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    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2022-003478-22
    Sponsor's Protocol Code Number:P2202GF
    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:2022-12-02
    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 number2022-003478-22
    A.3Full title of the trial
    A randomised, placebo-controlled, double-blind parallel-group trial
    to assess the efficacy and safety of PB432 in outpatients with
    COVID-19 induced acute respiratory infection - COVARI-2 study-

    Eine randomisierte, Placebo-kontrollierte, doppelblinde Parallelgruppenstudie zur Bewertung der Wirksamkeit und Sicherheit von PB432 bei ambulanten Patienten mit COVID-19 induzierter akuter Atemwegsinfektion
    - COVARI-2 Studie-
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to assess the efficacy and safety of PB432 in COVID-19 positive out-patients with acute respiratory problems.
    Eine klinische Studie zur Bewertung der Wirksamkeit und Sicherheit von PB432 bei ambulanten Patienten mit COVID-19-bedingten akuten Atemwegsbeschwerden.
    A.4.1Sponsor's protocol code numberP2202GF
    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 SponsorG. Pohl-Boskamp GmbH & Co. KG
    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 supportG. Pohl-Boskamp GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationG. Pohl-Boskamp GmbH & Co. KG
    B.5.2Functional name of contact pointSen. Director Med. & Clin. Research
    B.5.3 Address:
    B.5.3.1Street AddressKieler Strasse 11
    B.5.3.2Town/ cityHohenlockstedt
    B.5.3.3Post code25551
    B.5.3.4CountryGermany
    B.5.4Telephone number0049482659240
    B.5.5Fax number0049482659213
    B.5.6E-mailt.wittig@pohl-boskamp.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 GeloMyrtol forte
    D.2.1.1.2Name of the Marketing Authorisation holderG. Pohl-Boskamp GmbH & Co. KG,
    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 namePB432 300 mg capsule
    D.3.2Product code PB432
    D.3.4Pharmaceutical form Gastro-resistant capsule, soft
    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 INNDISTILLATE OF A MIXTURE OF RECTIFIED EUCALYPTUS OIL, RECTIFIED SWEET ORANGE OIL, RECTIFIED MYRTLE OIL AND RECTIFIED LEMON OIL IN A RATIO OF 66:32:1:1
    D.3.9.2Current sponsor codePB432
    D.3.9.3Other descriptive nameDISTILLATE OF A MIXTURE OF RECTIFIED EUCALYPTUS OIL, RECTIFIED SWEET ORANGE OIL, RECTIFIED MYRTLE OIL AND RECTIFIED LEMON OIL IN A RATIO OF 66:32:1:1
    D.3.9.4EV Substance CodeSUB116177
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 capsule, soft
    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
    COVID-19 with acute respiratory infection
    E.1.1.1Medical condition in easily understood language
    COVID-19 with acute respiratory infection
    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 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084401
    E.1.2Term COVID-19 respiratory infection
    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
    The trial is conducted to assess the efficacy of 2 weeks of treatment with 4 x 300 mg (total 1200 mg)/day oral PB432 in acute symptomatic COVID-19 outpatients with new onset of cough.
    E.2.2Secondary objectives of the trial
    To assess the safety of PB432 treatment in the studied out-patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 Male / female / diverse adults between ≥18 and ≤60 years of age at enrolment
    2 Acute coughing with new onset of cough, i.e., starting within 48 h (or 2 days) before enrolment and with sufficiently high
    coughing intensity, defined as a minimum score of 5 on 11-point NRS at Visit 1
    3 Signed informed consent and data protection declaration for SARS-CoV-2 antigen test prior to initiation of this trial-related
    procedure
    4 Confirmed SARS-CoV-2 infection (by test on-site) as determined by antigen test at Visit 1 before randomisation
    5 Signed informed consent and data protection declaration prior to initiation of any further trial procedures beyond SARS-CoV-2
    antigen test
    Note: For screening activities in first stage (confirmation of SARS-CoV-2 by antigen test) only inclusion criteria 1., 2. and 3. must be confirmed
    E.4Principal exclusion criteria
    1 Any clinical indication for immediate hospitalisation
    2 Need for supplemental oxygen
    3 Clinical indication for immediate systemic antibiotic therapy
    4 Patients that at the discretion of the responsible physician are likely to benefit from COVID-19-specific antiviral therapy
    5 Medical history suggesting chronic or readily recurrent sinusitis or bronchitis i.e., without previous acute sinusitis or bronchitis
    6 At time of study inclusion chronic cough (> 6 weeks), anamnestic knowledge of bronchiectasis, suspected pneumonia, and mucoviscidosis unless consistently treated at a constant dose from 1 week
    before Visit 1
    7 Exacerbation of COPD or asthma bronchiale with the need of systemic steroids
    8 Acute symptoms of a known allergic rhinitis
    9 Use of not permitted previous / concomitant medication or therapy and any other medication regularly used to treat concomitant or chronic diseases that is known to interfere with cough or mucus formation
    10 Use of, or anticipated use of inhaled, intranasal, or systemic steroid treatment during the trial
    11 Inflammatory gastrointestinal or severe hepatic disease or inflammation of the gallbladder or bile duct at the time of inclusion or within the last 6 months before Visit 1
    12 Known hypersensitivity to trial medication or its excipients
    13 Patients with rare hereditary problems of fructose intolerance
    14 Only for patients of childbearing potential:
    Pregnancy, positive urine pregnancy test on Day 0, breast feeding or no use of effective contraception
    15 Malignancy (active = running or immediately planned treatment options like e.g., surgery, chemo- or radiation therapy) or condition after carcinoma not longer than 5 years without relapse, which would make it in the opinion of the investigator unsafe or unsuitable for the patient to participate in this clinical trial.
    Watchful waiting in case of prostate carcinoma is not considered as an active malignancy, provided that the patient is free of symptoms and without therapy regarding the prostate carcinoma. Such a constellation does not fulfil this exclusion criterion. Final decision is at the discretion of the investigator
    16 Participation in clinical trial within 30 days before screening
    17 Known to be or suspected of being unable to comply with the study protocol (e.g., no permanent address, history of drug abuse, known to be non-compliant or presenting an unstable psychiatric history)
    18 Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope, and possible impact of the trial
    19 Patient in custody by juridical or official order evidence of an uncooperative attitude
    20 Patient, who is a member of the staff of the study center, staff of the sponsor or CRO, the investigator him- / herself or close relatives of the investigator
    E.5 End points
    E.5.1Primary end point(s)
    The following main efficacy endpoints will be analysed using the eDiary data:
    1. Number of coughing fits during the day using a manual counter from Day 1 to Day 13
    2. Severity of typical COVID-19-symptoms from Day 0 to Day 13 using a NRS 11

