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    Summary
    EudraCT Number:2021-001036-25
    Sponsor's Protocol Code Number:UNI91103-201
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-04-01
    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 number2021-001036-25
    A.3Full title of the trial
    A RANDOMIZED PLACEBO-CONTROLLED PHASE 2 STUDY TO ASSESS THE SAFETY AND EFFICACY OF UNI91103 INTRANASAL ADMINISTRATION IN ADULTS WITH ASYMPTOMATIC OR MILDLY SYMPTOMATIC COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to test UNI91103 in adults with Covid-19 and no or only mild symptoms
    A.4.1Sponsor's protocol code numberUNI91103-201
    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 SponsorUNION therapeutics A/S
    B.1.3.4CountryDenmark
    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 supportUNION therapeutics A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNION therapeutics A/S
    B.5.2Functional name of contact pointSr Director Clinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressTuborg Havnevej 18
    B.5.3.2Town/ cityHellerup
    B.5.3.3Post code2900
    B.5.3.4CountryDenmark
    B.5.4Telephone number+45619111065
    B.5.6E-mailasger.bering.kristensen@uniontherapeutics.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 nameNiclosamide
    D.3.2Product code Niclosamide
    D.3.4Pharmaceutical form Nasal spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNiclosamide Ethanolamine
    D.3.9.1CAS number 1420-04-8
    D.3.9.2Current sponsor codeUNI911
    D.3.9.3Other descriptive nameUNI911
    D.3.9.4EV Substance CodeSUB217057
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboNasal spray, solution
    D.8.4Route of administration of the placeboNasal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Covid-19
    E.1.1.1Medical condition in easily understood language
    Covid-19
    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 assess the efficacy of UNI91103 to prevent disease progression
    To assess the safety of UNI91103
    E.2.2Secondary objectives of the trial
    To assess the efficacy of UNI91103 on development of symptoms of COVID-19
    To assess UNI91103 on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on viral load
    To assess the effect of UNI91103 on the spread of COVID-19 from the index case
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The subject is male or female aged ≥ 45 years.
    2. The subject is able to understand and provide signed informed consent.
    3. The subject is tested to confirm infection with SARS-CoV-2 by lateral flow antigen test or RT-PCR on a sample taken within 3 days before randomization.
    4. The subject is either without symptoms or has one or more of the following symptoms: stuffy or runny nose, sore throat, loss of taste, loss of smell, or headache (to be entered in the FDA COVID-19 questionnaire). Conjunctivitis is also acceptable. None of the symptoms should have been present > 5 days.
    5. Men whose sexual partners are women of childbearing potential (WOCBP) must agree to comply with one of the following contraception requirements from the time of first dose of screening until at least 30 days after the last dose of study medication:
    a. Vasectomy with documentation of azoospermia.
    b. Sexual abstinence (defined as refraining from heterosexual intercourse from the time of screening until at least 30 days after the last dose of study medication)
    c. Male condom plus partner use of one of the contraceptive options below: contraceptive subdermal implant; intrauterine device of intrauterine system; oral contraceptive, either combine or progestogen alone; injectable progestogen; contraceptive vaginal ring; percutaneous contraceptive patches.
    The above is an all-inclusive list of those methods that meet the following definition of highly effective: having a failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label. For non-product methods (e.g., male sterility), the investigatory will determine what is consistent and correct use. The investigator is responsible for ensuring that patients understand how to properly use these methods of contraception.
    6. WOCBP must agree to comply with one of the following contraception requirements from the time of screening until at least 30 days after the last dose of study medication:
    a. Sexual abstinence (defined as refraining from heterosexual intercourse from the time of screening until at least 30 days after the last dose of study medication).
    b. Use of one of the contraceptive options below plus use of a condom by male partner: contraceptive subdermal implant; intrauterine device or intrauterine system; oral contraceptive, either combined or progestogen alone; injectable progestogen; contraceptive vaginal ring; percutaneous contraceptive patches.
    c. Vasectomy of male partner with documentation of azoospermia.
    The above is an all-inclusive list of those methods that meet the following definition of highly effective: having a failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label. The investigator is responsible for ensuring that patients understand how to properly use these methods of contraception. Women of non-reproductive potential are defined as: a) Premenopausal females with one of the following: documented tubal ligation; documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; hysterectomy; documented bilateral oophorectomy. b) Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample will be required with simultaneous follicle stimulating hormone and estradiol levels tested locally and consistent with menopause [refer to local laboratory reference ranges for confirmatory levels]). Women on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods listed above if they wish to continue their HRT during the study.
    E.4Principal exclusion criteria
    1. The subject has been enrolled in a study with niclosamide in the previous 6 months.
    2. The subject is allergic to niclosamide or history of significant adverse reaction to niclosamide or related compounds, or to any of the excipient used.
    3. The subject has an underlying condition that may interfere with intranasal administration of the investigational medicinal product (IMP), for example chronic ulcer(s) in the nose.
    4. The subject has an acute or chronic condition that, as judged by the investigator, would jeopardize the safety of the participant.
    5. The subject has a condition the investigator believes would interfere with the ability to provide consent, or comply with study instructions, or that might confound the interpretation of the study results.
    6. 6. Subjects with symptoms suggesting engagement of the lower respiratory tract or a systemic engagement such as cough, feeling feverish, chills, shivering, feeling hot, low energy, tiredness, body aches and pains, fatigue, shortness of breath, loss of appetite, nausea, vomiting, or diarrhea (to be entered in the FDA COVID-19 questionnaire), or other symptoms not mentioned in inclusion criteria 5.
    7. The subject has an active or acute infection other than SARS-CoV-2.
    8. The subject has used other investigational products the month prior to Day 1.
    9. Antiviral medications and approved or experimental medications targeting COVID-19.
    10. Another member of the same household recruited to this study.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in symptoms through Day 10 defined as aggregated Food and Drug Administration (FDA) COVID-19 questionnaire score from baseline through Day 10 comparing UNI91103 vs placebo.
    Safety of UNI91103 nasal spray as assessed by adverse events, vital signs, hematology, and clinical chemistry
    E.5.1.1Timepoint(s) of evaluation of this end point
    as defined in the end point and according to protocol assessments
    E.5.2Secondary end point(s)
    • Maximal intensity of symptoms in the modified FDA COVID-19 questionnaire
    • Number of days free of COVID-19 symptoms as defined by the FDA COVID-19 questionnaire
    • Subject-reported global impression items assessing a) return to usual health; b) return to usual activities; and c) severity of change of overall COVID-19 related symptoms
    • Proportion of subjects remaining asymptomatic on Day 10
    • Proportion of subjects requiring visits to urgent care (UC) or emergency department (ED) facilities, or hospitalization due to signs or symptoms of COVID-19
    • Proportion of subjects admitted to intensive care units (ICU)
    • Change from baseline in SARS-CoV-2 viral load at Day 10 as assessed by quantitative reverse transcription polymerase chain reaction (qRT-PCR).
    • Change from baseline in SARS-CoV-2 viral load at Day 5 as assessed by qRT-PCR.
    • Presence of long-term COVID-19 symptoms as defined by the FDA COVID-19 questionnaire
    E.5.2.1Timepoint(s) of evaluation of this end point
    as defined in the end point and according to protocol assessments
    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 Yes
    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 No
    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 concerned3
    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
    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: 231
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 99
    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 state330
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 330
    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)
    none. After completion of the clinical trial participants will be treated according current state of the art therapy recommendations
    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 Decision2021-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-01
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-12-10
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