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    Summary
    EudraCT Number:2020-001492-33
    Sponsor's Protocol Code Number:CGE_2020_9
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-04-01
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-001492-33
    A.3Full title of the trial
    Interest in the administration of Dornase alpha aerosol in ARDS secondary to respiratory infection by the coronavirus SRASCoV-2 / COVID-19
    Intérêt de l'administration de Dornase alpha en aérosol dans le SDRA secondaire à une infection respiratoire par le coronavirus SRASCoV-2 / COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Interest in the administration of Dornase alpha aerosol in Acute Respiratory Distress Syndrome secondary to respiratory infection by the coronavirus SRASCoV-2 / COVID-19
    Intérêt de l'administration de Dornase alpha en aérosol dans le Syndrome de Détresse Respiratoire Aigue secondaire à une infection respiratoire par le coronavirus SRASCoV-2 / COVID-19
    A.3.2Name or abbreviated title of the trial where available
    COVID19-COVIDornase
    COVID19-COVIDornase
    A.4.1Sponsor's protocol code numberCGE_2020_9
    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 SponsorHôpital Fondation Adolphe de Rothschild
    B.1.3.4CountryFrance
    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 supportHôpital Fondation Adolphe de Rothschild
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHôpital Fondation Adolphe de Rothschild
    B.5.2Functional name of contact pointClinical Research Director
    B.5.3 Address:
    B.5.3.1Street Address29 rue Manin
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75019
    B.5.3.4CountryFrance
    B.5.4Telephone number33148036433
    B.5.6E-mailpvachey@for.paris
    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 Pulmozyme 2500 U/2,5ml, solution pour inhalation par nébuliseur
    D.2.1.1.2Name of the Marketing Authorisation holderRoche
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 Inhalation solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation 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 Yes
    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
    Patients on mechanical ventilation, inpatient resuscitation for ARDS, secondary to COVID-19 infection
    Patients sous ventilation mécanique, hospitalisés en réanimation pour un SDRA, secondaire à une infection par COVID-19
    E.1.1.1Medical condition in easily understood language
    Patients on mechanical ventilation, inpatient resuscitation for ARDS, secondary to COVID-19 infection
    Patients sous ventilation mécanique, hospitalisés en réanimation pour un SDRA, secondaire à une infection par COVID-19
    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 intratracheal administration of dornase alfa (Pulmozyme) on the evolution of ventilatory parameters at D7
    Evaluer l'efficacité de l'administration intratrachéale de dornase alfa (Pulmozyme) sur l'évolution des paramètres ventilatoires à J7
    E.2.2Secondary objectives of the trial
    1) all-cause mortality at D28
    2) the clinical evolution at D28 ;
    3) the duration of mechanical ventilation;
    4) the number of days without mechanical ventilation at D28;
    5) the length of stay in intensive care ;
    6) the concentrations of blood markers of inflammation over time;
    7) NET concentrations in bronchial secretions over time
    8) the occurrence of adverse events
    Les objectifs secondaires sont de comparer entre les deux bras de randomisation :
    1) la mortalité toute cause à J28
    2) l’évolution clinique à J28 ;
    3) la durée de ventilation mécanique ;
    4) le nombre de jours sans ventilation mécanique à J8
    5) la durée de séjour en réanimation ;
    6) les concentrations des marqueurs sanguins de l’inflammation au cours du temps
    7) les concentrations de NETs au sein des sécrétions bronchiques au cours du temps
    8) la survenue d’événements indésirables
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Major patient (age ≥ 18 years old);
    - Hospitalized in intensive care;
    - Severe pneumonia COVID-19 with Berlin criteria for ARDS (PaO2/FiO2<300 and PEP>5).
    - Intubated for less than 8 days ;
    - Expected duration of mechanical ventilation is >48 hours;
    - Carrying an arterial catheter;
    - Affiliated with or beneficiary of a health insurance social protection scheme
    - Patient majeur (âge ≥ 18 ans) ;
    - Hospitalisé en réanimation ;
    - Atteint d’une pneumonie grave COVID-19 avec critères de SDRA selon les critères de Berlin (PaO2/FiO2<300 et PEP>5).
    - Intubé depuis moins de 8 jours ;
    - Dont la durée prévisible de ventilation mécanique est > 48h ;
    - Porteur d’un cathéter artériel ;
    - Affilié ou bénéficiaire d’un régime de protection sociale d’assurance maladie
    E.4Principal exclusion criteria
    - Known hypersensitivity to Dornase alfa or any of the excipients;
    - Pregnant or nursing woman;
    - Patient with legal pro
    - Hypersensibilité connue à la Dornase alfa ou à l’un des excipients ;
    - Femme enceinte ou allaitant ;
    - Patient bénéficiant d’une mesure de protection juridique
    E.5 End points
    E.5.1Primary end point(s)
    Comparison between the two treatment arms of the evolution of the PaO2/FiO2 ratio between D0 (inclusion) and D7
    Comparaison entre les deux bras de traitement de l’évolution du rapport PaO2/FiO2 entre J0 (inclusion) et J7
    E.5.1.1Timepoint(s) of evaluation of this end point
    D7
    J7
    E.5.2Secondary end point(s)
    Secondary endpoints:
    1) all-cause mortality at D28
    2) Delay until improvement of at least 2 points on a 7-point ordinal scale (based on Cao et al. 2020), or until hospital discharge;
    3) Duration of mechanical ventilation (days);
    4) Number of days without mechanical ventilation at D28
    5) Length of stay in intensive care (days) ;
    6) Concentrations of blood markers of inflammation (D0, D2, D7 and discharge);
    7) NET concentrations in bronchial secretions (D0, D2, D7 and discharge);
    8) Rates of adverse events and serious adverse events.
    Critères de jugement secondaires :
    1) la mortalité toute cause à J28
    2) Délai jusqu’à l’amélioration d’au moins deux points sur une échelle ordinale à 7 niveaux (d’après Cao et al. 2020), ou jusqu’à la sortie d’hospitalisation;
    3) Durée de ventilation mécanique (jours) ;
    4) Nombre de jours sans ventilation mécanique
    5) Durée de séjour en réanimation (jours) ;
    6) Concentrations des marqueurs sanguins de l’inflammation (J0, J2, J7 et sortie d’hospitalisation) ;
    7) Concentrations de NETs au sein des sécrétions bronchiques (J0, J2, J7 et sortie d’hospitalisation) ;
    8) Taux d’événements indésirables et d’événements indésirables graves.
    E.5.2.1Timepoint(s) of evaluation of this end point
    D28
    J28
    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) No
    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 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 Yes
    E.8.2.3.1Comparator description
    traitement habituel
    usual treatment
    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 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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    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)
    None
    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 Decision2020-04-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-12-15
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