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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:2020-001154-22
    Sponsor's Protocol Code Number:WA42380
    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:2020-04-03
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2020-001154-22
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF TOCILIZUMAB IN PATIENTS WITH SEVERE COVID-19 PNEUMONIA.
    ESTUDIO ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO Y MULTICÉNTRICO PARA EVALUAR LA SEGURIDAD Y LA EFICACIA DE TOCILIZUMAB EN PACIENTES CON NEUMONÍA GRAVE POR EL COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tocilizumab plus background therapy versus placebo plus background therapy in patients with severe COVID-19 pneumonia.
    Tocilizumab más terapia de base versus placebo más terapia de base en pacientes con neumonía grave por COVID-19
    A.4.1Sponsor's protocol code numberWA42380
    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 SponsorF. Hoffmann-La Roche Ltd.
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportBARDA
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number34913257300
    B.5.5Fax number34913248195
    B.5.6E-mailspain.start_up_unit@roche.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 Actemra®/ 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.3.2Product code RO4877533/F03-01
    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.3.9.2Current sponsor codeRO4877533
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe COVID-19 pneumonia
    NEUMONÍA GRAVE POR EL COVID-19
    E.1.1.1Medical condition in easily understood language
    Severe COVID-19 pneumonia
    NEUMONÍA GRAVE POR EL COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10035737
    E.1.2Term Pneumonia viral
    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
    The primary objective for this study is to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of TCZ compared with placebo in combination with SOC for the treatment of severe COVID-19 pneumonia
    El objetivo principal de este estudio es evaluar la eficacia, seguridad, farmacodinámica y farmacocinética de tocilizumab (TCZ) en comparación con el placebo correspondiente en combinación con el tratamiento estándar (TE) en pacientes hospitalizados con neumonía grave por COVID-19
    E.2.2Secondary objectives of the trial
    "Not applicable"
    "NA"
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age >= 18 years
    - Hospitalized with COVID-19 pneumonia confirmed per WHO criteria (including a positive PCR of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid) and evidenced by chest X-ray or CT scan
    - SpO2 <= 93% or PaO2/FiO2 < 300 mmHg.
    -Edad ≥18 años
    - Hospitalizado con neumonía de la COVID-19 confirmada según los criterios de la OMS (incluida una RCP positiva de cualquier muestra; p. ej., respiratoria, sangre, orina, heces, otro líquido corporal) y mediante radiografía de tórax o TAC
    -SpO2 ≤93 % o PaO2/FiO2 <300 mmhg
    E.4Principal exclusion criteria
    - Known severe allergic reactions to TCZ or other monoclonal antibodies
    - Active TB infection
    - Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)
    - In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
    - Have received oral anti-rejection or immunomodulatory drugs (including tocilizumab) within past 6 months
    - Pregnant or lactating women
    - Participating in other drug clinical trials (with possible exception of anti-viral trials)
    - ANC < 1000/mm3
    - Platelet count < 50,000/mm3
    - ALT or AST > 10 x ULN
    - Treatment with an investigational drug within 5 half-lives or 30 days
    - Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator’s judgment, precludes the patient’s safe participation in and completion of the study.
    -Reacciones alérgicas graves conocidas a TCZ u otros anticuerpos monoclonales
    -Infección por tuberculosis activa
    -Sospecha de infección bacteriana, fúngica, vírica u otra infección (además de COVID-19)
    - En opinión del investigador, la progresión a la muerte es inminente e inevitable en las próximas 24 horas, independientemente de la administración de tratamientos
    -Haber recibido fármacos antirrechazo orales o inmunomoduladores (incluido TCZ) en los últimos 6 meses
    -Embarazo o lactancia, o prueba de embarazo positiva en un examen previo a la dosis
    -Participación en otros ensayos clínicos con fármacos (con posible excepción de ensayos antivirales)
    -(RAN) <1000/µl en la visita de selección
    - Recuento de plaquetas <50 000/µl
    -ALT o AST >10 x LSN
    -Tratamiento con un fármaco en investigación en las 5 semividas o 30 días
    -Cualquier afección médica grave o anomalía en pruebas analíticas clínicas que, a juicio del investigador, impidan la participación segura del paciente y la realización del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is Clinical status assessed using a 7-category ordinal scale.
    El objetivo principal de eficacia es la evaluación del estado clínico mediante una escala ordinal de 7
    E.5.1.1Timepoint(s) of evaluation of this end point
    at Day 28
    en el dia 28
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are:
    • Time to clinical improvement
    • Time to improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status
    • Incidence of mechanical ventilation
    • Ventilator-free days
    • Organ failure-free
    • Incidence of intensive care unit (ICU) stay
    • Duration of ICU stay
    • Time to clinical failure, defined as the time to death, mechanical ventilation, ICU admission, or withdrawal
    • Mortality rate
    • Time to hospital discharge or “ready for discharge”
    • Duration of supplemental oxygen.
    Los secondary endponts son:
    • Tiempo hasta la mejoría clínica.
    • Tiempo hasta la mejora clínica de al menos 2 categorías con respecto al inicio en una escala ordinal de 7 categorías del estado clínico
    • Incidencia de ventilación mecánica.
    • Días sin ventilador.
    • Días sin fallo orgánico
    • Incidencia de estancia en la unidad de cuidados intensivos (UCI)
    • Duración de la estancia en la UCI
    • Tiempo hasta el fracaso clínico, definido como el tiempo hasta la muerte, la ventilación mecánica, el
    ingreso en la UCI o la retirada
    • Tasa de mortalidad
    • Tiempo hasta el alta hospitalaria o “listo para el alta”
    • Duración del oxígeno suplementario.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At time points throughout the study
    En puntos temporales especificados a lo largo del estudio
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Denmark
    France
    Germany
    Ireland
    Italy
    Netherlands
    Spain
    Sweden
    Switzerland
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of this study is defined as the date when the last patient, last visit (LPLV) occurs or the date at which the last data point required for statistical analysis or safety follow-up is received from the last patient, whichever occurs later.
    In addition, the Sponsor may decide to terminate the study at any time.
    El final de este estudio se define como la fecha en la que tenga lugar la última visita del último paciente, o la fecha en la que se recibe el último punto de datos necesarios para el último seguimiento del último paciente, lo que ocurra más tarde.
    Además, el promotor podrá decidir poner fin al estudio en cualquier momento
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 260
    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 Yes
    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
    For patients with severe/critical COVID-19 pneumonia, they may not be able to sign by themselves.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 330
    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)
    Since the tocilizumab treatment is not intended for continued therapy, the Sponsor does not have any plans to provide Roche tocilizumab or any other study treatments to patients who have completed the study. The Roche Global Policy on Continued Access to Investigational Medicinal Product is available at the following website:
    http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    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 Decision2020-03-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-07-28
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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