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    Summary
    EudraCT Number:2020-005863-29
    Sponsor's Protocol Code Number:HelmetHeparin
    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:2021-08-17
    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 number2020-005863-29
    A.3Full title of the trial
    Nebulised heparin in COVID-19-related ARDS patients undergoing non-invasive ventilation with helmet cPAP: a prospective, randomised, double blind, placebo-controlled, multicentre study
    Ruolo dell’eparina nebulizzata nel trattamento dell’ARDS COVID-19-correlata in pazienti sottoposti a ventilazione non invasiva cPAP mediante casco: uno studio multicentrico, prospettico, randomizzato, in doppio cieco, controllato con placebo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Nebulised heparin in COVID-19-related ARDS patients undergoing helmet non-invasive ventilation
    Ruolo dell’eparina nebulizzata nel trattamento dell’ARDS COVID-19-correlata in pazienti sottoposti a ventilazione non invasiva mediante casco
    A.3.2Name or abbreviated title of the trial where available
    HelmetHeparin
    HelmetHeparin
    A.4.1Sponsor's protocol code numberHelmetHeparin
    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 SponsorASST FATEBENEFRATELLI SACCO
    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 supportAerogen
    B.4.2CountryIreland
    B.4.1Name of organisation providing supportMedic Italia
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFatebenefratelli e Oftalmico Hospital
    B.5.2Functional name of contact pointSophia Campbell Davies
    B.5.3 Address:
    B.5.3.1Street AddressC.so di Porta Nuova 23
    B.5.3.2Town/ cityMilan
    B.5.3.3Post code20121
    B.5.3.4CountryItaly
    B.5.6E-mailsophia.campbell@asst-fbf-sacco.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 No
    D.2.1.1.1Trade name VERACER - 25000 U.I./5ML SOLUZIONE INIETTABILE 10 FIALE
    D.2.1.1.2Name of the Marketing Authorisation holderMEDIC ITALIA S.R.L.
    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 nameEparina sodica 25.000 UI/5 ml (VERACER)
    D.3.2Product code [033344021]
    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 INNEPARINA SODICA
    D.3.9.1CAS number 9041-08-1
    D.3.9.2Current sponsor code033344021
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25000
    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 Yes
    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
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COVID-19-related Acute Respiratory Distress Syndrome (ARDS) patients undergoing non-invasive ventilation with helmet continuous positive airway pressure (cPAP)
    Pazienti con sindrome da distress respiratorio acuto COVID-19 correlata sottoposti a ventilazione non invasiva cPAP mediante casco
    E.1.1.1Medical condition in easily understood language
    COVID-19-related Acute Respiratory Distress Syndrome (ARDS) patients undergoing non-invasive ventilation with helmet continuous positive airway pressure
    Pazienti con sindrome da distress respiratorio acuto COVID-19 correlata sottoposti a ventilazione non invasiva mediante casco
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level LLT
    E.1.2Classification code 10052956
    E.1.2Term CPAP
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10084460
    E.1.2Term COVID-19 treatment
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10003083
    E.1.2Term ARDS
    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
    Assess the effect of 25,000 IU Q4 of nebulised unfractionated heparin (UFH) in COVID-19 patients undergoing non-invasive cPAP helmet ventilation in terms of reducing cPAP use.
    Valutazione dell’effetto dell’eparina sodica in forma nebulizzata alla dose di 25.000 IU ogni 6 ore sull’outcome ospedaliero, in termini di riduzione dei giorni di ventilazione non invasiva (cPAP) in casco, rispetto al controllo, nei pazienti che non vanno incontro a intubazione tracheale o a morte.
    E.2.2Secondary objectives of the trial
    Assess the effect of 25,000 IU Q4 nebulised UFH in terms of:
    • need for cPAP helmet ventilation;
    • need for mechanical ventilation;
    • duration of mechanical ventilation (when needed);
    • mortality during the 28 days following the beginning of cPAP
    • safety
    in patients undergoing non-invasive cPAP helmet ventilation for COVID-19 pneumonia.
    Valutazione dell’effetto dell’eparina sodica in forma nebulizzata alla dose di 25.000 IU ogni 6 ore in termini di:
    - necessità di ventilazione non invasiva cPAP
    - necessità di ventilazione meccanica
    - durata della ventilazione meccanica (quando necessaria)
    - mortalità durante i 28 giorni dalla randomizzazione
    - sicurezza
    in pazienti sottoposti a ventilazione non invasiva cPAP con casco per polmonite da COVID-19.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 18 years or older;
    - Positive molecular COVID-19 test on nasopharyngeal swab;
    - Interstitial pneumonia confirmed on lung CT scan;
    - Indication to helmet cPAP according to the COVID-19 Treatment Guideline criteria (21), i.e. the presence of at least one of the following signs during O2 therapy with O2 mask reservoir-bag 15 L/min: SpO2 < 92% and respiratory rate > 26/min and/or evident respiratory distress (point 5 on the WHO ordinal scale).
