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    Summary
    EudraCT Number:2020-005523-37
    Sponsor's Protocol Code Number:BromCO
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-04-26
    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 ConcernedGermany - BfArM
    A.2EudraCT number2020-005523-37
    A.3Full title of the trial
    A prospective controlled proof-of-concept trial to demonstrate anti-viral effects of oral bromelaine in COVID-19 positive patients
    Eine prospektive kontrollierte Proof-of-Concept-Studie zum Nachweis der antiviralen Wirkung von oralem Bromelain bei COVID-19 positiven Patienten.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A prospective controlled proof-of-concept trial to demonstrate anti-viral effects of oral bromelaine in COVID-19 positive patients
    A.4.1Sponsor's protocol code numberBromCO
    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 SponsorURSAPHARM Arzneimittel GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportURSAPHARM Arzneimittel GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinCompetence Cologne GmbH
    B.5.2Functional name of contact pointContract Research Organization
    B.5.3 Address:
    B.5.3.1Street AddressTheodor-Heuss-Ring 14
    B.5.3.2Town/ cityKöln
    B.5.3.3Post code50668
    B.5.3.4CountryGermany
    B.5.4Telephone number+4922171613320
    B.5.5Fax number+4922171613329
    B.5.6E-mailinfo@clincompetence.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 Bromelaintabletten hysan, 500 F.I.P.-Einheiten, magensaftresistente Tabletten
    D.2.1.1.2Name of the Marketing Authorisation holderURSAPHARM Arzneimittel GmbH
    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.3.4Pharmaceutical form Gastro-resistant tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBromelains
    D.3.9.1CAS number 9001-00-7
    D.3.9.2Current sponsor codeBromelain
    D.3.9.3Other descriptive nameBromelaina
    D.3.9.4EV Substance CodeSUB22009
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboGastro-resistant tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diagnosis of SARS-CoV-2 infection documented by a positive PCR test
    E.1.1.1Medical condition in easily understood language
    Diagnosis of SARS-CoV-2 infection documented by a positive PCR test
    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 PT
    E.1.2Classification code 10084460
    E.1.2Term COVID-19 treatment
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    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 of the treatment with Bromelain tablets in COVID-19 positive patients is to assess the change in Patient reported symptoms.
    E.2.2Secondary objectives of the trial
    Secondary objectives of the Trial are:
    - to assess the Clinical improvement of the Patient Status via a WHO ordinal scale
    - to assess the Clinical improvement of the Patient state via measurement of Body temperature and blood Oxygen Saturation
    - to assess the Clinical improvement of the Patient state via measurement of blood Parameters
    - to assess the Clinical improvement of the Patient state via measurement of Virus load in nasopharyngeal swabs (Ct values)
    - to assess the clincal Impact of the Treatment with Bromelain tablets with regards to Quality of Life
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following inclusion criteria in order to participate in this study:

    - Legally competent patients who are personally capable of giving informed consent and to sign and date the Consent Form prior to any trial related activity,
    - Patients aged from 18 - 60 years
    - Having the diagnosis of SARS-CoV-2 infection documented by a positive PCR test
    - Patients showing at least one of the typical symptoms for COVID-19 disease, such as fever, shortness of breath, cough, anosmia (loss of odor), or ageusia (loss of taste).
    - Enrolment should generally done on the day of availability of positive COVID-19 PCR test result, and on the subsequent day. The interval between sample collection and enrolment should generally not exceed 48 hours. If justified by persistent or increasing Symptoms, this interval can be extended to <100 hrs.
    - For females: non-pregnant, non-lactating with adequate contraception*, until D16 or females unable to bear children (i.e., tubal ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period).
    E.4Principal exclusion criteria
    Patients must not meet any of the following non-inclusion criteria in order to participate in this study:

    - Patients requiring hospitalization,
    - Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion,
    - No enrolment permitted if COVID-19 testing was performed more than 48 hours ago
    - Being in any relationship or dependence with the Sponsor, CRO and/or Investigator,
    - Patients being hypersensitive/allergic to bromelain, pineapple or any of the other excipients of the investigational drug,
    - Patients with blood coagulation disorders, e.g., haemophilia,
    - Patients treated with anticoagulants or inhibitors of platelet aggregation,
    - Patients being on risk for a serious course of the disease (e.g., insulin-dependent diabetic patients, patients treated with antihypertensive drugs),
    - Inability to understand instructions/study documents,
    - Inability to administer or swallow the tablets
    - Specific vulnerable patients: subjects who are detained or committed to institutions by law court or by legal authorities, such as psychiatric wards, prisons or other state institutions,
    - Any concurrent anti-histamine therapy, any anti-histamine therapy 30 days prior to enrolment
    - Females who are pregnant, lactating, or of child-bearing potential and not using an adequate contraceptive method* until D16,
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint of the efficacy of Bromelain tablets in COVID-positive patients is the baseline-adjusted course of the median of Symptoms (anosmia, ageusia, fever, cough, sore throat, shortness of breath, coryza, general weakness, headache, aching limbs, loss of appetite, nausea, abdominal pain, vomiting, diarrhoea, conjunctivitis, rash, lymph node swelling, apathy, somnolence) documented over the course of the study (day 1 - day 11).
    E.5.1.1Timepoint(s) of evaluation of this end point
    COVID-19 symptom severity will be assessed daily (day 1 to day 11).
    E.5.2Secondary end point(s)
    1. baseline-adjusted area under the curve of the total symptom score
    2. baseline-adjusted area under the curve of each individual symptom
    3. proportion of patients who show a decrease in their baseline-adjusted symptoms score of SARS-CoV-2 within 3 days of treatment
    4. change in patient status via measurement of virus load in nasopharyngeal swabs (Ct value at baseline V1 (D1) vs. Ct-values at V2 (D4 +/- 1 day), V3 (D7 +/- 1 day) and V4 (D11 +/- 2 days)).
    5. proportion of patients with the presence of a positive PCR-test at V4 (D11 +/- 2 days) (virus load in nasopharyngeal swabs)
    6. change in patient status using a 11-category ordinal score as proposed by the WHO
    7. baseline-adjusted change in patient status by measurement of temperature (fever) and oxygen saturation of the blood
    8. baseline-adjusted Change in patient status via measurement of blood parameters
    9. baseline-adjusted change in quality of life as assessed by the SF-36 generic quality of life questionnaire.
    10. Treatment emergent adverse Events and adverse drug reactions
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) baseline-adjusted area under the curve (day 1 - day 11)
    2) baseline-adjusted area under the curve (day 1 - day 11)
    3) V2 (D4 +/- 1 day)
    4) V1, V2, V4 and V4
    5) V4
    6) V1, V2, V3, V4, V5, V6
    7) V1, V2, V3, V4
    8) V1, V2, V3, V4
    9) V1, V2, V3, V4
    10) over the entire study period (V1 - V6)

    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 Yes
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 months4
    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: 120
    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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    SARS-CoV-2 positive patients
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    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)
    Patients suffering from persistent symptoms after the 11-day treatment as part of the study, or patients getting much worse condition during the study will be treated according to current medical Guidelines.
    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 Decision2021-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-02-14
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