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    Summary
    EudraCT Number:2021-005332-27
    Sponsor's Protocol Code Number:WA43811
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-12-30
    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 ConcernedItaly - Italian Medicines Agency
    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
    Studio di fase Ib, a braccio singolo, in aperto volto a valutare la farmacocinetica, la farmacodinamica e la sicurezza di TOCILIZUMAB in pazienti pediatrici ricoverati 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
    Studio per valutare la farmacocinetica, la farmacodinamica e la sicurezza di Tocilizumab in pazienti pediatrici ricoverati con COVID 19
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    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 number00416168881111
    B.5.5Fax number0041616919319
    B.5.6E-mailglobal.rochegenentechtrials@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.2.5The 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.3.8 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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)
    Malattia da 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-19 è malatt contagiosa causata da sindr espiratoria acuta grave da coronavirus2(SARS-CoV-2).Maggior parte di persone infettate dal virus sperimenta una malattia respiratoria da lieve a moderata.
    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 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084401
    E.1.2Term COVID-19 respiratory infection
    E.1.2System Organ Class 100000004862
    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
    Caratterizzare la farmacocinetica di tocilizumab (TCZ) fino al giorno 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
    - Caratterizzare la farmacodinamica di TCZ fino al giorno 60
    - Valutare la sicurezza di TCZ fino al giorno 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
    - età inferiore a 18 anni al momento della firma del modulo di consenso informato o dell'assenso (se applicabile)
    - Capacità di rispettare il protocollo di studio, a giudizio dello sperimentatore
    - Ricoverato in ospedale per COVID-19: condizione confermata da una reazione a catena della polimerasi (PCR) positiva su qualsiasi campione e evidenziata da radiografia del torace o TAC
    - Ricezione di corticosteroidi sistemici al basale
    - Saturazione di ossigeno <93% nell'aria ambiente, o che richiedono ossigeno supplementare, ventilazione meccanica non invasiva o invasiva o ossigenazione extracorporea a membrana (ECMO) per mantenere la saturazione di ossigeno >92% allo screening e al basale
    - Per le partecipanti di sesso femminile in età fertile: concordi nel rimanere astinenti (astenersi da rapporti eterosessuali) o nell'utilizzare la contraccezione e accettare di astenersi dal donare ovuli durante il periodo di trattamento e per 90 giorni dopo la dose finale di TCZ
    - Per i partecipanti di sesso maschile: concordi nel rimanere astinenti (astenersi da rapporti eterosessuali) o nell'utilizzare un preservativo e accettare di astenersi dal donare sperma, durante il periodo di trattamento e per 60 giorni dopo la dose finale di TCZ per evitare l'esporre dell'embrione
    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
    - Età gestazionale <37 settimane
    - Reazioni allergiche gravi note a TCZ o altri anticorpi monoclonali
    - Infezione da tubercolosi attiva
    - Infezioni attive incontrollate batteriche, fungine, virali o di altro tipo (oltre a COVID-19)
    - Diagnosi o sospetta diagnosi di sindrome infiammatoria multisistemica nei bambini (MIS-C)
    - Secondo l’opinione dello sperimentatore, la progressione al decesso è imminente e,pertanto, inevitabile entro le 24 ore successive, indipendentemente dalla somministrazione di trattamenti
    -Aver ricevuto farmaci antirigetto orali o immunomodulatori (compreso tocilizumab) negli ultimi 3 mesi prima dell'arruolamento
    - Alanina aminotransferasi (ALT) o aspartato aminotransferasi (AST) >10 volte il limite superiore della norma (ULN) rilevato entro 24 ore dallo screening
    - Conta piastrinica <50.000/µL allo screening
    - Gravidanza o allattamento, o intenzione di iniziare una gravidanza durante lo studio o entro 90 giorni dopo la dose finale di TCZ
    - Trattamento con un farmaco sperimentale entro 5 emivite di eliminazione del farmaco o 30 giorni, a seconda di quale sia più lungo, dall'arruolamento (ad eccezione degli anticorpi anti-SARS-CoV-2 o degli antivirali ad azione diretta)
    - Partecipazione a un altro studio clinico di farmaci interventistici (ad eccezione degli anticorpi anti-SARS-CoV-2 o degli antivirali ad azione diretta)
    - Qualsiasi condizione medica grave o anomalia dei test clinici di laboratorio che, a giudizio dello sperimentatore, precluda la partecipazione sicura del paziente e il completamento dello studio
    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. Concentrazioni sieriche di TCZ in specifici momenti definiti e parametri PK derivati (concentrazione sierica massima [Cmax], area sotto la curva concentrazione-tempo fino al Giorno 28 [AUC Giorni 0-28], concentrazione sierica al Giorno 28 [C Giorno 28], clearance totale del farmaco [CL], e volume di distribuzione)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to Day 28
    1. fino al giorno 28
    E.5.2Secondary end point(s)
    1. Durata della saturazione al 90% del recettore solubile dell’interleuchina-6 (sIL-6R) fino al Giorno 28
    2. Concentrazioni di interleuchina 6 (IL-6), sIL-6R e proteina C-reattiva (CRP) in momenti definiti
    3. Incidenza e gravità degli eventi avversi, con la gravità stabilita in base alla scala di classificazione secondo i Criteri terminologici comuni per gli eventi avversi del National Cancer Institute, Versione 5.0
    4. Incidenza di eventi avversi seri
    5. Variazione dal basale nei segni vitali mirati
    6. Variazione dal basale nei risultati dei test clinici di laboratorio mirati
    1. Durata della saturazione al 90% di sIL-6R fino al Giorno 28
    2. Concentrazioni di IL-6, sIL-6R e proteina C reattiva CRP in momenti definiti
    3. Incidenza e gravità degli eventi avversi, con la gravità stabilita in base alla scala di classificazione secondo i Criteri terminologici comuni per gli eventi avversi del National Cancer Institute, Versione 5.0
    4. Incidenza di eventi avversi seri:
    5. Variazione dal basale nei segni vitali mirati:
    6. Variazione dal basale nei risultati dei test clinici di laboratorio mirati
    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. Fino al Giorno 28
    2. Fino al Giorno 60
    3-4. Approssimativamente fino al Giorno 60
    5-6. Basale (dal Giorno 1) al Giorno 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
    phase Ib
    fase 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 No
    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.8.2.4Number of treatment arms in the trial1
    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 concerned3
    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 Information not present in EudraCT
    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.
    La fine di questo studio è definita come la data dell’ultima visita dell'ultimo partecipante allo studio, o la data in cui viene ricevuto l'ultimo dato richiesto per l’analisi statistica o il follow-up di sicurezza in relazione all’ultimo partecipante, a seconda di quale delle due si verifichi più tardi. La fine dello studio è prevista circa 60 giorni dopo l'arruolamento dell'ultimo partecipante.
    Inoltre, lo Sponsor può decidere di interrompere lo studio in qualsiasi momento.
    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 months14
    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 months14
    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 Yes
    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.1.3Elderly (>=65 years) No
    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
    Lo studio prevede di arruolare pazienti di età inferiore a 3 anni
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    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
    Attualmente, lo Sponsor non ha in programma di fornire l’IMP Roche (TCZ) o altri trattamenti in studio ai partecipanti che hanno completato lo studio. Lo Sponsor può valutare se continuare a fornire TCZ in conformità alla politica globale di Roche sull'accesso continuo al prodotto medicinale sperimentale, disponibile nel seguente sito web: 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 Decision2022-01-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-13
    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
    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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