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    The EU Clinical Trials Register currently displays   40665   clinical trials with a EudraCT protocol, of which   6637   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-005291-35
    Sponsor's Protocol Code Number:ANTICIPANT
    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:2021-03-22
    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 number2020-005291-35
    A.3Full title of the trial
    A multicenter randomized trial to evaluate the efficacy of tocilizumab in patients with severe Coronavirus Disease 2019 (Covid-19) pneumonia failing glucocorticoids.
    Studio multicentrico randomizzato per valutare l'efficacia di tocilizumab in pazienti con polmonite severa da Coronavirus 2019 (Covid-19) che falliscono la terapia con glucocorticoidi.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter randomized trial to evaluate the efficacy of tocilizumab in patients with severe Coronavirus Disease 2019 (Covid-19) pneumonia failing glucocorticoids.
    Studio multicentrico randomizzato per valutare l'efficacia di tocilizumab in pazienti con polmonite severa da Coronavirus 2019 (Covid-19) che falliscono la terapia con glucocorticoidi.
    A.3.2Name or abbreviated title of the trial where available
    ANTICIPANT
    ANTICIPANT
    A.4.1Sponsor's protocol code numberANTICIPANT
    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 SponsorAOU POLICLINICO DI MODENA
    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 supportRegione Emilia Romagna
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportFondazione Cassa di Risparmio di Modena
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAOU di Modena
    B.5.2Functional name of contact pointUfficio Sperimentazioni Cliniche
    B.5.3 Address:
    B.5.3.1Street Addressvia del Pozzo 71
    B.5.3.2Town/ cityModena
    B.5.3.3Post code41124
    B.5.3.4CountryItaly
    B.5.5Fax number+390594222604
    B.5.6E-mailnb.protocolli@unimore.it
    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.2.5The 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 [DB06273]
    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 codeDB06273
    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
    polmonite severa da coronavirus 2019
    severe Coronavirus Disease 2019
    E.1.1.1Medical condition in easily understood language
    polmonite severa da coronavirus 2019
    severe Coronavirus Disease 2019
    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 LLT
    E.1.2Classification code 10053983
    E.1.2Term Corona virus 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
    Evaluate the efficacy of tocilizumab in preventing intubation or death in patients with COVID-19 severe pneumonia who are deteriorating their respiratory function on glucocorticoids.
    Valutare l'efficacia di tocilizumab nel prevenire l'intubazione o la morte in pazienti con polmonite grave da COVID-19 la cui funzione respiratoria peggiora in presenza di glucocorticoidi.
    E.2.2Secondary objectives of the trial
    Valutare la corretta tempistica di somministrazione di tocilizumab.
    Valutare la sicurezza di tocilizumab dopo glucocorticoidi.
    Evaluate the correct timing for tocilizumab administration.
    Evaluate the safety of tocilizumab after glucocorticoids.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • age>= 18 years;
    • Informed consent for participation in the study;
    • Polymerase Chain Reaction (Real-time PCR) diagnosis of Sars-CoV2 infection;
    • Hospitalization;
    • Clinical/instrumental diagnosis (high resolution chest computed tomography scan or chest x-ray or pulmonary ultrasound) of COVID-19 pneumonia;
    • PaO2/FiO2 ratio in room air <250 mmHg and decreased by more than 20% and/or respiratory distress (RR> 30 bpm and/or use of accessory respiratory muscles) occurs despite treatment at least 36 hours from first dexamethasone dose. The interval has been chosen on the basis of clinical experience with the timing of clinical improvement after starting this treatment.
    • An hyperinflammation condition defined by the presence of at least two of the following criteria at any time from admission: a) blood lymphocytes < 1000/mmc; b) ferritin > 500ng/mL; c) LDH > 300 U/L; d) D-dimers > 1000 ng/mL; e) Creactive protein > 3mg/dL
    • età>= 18 anni;
    • Consenso informato per la partecipazione allo studio;
    • diagnosi di infezione da Sars-CoV2 (PCR);
    • Ospedalizzazione;
    • Diagnosi clinica/strumentale (tomografia computerizzata del torace ad alta risoluzione o radiografia del torace o ecografia polmonare) di polmonite COVID-19;
    • Rapporto PaO2 / FiO2 in aria ambiente <250 mmHg e diminuito di oltre il 20% e /o distress respiratorio (RR> 30 atti resp /min e / o uso di muscoli respiratori accessori), nonostante il trattamento ad almeno 36 ore dalla prima dose di desametasone. L’intervallo è stato scelto sulla base dell’esperienza clinica in merito alla tempistica del miglioramento clinico dopo l’inizio di questo trattamento;
    • una condizione di iperinfiammazione, definita dalla presenza di almeno 2 dei seguenti criteri in qualsiasi momento dal ricovero: a) linfociti < 1000/mmc; b) ferritina >500 ng/ml; c) LDH >300 U/L; d) D-Dimero> 1000ng/ml; e) PCR >3mmg/dL.
    E.4Principal exclusion criteria
    • Patient with acute respiratory distress syndrome with PaO2/FiO2 ratio > 250 mmHg;
    • Invasive ventilation (oro-tracheal intubation);
    • Known hypersensitivity to TCZ or its excipients;
    • Clinical conditions that contraindicate TCZ and cannot be treated or resolved according to the physician's judgment: e.g. Glutamate-pyruvate transaminase (GPT) or glutamine oxaloacetic transaminase (GOT) > 5 times the upper limit of the norm, Neutrophils < 500/mmc, Platelets < 50.000/mmc, Diverticulitis or intestinal perforation, suspicion of latent tuberculosis;
    • Previous or concomitant use of other immune-modulants for COVID-19: anti-IL-1, JAK-inhibitors, other anti-IL-6
    • PCT > 0.5 ng/mL
    • Pazienti con sindrome da distress respiratorio acuto con rapporto PaO2 / FiO2> 250 mmHg;
    • Ventilazione invasiva (intubazione oro-tracheale);
    • Nota ipersensibilità al TCZ o ai suoi eccipienti;
    • Condizioni cliniche che controindicano TCZ e non possono essere trattate o risolte secondo il giudizio del medico: ad es. Glutammato-piruvato transaminasi (GPT) o glutammina ossalacetica transaminasi (GOT)> 5 volte il limite superiore della norma, neutrofili <500 / mmc, piastrine <50.000 / mmc, diverticolite o perforazione intestinale, sospetto di tubercolosi latente;
    • Uso precedente o concomitante di altri immunomodulanti per COVID-19: anti-IL-1, JAK-inibitori, altri anti-IL-6
    • PCT > 0.5 ng/mL
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is defined by the occurrence, within 4 weeks of randomization, of one of these 3 events:
    a) entry into ICU (Intensive Care Unit) with invasive mechanical ventilation;
    b) death from all causes;
    c) reaching a PaO2/FiO2 <130 mmHg in room air
    L'endpoint primario è definito dal verificarsi, entro 4 settimane dalla randomizzazione, di uno di questi 3 eventi:
    a) ingresso in ICU (Unità di Terapia Intensiva) con ventilazione meccanica invasiva;
    b) morte per tutte le cause;
    c) raggiungendo una PaO2 / FiO2 <130 mmHg nell'aria ambiente
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 weeks
    4 settimane
    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 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) 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 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 Yes
    E.8.2.3.1Comparator description
    standard of care
    standard of care
    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 concerned22
    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 Information not present in EudraCT
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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 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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 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 state640
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 640
    F.4.2.2In the whole clinical trial 640
    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)
    as per clinical practice
    come da pratica clinica
    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 Decision2021-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-03
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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