Clinical Trials Register

Summary
EudraCT Number:	2020-001321-31
Sponsor's Protocol Code Number:	24032020
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2020-04-13
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

Spain - AEMPS

A.2

EudraCT number

2020-001321-31

A.3

Full title of the trial

Prospective, phase II, randomized, open-label, parallel group study to evaluate the efficacy of hydroxychloroquine together with baricitinib, imatinib or early lopinavir / ritonavir in patients with SARS Cov2 pneumonia (COVID-19 HUF)

Estudio prospectivo, fase II, aleatorizado, abierto, de grupos paralelos para evaluar la eficacia de hidroxicloroquina junto a baricitinib, imatinib o lopinavir/ritonavir precoz en pacientes con neumonía por SARS Cov2 (COVID-19 HUF)

A.3.1

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

Clinical trial phase II to evaluate the efficacy of 3 types of treatment in patients with pneumonia by COVID-19

Ensayo clínico fase II para evaluar la eficacia de 3 tipos de tratamiento en pacientes con neumonía por COVID-19

A.3.2

Name or abbreviated title of the trial where available

COVID-19 HUF

A.4.1

Sponsor's protocol code number

24032020

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	Hospital Universitario de Fuenlabrada
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	Hospital Universitario de Fuenlabrada
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	Hospital Universitario de Fuenlabrada
B.5.2	Functional name of contact point	Comisión de Investigación
B.5.3	Address:
B.5.3.1	Street Address	Calle Camino del Molino 2
B.5.3.2	Town/ city	Fuenlabrada /Madrid
B.5.3.3	Post code	28942
B.5.3.4	Country	Spain
B.5.4	Telephone number	34916006000
B.5.6	E-mail	fernando.bermejo@salud.madrid.org

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	Dolquine
D.2.1.1.2	Name of the Marketing Authorisation holder	Products and Technology SL
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	Coated 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	Dolquine
D.3.9.1	CAS number	747-36-4
D.3.9.3	Other descriptive name	HYDROXYCHLOROQUINE SULFATE
D.3.9.4	EV Substance Code	SUB02587MIG
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: 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	Kaletra versus Aluvia
D.2.1.1.2	Name of the Marketing Authorisation holder	Accord Healthcare SLU versus Abbvie
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	Coated 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	RITONAVIR
D.3.9.1	CAS number	155213-67-5
D.3.9.4	EV Substance Code	SUB10342MIG
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LOPINAVIR
D.3.9.1	CAS number	192725-17-0
D.3.9.4	EV Substance Code	SUB02970MIG
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	50
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	Imatinib
D.2.1.1.2	Name of the Marketing Authorisation holder	TEVA BV
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	Coated 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	Imatinib
D.3.9.1	CAS number	152459-95-5
D.3.9.3	Other descriptive name	IMATINIB
D.3.9.4	EV Substance Code	SUB25387
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	400 to 300
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	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	Olumiant
D.2.1.1.2	Name of the Marketing Authorisation holder	Eli Lilly Nederland BV
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	Coated 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	BARICITINIB
D.3.9.3	Other descriptive name	Olumiant
D.3.9.4	EV Substance Code	SUB180983
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	4 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.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

Pneumonia due to SARS Cov2 (COVID-19)

Neumonía por SARS Cov2 (COVID-19)

E.1.1.1

Medical condition in easily understood language

Pneumonia due to Covid-19

Neumonía por Covid-19

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To compare and evaluate the efficacy of 3 treatment regimens (Hydroxychloroquine in combination with baricitinib, imatinib or lopinavir / ritonavir) in SARS-CoV-2 patients with severe pneumonia requiring admission, considering primary efficacy as time to clinical improvement.

Comparar y evaluar la eficacia de 3 pautas de tratamiento (Hidroxicloroquina en combinación con baricitinib, imatinib o lopinavir/ritonavir) en pacientes con SARS-CoV-2 con neumonía grave que requieren ingreso, considerando la eficacia primaria como tiempo a mejoría clínica.

E.2.2

Secondary objectives of the trial

To assess the safety (serious adverse effects, premature discontinuation of treatment), tolerability and secondary efficacy parameters of the 3 treatment guidelines, understood as: absence of progression to respiratory failure, absence of increased O2 requirements; need for mechanical ventilation; reduction of analytical parameters associated with poor prognosis; radiological progression of the disease on day + 7 of starting treatment; average hospital stay, intensification treatments, such as steroid boluses and tocilizumab, ICU admission,% mortality at the end of follow-up.
In addition, in those patients who consent and participate in an additional sub-study, possible biomarkers and genetic markers of susceptibility to SARS-CoV-2 will be evaluated using high-performance techniques with serum DNA from the participants.

