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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2020-001995-13
    Sponsor's Protocol Code Number:BREATH-19
    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:2020-05-21
    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 number2020-001995-13
    A.3Full title of the trial
    A multicentre, open-label clinical trial to evaluate the effectiveness and safety of intravenous tocilizumab for treating patients with COVID-19 pneumonia: the BREATH-19 Study
    Ensayo clínico abierto y multicéntrico para evaluar la efectividad y seguridad de tocilizumab intravenoso en el tratamiento de pacientes con neumonía por COVID-19: estudio BREATH-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate the efficacy and safety of tocilizumab for treating patients with COVID-19 pneumonia: the BREATH-19 Study
    Ensayo clínico para evaluar la eficacia y seguridad de tocilizumab en el tratamiento de pacientes con neumonía por COVID-19: estudio BREATH-19
    A.4.1Sponsor's protocol code numberBREATH-19
    A.5.4Other Identifiers
    Name:FSG011-20Number:FSG011-20
    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 SponsorFundación SEIMC-GESIDA
    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 supportRoche Farma
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDynamic Science S.L.
    B.5.2Functional name of contact pointRaúl Montalbán Casado
    B.5.3 Address:
    B.5.3.1Street AddressC/Azcona, 31
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28028
    B.5.3.4CountrySpain
    B.5.4Telephone number003491 456 11 05
    B.5.5Fax number003491 456 11 26
    B.5.6E-mailraul.m@dynasolutions.com
    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 Roactemra
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTocilizumab
    D.3.9.1CAS number 375823-41-9
    D.3.9.3Other descriptive nameTOCILIZUMAB
    D.3.9.4EV Substance CodeSUB20313
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    COVID-19 pneumonia
    Neumonía por COVID-19
    E.1.1.1Medical condition in easily understood language
    COVID-19 pneumonia
    Neumonía por COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effectiveness of IV tocilizumab in treating patients with COVID-19 pneumonia. Improvement of respiratory function based on:
    - Time to intubation (if not previously intubated) and duration of intubation.
    - Time of non-invasive mechanical ventilation.
    - Time of oxygen therapy.

    Mortality rate
    Evaluar la efectividad del tocilizumab IV en el tratamiento de pacientes con neumonía por COVID-19. La mejora de la función respiratoria basada en:
    - Tiempo de intubación (si no se intubó previamente) y duración de la intubación.
    - Tiempo de ventilación mecánica no invasiva (VMNI).
    - Tiempo de oxigenoterapia.

    Tasa de mortalidad
    E.2.2Secondary objectives of the trial
    - To describe oxygen saturation (SpO2), PaO2/FiO2 (<300), or the equivalent SaO2/FiO2 (<315)
    - To evaluate radiological evolution
    - To describe the duration of hospitalization and/or ICU stay
    - To evaluate the requirement of additional organ support, including kidney dialysis, molecular adsorbent recirculating system (MARS), extracorporeal membrane oxygenation (ECMO), or other
    - To evaluate the effect of IV tocilizumab on the serum levels of inflammatory markers
    - To describe safety of IV tocilizumab in patients with COVID-19 pneumonia
    - To identify prognosis factors of IV tocilizumab effectiveness related to inflammatory markers and clinical/radiological features.
    - To assess time to reverse-transcriptase polymerase chain reaction (RT-PCR) virus negativity, as appropriate.
    - To compare the effectiveness and safety outcomes based on the different doses of IV tocilizumab used in the participating centres.
    - To identify patient profile suitable to be benefited with tocilizumab
    - Describir la saturación de oxígeno (SpO2), PaO2 / FiO2 (<300) o el equivalente de SaO2 / FiO2 (<315)
    - Evaluar la evolución radiológica
    - Describir la duración de la hospitalización y / o la estancia en la UCI
    - Evaluar la necesidad de soporte orgánico adicional, incluyendo diálisis de riñón, diálisis de hígado usando MARS, OMECu otras
    - Evaluar el efecto de tocilizumab sobre los niveles séricos de marcadores inflamatorios
    - Describir la seguridad de tocilizumab
    - Identificar los factores pronósticos de la efectividad de tocilizumab relacionados con marcadores inflamatorios y características clínicas / radiológicas.
    - Evaluar el tiempo hasta la aparición de resultado negativo del virus a través de la RT-PCR, según corresponda.
    - Comparar los resultados de efectividad y seguridad basados en las diferentes dosis de tocilizumab utilizadas en los centros participantes.
    - Identificar el perfil de paciente que se pueda beneficiar del tratamiento con tocilizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Provide oral informed consent to participate in this study.
    - At least 18 years of age.
    - Diagnosed with COVID-19 pneumonia by RT-PCR.
    - Have received the first dose of tocilizumab a maximum of two days before the inclusion or is candidate for tocilizumab treatment.
    - Hospitalized or admitted to ICU.
    - Proporcionar consentimiento informado oral para participar en este estudio.
    - Al menos 18 años de edad.
    - Diagnosticado con neumonía por COVID-19 por RT-PCR.
    - Haber recibido la primera dosis de tocilizumab un máximo de dos días antes de la inclusión o ser candidato para el tratamiento con tocilizumab.
    - Hospitalizado o ingresado en la UCI
    E.4Principal exclusion criteria
    - The patient has any other medical condition or is receiving concomitant medication that could, in the opinion of the investigator, compromise the patient’s safety or collected data.
    - Known severe allergic reactions to tocilizumab or other monoclonal antibodies.
    - Active acute and severe infections, including tuberculosis infection.
    - Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
    - El paciente tiene cualquier otra afección médica o está recibiendo medicación concomitante que podría, en opinión del investigador, comprometer la seguridad del paciente o los datos obtenidos.
    - Reacciones alérgicas graves conocidas a tocilizumab u otros anticuerpos monoclonales.
    - Infecciones agudas y graves activas, incluida la infección tuberculosa.
    - Embarazada o lactante, o prueba de embarazo positiva en un examen previo a la dosis.
    E.5 End points
    E.5.1Primary end point(s)
    - Respiratory function, defined as:
    Start date of intubation (in patients not previously initiated).
    Date of extubation.
    Start date of NIMV and date of independence from NIMV (duration of NIMV).
    Start date of oxygen therapy and date of independence from oxygen therapy (duration of oxygen therapy).

