Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7294   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-002632-75
    Sponsor's Protocol Code Number:CLI-050000-04
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-06-07
    Trial results View 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 number2020-002632-75
    A.3Full title of the trial
    COVID-19- Multicenter, open-label, randomised trial to assess the efficacy and tolerability of poractant alfa (porcine surfactant, Curosurf®) in hospitalized patients with SARS-COV-19 acute respiratory distress syndrome (ARDS)
    COVID-19- Studio multicentrico, in aperto, randomizzato per valutare l'efficacia e la tollerabilità di poractant alfa (surfattante suino, Curosurf®) in pazienti ospedalizzati con sindrome da distress respiratorio acuto SARS-COV-19 (ARDS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    COVID-19- Study conducted in more than 1 site, randomized, to evaluate the efficacy and tolerability of poractant alfa (porcine surfactant, Curosurf®) in hospitalized patients affected by SARS-COV-19 acute respiratory distress syndrome (ARDS)
    COVID-19- Studio condotto in più di un centro, randomizzato, per valutare l’efficacia e la tollerabilità di poractant alfa (surfattante suino, Curosurf ®) in pazienti ospedalizzati affetti da sindrome da distress respiratorio acuto (ARDS) da SARS-COV-19
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberCLI-050000-04
    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 SponsorCHIESI FARMACEUTICI S.P.A.
    B.1.3.4CountryItaly
    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 supportChiesi Farmaceutici S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChiesi Farmaceutici S.p.A.
    B.5.2Functional name of contact pointClinical Project Manager
    B.5.3 Address:
    B.5.3.1Street Addresslargo Francesco Belloli 11/A
    B.5.3.2Town/ cityParma
    B.5.3.3Post code43122
    B.5.3.4CountryItaly
    B.5.4Telephone number003905211689176
    B.5.6E-mailclinicaltrials_info@chiesi.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 CUROSURF - 80 MG/ML SOSPENSIONE PER INSTILLAZIONE ENDOTRACHEOBRONCHIALE 1 FLACONCINO 3 ML
    D.2.1.1.2Name of the Marketing Authorisation holderCHIESI FARMACEUTICI S.P.A.
    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 nameCUROSURF®
    D.3.2Product code [CHF 1534]
    D.3.4Pharmaceutical form Endotracheopulmonary instillation, suspension
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPEndotracheopulmonary use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPoractant alfa
    D.3.9.1CAS number 129069-19-8
    D.3.9.2Current sponsor codeCHF 1534
    D.3.9.3Other descriptive namePORACTANT ALFA
    D.3.9.4EV Substance CodeSUB22150
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 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
    Hospitalized patients with SARS-COV-19 acute respiratory distress syndrome (ARDS)
    Pazienti ospedalizzati con sindrome da distress respiratorio acuto da SARS-COV-19 (ARDS)
    E.1.1.1Medical condition in easily understood language
    Hospitalized patients with a respiratory acute disease due to SARS-COV-19
    Pazienti ospedalizzati con patologia respiratoria acuta causata da SARS-COV-19
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10001052
    E.1.2Term Acute respiratory distress syndrome
    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 evaluate the efficacy and safety of poractant alfa (porcine surfactant, Curosurf®), administered by endotracheal (ET) instillation, in terms of ventilatory free days during the 21 days after randomization, in adult patients with ARDS due to SARS-COV-19 infection.
    Valutare l'efficacia e la sicurezza di poractant alfa (surfattante suino, Curosurf®) somministrato mediante instillazione endotracheale (ET), in termini di giorni senza ventilazione durante i 21 giorni successivi alla randomizzazione, in pazienti adulti con ARDS dovuta a infezione da SARS-COV-19.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy and safety of poractant alfa administered by ET Instillation compared to control group, in terms of oxygenation (PaO2 / FiO2), FiO2, free days from invasive and non-invasive mechanical ventilation, length of ICU stay, mortality at 28 days, SOFA score, incidence of AEs, vital signs and laboratory parameters.
