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    Summary
    EudraCT Number:2020-002632-75
    Sponsor's Protocol Code Number:CLI-050000-04
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-06-01
    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 ConcernedUK - MHRA
    A.2EudraCT number2020-002632-75
    A.3Full title of the trial
    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)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial to be conducted in more sites, with drug known to both patient and Investigator, in which patients will be assigned randomly to receive the drug or not in order to assess the efficacy and tolerability of the drug (porcine surfactant, Curosurf®) in hospitalized patients with SARS-COV-19 (COVID-19 INFECTION) acute respiratory distress syndrome
    A.3.2Name or abbreviated title of the trial where available
    COVID19 - Curosurf_ARDS_COV19
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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®
    D.2.1.1.2Name of the Marketing Authorisation holderChiesi Limited
    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.3.1Product nameCUROSURF®
    D.3.2Product code CHF 1534
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPEndotracheopulmonary use
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    patients with SARS-COV-19 acute respiratory distress syndrome (ARDS)
    E.1.1.1Medical condition in easily understood language
    patients with COVID-19 infection and acute respiratory distress syndrome
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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
    To evaluate the efficacy of the investigational drug Curosurf®, administered by
    endotracheal (ET) instillation in terms of ventilatory free days in adult patients with Acute Respiratory Distress Syndrome (ARDS) due to 2019-nCoV infection.
    The same evaluation is planned in a separate cohort of patients under extracorporeal membrane oxygenation (vvECMO) in terms of ECMO free days during the 21 days after randomization.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy and safety of Curosurf® administered by ET Instillation compared to control cohort (patient not treated with Curosurf®), in terms of oxygenation (PaO2 / FiO2), FiO2, free days from invasive and non-invasive mechanical ventilation, length of Intensive Care Units (ICU)stay, mortality at 28 days, SOFA score (overall organ -failure measurement), duration and free days from ECMO (applicable only for ECMO-cohort),incidence of AEs, vital signs and laboratory parameters,incidence of adverse events, vital signs and laboratory parameters.
    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 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*
    *[Criterion not applicable to the ECMO additional cohort]
    Additional inclusion criterion for ECMO-cohort:
    7. Intubated and artificially ventilated less than 48 hours before the first poractant alfa administration
    OR
    8. Supported with vvECMO less than 48 hours before
    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*
    * [Exclusion criterion NOT applicable for patients eligible for the ECMO-cohort]
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome variable will be the number of ventilator-free days defined as the number of days the patient is not receiving mechanical ventilation during the 21 days after 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 any type of both invasive and non-invasive ventilation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Starting from the 21 days after ranfomization
    E.5.2Secondary end point(s)
    - Number of free days from invasive ventilation
    - Number of free days from non-invasive ventilation (NIV)
    - Change from baseline in PaO2/FiO2 ratio at 6 and 12 hours following each dose administration in the treated group relative 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 since treatment/randomisation till the patient is discharged from the ICU)
    - Percentage of patients with PaO2/ FiO2 improvement >20% at 6 and 12 hours following each dose administration in the treated group and relative timepoints in the control group (6, 12, 30, 36, 54 and 60 hours after randomisation)
    - Percentage of patients with PaO2/ FiO2 improvement >20% at additional timepoints (i.e. every 24 hours after treatment/randomisation till the patient is discharged from the ICU)
    - Change from baseline in FiO2 at 6 and 12 hours following each dose administration in the treated group and relative 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 till the patient is discharged from the ICU)
    - Length of ICU stay (days)
    - Mortality at Day 28
    - Delta SOFA Score measured on Day 3 at Discharge and Day 28
    - 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 administration or randomisation up to 72 hours and then every 24 hours till 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 administration or randomisation up to 72 hours and then every 24 hours till the patient is discharged from the ICU.
    - Number of Extracorporeal Membrane Oxygenation (ECMO)-free days during the 21 days after randomisation, defined as the number of days the patient is not receiving ECMO (ECMO cohort)
    E.5.2.1Timepoint(s) of evaluation of this end point
    as detailed in the study protocol for the whole duration of the study
    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 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.8.3 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 concerned7
    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 No
    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
    A participant is considered to have completed the study if he/she has completed the last scheduled procedure shown in the schedule of assessments: follow up at Day 28. The end of the study is definedas the date of the last follow up visit at Day 28 for the last participant in the trial globally.
    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 months5
    E.8.9.1In the Member State concerned days23
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days23
    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: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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
    If the patient is incapable of giving an informed consent, consent should be provided by patient’s personal legal representative/professional legal representative
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state85
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 85
    F.4.2.2In the whole clinical trial 85
    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)
    The current study use represent a proof of concept study, the study treatment is currently marketed as treatment of premature neonates with RDS and not for the adult affected by ARDS. (to be confirmed by Sponsor))
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-06-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-08
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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