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    Summary
    EudraCT Number:2020-004743-83
    Sponsor's Protocol Code Number:SG018
    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:2022-05-11
    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 number2020-004743-83
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled, Phase III trial to determine the efficacy and safety of inhaled SNG001 for the treatment of patients hospitalised due to moderate COVID-19
    Ensayo de fase III, aleatorizado, en doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de SNG001 administrado por vía inhalatoria en el tratamiento de pacientes hospitalizados con COVID-19 de grado moderado
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial of an inhaled antiviral drug to treat or prevent severe respiratory difficulties in patients hospitalised with moderate COVID-19
    Ensayo clínico de un fármaco antiviral inhalado para tratar o evitar dificultades respiratorias severas en pacientes hospitalizados con COVID-19 moderado.
    A.3.2Name or abbreviated title of the trial where available
    SPRINTER
    A.4.1Sponsor's protocol code numberSG018
    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 SponsorSynairgen Research Limited
    B.1.3.4CountryUnited Kingdom
    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 supportSynairgen Research Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSynairgen Research Ltd
    B.5.2Functional name of contact pointSophie Hemmings
    B.5.3 Address:
    B.5.3.1Street AddressMail Point 810, Level F, Southampton General Hospital
    B.5.3.2Town/ cityTremona Road, Southampton
    B.5.3.3Post codeSO16 6YD
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02380512800
    B.5.5Fax number02380512800
    B.5.6E-mailSophie.Hemmings@synairgen.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 nameInterferon beta-1a (IFN-β1a)
    D.3.2Product code SNG001
    D.3.4Pharmaceutical form Inhalation solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInterferon beta-1a
    D.3.9.2Current sponsor codeSNG001
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit million IU million international units
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboNebuliser solution
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COVID-19
    COVID-19
    E.1.1.1Medical condition in easily understood language
    Lung disease caused by the new coronavirus
    Enfermedad pulmonar causada por el nuevo coronavirus
    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 recovery in patients with moderate COVID-19 after administration of SNG001 compared to placebo.
    Evaluar la recuperación de los pacientes hospitalizados COVID-19 moderado después de la administración de SNG001 en comparación con placebo.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of SNG001 compared to placebo in patients with moderate COVID-19, using a range of endpoints.

    To assess the general safety and tolerability of SNG001 compared to placebo when administered to patients with moderate COVID-19.
    Evaluar la eficacia de SNG001, en comparación con placebo, en los pacientes con COVID-19 de grado moderado, utilizando para ello distintos criterios de valoración.

    Evaluar la seguridad y la tolerabilidad generales de SNG001, en comparación con placebo, tras su administración a pacientes con COVID-19 de grado moderado.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, ≥18 years of age at the time of consent.
    2. Admitted to hospital due to the severity of their COVID-19.
    3. Positive virus test for SARS-CoV-2 using a validated molecular assay or antigen assay. Patients who had positive virus test for SARS-CoV-2 prior to hospitalisation will be randomised no later than 48 hours after hospital admission. If the virus test was performed more than 96 hours prior to hospitalisation, the test will have to be repeated in the hospital prior to randomisation. Only patients whose repeated virus test is positive will be randomised, no later than 48 hours after confirmation of SARS-CoV-2 infection.
    Patients who had positive virus test for SARS-CoV-2 after hospitalisation will be randomised no later than 48 hours after confirmation of SARS-CoV-2 infection.
    4. Require oxygen therapy via nasal prongs or mask (OSCI score of 4).
    5. Provided informed consent.
    6. Female patients must be ≥1 year post-menopausal, surgically sterile, or using a highly effective method of contraception. Acceptable highly effective methods of contraception include;
    • bilateral tubal occlusion
    • intrauterine device (provided coils are copper-banded)
    • levonorgestrel intrauterine system (e.g., Mirena™)
    • medroxyprogesterone injections (e.g., Depo-Provera™)
    • etonogestrel implants (e.g., Implanon™, Norplan™)
    • normal and low dose combined oral pills
    • norelgestromin/ ethinylestradiol transdermal system
    • intravaginal device (e.g., ethinylestradiol and etonogestrel), desogestrel (e.g., Cerazette™)
    • total sexual abstinence (defined as refraining from heterosexual intercourse)
    • vasectomised sexual partner.
