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    Summary
    EudraCT Number:2021-006504-32
    Sponsor's Protocol Code Number:ACTIV-2d/A5407
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-09-29
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2021-006504-32
    A.3Full title of the trial
    A Phase 3, multicenter, randomized, double-blind, 24-week study of the clinical and antiviral effect of S-217622 compared with placebo in non-hospitalized participants with COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 24-week study of the clinical and antiviral effect of S-217622 compared with placebo in non-hospitalized participants with COVID-19
    A.3.2Name or abbreviated title of the trial where available
    SCORPIO-HR
    A.4.1Sponsor's protocol code numberACTIV-2d/A5407
    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 SponsorShionogi B.V.
    B.1.3.4CountryNetherlands
    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 supportNational Institute of Allergy and Infectious Diseases (NIH), Division of AIDS (DAIDS)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationShionogi & Co., Ltd
    B.5.2Functional name of contact pointCorporate Communications Department
    B.5.3 Address:
    B.5.3.1Street Address1-8, Doshomachi 3-chome Chuo-Ku
    B.5.3.2Town/ cityOsaka
    B.5.3.3Post code541-0045
    B.5.3.4CountryJapan
    B.5.6E-mailshionogiclintrials-admin@shionogi.co.jp
    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 nameS-217622
    D.3.4Pharmaceutical form Tablet
    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 INNNot established
    D.3.9.2Current sponsor code S-217622B
    D.3.9.3Other descriptive nameS-217622B
    D.3.9.4EV Substance CodeSUB235463
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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 placeboTablet
    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
    SARS-CoV-2 infection
    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 10084272
    E.1.2Term SARS-CoV-2 infection
    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 determine if S-217622 will reduce the time to sustained symptom
    resolution through Day 29 among outpatient adults with mild and
    moderate COVID-19 starting intervention within 3 days of symptom
    onset. Time to sustained symptom resolution is defined as the time from
    start of study intervention to the first day of 2 consecutive days with
    complete resolution of COVID-19 symptoms on participant selfassessment
    AND alive and without hospitalization for any reason by Day
    29 and will be compared using restricted mean symptom duration up to
    Day 28, which is the last timepoint at which the outcome can be
    achieved. Hospitalization is defined as ≥24 hours of acute care, in a
    hospital or similar acute care facility, including emergency rooms, urgent
    care clinics, or facilities instituted to address medical needs of those
    with COVID-19
    E.2.2Secondary objectives of the trial
    To determine whether S-217622 reduces COVID-19- related
    hospitalization (adjudicated) and all deaths regardless of occurrence outside of hospital or during hospitalization (not adjudicated) through Day 29 among outpatient adults with SARS-CoV-2 starting intervention within 3 days of symptom onset.
    To determine if S-217622 will reduce the time to sustained symptom resolution through Day 29 among all outpatient adults with SARS-CoV-2.
    To determine the effect of S-217622 compared with placebo on:
    - To determine the change from baseline in quantitative log10 SARSCoV-2 RNA levels by PCR on NP swab at Day 4 among all outpatient adults with SARS-CoV-2 (and when starting intervention within 3 days of symptom onset).
    - on the occurrence of persistent and/or late-onset symptoms of COVID19 at Week 12 among all outpatient adults with SARS-CoV-2 (and when starting intervention within 3 days of symptom onset).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For all participants
    -Ability and willingness of participant to provide informed consent prior
    to initiation of any study procedures.
    -Age ≥18 years.
    -Documentation of laboratory-confirmed active SARS-CoV-2 infection, as
    determined by a nucleic acid (e.g., reverse-transcriptase PCR) or antigen
    test from any respiratory tract specimen (e.g., oropharyngeal, NP or
    nasal swab, or saliva) collected ≤72 hours (3 days) prior to
    randomization.
    -Participants are expected to begin study intervention ≤3 days from selfreported
    date of onset of any of the COVID-19-related symptoms as
    described in the study protocol.
    For high-risk participants (excluded in the US)
    Participants at higher risk of progression to severe COVID-19 are
    defined as follows:
     Age ≥65 years
     Age ≥18 with 1 of the following:
    o Obesity (body mass index [BMI] ≥30 kg/m2). Note: BMI is rounded to
    the nearest whole number, for example 29.5 kg/m2 is rounded to 30
    kg/m2.
