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    Summary
    EudraCT Number:2021-000264-29
    Sponsor's Protocol Code Number:VP-C21-008
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-03
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2021-000264-29
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, parallel group, phase 3, multicenter trial investigating the efficacy and safety of C21 as add on to standard of care in adult subjects with COVID-19.
    Randomizované, dvojitě zaslepené, placebem kontrolované multicentrické klinické hodnocení fáze 3 s paralelními skupinami hodnotící účinnost a bezpečnost přípravku C21 jako přídatné léčby ke standardní péči u dospělých pacientů s onemocněním covid-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to investigate recovery from COVID-19 with C21 in adult subjects.
    A.3.2Name or abbreviated title of the trial where available
    ATTRACT-3
    A.4.1Sponsor's protocol code numberVP-C21-008
    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 SponsorVicore Pharma AB
    B.1.3.4CountrySweden
    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 supportVicore Pharma AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVicore Pharma AB
    B.5.2Functional name of contact pointHead of Clinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressKronhusgatan 11
    B.5.3.2Town/ cityGothenburg
    B.5.3.3Post codeSE-411 05
    B.5.3.4CountrySweden
    B.5.6E-mailanne-katrine.cohrt@vicorepharma.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 nameCompound 21
    D.3.2Product code C21
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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 placeboCapsule
    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
    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 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084270
    E.1.2Term SARS-CoV-2 acute respiratory disease
    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
    Evaluate the efficacy of C21 versus placebo as add on to Standard of Care on recovery in subjects with COVID-19.
    E.2.2Secondary objectives of the trial
    • Evaluate the safety profile of C21 versus placebo as add on to SoC in subjects with COVID-19.
    • Characterize the PK profile of C21 in subjects with COVID-19.
    • Evaluate the efficacy profile of C21 versus placebo as add on to SoC in subjects with COVID-19.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥18 years or the legal age of consent
    2. Hospitalized due to SARS-CoV-2 infection confirmed by polymerase chain reaction (PCR) test, documented by either of the following:
    a. PCR positive in sample collected <72 hours prior to randomization (Visit 2); OR
    b. PCR positive in sample collected ≥72 hours and ≤7 days prior to randomization, documented inability to obtain a repeat sample AND progressive disease suggestive of ongoing SARS-CoV-2 infection.
    3. A score of 5 or 6 on the 8-point ordinal scale:
    a. Score 5: Hospitalized, requiring supplemental oxygen.
    b. Score 6: Hospitalized, on non-invasive ventilation or high-flow oxygen device.
    4. Contraceptive use by men and women of childbearing potential
    5. Written informed consent obtained before the initiation of any trial-related procedure.
    6. Capable of giving signed informed consent
    E.4Principal exclusion criteria
    1. Concurrent serious medical condition which in the opinion of the investigator constitutes a risk or a contraindication for the participation in the trial or that could interfere with the trial objectives, conduct or evaluation.
    2. Known, active hepatitis B, C, or human immunodeficiency virus (HIV) infection
    3. Impaired hepatic function (i.e., Child-Pugh class A or B)
    4. Severe renal impairment (i.e., estimated glomerular filtration rate (eGFR) ≤30 ml/min/1.73 m2).
    5. COVID-19 symptom onset >14 days prior to screening (Visit 1).
    6. Hospitalized due to COVID-19 for >72 hours at screening (Visit 1).
    7. Invasive mechanical ventilation or ECMO within 72 hours of screening (Visit 1)
    8. Expected need for invasive mechanical ventilation or ECMO in <48 hours in the opinion of the investigator.
    9. Moderate to severe ARDS (e.g., PaO2/FiO2 ≤200 mmHg), if on non-invasive mechanical ventilation or high-flow oxygen.
    10. Pregnant or breast-feeding female subjects.
    11. Any previous and concurrent experimental treatment for COVID-19 that is not considered local SoC.
    12. Treatment with the medications listed below within 1 week prior to screening (Visit 1) or anticipated need for such medication during the participation in this trial:
    a. Strong Cytochrome P450 (CYP) 3A4 inducers.
    b. P-glycoprotein (P-gp) substrates with narrow therapeutic index.
    c. High dose BCRP sensitive substrates.
    d. Warfarin.
    e. Sulphasalazine or rosuvastatin.
    13. Current or previous participation in any other clinical trial where the subject has received a dose of IMP within 1 month or 5 half-lives of the IMP, whichever is longest, prior to screening (Visit 1).
    14. Positive pregnancy test
    15. Abnormal laboratory value at screening (Visit 1) indicating a potential risk for the subject if enrolled in the trial as evaluated by the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    • Proportion of subjects discharged from hospital and free of supplemental oxygen at Day 15.
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Proportion of subjects discharged from hospital and free of supplemental oxygen at Day 15.
    E.5.2Secondary end point(s)
    • Supplemental oxygen free days up to Day 29.
    • Proportion of subjects free of respiratory failure, defined as an 8-point ordinal scale score <6, at Day 15.
    • Time to sustained hospital discharge up to Day 60.
    • All-cause mortality up to Day 60.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Supplemental oxygen free days up to Day 29.
    • Proportion of subjects free of respiratory failure, defined as an 8-point ordinal scale score <6, at Day 15.
    • Time to sustained hospital discharge up to Day 60.
    • All-cause mortality up to Day 60.
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Brazil
    Colombia
    India
    Peru
    South Africa
    United States
    Poland
    Argentina
    E.8.7Trial has a data monitoring committee Yes
    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
    last visit of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 40
    F.4.2.2In the whole clinical trial 600
    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)
    Standard of Care
    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 Decision2021-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-04-25
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