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    Summary
    EudraCT Number:2020-002091-12
    Sponsor's Protocol Code Number:HUVE-19-CT-001
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-05-05
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2020-002091-12
    A.3Full title of the trial
    Multicenter, randomized, double-blind, placebo-controlled study investigating efficacy, safety and tolerability of ivermectin HUVE-19 in patients with proven SARS-CoV-2 infection (COVID-19) and manifested clinical symptoms.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of ivermectin against COVID-19
    A.4.1Sponsor's protocol code numberHUVE-19-CT-001
    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 SponsorHUVEPHARMA EOOD
    B.1.3.4CountryBulgaria
    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 supportHUVEPHARMA EOOD
    B.4.2CountryBulgaria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHUVEPHARMA EOOD
    B.5.2Functional name of contact pointSpas Petkov
    B.5.3 Address:
    B.5.3.1Street Address3A Nikolay Haytov Str., 5th floor
    B.5.3.2Town/ citySofia
    B.5.3.3Post code1113
    B.5.3.4CountryBulgaria
    B.5.4Telephone number359887224426
    B.5.6E-mailSpas.Petkov@huvepharma.com
    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 No
    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.3.2Product code HUVE-19
    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 INNivermectin
    D.3.9.1CAS number 70288-86-7
    D.3.9.2Current sponsor codeHUVE-19
    D.3.9.3Other descriptive name22,23-Dihydroavermectin B1
    D.3.9.4EV Substance CodeSUB34686
    D.3.10 Strength
    D.3.10.1Concentration unit µg/kg microgram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 No
    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 placeboTablet
    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
    confirmed SARS-CoV-2 infection
    E.1.1.1Medical condition in easily understood language
    COVID-19 infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    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 Ivermectin plus investigator’s choice of standard of care therapy (SoC) vs placebo plus SoC in the treatment of coronavirus disease 2019 (COVID-19) based on the qualitative virological clearance in upper respiratory tract swab samples on Day 7.
    E.2.2Secondary objectives of the trial
    1. To evaluate the efficacy of Ivermectin plus investigator’s choice of standard of care therapy (SoC) vs placebo plus SoC in the treatment of coronavirus disease 2019 (COVID-19) based on clinical improvement on Day7 and Day14
    2. To evaluate the efficacy of Ivermectin plus investigator’s choice of standard of care therapy (SoC) vs placebo plus SoC in the treatment of coronavirus disease 2019 (COVID-19) based on clinical recovery on Day 7 and Day 14.

    Additional secondary objectives
    1. To evaluate the efficacy of Ivermectin plus investigator’s choice of standard of care therapy (SoC) vs placebo plus SoC in the treatment of coronavirus disease 2019 (COVID-19) based on different additional clinical endpoints
    2. To evaluate the effect of treatment with Ivermectin plus investigator’s choice of standard of care therapy (SoC) vs placebo plus SoC on hematology and inflammatory markers
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients at least 18 years old
    2. Signed informed consent
    3. Admitted to hospital for treatment of COVID -19. The hospitalization must be for medical and not for social reasons.
    4. Patient within 7 days from symptom onset and within 72 hours after laboratory diagnosis (SARS-CoV-2 RT-PCR)
    5. Mild to Moderate COVID-19 disease defined as clinical status category 3 or 4 on the WHO 9-point ordinal scale
    • Hospitalized, no oxygen treatment
    • Oxygen by mask or nasal prongs
    6. Presence of at least 1 symptom characteristic for COVID-19 disease, e.g. fever, cough, sore throat, myalgia, fatigue, GI disorders, skin lesions etc
    7. In women of childbearing potential, negative pregnancy test and commitment to use contraceptive method throughout the study
    E.4Principal exclusion criteria
    1. Critical patients with expected survival time < 72 hours
    2. Presence of respiratory failure, shock, and/or combined failure of other organs that requires ICU monitoring
    3. Participation in the trial is not in the patient`s best interest based on the judgement of the Investigator
    4. Presence of the following laboratory values at screening
    • White blood cell count <1,5X109/L
    • Platelet count< 100000 mm3(<100 X109/L)
    • Total bilirubin>2 X upper limit of normal (ULN)
    • Alanine aminotransferase (ALT) or gamma glutamyl transferase (GGT) > 3 X ULN
    5. Clinical suspicion for a bacterial superinfection at screening
    6. Allergic or hypersensitive to the IMP or any of the ingredients
    7. Patients who cannot take drugs orally, or have severe gastro-intestinal disorders, extensive bowel resection or bowel obstruction.
    8. Previous (in the past 3 months) or concurrent use of any other Investigational product (IP)
    9. Use of the prohibited medications during the treatment with IP, as defined in the protocol;
    10. Patients with end stage liver disease (Child Pugh C score)
    11. History or presence of serious or acute heart disease such as uncontrolled cardiac dysrhythmia or arrhythmia, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure (NYHA class III or 4)
    12. Presence of acute stroke at screening or a history of acute stroke within the last 6 months.
    13. Pregnant or breastfeeding
    14. Legal incapacity, limited legal capacity, or any other condition that makes the patient unable to provide consent for the trial.
    15. Patients who are institutionalized due to judicial order.
    16. An employee or immediate relative of the Investigator or Sponsor.
    17. Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including asthma and COPD), renal, hepatic, endocrine (including uncontrolled diabetes mellitus) or gastro-intestinal disorder, that according to Investigator could jeopardize the safety of the patient, or the integrity of the study
    E.5 End points
    E.5.1Primary end point(s)
    Rate of subjects converted to negative SARS-CoV-2 (qualitative) test on Days 7
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 7
    E.5.2Secondary end point(s)
    •Number of patients achieving clinical recovery on Day 7
    •Number of patients achieving clinical recovery on Day 14

    Additional secondary end points
    •Time to conversion to a negative SARS-CoV-2 (qualitative) test until Day 28
    •Time to achieving clinical improvement until Day 28
    •Time to achieving clinical recovery until Day 28
    •Rate of subjects conversion converted to a negative SARS-CoV-2 (qualitative) test on Day 4
    •Rate of subjects conversion converted to a negative SARS-CoV-2 (qualitative) test on Day 9 and Day 12
    •Rate of subjects conversion converted to a negative SARS-CoV-2 (qualitative) test on Day 14
    •Time to hospital discharge
    •Number of patients who have needed high flow oxygen therapy
    •Number of patients who have needed ICU treatment

    •Inflammatory and FBC markers
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 4, 7, 9, 12, 14,
    Until 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 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 concerned9
    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
    LSLV (Day 28)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months3
    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: 40
    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)
    N/A
    N/A
    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 Decision2020-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-10-08
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