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    The EU Clinical Trials Register currently displays   38153   clinical trials with a EudraCT protocol, of which   6266   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-001052-18
    Sponsor's Protocol Code Number:010
    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:2020-04-07
    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 number2020-001052-18
    A.3Full title of the trial
    A Multicenter, Adaptive, Randomised Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults - Version for European Union/United Kingdom Sites
    Ensayo clínico controlado multicéntrico, adaptativo, ciego, aleatorizado, de seguridad y eficacia de la terapia en investigación para el tratamiento de COVID-19 en adultos hospitalizados - Versión para centros de la Unión Europea / Reino Unido
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multicenter, Adaptive, Randomised Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults - Version for Eurpean Union/United Kingdom Sites
    Ensayo clínico controlado multicéntrico, adaptativo, ciego, aleatorizado, de seguridad y eficacia de la terapia en investigación para el tratamiento de COVID-19 en adultos hospitalizados - Versión para centros de la Unión Europea / Reino Unido
    A.3.2Name or abbreviated title of the trial where available
    Adaptive COVID-19 Treatment Trial in the EU & UK (ACTT-EU/UK)
    Ensayo de tratamiento adaptativo con COVID-19 en la UE y el Reino Unido (ACTT-EU / UK)
    A.4.1Sponsor's protocol code number010
    A.5.4Other Identifiers
    Name:DMID - NIHNumber:20-0006, Version no. 2.0
    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 SponsorRegents of the University of Minnesota
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNational Institute of Health
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportUniversity of Minnesota
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHOSPITAL GERMANS TRIAS I PUJOL
    B.5.2Functional name of contact pointRoger Paredes
    B.5.3 Address:
    B.5.3.1Street AddressCarretera de Canyet, s/n
    B.5.3.2Town/ cityBadalona
    B.5.3.3Post code08916
    B.5.3.4CountrySpain
    B.5.4Telephone number+3493465 6374
    B.5.5Fax number+3493465 3968
    B.5.6E-mailrparedes@irsicaixa.es
    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 nameREMDESEVIR
    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 typerange
    D.3.10.3Concentration number100 to 200
    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
    Influenza COVID-19
    Influenza COVID-19
    E.1.1.1Medical condition in easily understood language
    Influenza COVID-19
    Influenza 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 20.0
    E.1.2Level HLT
    E.1.2Classification code 10022005
    E.1.2Term Influenza viral infections
    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
    The overall objective of the study is to evaluate the clinical efficaty of different investigational therapeutics relative to the control arm in adults hospitalised with COVID-19.
    The primary objective will be determined by a pilot study of the first 100 subjects
    Subject clinical status (8-point ordinal scale) at day 15 is the default primary endpoint
    El objetivo general del estudio es evaluar la eficacia clínica de diferentes terapias de investigación en relación con el brazo de control en adultos hospitalizados con COVID-19.
    El objetivo principal será determinado por un estudio piloto de los primeros 100 sujetos.
    El estado clínico del sujeto (escala ordinal de 8 puntos) en el día 15 es el punto final primario predeterminado
    E.2.2Secondary objectives of the trial
    1. Evaluate the clinical efficaty of different investigational therapeutics as compared to the control arm as assessed by:
    Clinical Severity: Ordinal scale, National Early Warning Scores, Oxygenation; Non-invasive ventilation/high flow oxygen, Invasive Mechanical ventilation/extracoporeal membrane oxygenation (ECMO)
    Hospitalisation: Duration of hospitalisation
    Mortality: 14-day mortality, 28-day mortality

    2. Evaluate the safety of different investigational therapeutics as compared to the control arm as assessed by:
    Commulative incidence of SAE thorough Day 29
    Commulative incidence of Grade 3 and 4 clincial and/or laboratory AEs through Day 29
    Discontinuation or temporary suspensiion of infusions (for any reason)
    Changes in WBC with differential, hemoglobin, platelets, creatinine, total bilirubin, ALT, AST, and PT over time (analysis of lab. values in addition to AEs noted above

    Exploratory with stored samples (separate consent required) Evaluation of Virology efficacy
    1. Evaluar la eficacia clínica de diferentes terapias de investigación en comparación con el brazo de control según:
    Severidad clínica: escala ordinal, puntajes nacionales de alerta temprana, oxigenación; Ventilación no invasiva / oxígeno de alto flujo, ventilación mecánica invasiva / oxigenación por membrana extracorporal
