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    The EU Clinical Trials Register currently displays   38185   clinical trials with a EudraCT protocol, of which   6272   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-000841-15
    Sponsor's Protocol Code Number:GS-US-540-5773
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-03-11
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2020-000841-15
    A.3Full title of the trial
    A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants with Severe COVID-19
    Estudio de Fase 3 Aleatorizado para Evaluar la Seguridad y la Actividad Antiviral de Remdesivir (GS-5734™) en Participantes con infección grave por el COVID-19.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This study will test a drug named remdesivir (GS-5734™) to evaluate the safety and effectiveness of the drug in treating patients with severe coronavirus disease 2019 (COVID-19).
    Este estudio probará un medicamento llamado remdesivir (GS-5734™) para evaluar la seguridad y efectividad del medicamento en el tratamiento de pacientes con enfermedad grave por el coronavirus 2019 (COVID-19).
    A.4.1Sponsor's protocol code numberGS-US-540-5773
    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 nameRemdesivir
    D.3.2Product code GS-5734
    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
    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)
    Enfermedad por el Coronavirus 2019 (COVID-19)
    E.1.1.1Medical condition in easily understood language
    Coronavirus disease 2019 (COVID-19)
    Enfermedad por el Coronavirus 2019 (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 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 two remdesivir (RDV) regimens with respect to the normalization of temperature and oxygen saturation through Day 14
    Evaluar la eficacia de dos pautas terapéuticas de remdesivir (RDV) con respecto a la normalización de la temperatura y la saturación de oxígeno hasta el día 14
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of RDV
    Evaluar la seguridad y la tolerabilidad de RDV
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Willing and able to provide written informed consent prior to performing study procedures
    2) Aged ≥ 18 years
    3) SARS-CoV-2 infection confirmed by PCR ≤ 4 days before randomization
    4) Currently hospitalized with fever defined as ≥ 36.6 °C armpit, ≥ 37.2°C oral, ≥ 37.8 °C rectal
    5) SpO2 > 94% on room air at screening
    6) Radiographc evidence of pulmonary infiltrates
    7) Men and women of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Protocol Appendix 3.
    1) Disposición y capacidad para otorgar el consentimiento informado por escrito antes de realizar los procedimientos del estudio
    2) Edad ≥ 18 años
    3) Infección por el SARS-CoV-2 confirmada mediante PCR ≤ 4 días antes de la aleatorización
    4) Hospitalización con fiebre, definida como una temperatura ≥ 36,6 °C en la axila, ≥ 37,2 °C en la boca y ≥ 37,8 °C en el recto
    5) SpO2 ≤ 94% con aire ambiente en la fase de selección
    6) Signos radiológicos de infiltrados pulmonares
    7) Los varones y las mujeres con capacidad de procrear que mantengan relaciones heterosexuales deben comprometerse a utilizar métodos anticonceptivos especificados en el protocolo, tal como se describe en el Apéndice 3.
    E.4Principal exclusion criteria
    1) Participation in any other clinical trial of an experimental treatment for COVID-19
    2) Concurrent treatment with other agents with actual or possible direct
    acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study drug dosing
    3) Evidence of multiorgan failure
    4) Requiring mechanical ventilation at screening
    5) ALT or AST > 5 x upper limit of normal (ULN)
    6) Creatinine clearance < 50 mL/min
    7) Positive pregnancy test (Protocol; Appendix 3)
    8) Breastfeeding woman
    9) Known hypersensitivity to the study drug, the metabolites, or formulation excipient
    1)Participación en cualquier otro ensayo clínico de un tratamiento experimental contra el COVID-19.
    2)Queda prohibido el tratamiento concomitante con otros fármacos con actividad antiviral directa real o posible contra el SARS-CoV-2 en las 24 horas previas a la administración del fármaco del estudio.
    3) Signos de insuficiencia multiorgánica
    4) Necesidad de ventilación mecánica en la fase de selección
    5) ALT or AST > 5 x Límite Superior de Normalidad (LSN)
    6) Aclaramiento de creatinina < 50 mL/min
    7) Prueba de embarazo positiva (protocolo, apendix 3)
    8) Mujeres lactantes
    9) Hipersensibilidad conocida al fármaco del estudio, sus metabolitos o los excipientes de la formulación.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of participants in each group with normalization of fever and oxygen saturation [criteria for normalization: temperature < 36.6°C armpit, < 37.2°C oral, < 37.8°C rectal; and SpO2 > 94%, sustained for at least 24 hours] through Day 14
    La proporción de participantes en cada grupo con normalización de la fiebre y la saturación de óxigeno [criterios de normalización: fiebre, temperatura < 36.6°C en la axila, < 37.2°C en la boca, < 37.8°C en el recto; y SpO2 > 94%, mantenida durante al menos 24 hours] hasta el día 14
    E.5.1.1Timepoint(s) of evaluation of this end point
    From initiation of study medication until Day 14
    Desde el inicio de la medicación del estudio hasta el día 14
    E.5.2Secondary end point(s)
    The proportion of participants with treatment emergent adverse events leading to study drug discontinuation
    La proporción de participantes con efectos adversos emergentes en el tratamiento que llevan a la interrupción del fármaco de estudio
    E.5.2.1Timepoint(s) of evaluation of this end point
    From initiation of study medication until Day 14
    Desde el inicio de la medicación del estudio hasta el día 14
    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 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 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 No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    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 EEA12
    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
    China
    France
    Germany
    Hong Kong
    Italy
    Japan
    Korea, Republic of
    Singapore
    Spain
    Taiwan
    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
    LVLS
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months3
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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
    Men of childbearing potential who engage in heterosexual intercourse using contraception
    Hombres en edad fértil que tienen relaciones heterosexuales utilizando anticonceptivos
    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 150
    F.4.2.2In the whole clinical trial 400
    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.
    La atención a largo plazo del participante seguirá siendo responsabilidad de su médico tratante primario. Remdesivir se suministra con fines curativos. No hay provisiones para la disponibilidad posterior al estudio.
    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 Decision2020-03-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-06-30
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