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    Summary
    EudraCT Number:2021-001665-20
    Sponsor's Protocol Code Number:BCAR-RESP-SE21
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-03-26
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2021-001665-20
    A.3Full title of the trial
    Prospective, randomized, controlled, double-blinded study on the efficacy of nebulized 4.2% sodium-bicarbonate in COVID-19 pneumonia
    Prospektív, kontrollált, randomizált kettős vak vizsgálat 4,2 %-os nátrium-hidrogénkarbonát aeroszol inhaláció terápiás hatékonyságának igazolására COVID pneumónia kezelésében
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of nebulized 4.2% sodium-bicarbonate in COVID-19 pneumonia
    A 4,2 %-os nátrium-hidrogénkarbonát aeroszol inhaláció hatékonysága COVID-19 okozta tüdőgyulladásban
    A.4.1Sponsor's protocol code numberBCAR-RESP-SE21
    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 SponsorSemmelweis University Department of Oralbiology
    B.1.3.4CountryHungary
    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 supportSemmelweis University
    B.4.2CountryHungary
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSemmelweis University
    B.5.2Functional name of contact pointDepartment of Oralbiology
    B.5.3 Address:
    B.5.3.1Street AddressNagyvárad tér 4.
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post code1089
    B.5.3.4CountryHungary
    B.5.6E-mailzsembery.akos@dent.semmelweis-univ.hu
    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 Natrium-hydrogen-carbonicum Pharmamagist 42 mg/ml oldatos injekció
    D.2.1.1.2Name of the Marketing Authorisation holderPharmamagist Kft.
    D.2.1.2Country which granted the Marketing AuthorisationHungary
    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 Solution for injection/infusion
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInhalation solution
    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
    severe COVID-19 pneumonia requires invasive ventillatory support
    invazív gépi lélegeztetésre szoruló COVID-19 pneumonia
    E.1.1.1Medical condition in easily understood language
    severe COVID-19 pneumonia requires invasive ventillatory support
    invazív gépi lélegeztetésre szoruló COVID-19 tüdőgyulladás
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084564
    E.1.2Term SARS-CoV-2 pneumonia
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effect of nebulized 4.2% sodium bicarbonate on the oxygenization of ventillated patients with COVID-19 pneumonia
    A 4.2%-os nátrium-hidrogénkarbonát aeroszol inhaláció lélegeztetett betegek oxigenizációjára gyakorolt hatásának vizsgálata COVID-19 pneumóniában
    E.2.2Secondary objectives of the trial
    To assess the effect of nebulized 4.2% sodium bicarbonate on the clinical and inflammatory status of ventillated patients with COVID-19 pneumonia
    To assess the safety of nebulized 4.2% sodium bicarbonate in ventillated patients with COVID-19 pneumonia
    A 4.2%-os nátrium-hidrogénkarbonát aeroszol inhaláció lélegeztetett betegek klinikai és gyulladásos státuszára gyakorolt hatásának vizsgálata COVID-19 pneumóniában
    A 4.2%-os nátrium-hidrogénkarbonát aeroszol inhaláció biztonságosságának vizsgálata COVID-19 pneumónia miatt lélegeztetett betegekben
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - antigen or PCR test verified COVID-19 pneumonia
    - age: 18-64 yrs
    - informed consent
    - CT-verified bilateral GGO > 50% (CORADS 6)
    - invasive ventillation within 48hrs
    - PaO2/FiO2 <200 (at PEEP > 5 H2O cm)
    - serum prokalcitonin < 0.5 ng/ml
    - serum ferritin > 500 ng/ml
    - 20 < BMI <45
    - antigén teszttel vagy PCR-el igazolt COVID pneumonia
    - életkor: 18-64 év
    - a beteg vagy közeli hozzátartozója informált beleegyezését adta a vizsgálatba
    - CT-vel igazolt bilaterális GGO > 50% (CORADS 6)
    - bevonástól számított 48 órán belül intubált gépi lélegeztetett beteg
    - PaO2/FiO2 <200 (PEEP > 5 H2O cm mellett).