    - Mortality rate.
    - Función respiratoria, definida como:
    Fecha de inicio de la intubación (en pacientes no iniciados previamente).
    Fecha de extubación.
    Fecha de inicio de VMNI y fecha de independencia de VMNI (duración de VMNI).
    Fecha de inicio de la oxigenoterapia y fecha de independencia de la oxigenoterapia (duración de la oxigenoterapia).

    - Tasa de mortalidad.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End points will be evaluated on a ongoing basis during the clinical trial
    Las variables serán evaluadas forma continua durante el ensayo clínico
    E.5.2Secondary end point(s)
    - Levels of oxygen saturation (SpO2), PaO2/FiO2 (<300), or the equivalent SaO2/FiO2 (<315) at 1 day after the first dose and every 3 days during the hospitalization.
    - Results from the chest x-ray/computed tomography (CT) scan, including extension of lung affection (unilobar or multilobar, unilateral or bilateral, diffuse) and type (opacities, interstitial infiltrates, pneumothorax, pleural effusion) obtained (when available) throughout the study.
    - Days of hospitalization in survivors and/or days at ICU throughout the study.
    - Need of additional organ support, including kidney dialysis, MARS, ECMO, or other throughout the study.
    - Levels of IL-6, CRP, procalcitonin (PCT), D-dimer and ferritin (when available) throughout the study.
    - Adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs), vital signs, physical examinations, and concomitant medication use over time.
    - Association between the abovementioned clinical and radiological features and IV tocilizumab effectiveness.
    - Time to RT-PCR virus negativity, as appropriate.
    - Respiratory function and adverse events using different doses of tocilizumab in the participating centres.
    - Categorization of the different parameters of effectiveness and its relation with different factors related to the study treatment, disease status and demographic and clinical factors
    - Niveles de saturación de oxígeno (SpO2), PaO2 / FiO2 (<300), o el equivalente de SaO2 / FiO2 (<315) 1 día después de la primera dosis y cada 3 días durante la hospitalización.
    - Resultados de la radiografía de tórax/escáner de Tomografía computarizada (TC), incluyendo la extensión de la afección pulmonar (unilobular o multilobular, unilateral o bilateral, difusa) y tipo (opacidades, infiltrados intersticiales, neumotórax, derrame pleural), obtenidos (cuando estén disponibles) durante todo el estudio.
    - Días de hospitalización en supervivientes y / o días en la UCI durante todo el estudio.
    - Necesidad de soporte orgánico adicional, incluyendo diálisis de riñón, diálisis de hígado usando MARS (Molecular Adsorbents Recirculation System), oxigenación por membrana extracorpórea (OMEC), u otras durante todo el estudio.
    - Niveles de IL-6, proteína C reactiva (PCR), procalcitonina (PCT), dímero D y ferritina (cuando estén disponibles) durante todo el estudio.
    - Acontecimientos adversos (AA), acontecimientos adversos graves, acontecimientos adversos de especial interés, signos vitales, exámenes físicos y el uso concomitante de medicamentos con el tiempo.
    - Asociación entre las características clínicas y radiológicas mencionadas anteriormente y la efectividad de tocilizumab.
    - Tiempo hasta la negatividad del virus por RT-PCR, según corresponda.
    - Función respiratoria y acontecimientos adversos usando diferentes dosis de tocilizumab en los centros participantes.
    - Categorización de los diferentes parámetros de efectividad y su relación con diferentes factores relacionados con el tratamiento del estudio, el estado de la enfermedad y los factores demográficos y clínicos
    E.5.2.1Timepoint(s) of evaluation of this end point
    End points will be evaluated on a ongoing basis during the clinical trial
    Las variables serán evaluadas forma continua durante el ensayo clínico
    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 No
    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 No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned42
    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
    LVLS
    Ultima visita del último paciente
    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 months3
    E.8.9.1In the Member State concerned days
    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: 500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 500
    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 Yes
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients that given their clinical situation due to COVID-19 pneumonia cannot give consent personally
    Pacientes que debido a su situación clínica derivada de la neumonía por COVD-19 no puedan dar el consentimiento para participar en el ensayo
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state500
    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)
    According to clinical standard practice
    De acuerdo a la práctica clínica habitual
    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 Decision2020-05-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-14
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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