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    Summary
    EudraCT Number:2020-005416-22
    Sponsor's Protocol Code Number:GS-US-540-5912
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-01-18
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2020-005416-22
    A.3Full title of the trial
    A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Evaluating the Efficacy and Safety of Remdesivir in Participants with Severely Reduced Kidney Function who are Hospitalized for COVID-19
    Estudio de fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos para evaluar la eficacia y la seguridad de remdesivir en participantes con reducción severa de la función renal hospitalizados por COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 Study of Remdesivir in Participants with Severe Renal Impairment who are in Hospital for COVID-19
    Estudio de fase 3 de Remdesivir en participantes con insuficiencia renal grave que están hospitalizados por COVID-19
    A.4.1Sponsor's protocol code numberGS-US-540-5912
    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+441223 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 placeboSolution 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
    Coronavirus disease 2019 (COVID-19) in patients with chronic renal impairment
    Enfermedad por coronavirus 2019 (COVID-19) en pacientes con insuficiencia renal crónica
    E.1.1.1Medical condition in easily understood language
    Coronavirus disease 2019 (COVID-19) in patients with loss of kidney function
    Enfermedad por coronavirus 2019 (COVID-19) en pacientes con pérdida de la función renal
    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 whether RDV reduces the composite risk of death or IMV through Day 29 in participants with severely reduced kidney function who are hospitalized for COVID-19.
    Evaluar si RDV reduce el riesgo combinado de muerte o ventilación mecánica invasiva (VMI) hasta el día 29 en participantes con una disminución intensa de la función renal que están hospitalizados por coronavirus (COVID-19)
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are as follows:
    - To evaluate whether RDV reduces the risk of death through Day 29
    - To evaluate whether RDV reduces the risk of IMV through Day 29
    - To evaluate the time to recovery (defined as satisfying category 1, 2, or 3 by the 8-point ordinal scale)
    - To evaluate the effect of RDV on clinical status assessed by an 8-point ordinal scale at Day 15 and Day 29
    - To evaluate the effect of RDV on RRT-free days (among those without ESKD) through Day 29
    - To evaluate the effect of RDV on recovery through Day 29
    - To evaluate the safety and tolerability of RDV in participants with severely reduced kidney function who are hospitalized for COVID-19
    - Evaluar si el RDV reduce el riesgo de muerte hasta el día 29
    - Evaluar si el RDV reduce el riesgo de VMI hasta el día 29
    - Evaluar el tiempo hasta la recuperación (definido como el que cumple la categoría 1, 2 o 3 según la escala ordinal de 8 puntos)
    - Evaluar el efecto de RDV sobre el estado clínico evaluado mediante una escala ordinal de 8 puntos el día 15 y el día 29
    - Evaluar el efecto de RDV en los días sin tratamiento sustitutivo renal (TSR) (entre aquellos sin enfermedad renal terminal [ERT]) hasta el día 29
    - Evaluar el efecto de RDV en la recuperación hasta el día 29
    - Evaluar la seguridad y tolerabilidad de RDV en participantes con una disminución intensa de la función renal que están hospitalizados por COVID-19
    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) SARS-CoV-2 positive as determined by polymerase chain reaction (PCR) or other commercially available or public health assay (eg, nucleic acid amplification test and antigen tests) in any respiratory specimen
    2) Hospitalized for COVID-19
    3) Age ≥ 12 years and weighing at least 40 kg
    4) O2 saturation ≤ 94% on room air or requiring O2 supplementation OR radiographic evidence of pulmonary infiltrates for COVID-19
    5) Have either:
    a) Severely reduced kidney function (eGFR < 30 mL/min/1.73 m2), using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and revised Schwartz equations for adults and adolescents, respectively, including people with ESKD requiring chronic dialysis but not people requiring RRT for AKI {Levey 2009, Schwartz 2009} Adults: eGFR (mL/min/1.73 m²) 141 × min(Scr/κ, 1)α × max(Scr/κ, 1)-1.209 ×0.993Age × 1.018
    [if female] × 1.159 [if African American]
    κ = 0.7 for females; 0.9 for males
    α = -0.329 for females; -0.411 for males
    Adolescents (age 12–17 years): eGFR (mL/min/1.73 m²) = (0.41 ×Height in cm) / Scr
    SCr in mg/dL, age in years (See Appendix 7 of Protocol for web links to
    adult and adolescent eGFR calculators), OR
    b) Ongoing AKI: defined as a 50% increase in SCr within a 48-hour period that is sustained (ie, requires confirmatory SCr) for ≥ 6 hours despite supportive care
    6) Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under International Council for Harmonisation (of Technical Requirements for Pharmaceuticals for Human Use) (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (age ≥18) prior to performing study procedures
    7) The interval between COVID-19 symptoms onset and randomization is no more than 10 days
    8) Male participants and female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Appendix 4 of the Protocol
    Los participantes deben cumplir con todos los siguientes criterios de inclusión para ser elegibles para participar en este estudio:
    1) Positivos para SARS-CoV-2 según lo determinado por la reacción en cadena de la polimerasa (PCR) u otro análisis comercialmente disponible o de salud pública (p. ej., prueba de amplificación del ácido nucleico y pruebas de antígenos) en cualquier muestra respiratoria
    2) Hospitalizados por COVID-19
    3) Edad ≥12 años y peso inferior a 40 kg
    4) Saturación de O2 ≤94 % con aire ambiental o que requiere suministro complementario de O2 O evidencia radiográfica de infiltrados pulmonares para la COVID-19.
    5) Presentar, o bien:
    a)Disminución intensa de la función renal (tasa de filtración glomerular estimada [TFGe] <30 ml/min/1,73 m2) usando la ecuación de la Colaboración Epidemiológica de la Enfermedad Renal Crónica (Chronic Kidney Disease Epidemiology Collaboration, CKD-EPI) y las ecuaciones de Schwartz revisadas para adultos y adolescentes, respectivamente, incluidas las personas con ERT que requieren diálisis crónica pero no las personas que requieren TSR para DRA.
    Adultos: TFGe (ml / min / 1,73 m²) 141 × min (Scr / κ, 1) α × max (Scr / κ, 1) -1,209 × 0,993 Edad × 1,018 [si es mujer] × 1,159 [si es afroamericano]
    κ = 0,7 para las mujeres; 0,9 para los hombres
    α = -0,329 para las mujeres; -0,411 para los hombres
    Adolescentes (de 12 a 17 años de edad): TFGe (ml / min / 1,73 m²) = (0,41 × Altura en cm) / Scr
    SCr en mg / dL, edad en años (Consulte el Apéndice 7 del Protocolo para obtener enlaces web a calculadoras de TFGe para adultos y adolescentes),
    Presentar, o bien:
    b) DRA en curso: definido como un aumento del 50 % en la CrS en un periodo de 48 horas, que se mantiene (es decir, requiere confirmación de CrS) durante ≥ 6 horas a pesar del tratamiento de apoyo.