Evaluar la seguridad (efectos adversos grave, discontinuación prematura de tratamiento), tolerabilidad y parámetros secundarios de eficacia de las 3 pautas de tratamiento entendidos como: ausencia de progresión a insuficiencia respiratoria, ausencia de mayores requerimientos de O2; necesidad de ventilación mecánica; reducción de parámetros analíticos asociados a mal pronóstico; progresión radiológica de la enfermedad en el día + 7 de iniciado el tratamiento; estancia media hospitalaria, tratamientos de intensificación, como bolos de esteroides y tocilizumab, ingreso en UCI, % de mortalidad a final de seguimiento.
Además en aquellos pacientes que consientan y participen en subestudio adicional se evaluarán posibles biomarcadores y marcadores genéticos de susceptibilidad al SARS-CoV-2 mediante técnicas de alto rendimiento con DNA sérico de los participantes.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Included in protocol v1.1 of 01 April 2020

Incluido en protocolo v1.1 del 01 abril 2020

E.3

Principal inclusion criteria

i. Signed informed consent form
ii. ≥18 years
iii. Confirmed diagnosis Pneumonia Covid19 +
iv. ECOG functional state 0 or 1
v. Less than 7 days from onset of symptoms
saw. NO contraindication for medication
vii. ECG QT <0.4
viii. Adequate liver, kidney and hematological function (or within the safety range to use these drugs)
1. Absolute granulocyte count> 1.5 x 109 / L
2. Absolute platelet count> 100 x 109 / L
3. Hb> 10 g / dL
4. Cr <1.5 mg / dL or Clearance> 50mL / min
5. Bilirubin <3 ULN
6. AST / ALT ≤ 2.5 times ULN

i. Formulario consentimiento informado firmado
ii. ≥18 años
iii. Diagnostico confirmado Neumonía Covid19+
iv. Estado funcional ECOG 0 o 1
v. Menos de 7 días desde inicio de los síntomas
vi. NO contraindicación para medicación
vii. ECG QT < 0.4
viii. Función hepática, renal y hematológica adecuada (o dentro de rango seguridad para utilizar estos fármacos)
1. Recuento absoluto de granulocitos > 1.5 x 109/L
2. Recuento absoluto plaquetas > 100 x 109/L
3. Hb > 10 g/dL
4. Cr < 1.5 mg/dL o Aclaramiento > 50mL/min
5. Bilirrubina < 3 LSN
6. AST/ALT ≤ 2,5 veces LSN

E.4

Principal exclusion criteria

i. No Covid confirmation
ii. No pneumonia
iii. Previous treatment with any of the study drugs
iv. Concomitant serious medical condition
1. ICC
2. IAM 6 months prior
3. Unstable Angina
4. Cardiomyopathy
5. Unstable Ventricular Arrhythmia
6. uncontrolled HTA
7. Uncontrolled psychotic disorders
8. Serious active infections
9. HIV
10. Active hepatitis
11. Neoplasia in active cancer treatment
v. Inability to take oral medication or malabsorption syndrome
saw.
vi. Inability to comply with study and follow-up procedures
vii. History of only relevant thromboembolic or hemorrhagic episodes in the last 6 months
viii. Contraindication to any study medication
ix. Pregnant women

i. No confirmación Covid
ii. No neumonía
iii. Tratamiento previo con alguna de las drogas de estudio
iv. Afectación médica concomitante grave
1. ICC
2. IAM 6 meses previos
3. Angina inestable
4. Miocardiopatía
5. Arritmia ventricular inestable
6. HTA no controlada
7. Trastornos psicóticos no controlados
8. Infecciones graves activas
9. VIH
10. Hepatitis activas
11. Neoplasia en tratamiento oncológico activo
v. Incapacidad para tomar medicación oral o síndrome de malabsorción
vi. Incapacidad para cumplir el estudio y los procedimientos de seguimiento
vii. Antecedentes de episodios tromboembólicos o hemorrágicos clínicamente relevantes en últimos 6 meses
viii. Contraindicación alguna medicación de estudio
ix. Mujeres embarazadas

E.5 End points

E.5.1

Primary end point(s)

8.1 Demographics
Age
Sex
Tobacco
Alcohol
Significant comorbidity
- HTA
- Cardiovascular disease
- DM
- COPD
- Cancer
- Chronic liver disease
- I kidney
- Known immunosuppression

8.2 Laboratory parameters
COVID BIOMARKERS
- PCR
- Procalcitonin
- LDH
- Dimero D
- Ferritin
- IL6
BIOCHEMICAL PARAMETERS
- Enzymatic creatinine
- ALT
- AST
- Bilirubin
- GGT
- F Alkaline
- Albumine
- Venous lactate
- Ultrasensitive Troponin I
- Creatin Kinasa (CK)

HEMATOLOGICAL PARAMETERS
- White Series
- Leukocytes (in absolute value)
- Neutrophils (in absolute value)
- Lymphocytes (in absolute value)
- Neutrophil / lymphocyte ratio
- Platelet / lymphocyte ratio
- Red Series
- erythrocytes
- Hb
- Platelets
- Coagulation
- Fibrinogen
- Coagulation Study