    Women should have been stable on their chosen method of birth control for a minimum of 3 months before entering the trial and should continue with birth control for 1 month after the last dose of inhaled IFN-β1a/matching placebo. In addition to the highly effective method of contraception (except for the practice of total sexual abstinence), a condom (in UK with spermicides) should be used by the male partner for sexual intercourse from randomisation (Visit 2) and for 1 month after the last dose of inhaled IFN-β1a/matching placebo to prevent pregnancy.
    7. Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months prior to the planned date of randomisation without an alternative medical cause. The following age specific requirements apply:
    • Women <50 years old would be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous
    hormonal treatment and if follicle stimulating hormone (FSH) levels are in the postmenopausal range.
    • Women ≥50 years old would be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment.
    If, in the setting of the pandemic, the use of an acceptable birth control method is not possible, the decision to enrol a woman of childbearing potential should be based on the benefit-risk for the patient, which should be discussed with the patient at the time of the informed consent.
    1. Hombre o mujer, ≥18 años en el momento de otorgar el consentimiento.
    2. Haber sido ingresado en el hospital debido a la gravedad de la COVID-19.
    3. Prueba vírica positiva para el SARS-CoV-2, mediante un ensayo molecular validado o una prueba de antígenos validada. Los pacientes cuya prueba vírica haya resultado positiva para SARS-CoV-2 antes de la hospitalización se aleatorizarán no más tarde de 48 horas tras su ingreso. Si la prueba vírica se hubiese realizado más de 96 horas antes de la hospitalización, deberá repetirse en el hospital antes de la aleatorización. Solamente se aleatorizarán los pacientes cuya repetición de la prueba vírica sea positiva, no más tarde de 48 horas tras la confirmación de la infección por SARS-CoV-2.
    Los pacientes cuya prueba vírica sea positiva para SARS-CoV-2 después de la hospitalización se aleatorizarán no más tarde de 48 horas tras la confirmación de la infección por SARS-CoV-2.
    4. Paciente que requiera oxigenoterapia mediante gafas nasales o mascarilla (puntuación OSCI de 4).
    5. Haber otorgado su consentimiento informado.
    6. Las mujeres deberán ser posmenopáusicas desde ≥1 año, haber sido esterilizadas quirúrgicamente o estar utilizando un método anticonceptivo de elevada eficacia. Los métodos anticonceptivos de elevada eficacia son:
    • oclusión tubárica bilateral
    • dispositivo intrauterino (a condición de que sea de cobre)
    • sistema intrauterino de levonorgestrel (p. ej., Mirena™)
    • inyecciones de medroxiprogesterona (p. ej., Depo-Provera™)
    • implantes de etonogestrel (p. ej., Implanon™, Norplan™)
    • anticonceptivos orales combinados de dosis normal o baja
    • sistema transdérmico de norelgestromina/etinilestradiol
    • dispositivo intravaginal (p. ej., etinilestradiol y etonogestrel), desogestrel (p. ej., Cerazette™)
    • abstinencia sexual completa (definida como ausencia de relaciones heterosexuales)
    • pareja sexual vasectomizada.
    Las mujeres deben haber utilizado de manera estable el método anticonceptivo elegido durante un mínimo de 3 meses antes de participar en el ensayo clínico, y deberán continuar con dicho método durante 1 mes después de la última administración de IFN-β1a/placebo de la misma apariencia por vía inhalatoria. Además del método anticonceptivo de elevada eficacia (excepto si se mantiene la abstinencia completa de relaciones sexuales), la pareja sexual masculina deberá utilizar preservativos (en el Reino Unido, más espermicidas) durante las relaciones sexuales, a partir de la aleatorización (visita 2) y hasta 1 mes después de la última administración de IFN-β1a/placebo de la misma apariencia por vía inhalatoria, con objeto de evitar el embarazo.
    7. Las mujeres sin capacidad para concebir se definen como aquellas que han sido esterilizadas de forma permanente (mediante histerectomía, ooforectomía bilateral o salpingectomía bilateral) y las que son menopáusicas. Las mujeres se considerarán posmenopáusicas si han presentado amenorrea durante 12 meses antes de la fecha de aleatorización programada, en ausencia de otras causas médicas alternativas. Se aplicarán los siguientes requisitos específicos, en función de la edad:
    • Una mujer <50 años se considerará posmenopáusica si ha permanecido amenorreica durante 12 meses o más tras el cese del tratamiento hormonal exógeno y la concentración de hormona foliculoestimulante (FSH) se encuentra en el rango posmenopáusico.
    • Una mujer ≥50 años se considerará posmenopáusica si ha permanecido amenorreica durante 12 meses o más tras el cese de todo el tratamiento hormonal exógeno.
