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    Summary
    EudraCT Number:2022-002741-18
    Sponsor's Protocol Code Number:GS-US-611-6273
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-10-13
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2022-002741-18
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5245 for the Treatment of COVID-19 in Participants With High-Risk for Disease Progression
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 Study for GS-5245 in Participants With COVID-19 Who Have a High Chance of Developing Serious or Severe Disease
    A.4.1Sponsor's protocol code numberGS-US-611-6273
    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 SponsorGilead Sciences, Inc.
    B.1.3.4CountryUnited States
    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 supportGilead Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd.
    B.5.2Functional name of contact pointClinical Trials Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityGreat Abington, Cambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441223897284
    B.5.6E-mailclinical.trials@gilead.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 nameObeldesivir
    D.3.2Product code GS-5245
    D.3.4Pharmaceutical form Film-coated 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 INNObeldesivir
    D.3.9.1CAS number 2647441-36-7
    D.3.9.2Current sponsor codeGS-5245
    D.3.9.3Other descriptive nameGS-5245
    D.3.9.4EV Substance CodeSUB268881
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number350
    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 placeboFilm-coated tablet
    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
    Coronavirus disease 2019 (COVID-19) in patients who have a high risk of developing serious or severe illness
    E.1.1.1Medical condition in easily understood language
    Coronavirus disease 2019 (COVID-19) in patients who have a high chance of developing serious or severe illness
    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 PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus 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 evaluate the efficacy of GS-5245 in reducing the rate of COVID-19–related hospitalization or all-cause death
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    •To evaluate the safety and tolerability of GS-5245 administered in nonhospitalized participants with COVID-19
    •To evaluate the efficacy of GS-5245 in reducing all-cause hospitalization
    •To evaluate the efficacy of GS-5245 in reducing COVID-19–related medically attended visits (MAVs) or all-cause death
    •To evaluate the efficacy of GS-5245 in reducing COVID-19–related MAVs
    •To evaluate the efficacy of GS-5245 in reducing COVID-19–related all-cause death
    •To evaluate the efficacy of GS-5245 in reducing the duration and severity of COVID-19 symptoms
    •To evaluate the antiviral activity of GS-5245 on SARS-CoV-2 nasal swab viral load at Day 5
    •To evaluate the plasma PK of GS-441524 (metabolite of GS-5245)

    Exploratory Objective:
    See Protocol Section 2
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    There is an optional intensive PK substudy planned in approximately 30 participants. These participants will have intensive PK samples collected on Days 1 (first dose) and/or on Day 5 (morning or evening dose) at 0.25, 0.5, 0.75, 1.5, 3, 4-hour postdose. See Protocol Table 1 and Section 6.3.3.
    E.3Principal inclusion criteria
    Participants must meet all the following inclusion criteria to be eligible for participation in this study:
    1) Aged ≥ 18 years at screening.
    2) Willing and able to provide written informed consent, or with a legal representative who can provide informed consent (where locally and nationally approved).
    3) SARS-CoV-2 infection confirmed by PCR or an alternative approved assay locally approved (eg, Rapid Antigen Test) ≤ 5 days before randomization. Serologic tests will not be accepted.
    4) Initial onset of COVID-19 signs/symptoms ≤ 5 days before randomization with ≥ 1 of the following targeted signs/symptoms present at randomization.
    a. Stuffy or runny nose.
    b. Sore throat.
    c. Shortness of breath (difficulty breathing).
    d. Cough.
    e. Low energy or tiredness.
    f. Muscle or body aches.
    g. Headache.
    h. Chills or shivering.
    i. Feeling hot or feverish.
    j. Nausea.
    k. Vomiting.
    l. Diarrhoea.
    5) Not currently hospitalized or requiring hospitalization.
    6) Presence of ≥ 1 risk factor (if unvaccinated) or ≥ 2 risk factors (if vaccinated at any point) for progression to severe disease. Risk factors are the following:
    a. Aged ≥ 50 years.
    b. Current or recent (≤ 6 months prior to randomization) cancer (other than localized skin cancer).
    c. Have human immunodeficiency virus infection.
    d. Prior splenectomy.
    e. Prior solid organ, stem cell, or bone marrow transplant.
    f. Have systemic rheumatologic or dermatologic disorders.
    g. Use of systemic immunosuppressive agents, eg, high-dose corticosteroids (ie, ≥20 mg of prednisone or equivalent per day administered for ≥2 weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor necrosis factor (TNF) blockers, other biologic agents that are immunosuppressive or immunomodulatory.
    h. Have cerebrovascular disease.
    i. Have cardiovascular disease, including heart failure, coronary artery disease, cardiomyopathies, and hypertension.
