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    Summary
    EudraCT Number:2021-003237-11
    Sponsor's Protocol Code Number:TMP-2005-2020-36
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-08-02
    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 ConcernedGermany - BfArM
    A.2EudraCT number2021-003237-11
    A.3Full title of the trial
    Effect of Bronchipret on antiviral immune response in patients with mild COVID-19 (BroVID)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of Bronchipret on patient with mild Covid disease
    A.3.2Name or abbreviated title of the trial where available
    BroVID
    A.4.1Sponsor's protocol code numberTMP-2005-2020-36
    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 SponsorFraunhofer Gesellschaft for its Institute for translationale Medicine and Pharmacology ITMP
    B.1.3.4CountryGermany
    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 supportBionorica SE
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFraunhofer ITMP
    B.5.2Functional name of contact pointProject management
    B.5.3 Address:
    B.5.3.1Street AddressTheodor-Stern-Kai 7
    B.5.3.2Town/ cityFrankfurt
    B.5.3.3Post code60596
    B.5.3.4CountryGermany
    B.5.4Telephone number+49696301 80208
    B.5.5Fax number+4924160855 0040
    B.5.6E-mailclinicalreasearch@itmp.fraunhofer.de
    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 Bronchipret syrup
    D.2.1.1.2Name of the Marketing Authorisation holderBionorica SE
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameBronchipret
    D.3.4Pharmaceutical form Syrup
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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 Yes
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    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
    Adult patients suffering from mild COVID-19 with cough and at least one other symptoms will be recruited for this study.
    E.1.1.1Medical condition in easily understood language
    patient with positive SARS-COV2 infection and mild symptoms
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084272
    E.1.2Term SARS-CoV-2 infection
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10011224
    E.1.2Term Cough
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to demonstrate a clinically relevant treatment difference in several blood parameters involved in the immune response at day 7 between patients receiving Bronchipret vs. patients not receiving Bronchipret.
    E.2.2Secondary objectives of the trial
    1. Assessment of blood parameters:
    a. Endpoints: Concentration/Number of following blood parameters and change to BL (absolute change and percentage)
    b. Neutrophil to lymphocyte ratio, IL6/IL-10 ratio, and IL-6/IFNy ratio
    2. Assessment of symptom improvement/worsening and assessment of number of symptoms and symptom distribution
    3. Assessment of defervescence (for patients with fever at BL)
    4. Assessment of improvement or absence of coughing
    5. Assessment of intensity and distribution of most bothersome symptom (VAS) (the most bothersome symptom will be defined by the patient at BL)
    6. Assessment of quality of Life
    7. Requirement of hospitalisation or oxygen supplementation
    8. Disease progression/improvement
    9. Assessment of oxygen saturation
    10. Assessment of intake of concomitant medication
    11. Subgroup analysis of efficacy endpoints
    12. Assessment of SARS-CoV-2 negativity (PCR test)
    13. Assessment of compliance
    14. Safety assessments
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Measurement of respiratory air for COVID-19 relevant markers
    E.3Principal inclusion criteria
    1. Patients ≥ 18 years and ≤ 75 years
    If > 50 years, complete COVID-19 vaccination mandatory
    2. SARS-CoV-2 infection confirmed by PCR test ≤ 4 days before screening/baseline visit
    3. Onset of symptoms < 7 days before screening/baseline visit
    4. Mild COVID-19 with the following symptoms (outpatient management/non hospitalized patients):
    ᴑ Cough and
    ᴑ At least one other symptom (e.g., sore throat, nasal congestion, headache, nausea, low energy/fatigue, muscle or body ache, shortness of breath, fever, diarrhea, altered sense of smell or taste)
    5. Written informed consent obtained prior to the initiation of any protocol-required procedures by the patient
    6. Willingness to comply to study procedures and study protocol
    E.4Principal exclusion criteria
    1. WHO score ≥ 3
    2. Other advanced or chronic lung diseases (COPD, silicosis, bronchial asthma)
    3. Unable to take oral medication
    4. BMI > 35 or ≤ 43 kg
    5. Requirement for oxygen administration
    6. Current hospitalization
    7. Known hypersensitivity to the active substances ivy, thyme, plants of the aralia family or other labiates (Lamiaceae), birch, mugwort, celery or to any of the excipients
    8. Patients with rare hereditary fructose intolerance
    9. Inability to monitor body temperature
    10. Patients regularily taking immune suprressive medication, NSARs or steroids (e.g., because of underlying disease)
    11. Known significant concomitant diseases or serious and/or uncontrolled diseases that are likely to interfere with the evaluation of the patient’s safety and with the study outcome such as stem cell or organ transplantation within the last 5 years, cardiovascular disease, diabetes mellitus, chronic liver disease, chronic kidney disease including dialysis patients, sickle cell anemia or thalassemia, and other forms of immunosuppression (e.g. tumor patients, HIV-infected patients with weakened immune system, iatrogenic immunosuppression) as judged by the study physician according to patient’s
    reports 12. COVID-19 vaccination planned within study period and/or COVID-19 vaccination within the last 28 days
    13. Women pregnant (patient reported at pre-SCR and confirmation via pregnancy test at BL) or nursing
    14. Males or females of reproductive potential not willing to use effective contraception (defined as PEARL index <1 - e.g. contraceptive pill, IUD)
    15. Alcohol, drug or chemical abuse
    16. Current participation in another interventional clinical trial
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective is to demonstrate a clinically relevant treatment difference in several blood parameters involved in the immune response at day 7 between patients receiving Bronchipret vs. patients not receiving Bronchipret.
