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    Summary
    EudraCT Number:2020-003779-17
    Sponsor's Protocol Code Number:P2003GF
    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:2020-11-13
    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 number2020-003779-17
    A.3Full title of the trial
    A clinical trial to assess the efficacy and safety of PB432 in COVID-19 positive inpatients with acute respiratory insufficiency (ARI)
    -COVARI-
    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 inpatients with acute respiratory problems
    A.4.1Sponsor's protocol code numberP2003GF
    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 insufficiency
    E.1.1.1Medical condition in easily understood language
    Covid-19 with acute respiratory problems
    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
    To evaluate the efficacy of orally administered PB432 capsules compared to placebo in hospitalised patients for 14 days in adults with stable COVID-19 with acute respiratory insufficiency
    E.2.2Secondary objectives of the trial
    To assess the safety of PB432 compared to placebo applied in patients with COVID-19
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male / female / diverse adult ≥18 years of age at time of enrolment
    2. Laboratory-confirmed SARS-CoV-2 infection (COVID-19) as determined by PCR or antigen test in any defined specimen prior to enrolment; samples of first positive test collected within 8 (for symptomatic patients at the time of test) respectively 14 (for asymptomatic patients at the time of test) calendar days prior to randomisation are accepted.
    3. Inpatient admitted to an isolation ward with dyspnoea and / or tachypnoea (e.g. respiratory rate >20/minute) in stable conditions (i.e. without immediate plans for intermediate (IMC) or intensive care unit (ICU) transfer) and a need for supplemental oxygen with low-flow (i.e. up to 5 l/min) nasal cannula according to investigators assessment.
    4. Signed informed consent and data protection declaration prior to initiation of any trial procedures
    E.4Principal exclusion criteria
    1. Acute respiratory distress syndrome (ARDS) at time of inclusion2.
    2. Relevant laboratory abnormality (serum liver enzymes (ASAT, ALAT, GGT) >3x upper range of normality)
    3. Known hypersensitivity to trial medication or excipients
    4. Presence of inflammatory gastrointestinal disease (e.g. Crohn´s Disease, or colitis ulcerosa, diverticulitis or non-infectious acute gastritis) at time of inclusion
    5. Presence of acute or recurrent inflammatory disease of the gall bladder and / or biliary ducts at time of inclusion
    6. Severe hepatic disease (e.g. liver cirrhosis Child Pugh B or C, ongoing viral hepatitis) at time of inclusion
    7. Hereditary fructose intolerance
    8. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <30 ml/min)
    9. Only for female patients of childbearing potential: Pregnancy, positive urine pregnancy test on Day 1, breast feeding or no use of effective contraception
    10. Active malignancy (active = running or immediately planned treatment options like e.g. surgery, chemo- or radiation therapy) or condition after carcinoma not longer than 2 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
    11. Use of systemic immunosuppressants (except corticosteroids) within 4 weeks before inclusion into the clinical trial
    12. Only for female subjects of childbearing potential: Woman who is pregnant or breast feeding, or without effective contraception
    13. Patient in another clinical trial with an investigational medicianl product within 30 days before inclusion into the clinical trial
    14. Known to be or suspected of being unable to comply with the clinical trial protocol (e.g. no permanent address, history of drug abuse, known to be non-compliant or presenting an unstable psychiatric history)
    15. Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the clinical trial
    16. Patient in custody by juridical or official order evidence of an uncooperative attitude
    17. Patient, who is a member of the staff of the study centre, staff of the sponsor or CRO, the investigator him- / herself or close relatives of the investigator
    Note for exclusion criterion no. 10: Watchful waiting of prostate carcinoma is not considered as an active carcinoma provided that the patient is free of symptoms and without therapy regarding the prostate carcinoma. Such a constellation does not fulfil exclusion criterion no. 10. Final decision is at the discretion of the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    1. The daily scores of OSS (Ordinal Status Score, i.e. Patient’s Clinical Status) will be summed-up from Day 2 to Day 15, defined as SOSS-14 and Day 1 value will be used as baseline.
    2. The number of days from Day 1 (randomisation) until first increase (improvement) by at least two points in OSS compared to Day 1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1 to Day 15
    E.5.2Secondary end point(s)
     The Daily Scores of OSS will be summed-up from Day 2 to Day 29, defined as SOSS-28.
     Time to patient satisfies categories 5, 6 or 7 on the above mentioned 7 category ordinal scale.
     Time to discharge from hospital (duration of hospitalisation)
     Time to OSS score ≤2 (ICU admission / death)
     Mortality
     Percent of patient discharged from hospital till Day 8, 15, 22, 29
     Proportion of patients SARS-CoV-2 free pharyngeal swabs / sputum samples (virus-free) on Days 8, 15, 22, 29
     Proportion of patients with interference of daily activities by dyspnoea at least once after discharge
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1 to Day 29
    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 No
    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) 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 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 concerned10
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months7
    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: 100
    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 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 state150
    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 Decision2020-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-07-19
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