do 3 mesiacov po poslednom užití skúšaného lieku
6. Negatívny výsledok tehotenského testu z moču (iba ženy v plodnom veku)

E.4

Principal exclusion criteria

1. Intake of Ivermectin within 30 days before screening (Visit 1.1)
2. Routine intake of antivirals, including antiretroviral treatment
3. Allergy, hypersensitivity or contraindication to Ivermectin, metabolites or excipients
4. Subjects with symptoms of disease severity (dyspnoea, SpO2 ≤ 94%)
5. Subjects requiring hospitalisation for any reason
6. Epidemiological risk or suspicion of being infected by Loa loa or other filariases
7. Previous enrolment in this trial or participation in any other drug investigational trial within the past 30 days (or five half-lives of investigational product [IP] whichever is longer) prior to screening (Visit 1.1)
8. Weight < 50 kg
9. Pregnancy or lactation
10. Inability to take oral medications
11. At least one of the following acute/chronic disease or deficiency:
a. History of bone marrow transplant or haematopoietic systems diseases
b. Moderate or severe liver disease (Child Pugh score ≥ B or ALT [alanine transaminase] or AST [aspartate transaminase] > 3 times upper limit as determined at screening (Visit 1.2), severe cholestasis, cirrhosis or severe hepatic failure
c. Transplanted patient under immunosuppressive treatment, disease that may need immunosuppressive treatments or other medical conditions that under the judgement of investigator would not benefit the patient to be included (including but not limited to psoriasis, G6PD (glucose-6-phosphate dehydrogenase) deficiency, porphyria, history of diverticulosis, seizure disorder, concurrent malignancy requiring chemotherapy, ongoing skin infection (e.g. pyodermitis) or evidence of current tuberculosis including latent untreated tuberculosis)
d. Ophthalmological or recent/ongoing neurological diseases
12. Active cardiac disease or a history of cardiac dysfunction including any of the following:
a. History of angina pectoris, symptomatic pericarditis, or myocardial infarction within 12 months prior to screening
b. History of congestive heart failure (New York Heart Association functional classification III-IV)
13. Concomitant use of barbiturates, sodium oxybate, valproic acid or warfarin
14. Laboratory abnormalities relevant for the trial, including but not limited to: neutropenia < 500/mm3, thrombocytopenia < 100 000/mm3
15. Any other significant disease, disorder or finding which, in the opinion of the investigator, may significantly increase the risk to the subject because of participation in the study, affect the ability of the subject to participate in the study or impair interpretation of the study data
16. Employees of the investigator or clinical trial site, with direct involvement in the proposed trial or other studies under the direction of that investigator or clinical trial site, as well as family members of the employees or the principal investigator
17. Persons committed to an institution by virtue of an order issued either by the judicial or other authorities