    Hospitalización: duración de la hospitalización
    Mortalidad: mortalidad a los 14 días, mortalidad a los 28 días

    2. Evaluar la seguridad de las terapias de investigación en comparación con el brazo de control según:
    Incidencia acumulativa de SAE hasta día 29
    Incidencia acumulativa de AA de grado 3 y 4 en clínica y/o laboratorio hasta día 29
    Interrupción o suspensión temporal de infusión (por cualquier motivo)
    Cambios en el recuento de glóbulos blancos diferencial, hemoglobina, plaquetas, creatinina, bilirrubina total, ALT, AST y Tiempo de protrombina a lo largo del tiempo

    3.Exploratorio con muestras almacenadas : Evaluación de la eficacia virológica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Admitted to a hospital with synmptoms suggestive of COVID-19 infection
    2. Subject (or legally authorised representative) provides written informed consent prior to initiation of any study procedures
    3. Subject (or legally authorised representative) understands and agrees to comply wiht planned study procedures
    4.Male or non-pregnant female adult ≥ 18 years of age at time of enrollment
    5. Has laboratory - confirmed SARS-CoV-2 infection as determined by PCR or othe rcommercial or public health assay in any specimen collected < 72 hous prior to randomisation
    6. Illness of any duaration, and at least one of the following:
    Radiographic infiltrates by imagin, OR Clincial assessment (evidence of rales/crackels on exam) AND SpO2 ≤ 94% on room air, OR Requiring supplemental oxygen, OR Requiring mechanical ventilation
    7. Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not incluidng hormonal contraception from the time of screening through Day 29
    8. Agrees to not participate in antoehr clinical trial for treatment of COVID-19 or SARS-CoV-2
    1. Ingresado en un hospital con síntomas sugestivos de infección por COVID-19
    2. Sujeto (o representante legalmente) que proporciona su consentimiento informado por escrito antes de iniciar cualquier procedimiento de estudio.
    3. Sujeto (o representante legalmente) que entiende y acepta cumplir con los procedimientos de estudio
    4.Hombres o mujeres no embarazadas ≥ 18 años de edad en el momento de inclusión
    5. Infección por SARS-CoV-2 confirmada por laboratorio por PCR u otro ensayo de salud comercial o pública en cualquier muestra recolectada <72 horas antes de la aleatorización.
    6. Enfermedad de cualquier duración, y al menos uno de los siguientes:
    • Infiltrados radiográficos por imagen, o evaluación clínica (evidencia de crepitaciones) y SpO2 ≤ 94% en aire ambiente, o requerir oxígeno suplementario, o requiere ventilación mecánica.
    7. Mujeres en edad fértil deben aceptar la abstinencia o utilizar al menos un método anticonceptivo primario que no incluya la anticoncepción hormonal desde el momento del examen hasta el día 29
    8. Acuerda no participar en otro ensayo clínico para el tratamiento de COVID-19 o SARS-CoV-2. hasta el día 29.
    E.4Principal exclusion criteria
    1. ALT/AST > 5 times the upper limit of normal
    2. Estimated glumerular filtration rate (eGFR) < 50 or requiring dialysis
    3. Pregnancy or breast feeding
    4. Anticipated transfer to another hospital which is not a study site within 72 hours
    5. Allergy to any study medication
    1. ALT / AST> 5 veces el límite superior de lo normal
    2. Tasa estimada de filtración glumerular (eTFG) <50 o que requiere diálisis
    3. Embarazo o lactancia.
    4. Transferencia anticipada a otro hospital que no es un sitio de estudio dentro de las 72 horas
    5. Alergia a cualquier medicamento del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Death
    Hospitalised on invasive mechanical ventilation or ECMO
    Hospitalised on non-invasive ventilation or high flow oxygen devices
    Hospitalised, requiring supplemental oxygen
    Hospitallised, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
    Hospitalised, not requiring supplemental oxygen - no longer requires ongoing medical care
    Not hospitalised, limitation on activities and/or requiring home oxygen
    Not hospitalised, no limitations on activities
    Muerte
    Hospitalizado con ventilación mecánica invasiva o ECMO
    Hospitalizado con ventilación no invasiva o dispositivos de oxígeno de alto flujo
    Hospitalizado, que requiere oxígeno suplementario
    Hospitalizado, no requiere oxígeno suplementario, requiere atención médica continua (relacionada con COVID-19 o de otra manera)
    Hospitalizado, que no requiere oxígeno suplementario: ya no requiere atención médica continua
    No hospitalizado, limitación de actividades y / o que requiere oxígeno en el hogar
    No hospitalizado, sin limitaciones en las actividades.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Subjects will be assessed daily while hospitalised.
