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    Summary
    EudraCT Number:2021-001391-42
    Sponsor's Protocol Code Number:Speed-Covid
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-04-13
    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 ConcernedAustria - BASG
    A.2EudraCT number2021-001391-42
    A.3Full title of the trial
    Characterisation of the effects of Spermidine on the immune response to Covid-19 vaccine in older people - a feasibility study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of Spermidine intake on the immune response to Covid-19 vaccine
    A.3.2Name or abbreviated title of the trial where available
    Spermidine and Covid-19 vaccination in older people
    A.4.1Sponsor's protocol code numberSpeed-Covid
    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 SponsorMedical University of Graz
    B.1.3.4CountryAustria
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMedical University of Graz
    B.4.2CountryAustria
    B.4.1Name of organisation providing supportAstraZeneca
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportLongevity Labs+
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Graz
    B.5.2Functional name of contact pointOliver Malle
    B.5.3 Address:
    B.5.3.1Street AddressAuenbruggerplatz 15
    B.5.3.2Town/ cityGraz
    B.5.3.3Post code8036
    B.5.3.4CountryAustria
    B.5.4Telephone number+4331638531013
    B.5.6E-mailoliver.malle@medunigraz.at
    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 Spermidine (spermidineLIFE®, food supplement)
    D.2.1.1.2Name of the Marketing Authorisation holderTLL The Longevity Labs GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameSpermidineLIFE (dietary supplement)
    D.3.4Pharmaceutical form Powder for oral suspension
    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 INNSpermidine
    D.3.9.3Other descriptive nameSpermidine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral suspension in sachet
    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
    For assessing the immune cell function after COVID-19 vaccine, peripheral blood mononuclear cells (PBMC) will be separated after blood sampling and measurements as follows will be done:
    • FACS analysis
    • DNA and RNA analysis of immune related molecules.
    • Assays of T-cell function, B-cell function and macrophage/monocyte function
    E.1.1.1Medical condition in easily understood language
    The white blood cell layer, further the immune cells, will be isolated and analysed regarding their cell functions, DNA/RNA and proteins.
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    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
    The primary objective of this feasibility study is to determine the effects of daily Spermidine supplements on the immune response to the Covid-19 vaccine in older people. We will examine if Spermidine improves the age-related impaired immune response to the Covid-19 vaccine and determine the molecular and immunological signature driving immunity.
    E.2.2Secondary objectives of the trial
    Our secondary objective is to determine the acceptability of daily Spermidine supplements to participants. We will also use data collected to perform a power calculation for future larger studies.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Capacity to provide written informed consent
    2. Age ≥65 and <90 years at consent
    E.4Principal exclusion criteria
    1. Incapacity to provide written informed consent
    2. Active signs or symptoms of acute infection at the time of screening
    3. Ongoing or previous SARS-CoV-2 vaccination
    4. Positive SARS-CoV-2 PCR in the past or during the study period.
    5. Glucocorticoid, immunosuppressive or other immune modifying therapy, current or within 3 months prior to first study visit
    6. Medical history of current or past human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection
    7. Receipt of blood, blood products and/or plasma derivatives or any immunoglobulin preparation, current or within 3 months prior to first study intervention
    8. Medical conditions that can suppress the immune system
    9. Any complicating medical issues or abnormal clinical laboratory results that may interfere with study conduct.
    10. History of liver insufficiency or laboratory evidence of liver dysfunction with aspartate transaminase (AST) or alanine transaminase (ALT) greater than 3 times the upper limits of normal
    11. Previous allergy to vaccinations or their constituent parts
    12. History of malignancies other than skin
    13. Hypersensitivity to Spermidine or to any of its excipients
    14. Gluten intolerance
    15. Contraindication to vaccination
    16. Use of any other investigational drug in the previous 30 days and/or intent on using any investigational drug for the duration of the trial
    17. Any condition that in the investigator's opinion may adversely affect study participation or may compromise the study results
    E.5 End points
    E.5.1Primary end point(s)
    FACS analysis in peripheral blood mononuclear cells (PBMC) for deep immune phenotyping (focusing on T- and B-cell subtypes)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At baseline, 2 weeks and 4 weeks after first COVID-19 vaccination, further 2 weeks and 26 weeks after 2nd vaccination
    E.5.2Secondary end point(s)
    • Cell sorting, using antibodies and fluorescent multimeric peptide-HLA molecules.
    • DNA and RNA analysis of immune related molecules.
    • Assays of T-cell function, including ELISPOT, ELISA, FACS surface staining, intracellular staining, cytokine secretion assays, cytotoxic function.
    • Assays of B-cell function, including ELISPOT, ELISA, FACS surface staining, intracellular staining, cytokine secretion assays.
    • Assays of macrophage/monocyte function, including ELISA, intracellular staining, cytokine secretion assays, phagocytosis, FACS.
    • In summary PBMCs will be isolated from peripheral blood, analysed by FACS, sorted for specific immune cell tests or used in functional assays. All cells will be disposed in virkon solution by the end of the day.
    • Immune cells sorted from PBMC may be used in DNA/RNA and proteomic analysis experiments, these cells will be rendered acellular on the day of separation during the process of the experiment.
    • Immune cells sorted from PBMC may be used in protein analysis experiments including western blot and proteomics, these cells will be rendered acellular on the day of separation during the process of the experiment.
    • Immune cells sorted from PBMC may be used in metabolite analysis experiments including detection of polyamines by GC-MS, these cells will be rendered acellular on the day of separation during the process of the experiment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At baseline, 2 weeks and 4 weeks after first COVID-19 vaccination, further 2 weeks and 26 weeks after 2nd vaccination (same as in primary end point)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 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 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 years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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) No
    F.1.2.1Number of subjects for this age range: 0
    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 Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state40
    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)
    We do not expect any need for treatment 6 months after completion of Spermidine supplementation. At the present, long term effects of COVID-19 vaccine are unknown.
    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 Decision2021-05-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-05-11
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