MICROBIOLOGICAL PARAMETERS
- SARS-Cov2 PCR in nasopharyngeal exudate

8.3 Radiodiagnosis
- Unilateral, unilobar, bilobar pneumonia ...
- Bilateral pneumonia
- Resolution infiltrators
- Infiltration resolution days
- Stabilization
- Radiological progression

8.4 Clinical variables
- Symptom onset days
- Days resolution symptoms
- Fever days
- Respiratory improvement (days)
- Temperature (<38.4 / 38.4-39.4 /> 39.4) * From The The Hscore11
- Organomegaly (No, liver or spleen, both) * From The Hscore11
- Fever
- Dry cough
- productive cough
- Hemoptysis
- dyspnea
- Asthenia
- Myalgia
- headache
- nausea
Vomiting
- Diarrhea
- Abdominal discomfort
- ARDS
- I cardiac
- FRA
- SHOCK
- death
- Secondary infection
- O2 saturation levels.
- Need O2, nasal goggles, liters VM non-invasive reservoir Intubation

8.5 Clinical management variables
- Hospital stay
- ICU admission
- No. of registrations

8.1 Demográficas
Edad
Sexo
Tabaco
Alcohol
Comorbilidad importante
- HTA
- Enfermedad cardiovascular
- DM
- EPOC
- Cáncer
- Hepatopatía crónica
- I renal
- Inmunosupresión conocida

8.2 Parámetros de laboratorio
BIOMARCADORES DE COVID
- PCR
- Procalcitonina
- LDH
- Dimero D
- Ferritina
- IL6
PARÁMETROS BIOQUIMICOS
- Creatinina enzimática
- ALT
- AST
- Bilirrubina
- GGT
- F Alcalina
- Albumina
- Lactato venoso
- Troponina I ultrasensible
- Creatin Kinasa (CK)

PARÁMETROS HEMATOLÓGICOS
- Serie Blanca
- Leucocitos (en valor absoluto)
- Neutrofilos(en valor absoluto)
- Linfocitos (en valor absoluto)
- Ratio Neutrofilos/linfocito
- Ratio plaquetas/linfocito
- Serie Roja
- Eritrocitos
- Hb
- Plaquetas
- Coagulación
- Fibrinógeno
- Estudio de Coagulación

PARÁMETROS MICROBIOLÓGICOS
- PCR SARS-Cov2 en exudado nasofaríngeo

8.3 Radiodiagnóstico
- Neumonía unilateral, unilobar, bilobar…
- Neumonía bilateral
- Resolución infiltrados
- Dias resolución infiltrados
- Estabilización
- Progresión radiológica

8.4 Variables clínicas
- Días inicio de síntomas
- Días resolución síntomas
- Días fiebre
- Mejora respiratoria (días)
- Temperatura (<38.4 / 38.4-39.4 / > 39.4)* Del The Hscore11
- Organomegalia (No, hepato o esplneo, ambas)* Del The Hscore11
- Fiebre
- Tos seca
- Tos productiva
- Hemoptisis
- Disnea
- Astenia
- Mialgias
- Cefalea
- Nauseas
- Vómitos
- Diarrea
- Disconfort abdominal
- SDRA
- I cardiaca
- FRA
- SHOCK
- Muerte
- Infección secundaria
- Niveles saturación de O2.
- Necesidad O2, gafas nasales, litros VM reservorio NO invasiva Intubación

8.5 Variables de gestión clínica
- Estancia hospitalaria
- Ingreso UCI
- Nº altas

E.5.1.1

Timepoint(s) of evaluation of this end point

Baseline, 7 days during treatment, day 14, day 35+/-5 and day 70+/-5

Basal, 7 días durante tratamiento, día 14, día 35+/-5 y día 70+/-5

E.5.2

Secondary end point(s)

Security variable.
The intensity of an AA will be classified according to version 5.0 of the NCI CTCAE.
https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_5x7.pdf

Variable de seguridad:
La intensidad de un AA se clasificará según la versión 5.0 de los CTCAE del NCI.
https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_5x7.pdf

E.5.2.1

Timepoint(s) of evaluation of this end point

Baseline, 7 days during treatment, day 14, day 35+/-5 and day 70+/-

Basal, 7 días durante tratamiento, día 14, día 35+/-5 y día 70+/-5

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

Yes

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)

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

Sin comparador

No comparator

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

When the sample size has been reached and the last patient included has made the last trial visit

Cuando se haya alcanzado el tamaño muestral y eñ último paciente incluido haya realizado la última visita del 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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

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

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

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

165

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

2020-04-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-04-10

P. End of Trial
P.	End of Trial Status	Completed

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IMP with orphan designation in the indication
Orphan Designation Number:
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