1. Užívanie ivermektínu do 30 dní pred skríningom (návšteva 1.1)
2. Rutinné užívanie antivirotík vrátane antiretrovirotík
3. Alergia, precitlivenosť alebo kontraindikácia týkajúca sa ivermektínu, metabolitov alebo pomocných látok
4. Účastníci s príznakmi závažnosti ochorenia (dyspnoe, SpO2 ≤ 94 %)
5. Účastníci vyžadujúci hospitalizáciu z akéhokoľvek dôvodu
6. Epidemiologické riziko alebo podozrenie na infekciu Loa loa alebo inými filáriami
7. Predchádzajúce zaradenie do tohto klinického skúšania alebo účasť v akomkoľvek inom klinickom skúšaní lieku počas posledných 30 dní (alebo piatich polčasov rozpadu skúšaného lieku, podľa toho, čo je dlhšie) pred skríningom (návšteva V1.1)
8. Telesná hmotnosť < 50 kg
9. Tehotenstvo alebo dojčenie
10. Neschopnosť užívať perorálne lieky
11. Aspoň jedno z nasledujúcich akútnych/chronických ochorení alebo deficitov:
a. Anamnéza transplantácie kostnej drene alebo ochorenia hematopoetických systémov
b. Stredné alebo závažné ochorenie pečene (skóre podľa Childa-Pugha ≥ B alebo hladina ALT [alaníntransamináza] alebo AST [aspartáttransamináza] > 3-krát vyššia ako horný limit stanovená pri skríningu (návšteva V1.2)), závažná cholestáza, cirhóza alebo závažné zlyhanie pečene
c. Pacient po transplantácii s imunosupresívnou liečbou, ochorením, ktoré môže vyžadovať imunosupresívnu liečbu, alebo iné zdravotné stavy, na základe ktorých by podľa posúdenia skúšajúceho lekára účasť pre pacienta nebola prínosná (zahŕňajúc okrem iného psoriázu, deficit G6PD (glukóza-6-fosfátdehydrogenáza), porfýriu, anamnézu divertikulózy, záchvatové ochorenie, súbežnú malignitu vyžadujúcu chemoterapiu, súčasné kožné ochorenie (napr. pyodermitída) alebo dôkazy o súčasnej tuberkulóze vrátane latentnej neliečenej tuberkulózy)
d. Oftalmologické alebo nedávne/súčasné neurologické poruchy
12. Aktívne srdcové ochorenie alebo anamnéza poruchy funkcie srdca vrátane čohokoľvek z nasledujúceho:
a. Anamnéza angíny pectoris, symptomatická perikarditída alebo infarkt myokardu do 12 mesiacov pred skríningom
b. Anamnéza kongestívneho srdcového zlyhávania (funkčná klasifikácia podľa NYHA (New York Heart Association) III – IV)
13. Súčasné užívanie barbiturátov, oxybátu sodného, kyseliny valproovej alebo warfarínu
14. Laboratórne abnormality relevantné pre klinické skúšanie zahŕňajúc okrem iného neutropéniu < 500/mm3, trombocytopéniu < 100 000/mm3
15. Každé iné významné ochorenia, poruchy alebo nálezy, ktoré môžu podľa názoru skúšajúceho lekára významne zvýšiť riziko pre účastníka z dôvodu účasti v klinickom skúšaní, ovplyvňujú schopnosť účastníka zúčastniť sa na klinickom skúšaní alebo narušia interpretáciu údajov z klinického skúšania
16. Zamestnanci skúšajúceho lekára alebo pracoviska klinického skúšania, ktorí sú priamo zapojení do navrhovaného skúšania alebo iných skúšaní pod vedením skúšajúceho lekára alebo pracoviska klinického skúšania, ako aj rodinní príslušníci zamestnancov alebo hlavného skúšajúceho lekára
17. Osoby vo vzťahu k inštitúcii na základe uznesenia vydaného súdnymi alebo inými orgánmi

E.5 End points

E.5.1

Primary end point(s)

Percentage of subjects requiring SARS-CoV-2 hospitalisation during 28 days after first IP administration

Percento účastníkov vyžadujúcich hospitalizáciu z dôvodu ochorenia vírusom SARS-CoV-2 počas 28 dní po prvom podaní skúšaného lieku

E.5.1.1

Timepoint(s) of evaluation of this end point

Data recorded on day 1, 2, 3, 4, 6, 8, 10, 12, 14, 21, 28. Final evaluation on day 28.

Údaje zaznamenané v 1., 2., 3., 4., 6., 8., 10., 12., 14., 21., 28. deň. Záverečné vyhodnotenie v 28. deň.

E.5.2

Secondary end point(s)

1. Change in subjects’ clinical status on Day 28
2. The occurrence of any adverse event related to Ivermectin treatment

1. Zmena klinického stavu účastníkov v deň 28
2. Výskyt akýchkoľvek nežiaducich udalostí súvisiacich s liečbou Ivermectinom

E.5.2.1

Timepoint(s) of evaluation of this end point

Data recorded on day 1, 2, 3, 4, 6, 8, 10, 12, 14, 21, 28. Final evaluation on day 28.

Údaje zaznamenané v 1., 2., 3., 4., 6., 8., 10., 12., 14., 21., 28. deň. Záverečné vyhodnotenie v 28. deň.

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

Yes

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

E.8.1.4

Double blind

Yes

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

Yes

E.8.2.3

Other

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

LVLS

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:

208

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

624

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-03-25.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

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

250

F.4.2

For a multinational trial

F.4.2.1

In the EEA

832

F.4.2.2

In the whole clinical trial

832

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

2021-04-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-03-25

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2021-06-21

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