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    Summary
    EudraCT Number:2021-000167-69
    Sponsor's Protocol Code Number:AIC649-02-II-01
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-03-03
    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 - PEI
    A.2EudraCT number2021-000167-69
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of AIC649 in the treatment of otherwise healthy subjects with asymptomatic or mildly symptomatic SARS-CoV-2 infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Novel AIC649 in otherwise healthy patients with asymptomatic or mildly symptomatic SARS-CoV-2 Infection
    A.4.1Sponsor's protocol code numberAIC649-02-II-01
    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 SponsorAiCuris Anti-Infective Cures AG
    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 supportAiCuris Anti-Infective Cures AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAiCuris Anti-Infective Cures AG
    B.5.2Functional name of contact pointHead of Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressFriedrich-Ebert-Strasse 475 / Geb. 302
    B.5.3.2Town/ cityWuppertal
    B.5.3.3Post code42117
    B.5.3.4CountryGermany
    B.5.4Telephone number+49202317631158
    B.5.5Fax number+49202317631701
    B.5.6E-mailsilvia.riffel-friedrich@Aicuris.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.3.1Product nameinactivated Parapoxvirus ovis (iPPVO)
    D.3.2Product code AIC649
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeORG-100006997
    D.3.9.3Other descriptive nameOrf virus, strain NZ-2, Inactivated
    D.3.9.4EV Substance CodeSUB221260
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number to 10^9 particles
    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) Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    asymptomatic or mildly symptomatic SARS-CoV-2 infection
    E.1.1.1Medical condition in easily understood language
    COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084467
    E.1.2Term Asymptomatic SARS-CoV-2 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 investigate the safety and tolerability of multiple dosing of AIC649
    E.2.2Secondary objectives of the trial
    • To investigate the impact of AIC649 on the clinical course of SARS-CoV-2 infections
    • To investigate the impact of AIC649 on SARS-CoV-2 virus replication and viral shedding (from daily throat wash)
    • To investigate the effect of AIC649 on the serum immunological pattern of subjects with SARS-CoV-2 infections
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects meeting the following criteria will be considered for inclusion into the trial:
    1. Subject has been informed both verbally and in writing about the objectives of the clinical trial, the methods, the anticipated benefits and potential risks and the discomfort to which he/she may be exposed. Subject has given written consent to participation in the trial and has delivered the signed Informed Consent Form to the site/Investigator prior to trial start and any trial-related procedure.
    Consent for sampling for epigenetic analysis will be obtained separately and is not mandatory for trial participation.
    2. Male and female subjects of any ethnic origin aged between 18 and 55 years (inclusive) for SARS-CoV-2 non-vaccinated or not fully vaccinated, and between 18 and 65 years (inclusive) when SARS-CoV-2 fully vaccinated. Assessed as otherwise healthy based on a pre-trial examination including medical history, physical examination, blood pressure, pulse rate, ECG assessment, and clinical laboratory results.
    3. SARS-CoV-2 positive by quantitative polymerase chain reaction (qRT-PCR) testing from a throat swab on Day -1 (with ≥10^5 viral copies for SARS-CoV-2 non-vaccinated subjects or not fully vaccinated; qRT-PCR positive without threshold for SARS-CoV-2 fully vaccinated subjects), but no relevant with at most mild COVID-19 symptoms (excluding: see exclusion criterion 10)
    4. SARS-CoV-2 non-vaccinated subjects or not fully vaccinated subjects only: First dosing as soon as possible and within 4 days of first positive SARS-CoV-2 (q)RT-PCR or antigen test
    5. Female subjects of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before starting treatment) or postmenopausal (defined as spontaneous amenorrhea for at least 2 years, with follicle-stimulating hormone (FSH) in the postmenopausal range at start of treatment based on the laboratory’s ranges).
    Female subjects of childbearing potential must use an adequate method of contraception (see definition below). Lesbian subjects who are refraining from heterosexual intercourse for at least 3 months prior to screening may be included without a contraceptive method if they agree to further refrain from heterosexual intercourse until the end of trial examination, and for at least one full month thereafter.

    An adequate method of contraception is defined as a highly effective method of contraception plus use of a condom during participation in this trial and for at least 1 complete month after the final dose of trial medication. A highly effective method of contraception is defined as:
    a. copper intrauterine device,
    b. the levonorgestrel-releasing intrauterine system,
    c. the progestogen implant,
    d. combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) associated with inhibition of ovulation,
    e. progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation.
    As vomiting or diarrhoea may reduce the efficacy of oral contraceptives, women of
    childbearing potential should use other methods or avoid heterosexual intercourse during the
    timeframe of potentially reduced efficacy.