    6) Estar dispuesto y ser capaz de proporcionar el consentimiento informado por escrito, o con un representante legal que pueda proporcionar el consentimiento informado, o inscribirse según las disposiciones de uso de urgencia de la ICH E6(R2) 4.8.15 según lo considere necesario el investigador (edad ≥18) antes de realizar los procedimientos del estudio
    7) El intervalo entre la aparición de los síntomas de la COVID-19 y la aleatorización no supera los 10 días.
    8) Los participantes varones y las participantes mujeres en edad fértil que mantengan relaciones heterosexuales deben aceptar utilizar los métodos anticonceptivos especificados en el protocolo, como se describe en el Apéndice 4..
    E.4Principal exclusion criteria
    Participants who meet any of the following exclusion criteria at screening and randomization are not eligible to be enrolled in this study:
    1) Received any investigational drug, RDV, or other antiviral treatment for COVID-19
    2) ALT or AST > 5 × ULN
    3) Invasive mechanical ventilation, noninvasive mechanical ventilation, ECMO, or RRT for AKI
    4) Positive serum pregnancy test at screening for women of childbearing potential or currently breastfeeding
    5) Known hypersensitivity to the investigational drug, metabolites, or formulation SBECD
    Los participantes que cumplan con cualquiera de los siguientes criterios de exclusión en la selección y la aleatorización no son elegibles para inscribirse en este estudio:
    1) Haber recibido cualquier fármaco en estudio, RDV u otro tratamiento antivírico para la COVID-19
    2) Alanina-aminotransferasa o aspartato-aminotransferasa >1,5 × límite superior de la normalidad
    3) Ventilación mecánica invasiva, ventilación mecánica no invasiva, oxigenación por membrana extracorpórea o TSR para DRA
    4) Prueba de embarazo en suero positiva en la selección para mujeres en edad fértil o en periodo de lactancia
    5) Hipersensibilidad conocida al fármaco en investigación, a los metabolitos o al SBECD de la formulación
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint:
    - The composite of all-cause mortality or invasive mechanical ventilation through Day 29
    Criterio valoración principal de la eficacia:
    - La combinación de mortalidad por cualquier causa o RMI hasta el día 29
    E.5.1.1Timepoint(s) of evaluation of this end point
    At various timepoints throughout the study
    En varios momentos a lo largo del estudio
    E.5.2Secondary end point(s)
    The key (α-controlled) secondary endpoint of this study is as follows:
    - All-cause mortality through Day 29

    Other secondary endpoints:
    - Invasive mechanical ventilation through Day 29
    - Time to recovery (defined as satisfying category 1, 2, or 3 by the 8-point ordinal scale)
    - Clinical status assessed by an 8-point ordinal scale on Day 15 and Day 29
    - RRT-free days (among those without ESKD at randomization) through Day 29
    - Recovery through Day 29
    - Serious adverse events (SAEs) and AEs leading to investigational drug discontinuation
    Criterio de valoración secundario clave:
    - Mortalidad por cualquier causa hasta el día 29

    Otros criterios de valoración secundarios:
    - Ventilación mecánica invasiva hasta el día 29
    - Tiempo hasta la recuperación (definido como que cumple la categoría 1, 2 o 3 según la escala ordinal de 8 puntos)
    - Estado clínico evaluado mediante una escala ordinal de 8 puntos el día 15 y el día 29
    - Días sin TSR (entre aquellos sin ERT en la aleatorización) hasta el día 29
    - Recuperación hasta el día 29
    - Eventos adversos graves (AAG) y EA que llevaron a la suspensión del fármaco en investigación
    E.5.2.1Timepoint(s) of evaluation of this end point
    At various timepoints throughout the study
    En varios momentos a lo largo del estudio
    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 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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Brazil
    Colombia
    India
    Mexico
    South Africa
    United States
    Spain
    Portugal
    United Kingdom
    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
    La última visita del último paciente
    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 days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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 Yes
    F.1.1Number of subjects for this age range: 50
    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: 50
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 533
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 533
    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
    Subjects with a legal representative who can provide informed consent, or enrolled under ICH E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (age ≥ 18) are eligible
    Son elegibles los sujetos con un representante legal que pueda proporcionar su consentimiento informado o que estén inscritos en las disposiciones de uso de emergencia de ICH E6 (R2) 4.8.15 según lo considere necesario el investigador (edad ≥ 18)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 104
    F.4.2.2In the whole clinical trial 1116
    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.
    Ninguno
    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 Decision2021-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-30
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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