Clinical Trials Register

Summary
EudraCT Number:	2020-002462-14
Sponsor's Protocol Code Number:	FRAGILE-COLCOVID19
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:	2020-06-12
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

2020-002462-14

A.3

Full title of the trial

Phase 2/3, randomized, open study to compare the efficacy and safety of colchicine and glucocorticoids compared with the standard of treatment for moderate/severe COVID-19 in a fragile and vulnerable population, admitted to a geriatric hospital unit or in a transicional care center

Estudio fase 2/3, aleatorizado, abierto, para comparar la eficacia y la seguridad de colchicina y glucocorticoides comparado con el estándar de tratamiento para la COVID-19 moderada/grave en población frágil y vulnerable, ingresada en una unidad hospitalaria de geriatría o en centros sociosanitarios

A.3.1

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

Study to compare the efficacy and safety of colchicine and glucocorticoids compared with the standard of treatment for moderate/severe COVID-19 in a fragile and vulnerable population, admitted to a geriatric hospital unit or in a transicional care center

Estudio para comparar la eficacia y la seguridad de colchicina y glucocorticoides comparado con el estándar de tratamiento para la COVID-19 moderada/grave en población frágil y vulnerable, ingresada en una unidad hospitalaria de geriatría o en centros sociosanitarios

A.4.1

Sponsor's protocol code number

FRAGILE-COLCOVID19

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	Fundació Clinic per a la Recerca Biomèdica (FCRB)
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	SEID, S.A.
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	CTU Clinic
B.5.2	Functional name of contact point	Maria Joyera
B.5.3	Address:
B.5.3.1	Street Address	Rosselló, 149
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08036
B.5.3.4	Country	Spain
B.5.4	Telephone number	349327754002336
B.5.5	Fax number	34932279877
B.5.6	E-mail	joyera@clinic.cat

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	Colchicina Seid
D.2.1.1.2	Name of the Marketing Authorisation holder	SEID, 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	Colchicina
D.3.9.1	CAS number	64-86-8
D.3.9.3	Other descriptive name	COLCHICINE
D.3.9.4	EV Substance Code	SUB01420MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	0.5 to 2
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	Dacortín
D.2.1.1.2	Name of the Marketing Authorisation holder	Laboratorios ERN, 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	Prednisona
D.3.9.3	Other descriptive name	PREDNISONE
D.3.9.4	EV Substance Code	SUB10020MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	20 to 90
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

Infection by COVID19

Infección por COVID19

E.1.1.1

Medical condition in easily understood language

Infection by COVID19

Infección por COVID19

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	28.0
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 whether treatment with a short cycle of steroids (with prednisone 60 mg/d for 3 consecutive days) administered together with colchicine (at doses of 0.5 to 1.5 mg/d, adjusted for weight and renal function, for 3 days and maintenance of 0.5 mg/d for 14 days in total) reduces mortality from COVID-19 in this population by at least 20%, compared to the approved standard treatment at participating centers.

Evaluar si el tratamiento con un ciclo corto de corticoides (con prednisona 60 mg/d durante 3 días consecutivos) administrado juntamente con colchicina (a dosis de 0,5 a 1,5 mg/d, ajustada a peso y función renal, durante 3 días y mantenimiento de 0,5 mg/d durante 14 días en total) reduce al menos un 20% la mortalidad de COVID-19 en esta población, comparado con el tratamiento estándar aprobado en los centros participantes.

E.2.2

Secondary objectives of the trial

1. To assess and compare the safety of colchicine and glucocorticoids throughout the treatment and in the two weeks following treatment according to the incidence of:
- Mild adverse events
-Serious adverse events
- Hypersensitivity (allergic) reactions of grade ≥ 2.
-Clinically significant invasive bacterial or fungal infections
2. Percentage of patients who stop medication due to adverse events.
3. Assess and compare the duration and severity of symptoms by COVID-19 in the two treatment arms (response to treatment to be assessed by overall survival at 28 days from the start of treatment).

