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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   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:2020-001390-76
    Sponsor's Protocol Code Number:ESCAPE
    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:2020-06-24
    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 number2020-001390-76
    A.3Full title of the trial
    A phase 3, randomized, open-labeled, multi-center study comparing clinical efficacy and safety of intravenous sarilumab plus standard of care compared to standard of care, in the treatment of patients with severe COVID-19 pneumonia
    Studio clinico di fase 3, randomizzato, in aperto, multicentrico volto a confrontare l’efficacia clinica e la sicurezza di Sarilumb per via endovenosa in aggiunta allo standard of care rispetto allo standard of care, nel trattamento di pazienti con polmonite severa da COVID-19.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 3, randomized, open-labeled, multi-center study comparing clinical efficacy and safety of intravenous sarilumab plus standard of care compared to standard of care, in the treatment of patients with severe COVID-19 pneumonia .
    Studio clinico di fase 3, randomizzato, in aperto, multicentrico volto a confrontare l’efficacia clinica e la sicurezza di Sarilumab per via endovenosa in aggiunta allo standard of care rispetto allo standard of care, nel trattamento di pazienti con polmonite severa da COVID-19.
    A.3.2Name or abbreviated title of the trial where available
    ESCAPE
    ESCAPE
    A.4.1Sponsor's protocol code numberESCAPE
    A.5.4Other Identifiers
    Name:-Number:-
    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 SponsorISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI"
    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 organisationIstituto Nazionale per le Malattie Infettive Lazzaro Spallanzani
    B.5.2Functional name of contact pointImmunodeficienze virali
    B.5.3 Address:
    B.5.3.1Street AddressVia Portuense 292
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00149
    B.5.3.4CountryItaly
    B.5.4Telephone number0655170546
    B.5.5Fax number0655170477
    B.5.6E-mailimmunodeficienzevirali@inmi.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.2.1.1.1Trade name sarilumab
    D.2.1.1.2Name of the Marketing Authorisation holdersanofi-aventis groupe
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namesarilumab
    D.3.2Product code [-]
    D.3.4Pharmaceutical form Solution for injection
    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 INNsarilumab
    D.3.9.1CAS number 1189541-98-7
    D.3.9.2Current sponsor code-
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    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 coronavirus infection
    infezione da coronavirus Covid-19
    E.1.1.1Medical condition in easily understood language
    Covid-19 coronavirus infection
    infezione da coronavirus Covid-19
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level HLT
    E.1.2Classification code 10047468
    E.1.2Term Viral lower respiratory tract infections
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of sarilumab, combined with standard of care, in patients affected by severe COVID-19 pneumonia.
    valutare l'efficacia di sarilumab, in aggiunta agli standard di cura, nei pazienti affetti da polmonite da COVID-19 grave.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of sarilumab on survival
    To evaluate the effect of sarilumab on clinical evolution
    To evaluate the effect of sarilumab on lung function
    To evaluate the effect of sarilumab on hyperinflammation parameters
    To evaluate the effect of sarilumab on other relevant laboratory parameters
    To evaluate the effect of sarilumab on radiological response
    To evaluate the effect of sarilumab on virological response
    To evaluate the effect of sarilumab on duration of hospitalization
    To describe safety profile of sarilumab
    valutare l'effetto di sarilumab sulla sopravvivenza
    valutare l'effetto di sarilumab sull'evoluzione clinica
    valutare l'effetto di sarilumab sulla funzione polmonare
    valutare l'effetto di sarilumab sui parametri di iperinfiammazione
    Valutare l’effetto del sarilumab sui parametri della risposta immunologica
    valutare l'effetto di sarilumab su altri parametri di laboratorio rilevanti
    valutare l'effetto di sarilumab sulla risposta radiologica
    valutare l'effetto di sarilumab sulla risposta virologica
    valutare l'effetto di sarilumab sulla durata del ricovero
    Descrivere il profilo di sicurezza di sarilumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    1. Age = 18 years
    2. Signed informed consent provided by the patient, or by the patient’s legally authorized representative(s), as applicable. Orally provisions could be considered in emergency conditions if deemed necessary by the investigator (signature of the informed consent will occur if and as soon as clinical conditions improve).
    3. Virological diagnosis of SARS-CoV-2 infection (SARS-CoV-2 infection confirmed by PCR test or positive serology)
    4. Evidence of pulmonary infiltrates at CT scan or Chest XRay
    5. Oxygen saturation (SpO2) at rest without oxygen supplementation < 93% or PaO2/FiO2 < 300 at rest in patients requiring oxygen supplementation (either Venturi mask or cPAP or NIV).