    Co-primary endpoints:
    Difference in average concentration/numbers of:
    - IL-2, IL-4, IL-6, IL-8, IL-10, INFy, CRP, IL-1β, IFNα, TNFα
    - neutrophils, lymphozytes, monocytes, eosinophils, basophils, platelets
    at day 7 compared to BL compared between patients receiving Bronchipret and patients in the control group
    E.5.1.1Timepoint(s) of evaluation of this end point
    BL, Day 7
    E.5.2Secondary end point(s)
    - Concentration/Number of blood parameters and change to BL
    - FDA symptom questionnaire score and change to BL
    - Number and percentage of patients with no symptoms or only mild symptoms
    - Time to all items of questionnaire ≤ 1 or 0
    - Number of symptoms according to the FDA questionnaire and change to BL
    - Mean score of encountered symptoms and change to BL
    - Symptom distribution
    - Time to defervescence in days
    - Number and proportion of patients who achieved defervescence
    - Absolute temperature values and change to BL
    - Time to cough reported as mild oder non existent in days
    - Time to non-existent coughing for all patients in days
    - Number and proportion of patients with moderate or severe cough at BL who achieved cough reported as mild or none existent
    - Number and proportion of patients who achieved cough reported as none existent
    - Most bothersome symptom distribution (i.e., percentage of patients with each symptom)
    - Intensity of most bothersome symptom (VAS) and change to BL
    - Number and proportion of patients who return to usual health
    - Number and proportion of patients who return to ususal activity
    - Number and proportion of patients requiring hospitalisation or oxygen supplementation
    - Number and proportion of patients with improved or progressed disease state (according to WHO scale)
    - Proportion of patients with each WHO score
    - WHO score and change to BL
    - Number and proportion of patients in each disease severity state (uninfected, mild, moderate, severe, dead) according to WHO score
    - Oxygen saturation and change to BL
    - Type and average daily dose of concomitant medication and total dose until day 14 (paracetamol)
    - Average days of additional intake of concomitant medication
    - Number and proportion of patients with a reduction in concomitant medication intake
    -Number and proportion of patients with hyposmia or anosmia
    - Number and proportion of patients with fever
    - Number and proportion of patients with COVID-19 vaccination (full and partly)
    - Number and proportion of recovered COVID-19 patients (patients who suffered from COVID-19 and recovered thereof before the study)
    - primary and selected secondary endpoints of subgroup analysis
    - Number and proportion of SARS-CoV-2 negative patients
    - Time to SARS-CoV-2 negativity (in days)
    - Compliance to IMP by dose taken (and as documented in patient diary)
    - Number of adverse events and serious adverse events
    - Type and severity (mild, moderate, severe) of (serious) adverse events
    - Seriousness and relatedness of (S)AEs
    E.5.2.1Timepoint(s) of evaluation of this end point
    BL, Day 4, Day 7, Day14
    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 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 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
    database hard lock after LPLV and data cleaning process is completed
    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 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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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 investigator will inform the patients about all available standard-of-care treatments for treatment after the study and the decision is left to the patient and investigator’s discretion.
    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 Decision2021-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-11-27
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