1. Evaluar y comparar la seguridad de colchicina y glucocorticoides a lo largo del tratamiento y en las dos semanas posteriores al mismo según la incidencia de:
- Acontecimientos adversos leves
-Acontecimientos adversos graves
- Reacciones de hipersensibilidad (por reacción alérgica) de grado ≥ 2.
-Infecciones bacterianas o fúngicas invasivas clínicamente significativas
2. Porcentaje de pacientes que abandonan la medicación por efectos adversos
3. Evaluar y comparar la duración y gravedad de los síntomas por COVID-19 en las dos ramas de tratamiento (la respuesta al tratamiento se evaluará mediante la supervivencia global a los 28 días del inicio del tratamiento).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Be at least 65 years old and be admitted to the Geriatrics Unit of the Internal Medicine Service (Hospital Clínic de Barcelona) or to a transicional care center.
2. Clinical diagnosis compatible with COVID-19 (in a favourable epidemiological context) with an illness considered moderate (grade 4) or severe (grade 5) according to the WHO 8-point ordinal scale for assessing clinical severity (https://www.who.int/publications/i/item/covid-19-therapeutic-trial-synopsis) This same scale will also be used to evaluate the evolution after applying the corresponding treatment. Baseline clinical parameters will include the presentation of fever and any respiratory symptoms, both of upper respiratory tract and dyspnea, affecting the general state or gastrointestinal manifestations, since it is known that in elderly people COVID-19 can present with atypical symptoms for a time that is difficult to determine, but it also tends to evolve to respiratory failure quickly and is associated with high mortality. For this reason, regardless of the time elapsed since the estimated onset of symptoms, patients with moderate disease with oxigen requirements grade 4 of the WHO, in which the presence of fever, mild dyspnea or any gastrointestinal manifestation attributable to the COVID-19, make an admission (in case of hospital) and a directed treatment (in all cases) are candidates to be included in the study. Patients with severe pneumonia, but who can be managed initially with high-flow oxygen therapy (WHO grade 5) may also be included in the study. The clinical diagnosis may be supported by radiological changes (via chest radiography, if available) suggestive of bilateral (established or incipient) pneumonia. At the time of diagnosis, biomarkers will also be collected, in an analysis that will include increased levels of PCR and/or ferritin and microbiological confirmation of SARS-CoV-2.
3. Patients in whom the current clinical situation and the basal functional situation condition a prognosis that makes them consider a limited therapy, which includes the contraindication of applying more aggressive (e.g. non-invasive ventilation) or invasive measures (e.g. cardiopulmonary resuscitation or orotracheal intubation and mechanical ventilation), both in patients admitted to the Geriatric Unit (Hospital Clínic de Barcelona) and in those admitted to a transicional care center. The latter patients are also not considered for transfer to a third level hospital (according to the criteria of fragility, available on page 14 of the CatSalut action protocols (https://canalsalut.gencat.cat/web/.content/_A-Z/C/coronavirus-2019-ncov/material-divulgatiu/recull-protocol-pneumonia.pdf).
4. Patient with a general condition that allows him/her to take the medication orally, without risk of bronchial aspiration.
5. Acceptance by the patient or responsible family member to participate in the study (written consent).