    6. Evidence of hyperinflammation defined as at least two of the following:
    i. Blood lymphocytes <1000/mm3
    ii. Ferritin > 500ng/mL;
    iii. LDH > 300 U/L;
    iv. D-Dimers > 1000 ng/mL
    v. C-reactive protein > 3 mg/dL
    7. Indication to start antiviral therapy with either hydroxychloroquine or lopinavir/ritonavir as regular clinical practice (or patients who have already started/finished antiviral therapy for SARS-CoV2)

    8. Men and women of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Appendix F.
    1. Età maggiore o uguale a 18 anni
    2. Consenso informato firmato dal paziente stesso o da parte del di un rappresentante legalmente autorizzato, se il paziente è impossibilitato a fornire il consenso di persona. In condizioni di emergenza, secondo quanto ritenuto dallo sperimentatore, il paziente o il legale rappresentante potranno fornire il consenso oralmente (la firma del consenso potrà avvenire successivamente se le condizioni lo permettono).
    3. Diagnosi virologica di SARS-CoV2 (infezione confermata da real-time PCR o sierologia positiva)
    4. Evidenza radiologica di infiltrati polmonari al RX torace e alla TC torace
    5. Saturazione di ossigeno (SO2) a riposo senza supplementazione di ossigeno < 93% o PaO2/FiO2 < 300 a riposo nei pazienti che richiedono supplemento di ossigeno (sia attraverso maschera di venturi che cPAP o NIV)
    6. Evidenza di iperinfiammazione definite come almeno due tra i seguenti parametri:
    i. linfociti<1000/mm3
    ii. ferritina > 500ng/mL;
    iii. LDH > 300 U/L;
    iv. D-Dimero > 1000 ng/mL
    v. PCR > 3 mg/dL
    7. Indicazione ad iniziare la terapia antivirale con idrossiclorochina o lopinavir/ritonavir secondo regolare pratica clinica (o pazienti che hanno già iniziato / terminato la terapia antivirale per SARSCoV2)
    8. Uomini e donne in età fertile che hanno rapporti sessuali devono essere d’accordo ad utilizzare metodi contraccettivi specificati in Appendice F
    E.4Principal exclusion criteria
    Exclusion criteria:
    1. Known hypersensitivity to sarilumab or its excipients
    2. Known active infections or other clinical condition that contraindicate sarilumab and cannot be treated or solved according to the judgement of the clinician
    3. Patient being treated with immunomodulators or anti-rejection drugs
    4. Pregnancy/lactation
    5. Neutrophils count < 500 cell/mm3
    6. Platelets count < 50.000/mm3
    7. ALT / AST> 5 times the upper limit of the normality
    8. Bowel diverticulitis or perforation
    9. Existence of any life-threatening co-morbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion.
    10. Severe hepatic dysfunction
    11. Creatinine clearance < 30 ml/min/1.73 m2
    12. Mechanical ventilation or ECMO
    13. Enrolment in another concurrent clinical interventional study
    14. Intake of an investigational drug within 3 months
    1. Criteri di esclusione:
    1. Ipersensibilità nota al sarilumab o ai suoi eccipienti
    2. Infezioni attive note o alter condizioni cliniche che controindicano l’utilizzo di sarilumab e che non possono essere trattate o risolte secondo il giudizio del clinico.
    3. Pazienti trattati con immunomodulatori o farmaci antirigetto
    4. Gravidanza/allattamento
    5. Conta dei neutrofili < 500 cell/mm3
    6. Conta piastrinica < 50.000/mm3
    7. ALT / AST> 5 volte il limite superior di normalità
    8. Diverticoli intestinali o perforazione
    9. Esistenza di qualsiasi comorbidità pericolosa per la vita o altra condizione medica che a giudizio dell’investigatore, rende il paziente non candidabile allo studio.
    10. Severa disfunzione eptica
    11. Creatinina clearance < 30 ml/min/1.73 m2
    12. Ventilazione Meccanica o ECMO
    13. Arruolamento in un altro trial clinico concorrente
    14. Assunzione di un farmaco sperimentale nei tre mesi precedenti.
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point was the time to clinical improvement, defined as the time from receiving the first dose of drug to an improvement of two points (from the status at baseline) on a 7-point category ordinal scale.
    The 7-point category ordinal scale consisted of the following categories:
    1. not hospitalized with resumption of normal activities;
    2. not hospitalized, but unable to resume normal activities;
    3. hospitalized, not requiring supplemental oxygen;
    4. hospitalized, requiring supplemental oxygen;
    5. hospitalized, requiring noninvasive mechanical ventilation (CPAP or NIV);
    6. hospitalized, requiring ECMO, invasive mechanical ventilation, or both;
    7. death.
    L'end point primario è il tempo al miglioramento clinico, definito come il tempo dal ricevimento della prima dose di farmaco a un miglioramento di due punti (dallo stato al basale) su una scala ordinale di categoria a 7 punti.
