Clinical Trials Register

Summary
EudraCT Number:	2020-001606-33
Sponsor's Protocol Code Number:	HIACO-19
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2020-04-07
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

Spain - AEMPS

A.2

EudraCT number

2020-001606-33

A.3

Full title of the trial

Randomized clinical trial to evaluate the efficacy of hydroxychloroquine associated or not with azithromycin as a treatment for COVID-19 infection.

Ensayo clínico aleatorizado para la evaluación de la eficacia de la hidroxicloroquina asociada o no a azitromicina como tratamiento para la infección COVID-19

A.3.1

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

Randomized clinical trial to evaluate the efficacy of hydroxychloroquine associated or not with azithromycin as a treatment for COVID-19 infection

Ensayo clínico aleatorizado para la evaluación de la eficacia de la hidroxicloroquina asociada o no a azitromicina como tratamiento para la infección COVID-19

A.3.2

Name or abbreviated title of the trial where available

Randomized clinical trial to evaluate the efficacy of a treatment for COVID-19 infection

Ensayo clínico aleatorizado para evaluar la eficacia de un tratamiento para la infección COVID-19

A.4.1

Sponsor's protocol code number

HIACO-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	Instituto Investigación Sanitario Biocruces Bizkaia
B.1.3.4	Country	Spain
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	Asociación Instituto Investigación Biocruces Bizkaia
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	Eunate Arana Arri (Instituto Investigación Biocruces Bizkaia)
B.5.2	Functional name of contact point	Epidemiologist
B.5.3	Address:
B.5.3.1	Street Address	Plaza de Cruces Nº12 Edificio 1 Planta 0
B.5.3.2	Town/ city	Barakaldo
B.5.3.3	Post code	48903
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034946182646
B.5.6	E-mail	eunate.aranaarri@osakidetza.eus

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.2.1.1.1	Trade name	Ibuprofen
D.2.1.1.2	Name of the Marketing Authorisation holder	LABORATORIOS NORMON, S.A
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	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	IBUPROFEN
D.3.9.1	CAS number	15687-27-1
D.3.9.4	EV Substance Code	SUB08098MIG
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	600
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	Hidroxicloroquina
D.2.1.1.2	Name of the Marketing Authorisation holder	PRODUCTS AND TECHNOLOGY S.L.,
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	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	Hydroxychloroquine
D.3.9.1	CAS number	118-42-3
D.3.9.4	EV Substance Code	SUB08077MIG
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	200
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	Azitromicina
D.2.1.1.2	Name of the Marketing Authorisation holder	KERN PHARMA, S.L.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	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	Azithromycin
D.3.9.1	CAS number	83905-01-5
D.3.9.3	Other descriptive name	AZITHROMYCIN
D.3.9.4	EV Substance Code	SUB05660MIG
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	500
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	Paracetamol
D.2.1.1.2	Name of the Marketing Authorisation holder	Laboratorios Normon, S.A
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Paracetamol
D.3.9.1	CAS number	103-90-2
D.3.9.3	Other descriptive name	PARACETAMOL
D.3.9.4	EV Substance Code	SUB09611MIG
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	500
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

COVID-19 infection

Infección por COVID-19

E.1.1.1

Medical condition in easily understood language

COVID-19 infection

Infección por 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	20.0
E.1.2	Level	PT
E.1.2	Classification code	10070255
E.1.2	Term	Coronavirus test positive
E.1.2	System Organ Class	10022891 - Investigations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Demonstrate the therapeutic effectiveness of Hydroxychloroquine associated with Azithromycin treatment for symptom control and negative viral load, in patients with comorbidities without pneumonia and COVID-19 infection.

Demostrar la efectividad terapéutica de la Hidroxicloroquina asociada al tratamiento con Azitromicina para el control de síntomas y la negativización de la carga viral, en pacientes con comorbilidades sin neumonía e infección por COVID-19

E.2.2

Secondary objectives of the trial

- Evaluate the safety of the treatment
- Assess tolerance of treatment

- Evaluar la seguridad del tratamiento
- Evaluar la tolerancia del tratamiento

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Patients of both sexes
- Patients ≥ 18 years with COVID and comorbidities (COPD, asthma, heart disease, HT, diabetes, neoplasia, chronic liver disease or with immunosuppressive treatment), without pneumonia or over 60 with COVID
- SARS-CoV-2 infection confirmed by PCR test
- Radiographic evidence of not presenting pneumonia
- O2 saturation> 92%
- Respiratory Rate <20 rpm
- Willing and able to sign the written informed consent before carrying out the study procedures. Exceptionally, oral consent is admitted, preferably before independent witnesses, documenting it in the medical record and provided that it can later be ratified.

- Pacientes de ambos sexos
- Pacientes ≥ 18 años con COVID y comorbilidades (EPOC, asma, cardiopatía, HTA, diabetes, neoplasia, hepatopatía crónica o con tratamiento inmunosupresor), sin neumonía o mayores de 60 con COVID
- Infección por SARS-CoV-2 confirmada por prueba de PCR
- Evidencia radiográfica de no presentar neumonía
- Saturación de O2 > 92%
- Frecuencia Respiratoria < 20 rpm
- Dispuesto y capaz de firmar el consentimiento informado por escrito antes de realizar los procedimientos del estudio. Excepcionalmente se admite el consentimiento oral, preferiblemente ante testigos independientes, documentándolo en la historia clínica y siempre que posteriormente se pueda ratificar.