    Si, en el contexto de la pandemia, no es posible utilizar un método anticonceptivo aceptable, la decisión de incluir en el estudio a una mujer con capacidad de quedarse embarazada deberá basarse en la relación de riesgo-beneficio para la paciente, lo que deberá comentarse con ella en el momento de firmar el documento de consentimiento informado.
    E.4Principal exclusion criteria
    1. Evidence of ongoing SARS-CoV-2 infection for more than 3 weeks, confirmed by a validated molecular assay or validated antigen assay.
    2. Non-invasive ventilation or high-flow oxygen (OSCI score of 5).
    3. Mechanical ventilation (continuous or intermittent CPAP or intubation) or admission to intensive care (OSCI score of ≥ 6).
    4. Previous SARS-CoV-2 infection confirmed by a validated molecular assay or validated antigen assay.
    5. Any condition, including findings in the patients’ medical history or in the pre-randomisation study assessments that in the opinion of the Investigator, constitute a risk or a contraindication for the participation of the patient into the study or that could interfere with the study objectives, conduct or evaluation.
    6. Participation in previous clinical trials of SNG001.
    7. Current or previous participation in another clinical trial where the patient has received a dose of an Investigational Medicinal Product (IMP) containing small molecules within 30 days or 5 half-lives (whichever is longer) prior to entry into this study or containing biologicals within 3 months prior to entry into this study.
    8. Inability to use a nebuliser with a mouthpiece.
    9. Inability to comply with the requirements for storage conditions of study medication in the home setting.
    10. History of hypersensitivity to natural or recombinant IFN-β or to any of the excipients in the drug preparation.
    11. Females who are breast-feeding, lactating, pregnant or intending to become pregnant.
    12. Previous SARS-CoV-2 vaccination.
    1. Evidencias de infección continuada por SARS-CoV-2 durante más de 3 semanas, confirmada mediante un ensayo molecular validado o una prueba de antígenos validada.
    2. Ventilación no invasiva u oxigenoterapia de alto flujo (puntuación OSCI de 5).
    3. Ventilación mecánica (CPAP continua o intermitente o intubación) o ingreso en la unidad de cuidados intensivos (puntuación OSCI ≥ 6).
    4. Infección por SARS-CoV-2 previa, confirmada mediante un ensayo molecular validado o una prueba de antígenos validada.
    5. Cualquier proceso patológico, incluidos los hallazgos en la historia clínica del paciente y las evaluaciones del estudio previas a la aleatorización que, en opinión del investigador, constituya un riesgo o contraindicación para que el paciente participe en el estudio o pueda interferir en los objetivos, la ejecución o la evaluación del estudio.
    6. Participación en ensayos clínicos de SNG001 anteriores.
    7. Participación actual o previa en otro ensayo clínico en el que el paciente haya recibido una administración de un producto en investigación (Investigational Medicinal Product, IMP) que contenga moléculas pequeñas en el plazo de los 30 días o 5 semividas (lo que sea más prolongado) anteriores al momento de inclusión en este estudio, o bien que contenga productos biológicos en el plazo de los 3 meses anteriores al momento de inclusión en este estudio.
    8. Imposibilidad de utilizar un nebulizador con boquilla.
    9. Imposibilidad de cumplir con los requisitos de almacenamiento de la medicación del estudio en el domicilio.
    10. Antecedentes de hipersensibilidad al IFN-β, ya sea en su forma natural o recombinante, o a cualquiera de los excipientes de la preparación farmacológica.
    11. Mujeres en período de lactancia, gestantes o que estén intentando quedarse embarazadas.
    12. Vacunación previa contra el SARS-CoV-2.
    E.5 End points
    E.5.1Primary end point(s)
    Time to hospital discharge, defined by the OSCI score of 2 or below, with no rebound at subsequent assessments.
    Time to recovery, where recovery is defined as the OSCI score of 1 or below, with no rebound at subsequent assessments.
    Tiempo hasta el alta hospitalaria, definida como una puntuación OSCI de 2 o inferior, sin recaída en las evaluaciones posteriores.
    Tiempo hasta la recuperación. La recuperación se define como una puntuación OSCI de 1 o inferior, sin recaída en las evaluaciones posteriores.
    E.5.1.1Timepoint(s) of evaluation of this end point
    OSCI assessments will be conducted daily between day 1 and day 35. Time to recovery will be assessed over the first 28 days of the study period. The OSCI assessments after day 28 will be used to assess relapse only.
