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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2021-005332-27
    Sponsor's Protocol Code Number:WA43811
    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:2021-12-20
    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 number2021-005332-27
    A.3Full title of the trial
    A PHASE Ib, SINGLE-ARM, OPEN-LABEL STUDY EVALUATING THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB IN PEDIATRIC PATIENTS HOSPITALIZED WITH COVID-19
    ESTUDIO DE FASE IB, ABIERTO Y ÚNICO BRAZO PARA EVALUAR LA FARMACOCINÉTICA, LA FARMACODINAMIA Y LA SEGURIDAD DE TOCILIZUMAB EN PACIENTES PEDIÁTRICOS HOSPITALIZADOS CON COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab in Pediatric Patients Hospitalized with COVID-19
    Estudio para evaluar la farmacocinética, la farmacodinamia y la seguridad de tocilizumab en pacientes pediátricos hospitalizados con COVID-19
    A.4.1Sponsor's protocol code numberWA43811
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/333/2021
    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.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 number+349132557300
    B.5.5Fax number+34913248196
    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.3.1Product nameTocilizumab
    D.3.2Product code RO4877533
    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.3.11 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
    Coronavirus disease 2019 (COVID-19)
    Enfermedad por coronavirus 2019 (COVID-19)
    E.1.1.1Medical condition in easily understood language
    COVID-19 is a contagious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Most people infected with the virus experience mild to moderate respiratory illness.
    COVID-19enfermedad contagiosa causada por el síndrome respiratorio agudo severo coronavirus2.La mayoría de las personas con el virus experimentan una enfermedad respiratoria de leve-moderada.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    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 characterize the pharmacokinetics of tocilizumab (TCZ) through Day 28
    Caracterizar la farmacocinética de TCZ hasta el día 28.
    E.2.2Secondary objectives of the trial
    - To characterize the pharmacodynamics of TCZ through Day 60
    - To evaluate the safety of TCZ through Day 60
    -Caracterizar la farmacodinamia de TCZ hasta el día 60.
    -Evaluar la seguridad de TCZ hasta el día 60
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Aged less than 18 years at the time of signing Informed Consent Form or Assent (if applicable)
    - Ability to comply with the study protocol, in the investigator's judgment
    - Hospitalized with COVID-19 confirmed per a positive polymerase chain reaction (PCR) of any specimen and evidenced by chest X-ray or CT scan
    - Receiving systemic corticosteroids at baseline
    - Oxygen saturation <93% on room air, or requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) to maintain oxygen saturation >92% at screening and baseline
    - For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating eggs during the treatment period and for 90 days after the final dose of TCZ
    - For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm, during the treatment period and for 60 days after the final dose of TCZ to avoid exposing the embryo
    1-Edad inferior a 18 años en el momento de firmar el documento de consentimiento informado o el asentimiento (si procede).
    2-Capacidad para cumplir el protocolo del estudio, en opinión del investigador.
    3-Hospitalización con COVID-19 confirmada por una PCR positiva en una muestra (por ejemplo, respiratoria, sangre, orina, heces u otro líquido corporal) y demostrada en una radiografía o TC de tórax.
    4-Tratamiento con corticosteroides sistémicos en el momento basal.
    5-Saturación de oxígeno <93% con aire ambiente o necesidad de oxigenoterapia, ventilación
    mecánica no invasiva o invasiva o ECMO para mantener una saturación de oxígeno >92%
    en las visitas de selección e inicial.
    6-Para las participantes con capacidad reproductiva: compromiso de practicar abstinencia
    sexual (ausencia de relaciones heterosexuales) o utilizar métodos anticonceptivos, así
    como de abstenerse de donar óvulos, durante el período de tratamiento y hasta 90 días después de la última dosis de TCZ.
    7-Para los varones: compromiso de practicar abstinencia sexual (abstenerse de mantener
    relaciones heterosexuales) o utilizar métodos anticonceptivos, así como de no donar
    semen, preservativo durante el período de tratamiento y hasta, como mínimo, 60 días después de la última dosis de TCZ para no exponer al embrión.
    E.4Principal exclusion criteria
    - Gestational age <37 weeks
    - Known severe allergic reactions to TCZ or other monoclonal antibodies
    - Active tuberculosis infection
    - Uncontrolled active bacterial, fungal, viral, or other infection (besides COVID-19)
    - Diagnosis or suspected diagnosis of multisystem inflammatory syndrome in children (MIS-C)
    - In the opinion of the investigator, progression to death is imminent and inevitable within the next 48 hours, irrespective of the provision of treatments
    - Have received oral anti-rejection or immunomodulatory drugs (including TCZ) within the past 3 months prior to enrollment
    - Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) >10 x upper limit of normal (ULN) detected within 24 hours of screening
    Platelet count <50,000/µL at screening
    - Pregnant or breastfeeding, or intention of becoming pregnant during the study or within 90 days after the final dose of TCZ
    - Treatment with an investigational drug within 5 drug-elimination half-lives or 30 days, whichever is longer, of enrollment (except for anti-SARS-CoV-2 antibodies or directly acting antivirals)
    - Participating in another interventional drug clinical trial (except for anti-SARS-CoV-2 antibodies or directly acting antivirals)
    - 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
    1-Edad gestacional <37 semanas.