    La scala ordinale di categoria a 7 punti era composta dalle seguenti categorie:
    1. non ospedalizzato con la ripresa delle normali attività;
    2. non ospedalizzato ma incapace di riprendere le normali attività;
    3. ospedalizzato, senza richiedere supplemento di ossigeno;
    4. ospedalizzato, con necessità di supplemento di ossigeno;
    5. ospedalizzato, con necessità di ventilazione meccanica non invasiva (cPAP o NIV);
    6. ospedalizzato, con necessità di ossigenazione extracorporea a membrana (ECMO) o ventilazione meccanica invasiva o entrambe;
    7. morte.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every visit
    Ogni visita
    E.5.2Secondary end point(s)
    The secondary endpoints of the study are:
    • Mortality rate within 30 days from baseline;
    • Time from treatment initiation to death
    • Time to mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
    • Time to non-invasive ventilation (in patients requiring only supplemental oxygen with venturi mask or not requiring oxygen at baseline)
    • Time to increase in PaO2/FiO2 of 50 or greater compared to the nadir PaO2/FiO2 for at least 48 hours;
    • Days of hypoxemia (SpO2 <93% on room air, or requiring supplemental oxygen, or non-invasive ventilation support)
    • Change from baseline in PaO2/FiO2
    • Time to change in MEWS from baseline
    • Time to resolution of fever (<36.6°C [axilla], or <37.2 °C [oral], or <37.8°C [rectal or tympanic])
    • Days with fever (>36.6°C [axilla], or >37.2 °C [oral], or >37.8°C [rectal or tympanic])
    • Change from baseline in lymphocyte count, ferritin, D-dimer, LDH, C-reactive protein
    • Change from baseline in inflammatory cytokines (IL1b, IL-6, IL-8, TNF-a) levels quantified by automated ELISA assay.
    • Change from baseline in differentiation and activation profile of CD4 and CD8 T cells analysed by flow cytometry.
    • Evolution from baseline of TLR expression and cytokines production by lymphocytes and monocytes tested by flow cytometry
    • Change from baseline in platelet count, fibrinogen creatinine
    • Improvement of CT scan findings repeated within 15 days from baseline
    • Proportion of patients achieving confirmed negative nasopharyngeal swabs (2 negative swabs within 24 hours)
    • Evolution of SARS-CoV2 serology
    • Days of hospitalization among survivors
    • Proportion of patients discharged hospital
    • Time to hospital discharge
    • Serious adverse events (including severe bacterial or fungal infections)
    • Treatment-emergent laboratory abnormalities
    • Tasso di mortalità entro 30 giorni dal baseline
    • Tempo dall’inizio del trattamento alla morte
    • Tempo alla ventilazione meccanica o all’ECMO
    • Tempo alla ventilazione non invasiva (nei pazienti che al basale necessitano solo supplemento di ossigeno con maschera di venturi o non necessitano di ossigeno)
    • Tempo all’aumento di PaO2/FiO2 maggiore o uguale al 50% per almeno 48 ore rispetto al nadir;
    • Giorni con ipossiemia (SpO2 <93% in aria ambiente, o richiedente supplemento di ossigeno o supporto ventilatorio meccanico invasivo o non invasivo)
    • Cambiamento della PaO2/FiO2 rispetto al basale
    • Tempo al cambiamento del MEWS rispetto al basale
    • Tempo alla normalizzazione della febbre (<36.6°C [ascellare], or <37.2 °C [orale], or <37.8°C [rettale o timpanica])
    • Giorni con la febbre (>36.6°C [ascellare], or >37.2 °C [orale], or >37.8°C [rettale o timpanico])
    • Cambiamento di conta dei linfociti, ferritina, D-dimero PCR e LDH rispetto al basale
    • Cambiamento rispetto al basale del livello delle citochine infiammatorie (IL1b, IL-6, IL-8, TNF-a) quantificato attraverso saggio automatizzato ELISA.
    • Cambiamento rispetto al basale della differenziazione e del profilo di attivazione dei linfociti T CD4 e CD8 analizzata attraverso citofluorimetria.
    • Evoluzione rispetto al basale dell’espressione del TLR e della produzione di citochine da parte dei linfociti e dei monociti testate attraverso citofluorimetria.
    • Cambiamento dei livelli di conta piastrinica, fibrinogeno e creatinina rispetto al basale
    • Miglioramento dei reperti radiologici alla TC ripetuta entro 15 giorni dal basale
    • Proporzione di pazienti che raggiungono la negatività confermata per SARS-COV2 su tamponi naso-faringei (2 tamponi negativi consecutivi a distanza di 24 ore)
    • Evoluzione sierologia SARS-CoV2
    • Giorni di ospedalizzazione tra i pazienti che sopravvivono
    • Proporzione di pazienti dimessa dall’ospedale
    • Tempo alla dimissione
    • Eventi avversi seri (incluse infezioni batteriche o fungine severe)
    • Anormalità di laboratorio di nuova insorgenza
    E.5.2.1Timepoint(s) of evaluation of this end point
    To see the study protocol
    Vedere il protocollo dello studio
    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 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
    Terapia standard
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 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 study will be considered concluded after the closure of the clinical centers.
    Lo studio sarà considerato concluso dopo la chiusura dei centri clinici.
    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 months0
    E.8.9.1In the Member State concerned days90
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days90
    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: 71
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state171
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 171
    F.4.2.2In the whole clinical trial 171
    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)
    After participating in the study, patients will be followed according to the protocols of normal clinical practice
    Dopo la partecipazione allo studio i pazienti saranno seguiti secondo i protocolli della normale 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 Decision2020-04-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-27
    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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