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    Summary
    EudraCT Number:2020-001321-31
    Sponsor's Protocol Code Number:24032020
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2020-001321-31
    A.3Full 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.3.1Title 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.3.2Name or abbreviated title of the trial where available
    COVID-19 HUF
    COVID-19 HUF
    A.4.1Sponsor's protocol code number24032020
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHospital Universitario de Fuenlabrada
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportHospital Universitario de Fuenlabrada
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario de Fuenlabrada
    B.5.2Functional name of contact pointComisión de Investigación
    B.5.3 Address:
    B.5.3.1Street AddressCalle Camino del Molino 2
    B.5.3.2Town/ cityFuenlabrada /Madrid
    B.5.3.3Post code28942
    B.5.3.4CountrySpain
    B.5.4Telephone number34916006000
    B.5.6E-mailfernando.bermejo@salud.madrid.org
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Dolquine
    D.2.1.1.2Name of the Marketing Authorisation holderProducts and Technology SL
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDolquine
    D.3.9.1CAS number 747-36-4
    D.3.9.3Other descriptive nameHYDROXYCHLOROQUINE SULFATE
    D.3.9.4EV Substance CodeSUB02587MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Kaletra versus Aluvia
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare SLU versus Abbvie
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITONAVIR
    D.3.9.1CAS number 155213-67-5
    D.3.9.4EV Substance CodeSUB10342MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLOPINAVIR
    D.3.9.1CAS number 192725-17-0
    D.3.9.4EV Substance CodeSUB02970MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Imatinib
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA BV
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNImatinib
    D.3.9.1CAS number 152459-95-5
    D.3.9.3Other descriptive nameIMATINIB
    D.3.9.4EV Substance CodeSUB25387
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number400 to 300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Olumiant
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland BV
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBARICITINIB
    D.3.9.3Other descriptive nameOlumiant
    D.3.9.4EV Substance CodeSUB180983
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4 to 2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another 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.1.1Medical condition(s) being investigated
    Pneumonia due to SARS Cov2 (COVID-19)
    Neumonía por SARS Cov2 (COVID-19)
    E.1.1.1Medical condition in easily understood language
    Pneumonia due to Covid-19
    Neumonía por Covid-19
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.2.2Secondary 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.2.3Trial contains a sub-study Yes
    E.2.3.1Full 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.3Principal 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.4Principal 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.5.1Primary 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.5.1.1Timepoint(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.5.2Secondary 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.5.2.1Timepoint(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.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Sin comparador
    No comparator
    E.8.2.4Number of treatment arms in the trial3
    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 No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 85
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state165
    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
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-04-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-10
    P. End of Trial
    P.End of Trial StatusOngoing
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