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    Summary
    EudraCT Number:2020-005961-16
    Sponsor's Protocol Code Number:QVID-001
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-12-15
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2020-005961-16
    A.3Full title of the trial
    Coenzyme Q10 as treatment for Long Term COVID-19
    (The QVID study)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Coenzym Q10 til behandling af senfølger efter COVID-19 (QVID studiet)
    A.3.2Name or abbreviated title of the trial where available
    QVID study
    A.4.1Sponsor's protocol code numberQVID-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 SponsorLars Jørgen Østergaard
    B.1.3.4CountryDenmark
    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 supportCentral Region of Denmark
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportAarhus University
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportNovo Nordisk Foundation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportPharma Nord
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAarhus University Hospital
    B.5.2Functional name of contact pointDepartment of Infectious Diseases
    B.5.3 Address:
    B.5.3.1Street AddressPalle Juul-Jensens Boulevard 99
    B.5.3.2Town/ cityAarhus N
    B.5.3.3Post code8200
    B.5.3.4CountryDenmark
    B.5.4Telephone number004578452800
    B.5.6E-mailKRTHAS@rm.dk
    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 Myoquinon 100 mg
    D.2.1.1.2Name of the Marketing Authorisation holderPharma Nord
    D.2.1.2Country which granted the Marketing AuthorisationHungary
    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.3.4Pharmaceutical form Capsule, soft
    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 INNUBIDECARENONE
    D.3.9.1CAS number 303-98-0
    D.3.9.4EV Substance CodeSUB11373MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    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 placeboCapsule, soft
    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
    Long Term COVID-19 illness
    Senfølger efter COVID-19
    E.1.1.1Medical condition in easily understood language
    Long term symptoms after acute COVID-19
    E.1.1.2Therapeutic area Body processes [G] - Cell Physiological Phenomena [G04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10084268
    E.1.2Term COVID-19
    E.1.2System Organ Class 10021881 - Infections and infestations
    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 effect of 6 weeks of CoQ10 treatment on the number and severity of self-reported symptoms in LTC patients
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    -To assess a potential persistent effect of CoQ10 after 6 weeks dosing and 4 weeks of follow-up on the number and severity of self-reported symptoms in LTC patients.
    -To assess the safety and tolerability of the IMP

    Potential exploratory objectives:
    -To investigate occurrence of auto-reactive antibodies at baseline compared to healthy controls (biobank samples).
    -To assess CoQ10 levels in plasma before and after CoQ10 treatment
    -To investigate if certain host genetic factors predict LTC
    -To perform quantitative proteomics of PBMCs by high mass accuracy nanoLC-MS/MS.
    -To assess cellular metabolic activities by Seahorse analyses of PBMCs samples
    -To assess oxidative stress in plasma through the marker 8-isoprostane (ELISA).
    -To assess a panel of cytokines in plasma through antibody based multiplexed analyses.
    -To assess metabolites of kynurenic pathway in plasma by UPLC-MS/MS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age above 18 years.
    2. Able to give informed consent.
    3. History of documented SARS-CoV-2 infection either by RT-PCR or antibody test.
    4. Symptoms related to LTC, defined as being investigated, diagnosed and followed by specialized infectious diseases physicians in the Long Term COVID-19 Outpatient Clinic, Central Region of Denmark, Aarhus University Hospital. This clinic covers all LTC patients referred from general practitioners and regional hospitals in Region Midtjylland.
    5. Symptoms not attributable to other co-morbidity/condition.
    E.4Principal exclusion criteria
    1. Symptoms of acute COVID-19, as defined by The Danish Health Authorities/Sundhedsstyrelsen.
    2. Pregnant or breast-feeding women.
    3. Known allergy to soy or peanuts.
    4. Individuals with reduced kidney or liver-function.
    5. Patients in anticoagulant therapy with warfarin or similar vitamin K antagonists.
    6. Any condition that, in the Investigator's opinion, will prevent adequate compliance with study therapy.
    E.5 End points
    E.5.1Primary end point(s)
    Number and severity of self-reported symptoms of LTC, measured by self-reporting in questionnaires before and after 6 weeks of CoQ10, measured by symptoms score.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation of primary endpoint after 6 weeks treatment, 4 weeks washout and 6 weeks placebo (order of intervention determined by allocation by randomization)
    E.5.2Secondary end point(s)
    1. Duration of a potential effect of CoQ10 measured as change in symptoms score
    2. Safety evaluation, as measured by adverse events (AEs), Adverse Reactions (ARs), serious adverse events (SAEs), Serious ARs (SARs).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 4 weeks after ending IMP: We aim to compare week 6 versus week 10 for study arm A and week 16 versus week 20 for study arm B.
    2. Safety will be evaluated at each study visit. Final AE/SAE summary will be completed after 20 weeks
    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 Yes
    E.6.13.1Other scope of the trial description
    Explore pathogenesis behind long term COVID-19 symptoms
    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 Yes
    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 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) Yes
    F.1.2.1Number of subjects for this age range: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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)
    Not different from normal treatment. Currently no treatment for long term COVID exists, but patients are followed by a specialized physician after EOS.
    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 Decision2021-02-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-02-10
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