    Las evaluaciones OSCI se llevarán a cabo diariamente entre el día 1 y el día 35. El tiempo de recuperación se evaluará durante los primeros 28 días del período de estudio. Las evaluaciones OSCI después del día 28 se utilizarán para evaluar la recaída únicamente.
    E.5.2Secondary end point(s)
    Key Secondary Endpoints:
    a. Progression to severe disease or death, defined by the OSCI score of 5 or above within 35 days of first dose.
    b. Progression to intubation or death, defined by the OSCI score of 6 or above within 35 days of first dose.
    c. Death within 35 days of first dose.
    Secondary Endpoints:
    a. Recovery, where recovery is defined as the OSCI score of 1 or below, with no rebound at subsequent assessments, at Days 7, 14, 21 and 28.
    b. Hospital discharge at Days 7, 14, 21 and 28.
    c. Improvement across the entire OSCI at Days 7, 14, 21 and 28.
    d. Changes in breathlessness, cough and sputum scale (BCSS) score during the study period, including disaggregated breathlessness and cough scores.
    e. Changes in National Early Warning Score 2 (NEWS2) during the hospitalisation period.
    f. Daily assessment of COVID-19 symptoms and limitation of usual activities.
    g. Quality of life measured using EQ-5D-5L.
    h. Long-COVID-19 symptoms.
    i. Safety and tolerability – vital signs, AEs and concomitant medications.
    Criterios de valoración secundarios clave:
    a. Progresión a enfermedad grave o muerte, definida como una puntuación OSCI de 5 o superior dentro de los 35 días posteriores a la administración de la primera nebulización.
    b. Progresión a intubación o muerte, definida como una puntuación OSCI de 6 o superior dentro de los 35 días posteriores a la administración de la primera nebulización.
    c. Muerte dentro de los 35 días posteriores a la administración de la primera nebulización.

    Criterios de valoración secundarios:
    a. Recuperación, definida como una puntuación OSCI de 1 o inferior, sin recaída en las evaluaciones posteriores, en los días 7, 14, 21 y 28.
    b. Alta hospitalaria en los días 7, 14, 21 y 28.
    c. Mejoría del cuestionario OSCI en su conjunto en los días 7, 14, 21 y 28.
    d. Cambios en la puntuación de la escala de disnea, tos y esputo (breathlessness, cough and sputum scale, BCSS) durante el período del estudio, incluidas las puntuaciones desagregadas de disnea y tos.
    e. Cambios en la Puntuación Nacional de Alerta Precoz 2 (National Early Warning Score 2, NEWS2) durante el período de hospitalización.
    f. Evaluación diaria de los síntomas de COVID-19 y de la limitación de las actividades habituales
    g. Calidad de vida, determinada con el EQ-5D-5L.
    h. Síntomas de COVID-19 persistente.
    i. Seguridad y tolerabilidad: constantes vitales, acontecimientos adversos y medicación concomitante.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Key secondary endpoints
    Progression to severe disease or death will be assessed using all post-baseline OSCI assessments up to day 28.
    Time to hospital discharge will be assessed over the first 28 days of the study period. The OSCI assessments after day 28 will be used to assess relapse only.
    For Secondary endpoints the timepoints for evaluation are stated in the endpoint wording as per questions E5-2.
    Criterios de valoración secundarios clave:
    La progresión hacia enfermedad severa o muerte se evaluará usando todas las mediciones OSCI post-basal hasta el día 28.
    El tiempo transcurrido hasta el alta hospitalaria se evaluará durante los primeros 28 días del estudio. Las evaluaciones OSCI tras el día 28 serán utilizadas para evaluar sólamente la recaída.
    Para los criterios de evaluación secundarios, las tiempos de evaluación están descritos en la descripción de los criteros, según las preguntas E5-2
    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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA46
    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
    Israel
    Mexico
    United States
    France
    Romania
    Spain
    Germany
    Italy
    Belgium
    Portugal
    Serbia
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days20
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days16
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 305
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 305
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state87
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 234
    F.4.2.2In the whole clinical trial 610
    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)
    As this study drug is only given once a day for 14 days while participants are enrolled onto the study and infected with SARS-CoV-2 infection, the study drug will not be available after the research has finished.
    Dado que este medicamento del estudio solo se administra una vez al día durante 14 días mientras los participantes están inscritos en el estudio y están infectados con la infección por SARS-CoV-2, el medicamento del estudio no estará disponible una vez finalizada la investigación.
    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 Transcrip
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-16
    P. End of Trial
    P.End of Trial StatusOngoing
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