    6. In women of childbearing potential, a negative serum ß-HCG (beta human chorionic gonadotropin) test at screening
    7. A Body Mass Index (BMI) between ≥18.0 and ≤30.0 kg/m², and a body weight >50.0 kg
    E.4Principal exclusion criteria
    A subject will not be eligible for inclusion if any of the following criteria apply:
    Safety concerns
    1. A known hypersensitivity to constituents of the IMP, including polygeline, patients with a history of allergies (severe drug allergies or severe insect bite allergy), hypersensitivities including asthma, chronic obstructive pulmonary disease (COPD), phaeochromocytomas, mastocytosis or mast cell activation disorders, patients with a history of anaphylactic/anaphylactoid reactions or existing anaphylactoid reactions and patients receiving histamine releasing agents.
    2. Known history or current evidence of hypertension, diabetes mellitus, cardiovascular disease, cancer, chronic lung and acute or chronic kidney diseases.
    3. Current evidence of being a smoker (defined as having smoked within 3 months prior to dosing)
    4. History or current evidence of autoimmune diseases such as psoriasis, multiple sclerosis, systemic lupus erythematosus, etc
    5. On treatment with interferons or other immunomodulatory/ immunosuppressive agents
    6. Any vaccinations (including SARS-CoV-2) within 14 days prior to screening or planned during the trial
    7. Clinically relevant abnormalities in clinical chemical, hematological or any other laboratory variables on Day -1
    8. Clinically relevant acute or chronic infections including HIV (exception SARS-CoV-2)
    9. Moderate, Severe or Critical SARS-CoV-2 infection (see Section 6.6.2.2), including with Acute Respiratory Distress Syndrome (ARDS), treated in an intensive care unit (ICU) or on mechanical ventilation.
    10. Moderate or severe cough and/or moderate (defined as ≥38.5°C) or severe fever.
    11. Blood lymphocyte count below the normal range or lactate dehydrogenase (LDH) above the normal range
    12. Clinically relevant elevation of serum inflammatory markers (eg, CRP, procalcitonin)
    13. Subject is participating in other investigational therapy clinical trial(s)
    14. Subject is lactating or breastfeeding.
    15. Not able to communicate meaningfully with the Investigator and site staff.
    16. Lack of ability or willingness to give informed consent.
    17. Anticipated non-availability for trial visits/procedures.
    18. Vulnerable subjects (eg, persons kept in detention or persons who have a dependent
    relationship to the Sponsor or Investigator).
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability endpoints
    • The following safety variables will be recorded at regular intervals during the study:
    • Nature, frequency, duration, severity, and causality of adverse events (AEs) and serious adverse events (SAEs)
    • Clinical laboratory, tests (hematology, clinical chemistry and urinalysis)
    • Vital signs (supine blood pressure [BP], pulse rate, oxygen saturation (SpO2), body temperature and respiratory rate [RR])
    • Standard 12-lead Electrocardiogram (ECG)
    • Concomitant medication assessments
    • Physical examinations
    • Local tolerance
    E.5.1.1Timepoint(s) of evaluation of this end point
    From first dosing (Day 1) until End-of-Trial/Early Termination
    E.5.2Secondary end point(s)
    Clinical efficacy

    • Proportion of patients in each COVID-19 symptom severity category (SARS-CoV-2 infection without symptoms, Mild COVID-19, Moderate COVID-19, Severe COVID-19 and Critical COVID-19) during the course of the study
    • Proportion of patients requires O2 supplementation during the course of the study
    • Proportion of patients requires COVID-19 specific medication during the course of the study
    • Time to COVID-19 progression
    Virological efficacy
    • Mean viral load (SARS-CoV-2 RNA) as measured by quantitative polymerase chain reaction (PCR) during the course of the study
    • Change from baseline in viral load (SARS-CoV-2 RNA) as measured by PCR during the course of the study
    • Area under the viral load (SARS-CoV-2 RNA) - time curve (AUC)
    • Time to viral load (SARS-CoV-2 RNA) free status as measured by PCR
    Immune response
    • Proportion of patients with anti-SARS-CoV-2 IgG and IgM at baseline and at the end of the study.
    • Pharmacodynamic chemokines/cytokine-panel (see section 6.6.2.4) at baseline and during the course of the study.
    • Determination of the cellular immune status at baseline and during the course of the study
    E.5.2.1Timepoint(s) of evaluation of this end point
    From first dosing (Day 1) until End-of-Trial/Early Termination
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    safety and efficacy
    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 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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    South Africa
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    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: 60
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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)
    Aim of the End-of-Trial examination is to guarantee the well-being of subjects and to verify that all values tested during the Pre-trial examination have remained within a clinically acceptable range. Values that are out of range and clinically significant will be followed up until they return to the reference range or until there is an adequate explanation.
    Any adverse event ongoing at End-of-Trial will be followed up until the condition is resolved or there is an adequate explanation.
    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 Decision2021-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-05-06
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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