1. Tener una edad mínima de 65 años y estar ingresado en la Unidad de Geriatría del Servicio de Medicina Interna (Hospital Clínic de Barcelona) o en un centro sociosanitario.
2. Diagnóstico clínico compatible con COVID-19 (en un contexto epidemiológico favorecedor) con una enfermedad considerada moderada (grado 4) o grave (grado 5) según la escala ordinal de 8 puntos de la OMS para valorar la gravedad clínica (https://www.who.int/publications/i/item/covid-19-therapeutic-trial-synopsis). Esta misma escala también se utilizará para evaluar la evolución después de aplicar el tratamiento correspondiente. Los parámetros clínicos basales incluirán la presentación de fiebre y cualquier síntoma respiratorio, tanto de vías respiratorias altas como de disnea, de afectación del estado general o manifestaciones gastrointestinales, ya que es conocido que en personas ancianas la COVID-19 se puede presentar con síntomas atípicos durante un tiempo difícil de determinar, pero igualmente suele evolucionar a fallo respiratorio de forma rápida y se asocia a una mortalidad elevada. Por este motivo, sin tener en cuenta el tiempo transcurrido desde el inicio estimado de los síntomas, serán candidatos a ser incluidos en el estudio los pacientes con una enfermedad moderada con requerimientos de oxígeno - grado 4 de la OMS, en los que la presencia de fiebre, disnea leve o cualquier manifestación gastrointestinal atribuible a la COVID-19, hagan recomendable un ingreso (en caso del hospital) y un tratamiento dirigido (en todos los casos). Los pacientes con una neumonía grave, pero que se puedan manejar inicialmente con oxigenoterapia de alto flujo (grado 5 de la OMS) también se podrán incluir en el estudio. El diagnóstico clínico puede estar apoyado en cambios radiológicos (mediante radiografía de tórax, si está disponible) sugestivos de neumonía bilateral (establecida o incipiente). En el momento del diagnóstico, también se recogerán los marcadores biológicos, en un análisis que incluirá un aumento de los niveles de PCR y/o ferritina y la confirmación microbiológica de SARS-CoV-2.
3. Paciente en el que la situación clínica actual y la situación funcional basal condicionan un pronóstico que hacen considerar un techo terapéutico limitado, que incluye la contraindicación de aplicar mediadas más agresivas (p.ej. ventilación no invasiva) o invasivas (p.ej. reanimación cardiopulmonar o intubación orotraqueal y ventilación mecánica), tanto en los pacientes ingresados en la Unidad de Geriatría (Hospital Clínic de Barcelona) como en los ingresados un centro sociosanitario. En estos últimos pacientes tampoco se contempla el traslado a un centro hospitalario de tercer nivel (según los criterios de fragilidad, disponibles en la página 14 de los protocolos de actuación del CatSalut (https://canalsalut.gencat.cat/web/.content/_A-Z/C/coronavirus-2019-ncov/material-divulgatiu/recull-protocol-pneumonia.pdf).
4. Paciente con un estado general que le permita tomar la medicación por vía oral, sin riesgo de broncoaspiración.
5. Aceptar el/la paciente o el familiar responsable, participar en el estudio (consentimiento escrito).

E.4

Principal exclusion criteria

1. Clinical situation of advanced basic disease or terminal illness in the clinical judgement of the responsible physician and according to the definition of the Spanish Society for Palliative Care (SECPAL), which describes it as an advanced disease in an evolutionary and irreversible phase with multiple symptoms, emotional impact, loss of autonomy, with very little or no capacity to respond to specific treatment and with a life prognosis limited to weeks or months, in a context of progressive fragility (http://envejecimiento.csic.es/documentos/documentos/navarro-cuidadospaliativos-01.pdf).
2. Clinical status which is advanced and severe or in which the level of consciousness has deteriorated and the oral route of taking the medication is not safely tolerated (in the opinion of the doctor in charge)
3. Taking any of the drugs in the trial (colchicine or prednisone) chronically or intermittently in the 7 days prior to study inclusion.
4. Absolute contraindication to the use of the study medication, including hypersensitivity to the active substance or to any of its excipients, severe renal failure (FG <30 ml/min) and patients undergoing haemodialysis, severe liver failure, severe gastrointestinal disorders, gastric ulcer or blood dyscrasias.
5. Concomitant treatment with macrolides (clarithromycin, erythromycin, telithromycin, azithromycin), antifungals (itraconazole, ketoconazole), cyclosporine and antivirals (lopinavir/ritonavir, indinavir, nelfinavir, saquinavir).

1. Situación clínica de enfermedad de base avanzada o en fase terminal a juicio clínico del médico responsable y según la definición de la Sociedad Española de Cuidados Paliativos (SECPAL), que la describe como una enfermedad avanzada en fase evolutiva e irreversible con síntomas múltiples, impacto emocional, pérdida de autonomía, con muy escasa o nula capacidad de respuesta al tratamiento específico y con un pronóstico de vida limitado a semanas o meses, en un contexto de fragilidad progresiva (http://envejecimiento.csic.es/documentos/documentos/navarro-cuidadospaliativos-01.pdf).
2. Estadio clínico evolucionado y grave o con deterioro del nivel de consciencia, en el que no se tolere la vía oral con seguridad para tomar la medicación (a juicio del facultativo encargado).
3. La toma de alguno de los fármacos del ensayo (colchicina o prednisona) de modo crónico o puntual en los 7 días previos a la inclusión en el estudio.
4. Contraindicación absoluta para la utilización de la medicación del estudio, que incluyen hipersensibilidad al principio activo o a alguno de sus excipientes, insuficiencia renal grave (FG <30 ml/min) y pacientes sometidos a hemodiálisis, insuficiencia hepática grave, trastornos gastrointestinales graves, úlcera gástrica o discrasias sanguíneas.
5. Tratamiento concomitante con macrólidos (claritromicina, eritromicina, telitromicina, azitromicina), antifúngicos (itraconazol, ketoconazol), ciclosporina y antivirales (lopinavir/ritonavir, indinavir, nelfinavir, saquinavir).