    - serum prokalcitonin szint < 0.5 ng/ml
    - serum ferritin > 500 ng/ml
    - 20 < BMI <45
    E.4Principal exclusion criteria
    - hypernatremia
    - metabolic alkalosis
    - relevant concomitant disease (excluding well-controlled hypertension)
    - renal failure: se creatinin > 200 µM (on adequate volume tehrapy)
    - liver failure (se bilirubin > 34 µM)
    - hematologic disease
    - chronic immune and/or hemopoetic disease
    - bacterial infection (evaluated as serum prokalcitonin szint > 0.5 ng/ml, purulent sputum, unilateral pulmonary consolidation)
    - hypernatrémia
    - metabolikus alkalózis
    - releváns kísérőbetegség (kivétel jól beállított magasvérnyomás betegség)
    - veseelégtelenség: egyensúlyi se creatinin > 200 µM (adekvát volumenterápia ellenére)
    - májelégtelenség (se bilirubin > 34 µM)
    - ismert vérképzőszervi betegség
    - bármilyen immun/vérképzőszervrendszert érintő krónikus megbetegedés
    - bakteriális fertőzés valószínűsége (serum prokalcitonin szint > 0.5 ng/ml, purulens köpet, féloldali pulmonális konszolidáció)
    E.5 End points
    E.5.1Primary end point(s)
    - the change in PaO2/FiO2 (Horowitz index)
    - the number of Ventillator Free Days (VFD) in an interval of 28 days
    - az oxigenizációs index változása (Az artériás oxigéntenzió PaO2 és a belégzett oxigénfrakció (FiO2) hányadosának naptári nap során mért legrosszabb értéke)
    - Ventillator Free Days (VFD) (időintervallum: 28 nap) (endotrachealis intubáció / tracheostoma nélkül töltött idő)
    E.5.1.1Timepoint(s) of evaluation of this end point
    the change in PaO2/FiO2 (Horowitz index): at day 7
    the number of Ventillator Free Days (VFD): at day 28
    Az oxigenizációs index változása: a 7. napon
    Ventillator Free Days (VFD): 28. napon
    E.5.2Secondary end point(s)
    change in PaO2/FiO2
    change in sequential organ failure score (SOFA score)
    length of invasive ventillation (in an interval of 28 days)
    length of ICU stay (LOS) (in an interval of 28 days)
    length of inotropic/vasopressor support (in an interval of 28 days)
    lenght of hospital stay (LOS) (in an interval of 28 days)
    mortality (in an interval of 28 days)
    ICU mortality (in an interval of 28 days)
    the effect on inflammatory response measured as changes in CRP and IL-6
    safety parameters as the frequency of serious adverse events
    az oxigenizációs index változása (Az artériás oxigéntenzió PaO2 és a belégzett oxigénfrakció (FiO2) hányadosának naptári nap során mért legrosszabb értéke)
    a szekvenciális szervi elégtelenséget becslő pontrendszer (SOFA score) változása
    invazív gépi lélegeztetés hossza
    intenzív osztályos tartózkodás hossza (LOS)
    inotrop és/vagy vazopresszor adagolás hossza
    kórházi ápolás hossza (LOS)
    mortalitás (időintervallum: 28 nap)
    intenzív osztályos mortalitás
    gyulladásos válaszra kifejtett hatás értékelése: CRP és IL-6 szintek változása
    súlyos mellékhatások frekvenciája
    E.5.2.1Timepoint(s) of evaluation of this end point
    at days 0, 1, 3, 7, 14, 28:
    change in PaO2/FiO2
    change in sequential organ failure score (SOFA score)
    changes in CRP and IL-6

    at day 28:
    length of invasive ventillation
    length of ICU stay (LOS)
    length of inotropic/vasopressor support
    lenght of hospital stay (LOS)
    mortality
    ICU mortality
    frequency of serious adverse events
    0, 1, 3, 7, 14, 28 nap:
    az oxigenizációs index változása (Az artériás oxigéntenzió PaO2 és a belégzett oxigénfrakció (FiO2) hányadosának naptári nap során mért legrosszabb értéke)
    a szekvenciális szervi elégtelenséget becslő pontrendszer (SOFA score) változása
    CRP és IL-6 szintek változása

    28 nap:
    invazív gépi lélegeztetés hossza
    intenzív osztályos tartózkodás hossza (LOS)
    inotrop és/vagy vazopresszor adagolás hossza
    kórházi ápolás hossza (LOS)
    mortalitás (időintervallum: 28 nap)
    intenzív osztályos mortalitás
    súlyos mellékhatások frekvenciája
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    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 months6
    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: 200
    F.1.3Elderly (>=65 years) No
    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 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 2021-03-26. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    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
    sedated, mechanically ventillated patients (medical condition), patients need urgent care
    beleegyezésre képtelenség oka: sürgősség, tudatállapot (lélegeztett, szedált betegek)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    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
    Nincs
    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 Decision2021-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-16
    P. End of Trial
    P.End of Trial StatusOngoing
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