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    The EU Clinical Trials Register currently displays   42752   clinical trials with a EudraCT protocol, of which   7042   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


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    Summary
    EudraCT Number:2021-000455-39
    Sponsor's Protocol Code Number:C21-109-09
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-02-15
    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 ConcernedSweden - MPA
    A.2EudraCT number2021-000455-39
    A.3Full title of the trial
    A double-blind, placebo-controlled, interventional parallel group study to evaluate the antiviral effect of a single nasal application of LTX-109 3% gel, in comparison to placebo gel, in subjects with COVID-19 infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A double-blind, placebo-controlled, interventional parallel group study to evaluate the antiviral effect of a single nasal application of LTX-109 3% gel, in comparison to placebo gel, in subjects with COVID-19 infection
    A.4.1Sponsor's protocol code numberC21-109-09
    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 SponsorPharma Holdings AS
    B.1.3.4CountryNorway
    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 supportPharma Holdings AS
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCTC Clinical Trial Consultant
    B.5.2Functional name of contact pointCRM
    B.5.3 Address:
    B.5.3.1Street AddressDag Hammarskjölds väg 10
    B.5.3.2Town/ cityUppsala
    B.5.3.3Post code75237
    B.5.3.4CountrySweden
    B.5.6E-mailanna.asplind@ctc-ab.se
    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 nameLTX-190 Hydrogel 3%
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    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 placeboGel
    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] - Virus Diseases [C02]
    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 effect of a single dose of LTX-109 3% nasal gel on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load, as measured by a standardised reverse transcription quantitative polymerase chain reaction (RT-qPCR) method on the sample material after virus cultivation to quantify the amount of live virus in the samples, from the deep nasal cavity in subjects with COVID-19 infection, as compared to placebo.
    E.2.2Secondary objectives of the trial
    1. 1. To evaluate the effect of a single dose of LTX-109 3% nasal gel on SARS-CoV-2 viral load, as measured by a standardised RT-qPCR method on the sample material after virus cultivation to quantify the amount of live virus in the samples from the anterior nasal cavity in subjects with COVID-19 infection, as compared to placebo.
    2. To evaluate safety and tolerability of a single dose of LTX-109 3% nasal gel, as compared to placebo.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Willing and able to give electronically signed informed consent for participation in the study.
    2. Male or female subject ≥18 years of age at screening.
    3. Women of child-bearing potential (for definition see Section 9.6.1):
     Have to agree to use an acceptable birth control method during participation in the investigation (see Section 9.6.1).
     A negative pregnancy test (beta human chorionic gonadotropin dipstick test in urine) at Day 1 will be required.
    4. A positive PCR test or antigen test for SARS-CoV-2. The positive result must be available no later than 4 days from initiation of symptoms, if any.
    5. Duration of symptoms not exceeding 6 days prior to baseline/IMP administration (Day 1).
    6. Access to a mobile phone or computer and ability to use the electronic diary application and to participate in web-based appointments.
    E.4Principal exclusion criteria
    1. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study.
    2. Other upper respiratory tract infection with concomitant symptoms that can influence the results, such as sinusitis or tonsilitis.
    3. Known allergy or hypersensitivity to the components of the IMP.
    4. Current use of immunosuppressive therapy within the last 4 weeks prior to Day 1 and during the study.
    5. Current use of nasally administered drugs within the last 2 weeks prior to Day 1 and during the study.
    6. Vaccinated against COVID-19 or scheduled for vaccination within the study period.
    7. Previous COVID-19 infection.
    8. Any systemic anti-viral treatment within the last 4 weeks prior to Day 1 and during the study.
    9. Pregnant, nursing or actively trying to conceive a child.
    10. Inability to take medications nasally.
    11. In situ nasal jewellery or open nasal piercings.
    12. Planned treatment or treatment with another investigational drug within 30 days prior to Day 1. Subjects consented and screened but not dosed in previous Phase I studies are not excluded.
    13. Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.
    E.5 End points
    E.5.1Primary end point(s)
    Reduction in SARS-CoV-2 viral load, based on the deep nasal swab sample, from baseline (pre-dose) to 2 hours (h) post-dose, as measured by a standardised RT-qPCR method after virus cultivation. Viral load will be expressed as relative amount of virions in samples after treatment compared to before treatment (set to 100).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Pre- and two hours post-dose
    E.5.2Secondary end point(s)
    Secondary endpoints
    1. Reduction in SARS-CoV-2 viral load, based on the anterior nasal swab sample, from baseline (pre-dose) to 2 h post-dose, as measured by a standardised RT-qPCR method after virus cultivation. Viral load will be expressed as relative amount of virions in samples after treatment compared to before treatment (set to 100).
    2. Frequency, intensity and seriousness of AEs.

    E.5.2.1Timepoint(s) of evaluation of this end point
    Pre- and two hours post dose for viral load.

    Through-out study until day 7 for safety (AEs).

    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 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 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
    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: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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)
    None
    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 Decision2021-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-08-22
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