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    Summary
    EudraCT Number:2022-001097-64
    Sponsor's Protocol Code Number:CVD19-ESCIN
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-04-22
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2022-001097-64
    A.3Full title of the trial
    An open-label, randomized, parallel-controlled, phase II clinical trial to evaluate the tolerability, efficacy and safety of Aesculus Hippocastanum L seed extract in COVID-19 patients with mild pneumonia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate the tolerability, efficacy and safety of Aesculus Hippocastanum L seed extract in COVID-19 patients with mild pneumonia
    A.3.2Name or abbreviated title of the trial where available
    Aesculus Hippocastanum L seed extract in Covid-19 patients
    A.4.1Sponsor's protocol code numberCVD19-ESCIN
    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 SponsorUAB Švenčionių vaistažolės
    B.1.3.4CountryLithuania
    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 supportUAB Švenčionių vaistažolės
    B.4.2CountryLithuania
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUAB Švenčionių vaistažolės
    B.5.2Functional name of contact pointprojektai@acorus.lt
    B.5.3 Address:
    B.5.3.1Street AddressAdutiškio g. 3
    B.5.3.2Town/ cityŠvenčionys
    B.5.3.3Post codeLT-18110
    B.5.3.4CountryLithuania
    B.5.6E-mailelmantas@acorus.lt
    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 Veinofytol
    D.2.1.1.2Name of the Marketing Authorisation holderTilman S.A.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameVeinofytol
    D.3.4Pharmaceutical form 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 INNVeinofytol
    D.3.9.2Current sponsor codeCVD19-ESCIN
    D.3.9.3Other descriptive nameAESCIN
    D.3.9.4EV Substance CodeSUB169258
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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
    COVID-19 patients with mild pneumonia
    E.1.1.1Medical condition in easily understood language
    COVID-19 patients
    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 10084380
    E.1.2Term COVID-19 pneumonia
    E.1.2System Organ Class 10021881 - Infections and infestations
    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 this clinical trial is to determine the therapeutic efficacy of
    Aesculus Hippocastanum L. seed extract for the COVID-19 disease with mild pneumonia treatment
    E.2.2Secondary objectives of the trial
    The evaluation of objective measurable indicators (time to improvement in body temperature, SpO2, chest imaging findings, and negative SARS-CoV-2). Also clinical laboratory evaluation of white blood cell count, haemoglobin level, platelet count, blood glucose concentration, serum total bilirubin, creatinine, ALT, AST, electrolytes, (Na+, K+), C-reactive albumin, IL-6, TNF-alfa, ferritin over the study time.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient age: 18 to 65 years
    2. The patient gave informed consent; patients who understand the essence of the study
    and can independently give the informed consent
    3. A positive SARS-CoV-2 sample (nasopharyngeal swab) was determined by RT-PCR
    4. Patients diagnosed with mild pneumonia with no identified lesions by chest X-ray
    5. Patients who have a fever
    6. Premenopausal women who had a negative pregnancy test
    E.4Principal exclusion criteria
    1. Fever 37.5 °C more than 14 days after the onset of fever
    2. Patients with SpO2 less than 95 % and not treated with O2 therapy
    3. Patients with suspected co-fungal infection
    4. Patients with congestive heart failure
    5. Patients with severe hepatic impairment.
    6. Patients with renal insufficiency
    7. Patients with impaired consciousness, such as those with dementia
    8. Pregnant women
    9. Women patients intending to breast-feed
    10. Patients with a gout or with hyperuricemia
    11. Patients taking immunosuppressants, cancer patients
    12. Patients with a recurrent SARS-CoV-2 infection
    13. Patients with epilepsy, bronchial asthma
    14. Unstable angina pectoris or myocardial infarction within 30 days prior to screening
    15. Patients participating in another clinical trial or if participation finished before 3
    months
    16. Patients have blood purification therapies (hemodialysis, hemofiltration,
    hemadsorption, plasma exchange, plasma adsorption, peritoneal dialysis, etc.)
    17. Patients who develops a disease with diarrhea syndrome
    18. Other patients who have been assessed as unfit by the principal investigator or
    designated physician
    E.5 End points
    E.5.1Primary end point(s)
    The study is aimed to determine whether the efficacy of Aesculus Hippocastanum L. seed extract exceeds the efficacy of maintenance treatment in the control group of SARS-CoV-2 infected patients (Covid-19 disease) with mild pneumonia.
    The primary endpoint is the determination of the period during which the Covid-19 disease
    clinical symptoms are reduced, and the patient's condition improves.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Until the end of the clinical trial day 28.
    E.5.2Secondary end point(s)
    The clinical endpoints of the study, which require regular evaluation in relation to the primary clinic of COVID-19 disease in the assessment of general respiratory symptoms, were selected as secondary endpoints based on their established relevance in clinical practice. They are the following:
    1. Changes in the patient's health condition (according to a 10-point scale)
    2. Time to the negative SARS-CoV-2 test (RT-PCR)
    3. Duration of pyrexia, normalization of body temperature, SpO2 records, and chest
    radiographic imaging data
    4. Changes in expression of clinical symptoms and vital signs
    5. Chest imaging picture data on Days 0, 14 (evaluated data of changes)
    6. The number (percentage) of patients requiring adjuvant O2 therapy; Duration of
    oxygen therapy (average)
    7. Patients requiring treatment in the intensive care department (percentage), requiring
    mechanical ventilation therapy (percentage)
    8. Clinical laboratory evaluation: white blood cell count, haemoglobin level, platelet count,
    blood glucose concentration, serum total bilirubin, creatinine, ALT, AST, electrolytes
    (Na+, K+), C-reactive albumin, IL-6, TNF-alfa, ferritin over the study time.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Until the end of the clinical trial day 28.
    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 No
    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 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
    Maintenance therapy - Supportive 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
    When the last subject completes the last visit in the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state60
    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)
    If the investigator-physician decides to discontinue TVP earlier due to patient condition
    improvement, patient monitoring and examination are not necessary, but monitoring and
    examination should be performed on 28th day.
    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 Decision2022-07-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-12
    P. End of Trial
    P.End of Trial StatusOngoing
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