    Valutare l'efficacia e la sicurezza del poractant alfa somministrato mediante instillazione endotracheale (ET) rispetto al gruppo di controllo, in termini di ossigenazione (PaO2 / FiO2), FiO2, giorni liberi da ventilazione meccanica invasiva e non invasiva, durata della degenza in terapia intensiva, mortalità a 28 giorni , Punteggio SOFA, incidenza di eventi avversi, segni vitali e parametri di laboratorio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female >/=18 and </= 80 years of age
    2. Informed consent for participation in the study (refer to section 15 of the protocol for detailed informed consent procedure)
    3. Positive 2019-nCoV rt-PCR before randomisation
    4. PaO2/FiO2 ratio < 150 mmHg
    5. Lung compliance </=45 ml/cmH20
    6. Intubated and artificially ventilated less than 48 hours before the first poractant alfa administration
    1. Uomo o donna di età >/=18 anni e </= 80 anni
    2. Consenso informato per la partecipazione allo studio (per la procedura dettagliata del consenso informato fare riferimento alla sezione 15 del protocollo)
    3. Positività a 2019-nCoV confermata tramite rt-PCR prima della randomizzazione
    4. Rapporto PaO2/FiO2 < 150 mmHg
    5. Compliance polmonare </=45 ml/cmH20
    6. Sottoposti a intubazione e ventilazione artificiale meno di 48 ore prima della prima somministrazione di poractant alfa
    E.4Principal exclusion criteria
    1. Any contraindications to surfactant administration e.g., pulmonary haemorrhage and pneumothorax
    2. Weight < 40kg
    3. Stage 4 severe chronic kidney disease (i.e., eGFR < 30)
    4. Pregnancy
    5. Administration of any nebulized surfactant in the 48 hours before the first poractant alfa administration
    6. Extracorporeal membrane oxygenation
    1. Eventuali controindicazioni alla somministrazione di surfattanti, ad es. emorragia polmonare e pneumotorace
    2. Peso < 40 kg
    3. Malattia renale cronica grave allo stadio 4 (ovvero eGFR < 30)
    4. Gravidanza
    5. Somministrazione di surfattanti nebulizzati nelle 48 ore precedenti la prima somministrazione di poractant alfa
    6. Ossigenazione extracorporea a membrana
    E.5 End points
    E.5.1Primary end point(s)
    Number of days alive ventilator-free, defined as the number of days the patient is alive and is not receiving mechanical ventilation over the 21 days following randomisation. Mechanical ventilation will be defined as invasive and non-invasive. Patient will be defined free of mechanical ventilation after 12 hours from the suspension of either invasive and non-invasive ventilation. Patients who die or are mechanically ventilated longer than this period are assessed as zero ventilator-free days
    Numero di giorni di vita senza ventilazione, definito come il numero di giorni in cui il paziente è vivo e non sottoposto a ventilazione meccanica nei 21 giorni successivi alla randomizzazione. La ventilazione meccanica viene definita come invasiva e non invasiva. Il paziente viene definito senza ventilazione meccanica dopo 12 ore dalla sospensione della ventilazione invasiva e non invasiva. Per i pazienti deceduti o ventilati meccanicamente per un periodo più lungo, la valutazione è di zero giorni senza ventilazione.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every day in the 21 days after randomization
    Ogni giorno nei 21 giorni dopo la randomizzazione
    E.5.2Secondary end point(s)
    Percentage of patients alive and with PaO2/FiO2 improvement of >20% at the additional timepoints (i.e. every 24 hours after treatment/randomisation until the patient is discharged from the ICU); Change from baseline in FiO2 at 6 and 12 hours following administration of each dose in the treated group and at similar timepoints in the control group (6, 12, 30, 36, 54 and 60 hours after randomisation); Change from baseline in FiO2 at additional timepoints (i.e. every 24 hours after treatment/randomisation until the patient is discharged from the ICU); Length of ICU stay (days) at Day 28. Patients who die or are mechanically ventilated longer than this period are assigned with 28 days; Percentage of patients alive and out of ICU at Day 28; Delta SOFA Score and sub-score components measured on Day 3 and Day 28 or Discharge whichever comes first; Percentage of patients alive and organ failure free (SOFA score=0) at Day 28 or Discharge whichever comes first; Change from baseline in ventilatory parameters [tidal volume (TV), respiratory rate (RR), dynamic compliance (Cdyn), static compliance (Cstat), positive end-expiratory pressure (PEEP), peak inspiratory pressure (PIP), plateau pressure (Pplat)] measured at 6-12-24h after each poractant alfa administration up to 72 hours and at similar timepoints in the control group (6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation) and then every 24 hours until the patient is discharged from the ICU; Change from baseline in blood gas analysis acid-base balance parameters (i.e. pH, pCO2, pO2, HCO3, lactate) measured at 6-12-24h after each poractant alfa administration up to 72 hours and at similar timepoints in the control group (6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation) and then every 24 hours till the patient is discharged from the ICU.; Percentage of patients alive and free of respiratory failure (i.e., need for mechanical ventilation, ECMO (Extracorporeal Membrane Oxygenation), non-invasive ventilation, or high-flow nasal cannula oxygen delivery) at Day 28.; Number of days alive and ventilator-free at Day 28; Mortality at Day 21 and Day 28; Number of alive and free from non-invasive ventilation (NIV) at Day 21 and Day 28; Number of alive and free from invasive ventilation at Day 21 and Day 28; Percentage of patients with improvement in severity status defined as a decrease in the severity score at Day 28 or Discharge; Change from baseline in PaO2/FiO2 ratio at 6 and 12 hours following administration of each dose in the treated group and at similar timepoints in the control group (6, 12, 30, 36, 54 and 60 hours after randomisation); Change from baseline in PaO2/FiO2 ratio at additional timepoints (i.e. every 24 hours after treatment/randomisation until the patient is discharged from the ICU); Percentage of patients alive and with PaO2/ FiO2 improvement >20% at 6 and 12 hours following administration of each dose in the treated group and at similar timepoints in the control group (6, 12, 30, 36, 54 and 60 hours after randomisation)
    Percentuale di pazienti vivi con miglioramento del rapporto PaO2/FiO2 > 20% in corrispondenza dei punti temporali aggiuntivi (ovvero ogni 24 ore dopo il trattamento/la randomizzazione fino alla dimissione del paziente dalla UTI); Variazione rispetto al basale del valore FiO2 a 6 e 12 ore dopo la somministrazione di ciascuna dose nel gruppo trattato e in punti temporali simili nel gruppo di controllo (6, 12, 30, 36, 54 e 60 ore dopo la randomizzazione); Variazione rispetto al basale del valore FiO2 in punti temporali aggiuntivi (ovvero ogni 24 ore dopo il trattamento/la randomizzazione fino alla dimissione del paziente dalla UTI); Durata del ricovero nella UTI (giorni) al giorno 28. Ai pazienti deceduti o che vengono ventilati meccanicamente più a lungo di questo periodo viene assegnato il valore 28 giorni; Percentuale di pazienti vivi e fuori dalla UTI al giorno 28; Punteggio Delta del SOFA e componenti del punteggio parziale misurati al giorno 3 e al giorno 28 o alla dimissione, a seconda dell'evento che si verifica per primo; Percentuale di pazienti vivi e senza insufficienza organica (punteggio SOFA=0) al giorno 28 o alla dimissione, a seconda dell'evento che si verifica per primo; Variazione rispetto al basale dei parametri ventilatori [volume corrente (TV), frequenza respiratoria (RR), compliance dinamica (Cdyn), compliance statica (Cstat), pressione positiva di fine espirazione (PEEP), picco di pressione inspiratoria (PIP), pressione di plateau (Pplat)], misurati 6-12-24 ore dopo ogni somministrazione di poractant alfa fino a 72 ore e in punti temporali simili per il gruppo di controllo (6, 12, 24, 30, 36, 48, 54, 60 e 72 ore dopo la randomizzazione) e successivamente ogni 24 ore finché il paziente non viene dimesso dalla UTI; Variazione rispetto al basale dei parametri dell'equilibrio acido-base nell'analisi dei gas ematici (ovvero pH, pCO2, pO2, HCO3, lattato) misurati 6-12-24 ore dopo ogni somministrazione di poractant alfa fino a 72 ore e in punti temporali simili nel gruppo di controllo (6, 12, 24, 30, 36, 48, 54, 60 e 72 ore dopo la randomizzazione) e successivamente ogni 24 ore finché il paziente non viene dimesso dalla UTI.; Percentuale