    o Diabetes mellitus
    o Hypertension requiring daily prescribed therapy
    o Cardiovascular disease requiring daily prescribed therapy or congenital
    heart disease
    o Chronic lung disease (e.g., chronic obstructive pulmonary disease
    [COPD], moderate to severe asthma, interstitial lung disease, cystic
    fibrosis, pulmonary hypertension) requiring daily prescribed therapy
    o Chronic kidney disease, defined as known current kidney impairment
    with a creatinine clearance (CrCl) or estimated glomerular filtration rate
    (eGFR) <60 mL/min/1.73m2 within the past 12 months prior to
    randomization, as long as the participant does not have known CrCl <30
    mL/min by Cockcroft-Gault or require dialysis (see Exclusion Criterion
    4.1.2.9)
    o Down syndrome
    o Sickle cell disease
    o One of the following immunocompromising conditions or
    immunosuppressive treatments:
     Receiving chemotherapy or other therapies for cancer
     Hematologic malignancy (active or in remission)
     History of a hematopoietic stem cell or a solid organ transplant
     HIV infection: not on antiretroviral therapy or with CD4+ cell count
    <200 cells/mm3
     Combined primary immunodeficiency disorder
     Taking immunosuppressive medications (e.g., drugs to suppress
    rejection of transplanted organs or to treat rheumatologic and
    gastrointestinal conditions, such as anti-tumor necrosis factor agents,
    mycophenolate, and rituximab)
    Note: Current use of some corticosteroids is exclusionary, due to concern
    for possible DDI with S-217622. See Section 5.4.2 for prohibited
    medications.
    For standard-risk participants
    Only standard-risk participants will be enrolled at US sites. Participants
    at standard risk for progression to severe COVID-19 are defined as ≥18
    to <65 years of age and meeting all criteria from Sections 4.1.1.1 to
    4.1.1.13 with none of the risk factors listed above
    E.4Principal exclusion criteria
    -History of hospitalization for the current SARS-CoV-2 infection (i.e.,
    prior hospitalization for a prior episode of SARS-CoV-2 infection is
    allowable).
    -For the current SARS-CoV-2 infection, any positive SARS-CoV-2
    molecular (nucleic acid) or antigen test from any respiratory tract
    specimen (e.g., oropharyngeal, NP or nasal swab, or saliva) collected
    >72 hours (3 days) prior to randomization.
    -Participants with reinfection, defined as prior SARS-CoV-2 infection that
    began >90 days prior to the current onset of symptoms with interval
    resolution of symptoms are eligible as long as the current infection has
    not been present for more than 3 days prior to randomization.
    -Current need for hospitalization or immediate medical attention in the
    opinion of the investigator.
    -Current use of any medications prohibited with the study intervention,
    as described in Section 5.4.2 of the protocol. Individuals who have used
    Paxlovid or any other oral, inhaled, or injectable medication intended to
    treat the current SARS-CoV-2 infection before randomization are
    excluded. After randomization, locally available SARS-CoV-2 treatment
    (including but not limited to molnupiravir, mAbs, outpatient IV
    remdesivir, convalescent plasma, inhaled budesonide, favipiravir, and
    fluvoxamine) will be permitted, as long as there are no concerns for
    DDIs as outlined in Section 5.4.2. of the protocol
    Note: Paxlovid use for a prior episode of COVID-19 is permitted.
    -Receipt of any investigational treatments for the current episode of
    SARS-CoV-2 at any time prior to randomization is exclusionary.
    NOTE: This does not include drugs approved for other uses and taken for
    those indications or COVID-19 vaccines.
    NOTE: Use of locally authorized or approved therapies to prevent COVID-
    19, such as mAbs given solely to prevent COVID-19, are not
    exclusionary.
    E.5 End points
    E.5.1Primary end point(s)
    Symptom duration for all targeted symptoms (including those occurring prior to COVID-19 infection): Time (days) from start of S-217622 or placebo (Day 1) until sustained resolution and being alive and without hospitalization for any reason by Day 29.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From start of S-217622 or placebo (Day 1) until sustained resolution and being alive and without hospitalization for any reason by Day 29.
    E.5.2Secondary end point(s)
    Key secondary virologic outcome: change from baseline in quantitative log SARS-Cov-2 RNA levels by PCR on NP swab at Day 4 among outpatient adults with SARS-CoV-2.
    Key secondary clinical outcome:
    The composite of COVID-19-related hospitalization (adjudicated) and all deaths regardless of occurrence outside of hospital or during hospitalization (not adjudicated) through Day 29 among outpatient adults with SARS-CoV-2 starting intervention within 3 days of symptom onset.
    Key secondary clinical outcome: The proportion of participants with persistent and/or late-onset symptoms of COVID-19 at Week 12 based on participants' assessments of the 5 symptoms specified by the WHO (fatigue, shortness of breath/difficulty breathing, difficulty with concentration/ thinking, difficulty reasoning/solving problems, and
    memory loss) plus taste disturbance and smell disturbance among outpatient adults with SARS-CoV-2 starting intervention within 3 days of symptom onset.
    E.5.2.1Timepoint(s) of evaluation of this end point
    virologic outcome: Day 4

    clinical outcome: Day 1 to Day 29
    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) 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    Argentina
    Colombia
    Egypt
    Ghana
    Malawi
    Philippines
    Uganda
    Puerto Rico
    Brazil
    India
    Japan
    Kenya
    Mexico
    Pakistan
    South Africa
    Thailand
    United States
    Poland
    Türkiye
    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
    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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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: 1600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Subjects with Down syndrome, sickle cell disease, dementia, Parkinson disease or care home residents
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 17
    F.4.2.2In the whole clinical trial 2000
    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 Decision2022-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-05-24
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