    The following main efficacy endpoints will be analysed using the investigator’s assessments:
    1. Severity of typical COVID-19-symptoms from at each Visit using a NRS 11
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 0 to Day 15
    E.5.2Secondary end point(s)
    The following exploratory efficacy endpoints will be analysed using the eDiary data:
    1. Symptom rate and extent
    2. Sleep disturbance due to any COVID-19 related symptom
    3. Global judgement of efficacy (patient’s ratings, 4-Point Verbal Rating Scale)
    4. Time to 50 % reduction in coughing fits compared to Day 1
    5. Time to 50 % reduction in coughing fits compared to Day of maximum coughing fits
    6. Time from Day 0 to symptom resolution or alleviation of cough and all typical
    COVID-19 symptoms
    7. Time from Day of maximum symptom score to symptom resolution or alleviation of cough and all typical COVID-19 symptoms
    8. Proportion of patients with no coughing fits separately for each study day
    9. Proportion of patients with no symptoms (for each symptom and total core) separately for each study day assessed on a 11-scale VAS (0-10)
    10. Proportion of patients with dyspnoea while climbing stairs

    The following further exploratory efficacy endpoints will be analysed:
    1. Proportion of patients hospitalized during study or on Visit 3 (Day 14 or discontinuation)

    The following safety endpoints will be analysed:
    1. Frequency and intensity of adverse events (AE)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 0 to Day 15
    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 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 concerned20
    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
    In the protocol is defined, that availability of first draft report is the end of the clinical trial.
    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 months11
    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 No
    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)
    Treatment or care after the subject has ended the participation in the trial is not different from the expected normal treatment of that condition.
    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 Decision2023-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-04-18
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