E.4

Principal exclusion criteria

- Participation in any other clinical trial with an experimental treatment for COVID-19
- Hypersensitivity to the active substance, to 4-aminoquinoline compounds or to any of the excipients included in section 6.1 of the hydroxychloroquine data sheet
- Hypersensitivity to azithromycin, erythromycin, any other macrolide or ketolide antibiotic or to any of the excipients listed in section 6.1 of the azithromycin SmPC
- psoriasis
- Patients with glucose-6-phosphate dehydrogenase deficiency
- Any contraindication according to the Technical Data Sheet of Hydroxychloroquine and Azithromycin
- pneumonia
- Myasthenia gravis
- Pre-existing maculopathy of the eye
- Presence of changes in acuity or visual field
- QT +/- 450 extension
- ALT or AST> 5 x ULN
- Creatinine clearance <50 ml / min
- Positive pregnancy test
- Woman with breastfeeding
- Active treatment with: artemeter / lumefantrine, mefloquine, natilizumab, live attenuated virus vaccines, pimecrolimus, tacrolimus (topical), mosifloxacin, and agalsidase alpha and beta
- Refusal by the patient to accept the commitment to comply with the procedures indicated during the research process

- Participación en cualquier otro ensayo clínico con un tratamiento experimental para COVID-19
- Hipersensibilidad al principio activo, a los compuestos de 4-aminoquinolina o a alguno de los excipientes incluidos en la sección 6.1 de la ficha técnica de la hidroxicloroquina
- Hipersensibilidad a azitromicina, eritromicina, a cualquier otro antibiótico macrólido o ketólido o a alguno de los excipientes incluidos en la sección 6.1 de la ficha técnica de la azitromicina
- Psoriasis
- Pacientes con déficit de glucosa-6-fosfato deshidrogenasa
- Cualquier contraindicación según la Ficha técnica de Hidroxicloroquina y Azitromicina
- Neumonía
- Miastenia gravis
- Maculopatía preexistente del ojo
- Presencia de alteraciones de la agudeza o del campo visual
- Prolongación del QT +/- 450
- ALT o AST> 5 x ULN
- Aclaramiento de creatinina <50 ml / min
- Prueba de embarazo positiva
- Mujer con lactancia materna
- Tratamiento activo con: artemeter/lumefantrina, mefloquina, natilizumab, vacunas de virus vivos atenuados, pimecrolimus, tacrolimus (tópico), mosifloxacino y agalsidasa alfa y beta
- Negativa por parte del paciente a aceptar el compromiso de cumplir los procedimientos indicados durante el proceso de investigación

E.5 End points

E.5.1

Primary end point(s)

Proportion of patients with negative viral load by CODV-19 [SARS-CoV-2 (PCR)] at 6 days after the start of treatment

Proporción de pacientes con negativización de la carga viral por CODV-19 [SARS-CoV-2 (PCR)] a los 6 días tras el inicio del tratamiento

E.5.1.1

Timepoint(s) of evaluation of this end point

30 DAYS

30 DÍAS

E.5.2

Secondary end point(s)

- Sociodemographic data
- Clinical data: temperature, FR, SatO2 and FC
- Analytical data: biochemistry, hematimetry, LDH, ferritin and dimers
- Time until the first normalization of fever (normalization criteria: temperature <36.6 ° C armpit, <37.2 ° C oral, <37.8 ° C rectal). This variable will be determined from the subcohort of patients who have fever between symptoms.
- Time until improvement of RF and O2 Saturation (normalization criteria: FR <16 rpm and SatO2> 98%).
- Duration of hospitalization in the Hospitalization Service at Home / Hospital if applicable (days)
- Percentage of patients who develop pneumonia
- Percentage of patients requiring hospital admission for poor evolution
- All-cause mortality on day 28
- Proportion of patients with adverse treatment events leading to withdrawal of drug administration. It is defined as a safety population: those patients who have given their IC, have been randomized and have received at least one dose of study treatment with at least one evaluation and follow-up visit.

- Datos sociodemográficos
- Datos clínicos: temperatura, FR, SatO2 y FC
- Datos analíticos: bioquímica, hematimetría, LDH, ferritina y dímeros
- Tiempo hasta la primera normalización de la fiebre (criterios de normalización: temperatura <36,6°C axila, <37,2°C oral, <37.8°C rectal). Esta variable se determinará de la subcohorte de pacientes que tengan fiebre entre los síntomas.
- Tiempo hasta la mejora de la FR y la Saturación de O2 (criterios de normalización: FR < 16 rpm y SatO2 >98%).
- Duración de la hospitalización en el servicio de Hospitalización a Domicilio / Hospitalario si procede (días)
- Porcentaje de pacientes que desarrollan neumonía
- Porcentaje de pacientes que requieren ingreso hospitalario por mala evolución
- Mortalidad por todas las causas en el día 28
- Proporción de pacientes con eventos adversos del tratamiento que conducen a la retirada de la administración del fármaco. Se define como población de seguridad: aquellos pacientes que han dado su CI, han sido aleatorizados y han recibido al menos una dosis del tratamiento del estudio con al menos una visita de evaluación y seguimiento

E.5.2.1

Timepoint(s) of evaluation of this end point

30 DAYS

30 DÍAS

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

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

IBUPROFENO, PARACETAMOL

IBUPROFEN, PARACETAMOL

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the 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

the last visit of the last subject undergoing the trial

La última visita del último sujeto sometido al ensayo

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

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:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

132

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

Ninguna

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

2020-04-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-04-02

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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