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    The EU Clinical Trials Register currently displays   42752   clinical trials with a EudraCT protocol, of which   7042   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-003510-12
    Sponsor's Protocol Code Number:GS-US-540-9012
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-09-02
    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 ConcernedUK - MHRA
    A.2EudraCT number2020-003510-12
    A.3Full title of the trial
    A Phase 3 Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of COVID-19 in an Outpatient Setting
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test a drug named remdesivir to evaluate the efficacy and safety of the drug in treating patients with COVID-19 in an outpatient setting (non-hospitalized)
    A.4.1Sponsor's protocol code numberGS-US-540-9012
    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+44 1223 897284
    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 Yes
    D.2.1.1.1Trade name Veklury 100 mg powder for concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences Ireland UC
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameRemdesivir for injection, 100 mg
    D.3.4Pharmaceutical form Lyophilisate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNREMDESIVIR
    D.3.9.2Current sponsor codeGS-5734
    D.3.9.4EV Substance CodeSUB195655
    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 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 placeboLyophilisate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous 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
    Coronavirus disease 2019
    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 10084382
    E.1.2Term Coronavirus disease 2019
    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
    - To evaluate the efficacy of RDV in reducing the rate of all-cause medically attended visits (MAVs; medical visits attended in person by the participant and a health care professional) or death when given over 3 days to non-hospitalized participants with early stage COVID-19.
    - To evaluate the safety of RDV administered in an outpatient setting
    E.2.2Secondary objectives of the trial
    - To determine the antiviral activity of RDV on SARS-CoV-2 viral load
    - To assess the impact of RDV on symptom duration and severity
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants must meet all of the following inclusion criteria to be eligible for participation in this
    study:
    1) Willing and able to provide written informed consent, or with a legal representative who can provide informed consent (participants ≥ 18 years of age) or assent (participants ≥ 12 and < 18 years of age) prior to performing study procedures. Participants aged ≥ 18 years may be enrolled with the consent of a legal representative where permitted
    according to local law and approved nationally and by the relevant institutional review board (IRB) or independent ethics committee (IEC). For participants ≥ 12 and < 18 years of age, a parent or legal guardian must be willing and able to provide written informed consent prior to performing study procedures
    2) Either:
    - Age ≥ 18 years (at all sites) or aged ≥ 12 and < 18 years of age weighing ≥ 40 kg (where permitted according to local law and approved nationally and by the relevant institutional review board [IRB] or independent ethics committee [IEC]) with at least 1 of the following pre-existing risk factors for progression to hospitalization:
    a) Chronic lung disease: chronic obstructive pulmonary disease, moderate-to-severe asthma, cystic fibrosis, pulmonary fibrosis
    b) Hypertension: systemic or pulmonary
    c) Cardiovascular or cerebrovascular disease: coronary artery disease, congenital heart disease, heart failure, cardiomyopathy, history of stroke,atrial fibrillation, hyperlipidemia
    d) Diabetes mellitus: Type 1, Type 2, or gestational
    e) Obesity (BMI ≥ 30)
    f) Immunocompromised state; having a solid organ transplant, blood, or
    bone marrow transplant; immune deficiencies; HIV with a low CD4 cell
    count or not on HIV treatment; prolonged use of corticosteroids; or use
    of other immune weakening medicines
    g) Chronic mild or moderate kidney disease
    h) Chronic liver disease
    i) Current cancer
    j) Sickle cell disease
    - OR aged ≥ 60 years, regardless of the presence of other pre-existing risk factors for progression
    3) SARS-CoV-2 infection confirmed by molecular diagnostics (nucleic
    acid [eg, PCR] or antigen testing) ≤ 4 days prior to screening
    4) Presence of ≥ 1 symptom(s) consistent with COVID-19 for ≤ 7 days prior to randomization (such as fever, cough, fatigue, shortness of breath, sore throat, headache, myalgia/arthralgia)
    5) Not currently receiving, requiring, or expected to require
    supplemental oxygen
    6) Not currently requiring hospitalization (hospitalization defined as ≥
    24 hours of acute care)
    7) Participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Protocol Appendix 3
    E.4Principal exclusion criteria
    Participants who meet any of the following exclusion criteria are not eligible to be enrolled in
    this study:
    1) Participation in any other clinical trial of an experimental treatment and prevention for COVID-19
    2) Prior hospitalization for COVID-19
    3) Treatment with other agents with actual or possible direct antiviral activity against SARS-CoV-2
    4) Requiring oxygen supplementation
    5) ALT or AST ≥ 5 ×upper limit of normal (ULN) at screening or within 90 days of screening Note: if per local practice only ALT is routinely measured, exclusion criteria will be evaluated on ALT alone
    6) Creatinine clearance < 30 mL/min at screening or within 90 days of screening using the Cockcroft-Gault formula in participants ≥ 18 years of age or 30 mL/min/1.73m2 at screening or within 90 days of screening
    using the Schwartz formula in participants < 18 years of age (see Protocol Section 6.6.1)
    7) Currently breastfeeding (nursing)
    8) Known hypersensitivity to the study drug, the metabolites, or formulation excipient
    9) Use or planned use of exclusionary medications, refer to Protocol Section 5.4
    E.5 End points
    E.5.1Primary end point(s)
    - Composite endpoint of all-cause medically attended visits (MAVs)
    (medical visits attended in person by the participant and a health care professional) or death by Day 28
    - The proportion of participants with treatment emergent adverse events

    E.5.1.1Timepoint(s) of evaluation of this end point
    At various timepoints as detailed in the Study Protocol
    E.5.2Secondary end point(s)
    - All-cause mortality at Day 28
    - Proportion of participants hospitalized by Day 28
    - Composite endpoint of all-cause MAVs (medical visits attended in
    person by the participant and a health care professional) or death by Day
    14
    - Time-weighted average change in SARS-CoV-2 viral load from baseline to Day 7
    - Time to alleviation (mild or absent) of baseline COVID-19 symptoms as
    reported in the COVID-19-adapted FLU-PRO Plus
    - Proportion of participants progressing to requiring oxygen supplementation by Day 28
    E.5.2.1Timepoint(s) of evaluation of this end point
    At various timepoints as detailed in the Study Protocol
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    Denmark
    France
    Germany
    Portugal
    Spain
    United Kingdom
    United States
    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
    LPLV
    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 months4
    E.8.9.1In the Member State concerned days
    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 Yes
    F.1.1Number of subjects for this age range: 126
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 126
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1012
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 126
    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
    For participants ≥ 12 and < 18 years of age, a parent or legal guardian must be willing and able to provide written informed consent prior to performing study procedures.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 380
    F.4.2.2In the whole clinical trial 1264
    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. Remdesivir is being supplied with curative intent. There is no provision for post-study 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 Decision2020-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-20
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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