    2-Reacciones alérgicas graves conocidas a TCZ u otros anticuerpos monoclonales.
    3-Infección activa por tuberculosis.
    4-Infección activa no controlada por bacterias, hongos, virus u otros microorganismos (aparte
    de COVID-19).
    5-Diagnóstico o sospecha de diagnóstico de SIMP.
    6-En opinión del investigador, la progresión a la muerte es inminente e inevitable en las 48
    horas siguientes, con independencia de la administración de tratamientos.
    7-Haber recibido fármacos antirrechazo o inmunomoduladores por vía oral (incluido TCZ) en los 3 meses previos a la inclusión.
    8-ALT o AST >10 x el límite superior de la normalidad (LSN) detectada en las 24 horas
    previas a la selección (según los intervalos de referencia del laboratorio local).
    9-Embarazo o lactancia, o intención de quedarse embarazada durante el estudio o en los 90
    días siguientes a la última dosis de TCZ (solo para las mujeres con capacidad
    reproductiva).
    10-Tratamiento con un fármaco en investigación en el plazo de 5 semividas de eliminación del
    fármaco o 30 días, lo que suponga más tiempo, antes de la inclusión (excepto anticuerpos
    anti-SARS-CoV-2 o antivirales de acción directa).
    11-Participación en otro ensayo clínico intervencionista con fármacos (excepto anticuerpos
    anti-SARS-CoV-2 o antivirales de acción directa).
    12-Cualquier enfermedad grave o alteración analítica que, en opinión del investigador,
    descarte la participación segura del paciente en el estudio y su finalización.
    E.5 End points
    E.5.1Primary end point(s)
    1. Serum concentrations of TCZ at specified timepoints and derived PK parameters (maximal serum concentration [Cmax], area under the concentration-time curve up to Day 28 [AUCDays 0-28], serum concentration on Day 28 [CDay28], total clearance of drug [CL], and volume of distribution)
    1.Concentraciones séricas de TCZ en momentos especificados y parámetros FC derivados (Cmáx, AUCDías 0-28, CDía 28, CL y volumen de distribución).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to Day 28
    1. Hasta el día 28
    E.5.2Secondary end point(s)
    1. Duration of 90% saturation of soluble interleukin-6 receptor (sIL-6R) through Day 28
    2. Concentrations of interleukin 6 (IL-6), sIL-6R, and C-reactive protein (CRP) at specified timepoints
    3. Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 grading scale
    4. Incidence of serious adverse events
    5. Change from baseline in targeted vital signs
    6. Change from baseline in targeted clinical laboratory test results
    1.Duración de la saturación del 90 % del sIL-6R hasta el día 28.
    2.Concentraciones de IL-6, sIL-6R y PCR en los momentos especificados.
    3.Incidencia e intensidad de los acontecimientos adversos, con determinación de la intensidad conforme al modelo de clasificación de los criterios terminológicos comunes para acontecimientos adversos del National Cancer Institute, versión 5.0.
    4.Incidencia de acontecimientos adversos graves
    5.Variación de las constantes vitales respecto al momento basal.
    6.Variación de los resultados analíticos de interés con respecto al momento basal.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Up to Day 28
    2. Up to Day 60
    3-4. Up to approximately Day 60
    5-6. Baseline (Day 1) to Day 60
    1. Hasta el día 28
    2. Hasta el día 60
    3-4. Hasta aproximadamente el día 60
    5-6. Visita basal (día 1) al día 60
    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 No
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Ib
    E.7.2Therapeutic exploratory (Phase II) No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Italy
    Spain
    United States
    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
    The end of this study is defined as the date of the last visit of the last participant in the study or the date at which the last data point required for statistical analysis or safety follow-up is received from the last participant, whichever occurs later. The end of the study is expected to occur approximately 60 days after the last participant is enrolled.
    In addition, the Sponsor may decide to terminate the study at any time.
    El final de este estudio se define como la fecha de la última visita del último participante en el estudio o la fecha en la que se recibe el último punto de datos requerido para el análisis estadístico o el seguimiento de seguridad del último participante, lo que ocurra más tarde. Se espera que el final del estudio ocurra aproximadamente 60 días después de que se inscriba al último participante.
    Además, el Promotor puede decidir finalizar el 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 months14
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months14
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 30
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 5
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 5
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Study aims to enroll patients under 3 years of age
    El estudio tiene como objetivo inscribir a pacientes menores de 3 años
    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 12
    F.4.2.2In the whole clinical trial 30
    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)
    Currently, the Sponsor does not have any plans to provide Roche IMP (TCZ) or any other study treatments to participants who have completed the study. The Sponsor may evaluate whether to continue providing TCZ in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product, 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 Decision2022-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-24
    P. End of Trial
    P.End of Trial StatusOngoing
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    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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