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    Summary
    EudraCT Number:2018-001294-25
    Sponsor's Protocol Code Number:IPOXVILI
    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:2019-03-14
    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 number2018-001294-25
    A.3Full title of the trial
    Regional Hypo-perfusion as metabolic raiser of ventilator-induced lung injury (VILI): pilot clinica trial
    L’IPOPERFUSIONE POLMONARE REGIONALE COME MOLTIPLICATORE DEL DANNO POLMONARE INDOTTO DALLA VENTILAZIONE: STUDIO CLINICO PILOTA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the role of regional pulmonary hypoperfusion in the development of vintilation induced lung injury
    Valutazione del contributo dell'ipoperfusione regionale polmonare allo sviluppo del danno indotto dalla ventilazione meccanica
    A.3.2Name or abbreviated title of the trial where available
    CO2 inhalation in severe ARDS on ECMO
    Aggiunta della CO2 inalata in ARDS grave in ECMO
    A.4.1Sponsor's protocol code numberIPOXVILI
    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 SponsorFONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
    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 supportMinistero della Salute - Bando Ricerca Finalizzata
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione IRCCS Ca' Granda Ospedalwe Maggiore Polclinico
    B.5.2Functional name of contact pointUOC Rianimazione e Terapia Intensiv
    B.5.3 Address:
    B.5.3.1Street AddressVia Francesco Sforza, 35
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20122
    B.5.3.4CountryItaly
    B.5.4Telephone number0255033293
    B.5.5Fax number0255032648
    B.5.6E-mailtommaso.mauri@policlinico.mi.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 5% Carbon Dioxide / Oxygen Medical Gas Mixture
    D.2.1.1.2Name of the Marketing Authorisation holderBOC Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN5% CO2/95% O2
    D.3.9.1CAS number 8063-77-2
    D.3.9.2Current sponsor codeCarbogen
    D.3.9.3Other descriptive nameCarbogen
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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 Yes
    D.3.11.13.1Other medicinal product typeGas medicinale compresso
    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
    Severe Acute Respiratory Distress Syndrome (ARDS)
    Sindrome da distress respitoria acuta grave
    E.1.1.1Medical condition in easily understood language
    Acute hypoxic respiratory failure with bilateral lung infiltrates and non-cardiogenic etiology
    Insufficienza respiratoria acuta ipossica con infiltrati polmonari bilaterali ad eziologia non cardiogena
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10038651
    E.1.2Term Respiration failure
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10001053
    E.1.2Term Acute respiratory failure
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10038738
    E.1.2Term Respiratory, thoracic and mediastinal disorders
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the feasibility and safety of adding inhaled CO2 5% during mechanical ventilation in ARDS patients on ECMO, while preventing changes in arterial CO2 and pH through the increase in extracorporeal CO2 removal by ECMO system.
    Testare fattibilità e sicurezza dell’aggiunta di CO2 al 5% al gas inspirato durante ventilazione meccanica nei pazienti con ARDS in trattamento ECMO, prevenendo le variazioni della PaCO2 e del pH arterioso mediante la rimozione extracorporea di CO2 tramite il sistema ECMO.
    E.2.2Secondary objectives of the trial
    Safety evaluation of adverse events
    Valutazione della sicurezza tramite raccolta degli eventi avversi
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ARDS diagnosis (according to Berlin definition), deep sedation and neuromuscular paralysis, controlled mechanical ventilation and veno-venous ECMO
    diagnosi di ARDS (in accordo con la definizione di Berlino), sedazione profonda e curarizzazione, ventilazione meccanica controllata e supporto ECMO veno-venoso.
    E.4Principal exclusion criteria
    Age lower than 18 years; hemodynamic instability; active air leakage from the lung; neurologic injury or clinical suspicion of increased intracranial pressure; pregnancy, moribundus status; refusal by the attending physician
    Età inferiore ai 18 anni; instabilità cardiovascolare; evidenza di perdita aerea attiva dal polmone; danno neurologico o sospetto clinico di pressioni intracraniche elevate; Gravidanza documentata; stato terminale; rifiuto da parte del medico curante.
    E.5 End points
    E.5.1Primary end point(s)
    Primary: To verify the feasibility of adding inhaled CO2 5% without changes in arterial CO2 and pH. i.e. keeping PaCO2 within the range 35-45 mmHg for two consecutive measurememts and during the whole period of observation (60-90 minutes) at least in 8 of 10 patients
    Primario: verificare la fattibilità dell’aggiunta di CO2 all’aria inspirata senza variazioni della PaCO2 e del pH arteriosi, ovvero il mantenimento della PaCO2 nel range 35-45 mmHg per due misurazioni consecutive a distanza di 10 minuti e per tutto il periodo di osservazione (60-90 minuti) in almeno 8 pazienti.

    E.5.1.1Timepoint(s) of evaluation of this end point
    Repeated arterial blood gas analysis at 5-10-20-30-60-90-120 minutes from the beginning of CO2 administration
    Controllo emogasanalitici seriati a 5-10-20-30-60-90-120 minuti dall’inizio della somministrazione di CO2
    E.5.2Secondary end point(s)
    Secondary: in order to assess the safety of CO2 administration, the incidence of the following advere events will be recorded: arterial pH < 7.2 in more than two consecutive measurements at least 10 minutes apart; hemodynamic instability with hypotension and hypertension; arrhythmias; pulmonary arterial hypertension
    Una valutazione preliminare della sicurezza valuterà l’incidenza dei seguenti eventi avversi: pH arterioso < 7.20 in più di due misurazioni successive a distanza di almeno 10 minuti; instabilità emodinamica con ipotensione o ipertensione; aritmie; ipertensione arteriosa polmonare
    E.5.2.1Timepoint(s) of evaluation of this end point
    Monitoring during two hours of trealtment
    Monitoraggio nelle due ore previste dal trattamento
    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 Yes
    E.6.5Efficacy No
    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 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 Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    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 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.8.5.1Number of sites anticipated in the EEA1
    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 months6
    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 months6
    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.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Unconscious patients for severe clinical status
    Pazienti incoscienti a causa delle gravi condizioni cliniche
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 10
    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)
    No specific treatment or care will be provided at the end of the study. Patients will be followed according to the standard of care.
    Nessun trattamento o assistenza aggiuntiva oltre alla normale pratica clinica è prevista per i soggetti al termine della loro partecipazione allo studio.
    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 Decision2018-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-10
    P. End of Trial
    P.End of Trial StatusOngoing
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