    - Età maggiore di 18 anni;
    - Tampone molecolare COVID-19 positivo;
    - Diagnosi di polmonite interstiziale confermato da TAC polmonare;
    - Indicazione a ventilazione non invasiva cPAP mediante casco secondo il criterio di mancata risposta a ossigeno terapia con O2 mask reservoir-bag 15 L/min intesa come: SpO2 < 92% e frequenzarespiratoria > 26/min e/o insufficienza respiratoria evidente (punteggio 5 sulla scala OMS).
    E.4Principal exclusion criteria
    - Age 80 years or older;
    - Ongoing anticoagulant therapy;
    - Clinically not compatible with helmet cPAP interruption for 10-25 minutes 4 times a day;
    - Home cPAP treatment;
    - Home O2 therapy;
    - Insulin-dependent diabetes mellitus
    - Acute myocardial infarction during the previous 6 months;
    - Ongoing oncological disease;
    - Chronic renal failure;
    - CT scan diagnosis of pulmonary thromboembolism;
    - Body Mass Index (BMI) over 40;
    - Uncontrolled bleeding;
    - Not able to understand or sign the informed consent.
    - Età maggiore o uguale a 80 anni;
    - Terapia anticoagulante in corso;
    - Clinicamente non compatibile con interruzione del trattamento con cPAP con casco per 10-25 minuti 4 volte al giorno;
    - Trattamento domiciliare con cPAP;
    - Terapia domiciliare con ossigeno;
    - Diagnosi di diabete mellito,
    - Infarto miocardico acuto durante i 6 mesi precedenti;
    - Patologie oncologiche in corso;
    - Insufficienza renale;
    - Diagnosi di tromboembolismo venoso;
    - BMI maggiore di 40;
    - Presenza di sanguinamenti incontrollati;
    - incapacità a comprendere o a firmare il consenso informato.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the number of days of cPAP use in COVID-19 patients undergoing non-invasive cPAP helmet ventilation who neither die nor undergo mechanical ventilation.
    L'endpoint primario corrisponde al numero di ore di cPAP in pazienti sottoposti a ventilazione non-invasiva con casco, nei pazienti che non vanno incontro a intubazione tracheale o a morte.
    E.5.1.1Timepoint(s) of evaluation of this end point
    10 days from randomisation
    10 giorni dalla randomizzazione
    E.5.2Secondary end point(s)
    Proportion of patients requiring removal of cPAP helmet ventilation (point 4, 3, 2, 1 on the WHO ordinal scale) within 10 days from randomisation; Proportion of patients requiring invasive mechanical ventilation (point 6-7 on the WHO ordinal scale) within 10 days from randomisation; Number of days of mechanical ventilation (if necessary); Proportion of patients who die within 28 days following the beginning of cPAP (point 8 on the WHO ordinal scale); Daily ratio of partial pressure of oxygen to FiO2 (PaO2/FiO2); Number and type of adverse reactions
    Proporzione di pazienti a cui viene rimossa la ventilazione cPAP con casco entro 10 giorni dalla randomizzazione (punteggio 1, 2, 3, 4 secondo la scala OMS); Proporzione di pazienti che necessitano di ventilazione meccanica entro 10 giorni dalla randomizzazione (punteggio 6, 7 secondo la scala OMS); Numero di giorni di ventilazione meccanica (se richiesta); Proporzione di pazienti con mortalità a 28 giorni dalla randomizzazione (punteggio 8 secondo la scala OMS); Rapporto giornaliero della pressione parziale di ossigeno a FiO2 (PaO2/FiO2); Numero e tipo di reazioni avverse
    E.5.2.1Timepoint(s) of evaluation of this end point
    10 days; 10 days; 10 days; 28 giorni; 10 days; 28 days (+10)
    10 giorni; 10 giorni; 10 giorni; 28 days; 10 giorni; 28 giorni (+10)
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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 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
    Last visit of the last subject (28 days after the end of treatment)
    Ultima visita dell'ultimo paziente arruolato (28 giorni dopo la fine del trattamento)
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    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.1.1.1In 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: 65
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 95
    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 state160
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 160
    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)
    Standard treatment
    Trattamento standard
    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 Opinion2021-07-15
    P. End of Trial
    P.End of Trial StatusOngoing
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