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    Summary
    EudraCT Number:2020-001386-37
    Sponsor's Protocol Code Number:RCT-TCZ-COVID-19
    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:2020-04-02
    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 number2020-001386-37
    A.3Full title of the trial
    Uno studio randomizzato multicentrico in aperto per valutare l’efficacia della somministrazione precoce del Tocilizumab (TCZ) in pazienti affetti da polmonite da COVID-19.
    Uno studio randomizzato multicentrico in aperto per valutare l’efficacia della somministrazione precoce del Tocilizumab (TCZ) in pazienti affetti da polmonite da COVID-19.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of Tocilizumab - COVID-19
    Efficacia del Tocilizumab - COVID-19
    A.3.2Name or abbreviated title of the trial where available
    TOCI-RE
    TOCI-RE
    A.4.1Sponsor's protocol code numberRCT-TCZ-COVID-19
    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 SponsorAzienda Unità Sanitaria Locale-IRCCS di Reggio Emilia
    B.1.3.4CountryItaly
    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 support
    B.4.2Country
    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.5.6E-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 RoActemra 20 mg/mL concentrato per soluzione per infusione – flacone 20 ml (400 mg)
    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 nameRoActemra 20 mg/mL concentrato per soluzione per infusione – flacone 20 ml (400 mg)
    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.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 RoActemra 20 mg/mL concentrato per soluzione per infusione – flacone 10 ml (200 mg)
    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 nameRoActemra 20 mg/mL concentrato per soluzione per infusione – flacone 10 ml (200 mg)
    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.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 RoActemra 20 mg/mL concentrato per soluzione per infusione – flacone 4 ml (80 mg)
    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 nameRoActemra 20 mg/mL concentrato per soluzione per infusione – flacone 4 ml (80 mg)
    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 infection
    infezione da Covid-19
    E.1.1.1Medical condition in easily understood language
    COVID-19 pneumonia
    Polmonite da COVID-19
    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
    L’obiettivo generale di questo studio è valutare se la terapia precoce con Tocilizumab è in grado di ridurre il numero dei pazienti con polmonite da SARS-CoV2 che richiedono una ventilazione meccanica.
    E.2.2Secondary objectives of the trial
    1. Confrontare l’efficacia del Tocilizumab in termini di ingresso in Terapia Intensiva con ventilazione meccanica invasiva in due gruppi:
    a. pazienti nei quali è somministrato precocemente come da protocollo
    b. pazienti nei quali viene somministrato all’aggravamento clinico (per un rapporto PaO2/FiO2 < 150)
    2. Confrontare l’efficacia del Tocilizumab in termini di mortalità per tutte le cause in due gruppi:
    a. pazienti nei quali è somministrato precocemente come da protocollo
    b. pazienti nei quali viene somministrato all’aggravamento clinico (per un rapporto PaO2/FiO2 < 150) oppure nelle prime 24 ore dopo l’ingresso in Terapia Intensiva.
    3. valutare la tossicità del Tocilizumab.
    4. Valutare i livelli di IL-6 e PCR e loro correlazione con l’efficacia del trattamento
    5. Valutare i livelli di ferritina, LDH e D-dimero e loro correlazione con l’effetto del trattamento
    6. valutarne l’andamento del rapport PaO2 / FiO2
    7. Valutare l’andamento nel tempo della conta dei linfociti
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    La popolazione in studio include i pazienti con polmonite da Covid-19 di recente insorgenza che richiedono assistenza ospedaliera, ma non procedure di ventilazione meccanica invasiva o semi-invasiva.
    1. età > 18 anni
    2. Consenso informato per la partecipazione allo studio
    3. Diagnosi real time PCR dell'infezione da Sars-CoV2
    4. Ricovero in Ospedale a causa della diagnosi clinica/strumentale (TAC torace ad alta risoluzione, Rx torace o ecografia polmonare)
    5. Presenza di sindrome da distress respiratorio acuta con PaO2/FiO2 compresi tra 200 e 300 mm/Hg
    6. Presenza di esagerata risposta infiammatoria definita dalla presenza di almeno 1 dei seguenti 3 criteri:
     Almeno una misurazione della temperatura corporea superiore ai 38°C negli ultimi due giorni;
     Proteina C reattiva sierica maggiore o uguale a 10 mg/dl
     Incremento della PCR di almeno 2 volte il valore basale
    E.4Principal exclusion criteria
    1. Paziente con sindrome da distress respiratorio con PaO2/FiO2 < 200 mm/Hg o in ventilazione non invasiva o in ventilazione invasiva o presenza di shock o presenza di concomitante insufficienza d’organo che richiede ammissione all’Unità di Cura Intensiva
    2. Insufficienza cardiaca e renale gravi
    3. Paziente gravida o in allattamento
    4. Paziente che, a giudizio del clinico o per espressa volontà del paziente, non andrà in terapia intensiva indipendentemente dall’evoluzione del quadro polmonare.
    5. Ipersensibilità nota al Tocilizumab o ai suoi eccipienti
    6. Paziente in trattamento con immunodepressori o farmaci antirigetto
    7. Infezioni attive note o altre condizioni cliniche che controindicano Tocilizumab e non possono essere trattate o risolte secondo il giudizio del medico
    8. ALT o AST > 5 volte il limite superiore della norma
    9. Neutrofili < 500/mmc
    10. Piastrine < 50.000/mmc
    11. Diverticolite o perforazione intestinale
    12. Sospetto clinico di tubercolosi latente
    E.5 End points
    E.5.1Primary end point(s)
    Comparsa di uno di questi 3 eventi:
    a. entrata in Terapia Intensiva con ventilazione meccanica invasiva
    b. morte per tutte le cause
    c. aggravamento clinico documentato dal riscontro di un rapporto PaO2/FiO2 < 150mm/Hg ad una delle misurazioni di EGA programmate o ad una misurazione in urgenza, ma comunque confermata da un secondo esame negativo entro 4 ore
    E.5.1.1Timepoint(s) of evaluation of this end point
    14 giorni dalla randomizzazione
    E.5.2Secondary end point(s)
    La valutazione degli endpoint secondari viene fatta seguendo l’ordine con cui sono presentati gli obiettivi dello studio. Più precisamente:
    1. ingresso in Terapia Intensiva con ventilazione meccanica invasiva
    2. mortalità per tutte le cause
    3. tossicità misurata secondo gli standard internazionalmente riconosciuti
    E.5.2.1Timepoint(s) of evaluation of this end point
    14 giorni dalla randomizzazione
    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 No
    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 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 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 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.8.5The trial involves multiple Member States Yes
    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 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
    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 months
    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.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-04-02. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state398
    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)
    viene confrontata la somministrazione precoce del Tocilizumab verso la somministrazione del Tocilizumab all’aggravamento. Più specificatamente:
    • il braccio sperimentale riceverà la terapia con Tocilizumab entro 8 ore dall’ingresso in studio + la terapia standard.
    • il braccio di controllo riceverà la terapia standard. In caso di aggravamento o di ingresso in terapia intensiva, i pazienti riceveranno Tocilizumab
    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 Decision2020-03-27
    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 StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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