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    Summary
    EudraCT Number:2020-003349-12
    Sponsor's Protocol Code Number:NUIG-2020-003
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-08-14
    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 ConcernedIreland - HPRA
    A.2EudraCT number2020-003349-12
    A.3Full title of the trial
    Can Nebulised HepArin Reduce acuTE lung injury in Patients with SARS-CoV-2 Requiring Advanced Respiratory support in Ireland
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a proof of principle / feasibility study aiming to evaluate the effect of nebulised unfractionated heparin on procoagulant markers related to acute respiratory distress syndrome in patients invasively ventilated for Covid 19 lung disease.
    A.3.2Name or abbreviated title of the trial where available
    Charter Trial
    A.4.1Sponsor's protocol code numberNUIG-2020-003
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN12345678
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT12345678
    A.5.3WHO Universal Trial Reference Number (UTRN)U1234-5678-1234
    A.5.4Other Identifiers
    Name:NUIG sponsor numberNumber:NUIG-2020-003
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation PlanP/123/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNUIG
    B.1.3.4CountryIreland
    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 supportCURAM/SFI
    B.4.2CountryIreland
    B.4.1Name of organisation providing supportAerogen
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNational University of Ireland Galway
    B.5.2Functional name of contact pointProf John Laffey
    B.5.3 Address:
    B.5.3.1Street AddressUniversity Road
    B.5.3.2Town/ cityGalway
    B.5.3.3Post codeH91 TK33
    B.5.3.4CountryIreland
    B.5.4Telephone number35391524411
    B.5.5Fax number35391524411
    B.5.6E-mailjohn.laffey@nuigalway.ie
    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 Heparin Sodium
    D.2.1.1.2Name of the Marketing Authorisation holderPinewood Laboratories Ltd,
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nameHeparin Sodium
    D.3.2Product code PA0281/229/005
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHEPARIN SODIUM
    D.3.9.1CAS number 9041-08-1
    D.3.9.3Other descriptive nameHeparin
    D.3.9.4EV Substance CodeSUB02478MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5000
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    This trial will be carried out in invasively ventilated ICU patients with suspected or confirmed COVID-19 infection
    E.1.1.1Medical condition in easily understood language
    Covid 19, Coronavirus
    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
    Effect of nebulised heparin on d-dimer profile, assessed via d-dimer AUC and via a mixed effects model, with data collected on days 1, 3, 5 and 10.
    Safety of nebulised heparin delivered by Aerogun vibrating-mesh nebuliser in patients with COVID-19 induced severe respiratory failure, as measured by the incidence of severe adverse events.
    E.2.2Secondary objectives of the trial
    -Determine the impact nebulised heparin (NH)on indices of oxygenation measured 6 hourly
    -Determine the effect of NH on ventilatory ratio measured every 6 hours.
    -Determine the effect of NH on pulmonary compliance measured on days 1,3,5 and 10.
    -Effect of NH on other inflammatory and soluble TNF receptor 1 and coagulation indices will be assessed.
    -In this study, ‘day 0’ describes the period from randomisation to midnight on the day of enrolment, ‘day 1’ the first calendar day after the day of enrolment, ‘day 2’ the second calendar day after the day of enrolment, and so forth.
    -Number tracheotomised to day 28
    -Time to separation from the ICU to day 28, where non-survivors to day 28 are treated as though not separated from intensive care
    -Survival to day 28; Survival to day 60; to hospital discharge, censored at day 60-
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible, a patient must satisfy all these inclusion criteria:
    1. Confirmed or suspected COVID-19. Note, if ‘suspected’, results must be pending or testing intended
    2. Ability to obtain informed consent/assent to participate in study
    3. Age 18 years or older
    4. Requiring high flow nasal oxygen or positive pressure ventilator support or invasive mechanical ventilation in the ICU / HDU for a time period of no greater than 48 hours
    5. D-dimers > 200 ng/ml
    6. PaO2 to FIO2 ratio less than or equal to 300
    7. Acute opacities on chest imaging affecting at least one lung quadrant. Note ‘Acute opacities’ do not include effusions, lobar/lung collapse or nodules
    8. Currently in a higher level of care area designated for inpatient care of patients where therapies including non-positive pressure ventilatory support can be provided.
    E.4Principal exclusion criteria
    To be eligible, a patient must have none of these exclusion criteria:
    1. Enrolled in another clinical trial that is unapproved for co-enrolment
    2. Heparin allergy or heparin-induced thrombocytopaenia
    3. APTT > 100 seconds
    4. Platelet count < 50 x 109 per L
    5. Pulmonary bleeding, which is frank bleeding in the trachea, bronchi or lungs with repeated haemoptysis or requiring repeated suctioning
    6. Uncontrolled bleeding
    7. Pregnant or suspected pregnancy (Urine or serum HCG will be recorded)
    8. Receiving or about to commence ECMO or HFOV
    9. Myopathy, spinal cord injury, or nerve injury or disease with a likely prolonged incapacity to breathe independently e.g. Guillain-Barre syndrome
    10. Usually receives home oxygen
    11. Dependent on others for personal care due to physical or cognitive decline (pre-morbid status)
    12. Death is imminent or inevitable within 24 hours
    13. The clinical team would not be able to set up the study nebuliser and ventilator circuit as required including with active humidification
    14. Clinician objection.
    15. The use or anticipated use of nebulised tobramycin during this clinical episode
    16. Any other specific contraindication to anticoagulation including prophylactic anticoagulation not otherwise listed here
    17. Relapse in clinical condition in patient that had weaned from advanced respiratory support
    18. Receiving any direct / novel oral anticoagulant
    E.5 End points
    E.5.1Primary end point(s)
    Nebulised heparin is administered 6-hourly from enrolment to day 10 post enrolment, provided the patient is receiving invasive mechanical ventilation. Data collection will be completed at day 60.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Nebulised heparin is administered 6-hourly from enrolment to day 10 post enrolment, provided the patient is receiving invasive mechanical ventilation. Data collection will be completed at day 60.
    E.5.2Secondary end point(s)
    N/A
    E.5.2.1Timepoint(s) of evaluation of this end point
    Data collection will be completed at day 60.
    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) 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
    Standard of care
    E.8.2.4Number of treatment arms in the trial1
    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 concerned2
    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 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
    - Vital status at day 60 and, if deceased, the date of death and whether death related (directly or indirectly) to COVID-19 infection
    - Place of residence at day 60
    - If not discharged from the acute hospital discharge status by day 28, the acute hospital discharge status at day 60 is ascertained and, if now discharged, the date of discharge and the discharge destination including whether deceased.
    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 months3
    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 months3
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-08-14. Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The participants in this trial may not have capacity to consent during the critical phase of their illness in the Intensive Care Unit as they may be in medically induced coma to facilitate mechanical ventilation and other forms of organ support.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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 their participation in the trial the subject will receive the typical standard of care for their condition(s).
    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 Decision2020-10-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-02-28
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