    j. Have chronic kidney disease (provided participant does not meet exclusion criteria 7).
    k. Have chronic lung disease (including interstitial lung disease, pulmonary embolism, pulmonary hypertension, bronchiectasis, or chronic obstructive pulmonary disease).
    l. Have chronic liver disease.
    m. Have cystic fibrosis.
    n. Have diabetes mellitus, type 1 and/or type 2.
    o. Have neurodevelopmental and/or neurodegenerative conditions.
    p. Have a body mass index ≥ 25 kg/m2.
    q. Have sickle cell disease.
    r. Have primary immunodeficiencies.
    s. Have compensated cirrhosis.
    t. Have asthma.
    u. Have ≥ 20 pack-year smoking history and currently smoking or have quit within the past 15 years.
    E.4Principal exclusion criteria
    Exclusion criteria for participation include:
    1) Anticipated access to and use of authorized or approved COVID-19 therapies during the current COVID-19 illness < 5 days after randomization (therapies include nirmatrelvir/ritonavir, molnupiravir, ensitrelvir, IV RDV, monoclonal antibodies).
    2) Received any approved, authorized, or investigational direct acting antiviral drug against SARS-CoV-2 for the treatment of COVID-19 < 28 days or < 5 half-lives, whichever is longer, before randomization.
    3) Anticipated need for hospitalization < 48 hours after randomization.
    4) New oxygen requirement < 24 hours before randomization.
    5) Known influenza or any other suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the valuation of response to the study drug.
    6) Decompensated cirrhosis (Child-Pugh class B or class C) or acute liver injury/failure.
    7) Undergoing dialysis, or known history of moderate or severe renal impairment or known CLcr < 60 mL/min (as calculated by Cockroft-Gault) or eGFR < 60 mL/min/1.73m2 within the last 6 months. Potential participants meeting the laboratory criterion may be enrolled if test results available before dosing show that renal function no longer meets this criterion. See Appendix 11.4 for country-specific requirements.
    8) Known history of any of the following abnormal laboratory results (< 6 months before randomization) unless confirmed as resolved to not meet criteria at screening. See Appendix 11.4 for country-specific requirements regarding these laboratory exclusions.
    a. ALT ≥ 5 x ULN.
    b. Bilirubin ≥ 2 x ULN (≥ 3 x ULN for participants with Gilbert’s syndrome).
    9) Positive urine pregnancy test at screening.
    10) Breastfeeding (nursing).
    11) Unwilling to use protocol-mandated birth control.
    12) Known hypersensitivity to the study drug, its metabolites, or formulation excipient.
    13) Requirement for ongoing therapy with or prior use of any prohibited medications. Prohibited medications are identified in Section 5.4.1.
    14) Received an approved, authorized, or investigational COVID-19 vaccine (including booster dose) < 120 days before randomization.
    15) Any inability to take study drug or comply with study procedures that, in the opinion of the investigator, would make the participant unsuitable for the study.
    E.5 End points
    E.5.1Primary end point(s)
    •Proportion of COVID-19-related hospitalization or all-cause death by Day 29
    E.5.1.1Timepoint(s) of evaluation of this end point
    At various timepoints throughout the study
    E.5.2Secondary end point(s)
    Secondary Endpoints:
    • Incidence of treatment-emergent AEs and laboratory abnormalities
    • Incidence of SAEs and AEs leading to study drug discontinuation
    • Proportion of participants with all cause hospitalization by Day 29
    • Proportion of participants with COVID-19-related MAVs or all-cause death by Day 29
    • Proportion of participants with COVID-19-related MAVs by Day 29
    • Proportion of participants with all-cause death by Day 29
    • Time to COVID-19 symptom alleviation by Day 15
    • Change from baseline (Day 1) in SARS-CoV-2 nasal swab viral load at Day 5
    • Plasma concentrations and PK parameters AUCtau, Ctau, and Cmax of GS-441524, as available.

    Exploratory Endpoint(s):
    See Section 2 of the amended Protocol.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At various timepoints throughout the study
    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 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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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
    Philippines
    Singapore
    Switzerland
    Taiwan
    Brazil
    Canada
    India
    Japan
    Kenya
    Korea, Republic of
    Mexico
    South Africa
    Turkey
    United Kingdom
    Bulgaria
    Czechia
    France
    Hungary
    Italy
    Poland
    Portugal
    Romania
    Spain
    Sweden
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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: 2520
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 630
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Willing and able to provide written informed consent, or with a legal representative who can provide informed consent (where locally and nationally approved).
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1800
    F.4.2.2In the whole clinical trial 3150
    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)
    The long-term care of the participant will remain the responsibility of their primary treating physician. There is no provision for poststudy availability.
    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 Decision2022-11-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-11-07
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