    Subjects discharged from the hospital will be asked to attend study visits at Days 15 and 29.
    The day 22 vist may be conducted by phone
    All subcject with undrgo a series of efficacy, safety and laboratory assessments.
    Blood samples and OP swabs will be obtained on Day 1 (prior to infusion), 3, 5, 8, 11 (while hospitalised) and Day 15 and 29
    Los sujetos serán evaluados diariamente mientras estén hospitalizados.
    Los sujetos dados de alta del hospital deberán asistir a las visitas de estudio en los días 15 y 29.
    El día 22 la visita puede realizarse por teléfono.
    Todos los sujetos están sujetos a una serie de evaluaciones de eficacia, seguridad y laboratorio.
    Las muestras de sangre y los hisopos OP se obtendrán el día 1 (antes de la infusión), 3, 5, 8, 11 (mientras esté hospitalizado) y los días 15 y 29
    E.5.2Secondary end point(s)
    Clinical outcome assessed using ordinal scale daily while hospitalised and on Day 15, 22 and 29
    NEWS assessed daily while hospitalised and on Day 15 and 29
    Days of supplemental oxygen (if applicable)
    Days of non-invasive ventilation (if applicable)
    Days of high flow oxygen (if applicable)
    Days of invasive mechanical ventilation (if applicable)
    Days of ECMO (if applicable)
    Days of hospitalisation
    Date and cause of death (if applicable)
    SAEs
    Grade 3 and 4 AEs
    WBC, with differential, haemoglobin, platelets, creatinine, glucose, total bilirubin, ALT, AST, and PT on Day 1, days 3, 5, 8 and 11 (while hospitalized) and Day 15 and 29 (if attends in-person visit or still hospitalized).
    Resultado clínico evaluado utilizando escala ordinal diariamente mientras está hospitalizado y en los días 15, 22 y 29
    Escala NEWS evaluada diariamente mientras esta hospitalizado y en los días 15 y 29
    Días de oxígeno suplementario (si corresponde)
    Días de ventilación no invasiva (si corresponde)
    Días de alto flujo de oxígeno (si corresponde)
    Días de ventilación mecánica invasiva (si corresponde)
    Días de ECMO (si corresponde)
    Días de hospitalización
    Fecha y causa de muerte (si corresponde)
    SAE
    Grado 3 y 4 AEs
    Recuento de glóbulos blancos diferencial, hemoglobina, plaquetas, creatinina, glucosa, bilirrubina total, ALT, AST y PT el día 1, días 3, 5, 8 y 11 (mientras está hospitalizado) y los días 15 y 29 (si asiste a una visita en persona o aún hospitalizado).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Subjects will be assessed daily while hospitalised.
    Subjects discharged from the hospital will be asked to attend study visits at Days 15 and 29.
    The day 22 vist may be conducted by phone
    All subcject with undrgo a series of efficacy, safety and laboratory assessments.
    Blood samples and OP swabs will be obtained on Day 1 (prior to infusion), 3, 5, 8, 11 (while hospitalised) and Day 15 and 29
    Los sujetos serán evaluados diariamente mientras estén hospitalizados.
    Los sujetos dados de alta del hospital deberán asistir a las visitas de estudio en los días 15 y 29.
    El día 22 la visita puede realizarse por teléfono.
    Todos los sujetos están sujetos a una serie de evaluaciones de eficacia, seguridad y laboratorio.
    Las muestras de sangre y los hisopos orofaringe se obtendrán el día 1 (antes de la infusión), 3, 5, 8, 11 (mientras esté hospitalizado) y los días 15 y 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 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 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 Yes
    E.8.1.7.1Other trial design description
    adaptativo
    Adaptive
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 EEA24
    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
    Germany
    Spain
    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
    Ultima visita ultimo participante
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 340
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 440
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation INSIGHT (International Network for Strategic Initiatives in Global HIV Trials)
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-06
    P. End of Trial
    P.End of Trial StatusOngoing
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