E.5 End points

E.5.1

Primary end point(s)

Ratio of patients who die within 28 days of the start of treatment.

Proporción de pacientes que fallecen en los 28 días tras el inicio del tratamiento.

E.5.1.1

Timepoint(s) of evaluation of this end point

28 days of the start of treatment

28 días tras el inicio del tratamiento

E.5.2

Secondary end point(s)

Secondary safety assessment criteria in both groups:
-Percentage of patients who develop mild adverse events (e.g., diarrhea, abdominal pain, mild nausea and vomiting, as the most frequent and expected) and/or serious adverse events (any new events accompanying the previous ones, not attributable to COVID-19).
- Ratio of patients who develop an allergy attributable to treatment.
- Ratio of patients who develop a bacterial or fungal infection during treatment
- Ratio of patients who drop out of treatment due to adverse effects.
Secondary endpoints related to disease progression in both groups
-Improvement in the WHO 8-point scale (https://www.who.int/publications/i/item/covid-19-therapeutic-trial-synopsis)
- The time until resolution of the initial clinical event, maintained for at least 72 hours
- Percentage of patients who worsen (e.g., development of dyspnea or worsening of basal dyspnea) during treatment
- Leukocyte count, hemoglobin, platelets, creatinine, total bilirubin, alanine aminotransferase (ALT), at baseline, between days 10-20 and 28 (if still admitted)
- Mortality from any cause.

Criterios de valoración secundarios de seguridad en ambos grupos
- Porcentaje de pacientes que desarrollan efectos adversos leves (p.ej. diarrea, dolor abdominal, náuseas y vómitos leves, por ser los más frecuentes y esperados) y/o graves (cualquier evento nuevo que acompañe a los previos, no atribuible a COVID-19).
- Proporción de pacientes que desarrollan un cuadro de alergia atribuible al tratamiento.
- Proporción de pacientes que desarrollan una infección bacteriana o fúngica durante el tratamiento.
- Proporción de pacientes que abandonan el tratamiento por efectos adversos.
Criterios de valoración secundarios relacionados con la evolución de la enfermedad en ambos grupos
-Mejoría en la escala de 8 puntos de la OMS (https://www.who.int/publications/i/item/covid-19-therapeutic-trial-synopsis)
- El tiempo hasta la resolución del cuadro clínico inicial, mantenida durante al menos 72 horas
- Porcentaje de pacientes que empeoran (p. ej. desarrollo de disnea o empeoramiento de la disnea basal) durante el tratamiento.
- Recuento de leucocitos, hemoglobina, plaquetas, creatinina, bilirrubina total, alanina aminotransferasa (ALT), al inicio, entre los días 10-20 y 28 (si aún se encuentra ingresado)
- Mortalidad por cualquier causa.

E.5.2.1

Timepoint(s) of evaluation of this end point

28 days of the start of treatment

28 días tras el inicio del tratamiento

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)

Yes

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

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

Tratamiento estándar del centro del estudio

Standard of treatment of study site

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

LVLS (last visit last subject)

LVLS (última visita último paciente)

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)

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:

144

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

F.3.3.7

Others

Yes

F.3.3.7.1

Details of other specific vulnerable populations

Fragil and vulnerable population (elderly people)

Población frágil y vulnerable (personas de edad avanzada)

F.4 Planned number of subjects to be included

F.4.1

In the member state

144

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

Ninguno

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

2020-08-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-07-31

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2021-05-31

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