di pazienti vivi e senza insufficienza respiratoria (ovvero necessità di ventilazione meccanica, ECMO (ossigenazione extracorporea a membrana), ventilazione non invasiva o erogazione di ossigeno con cannula nasale ad alto flusso) al giorno 28.; Numero di giorni di vita e senza ventilatore al giorno 28; Mortalità al giorno 21 e al giorno 28; Numero di pazienti in vita senza ventilazione non invasiva (NIV) al giorno 21 e al giorno 28; Numero di pazienti in vita senza ventilazione invasiva al giorno 21 e al giorno 28; Percentuale di pazienti con miglioramento dello stato definito come diminuzione del punteggio di gravità al giorno 28 o dimissione; Variazione rispetto al basale del rapporto PaO2/FiO2 a 6 e 12 ore dopo la somministrazione di ciascuna dose nel gruppo trattato e a punti temporali simili nel gruppo di controllo (6, 12, 30, 36, 54 e 60 ore dopo la randomizzazione); Variazione rispetto al basale del rapporto PaO2/FiO2 in corrispondenza di ulteriori punti temporali (ovvero ogni 24 ore dopo il trattamento/la randomizzazione fino alla dimissione del paziente dalla UTI); Percentuale di pazienti vivi con miglioramento del rapporto PaO2/FiO2 > 20% a 6 e 12 ore dopo la somministrazione di ciascuna dose nel gruppo trattato e a punti temporali simili nel gruppo di controllo (6, 12, 30, 36, 54 e 60 ore dopo la randomizzazione)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every 24 hours after treatment/randomisation until the patient is discharged; At baseline, 6 and 12 hours following administration of each dose in the treated group and at 6, 12, 30, 36, 54 and 60 hours after randomisation in the control group; Every 24 hours after treatment/randomisation until the patient is discharged; At Day 28; At Day 28; Day 3 and Day 28 or Discharge; At Day 28 or Discharge; At 6-12-24h after each poractant alfa administration up to 72 hours and at 6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation in the control group, and then every 24 hours until the patient is discharged; At 6-12-24h after each poractant alfa administration up to 72 hours and at 6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation in the control group and then every 24 hours
    Ogni 24 ore dopo il trattamento/la randomizzazione fino alla dimissione; Al basale, 6 e 12 ore dopo la somministrazione di ciascuna dose nel gruppo trattato e a 6, 12, 30, 36, 54 e 60 ore dopo la randomizzazione nel gruppo di controllo; Ogni 24 ore dopo il trattamento/la randomizzazione fino alla dimissione del paziente; Al giorno 28; Al giorno 28; Al giorno 3 e al giorno 28 o alla dimissione; Al giorno 28 o alla dimissione; A 6-12-24 ore dopo ogni somministrazione di poractant alfa fino a 72 ore e a 6, 12, 24, 30, 36, 48, 54, 60 e 72 ore dopo la randomizzazione per il gruppo di controllo e successivamente ogni 24 ore finché il paziente non viene dimesso; A 6-12-24 ore dopo ogni somministrazione di poractant alfa fino a 72 ore e a 6, 12, 24, 30, 36, 48, 54, 60 e 72 ore dopo la randomizzazi
    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 Yes
    E.6.13.1Other scope of the trial description
    Tollerability
    Tollerabilità
    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 Yes
    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
    Cura standard
    Standard 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 concerned3
    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 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
    United States
    Italy
    United Kingdom
    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
    LPLV
    LPLV
    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 months7
    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 months2
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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
    Intubated and artificially ventilated patients
    Pazienti intubati e ventilati artificialmente
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 70
    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)
    NA
    NA
    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 Decision2021-05-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-03-18
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri May 17 06:31:13 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA