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    Summary
    EudraCT Number:2020-004743-83
    Sponsor's Protocol Code Number:SG018
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-03-30
    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 ConcernedItaly - Italian Medicines Agency
    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
    Sperimentazione di fase III, randomizzata, in doppio cieco, controllata con placebo per determinare l’efficacia e la sicurezza di SNG001 per via inalatoria per il trattamento di pazienti ospedalizzati per COVID-19 di grado moderato
    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
    Sperimentazione su un farmaco antivirale per inalazione per il trattamento o la prevenzione di difficoltà respiratorie gravi nei pazienti ospedalizzati per COVID-19 moderato
    A.3.2Name or abbreviated title of the trial where available
    SPRINTER
    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-ß1a)
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 placeboInhalation 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
    Malattia polmonare causata dal nuovo 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 20.0
    E.1.2Level SOC
    E.1.2Classification code 10021881
    E.1.2Term Infections and infestations
    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.
    Valutare il recupero nei pazienti affetti da COVID-19 moderata in seguito alla somministrazione di SNG001 rispetto al 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.
    Valutare l’efficacia di SNG001 rispetto al placebo in pazienti affetti da COVID-19 moderata, utilizzando una serie di endpoint.

    Valutare la sicurezza e la tollerabilità generale di SNG001 rispetto al placebo, quando somministrato a pazienti affetti da COVID-19 moderata.
    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 SARSCoV-
    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 IFNß1a/
    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-ß1a/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. Sesso maschile o femminile, età =18 anni al momento del consenso.
    2. Ricoverato in ospedale a causa della gravità della COVID-19.
    3. Test virale positivo per SARS-CoV-2 mediante un test molecolare o un test per il rilevamento dell’antigene convalidato. I pazienti che presentavano positività al test virale per SARS-CoV-2 prima dell’ospedalizzazione saranno randomizzati non più tardi di 48 ore dopo il ricovero in ospedale. Se il test virale è stato effettuato più di 96 ore prima dell’ospedalizzazione, il test dovrà essere ripetuto in ospedale prima della randomizzazione. Solo i pazienti il cui test virale ripetuto risulta positivo saranno randomizzati, non più tardi di 48 ore dopo la conferma dell’infezione da SARS-CoV-2.
    I pazienti che presentavano positività al test virale per SARS-CoV-2 dopo l’ospedalizzazione saranno randomizzati non più tardi di 48 ore dopo la conferma dell’infezione da SARS-CoV-2.
    4. Necessita' di ossigenoterapia mediante forcelle nasali o maschera facciale (punteggio OSCI pari a 4).
    5. Ha ricevuto il consenso informato.
    6. Le pazienti di sesso femminile devono essere in post-menopausa da =1 anno, chirurgicamente sterili o utilizzare un metodo contraccettivo altamente efficace. I metodi contraccettivi altamente efficaci accettabili includono:
    • occlusione tubarica bilaterale
    • dispositivo intrauterino (a condizione che le spirali siano avvolte con rame)
    • sistema intrauterino a base di levonorgestrel (ad es., Mirena™)
    • iniezioni di medrossiprogesterone (ad es., Depo-Provera™)
    • impianti di etonogestrel (ad es., Implanon™, Norplan™)
    • pillole orali combinate a dose normale e bassa
    • sistema transdermico a base di norelgestromina/etinilestradiolo
    • dispositivo intravaginale (ad es., etinilestradiolo ed etonogestrel), desogestrel (ad es., Cerazette™)
    • astinenza sessuale totale (definita come l’astensione da rapporti eterosessuali)
    • partner vasectomizzato.
    Le donne devono seguire in modo stabile il metodo di contraccezione scelto da un minimo di 3 mesi prima di entrare nella sperimentazione e devono continuare con il metodo di contraccezione per 1 mese dopo l’ultima dose di IFN-ß1a/placebo corrispondente per via inalatoria. In aggiunta al metodo contraccettivo altamente efficace (fatta eccezione per la pratica di astinenza sessuale totale), un preservativo (nel Regno Unito con aggiunta di spermicidi) deve essere utilizzato dal partner di sesso maschile per i rapporti sessuali a partire dalla randomizzazione (Visita 2) e per 1 mese dopo l’ultima dose di IFN-ß1a/placebo corrispondente per via inalatoria al fine di prevenire la gravidanza.
    7. Le donne non potenzialmente fertili sono definite come donne che sono permanentemente sterilizzate (isterectomia, ovariectomia bilaterale o salpingectomia bilaterale) o che sono in postmenopausa. Le donne saranno considerate in postmenopausa se amenorroiche da 12 mesi prima della data prevista della randomizzazione senza una causa medica alternativa. Si applicano i seguenti requisiti specifici per l’età:
    • Le donne di età <50 anni saranno considerate essere in post-menopausa se amenorroiche da almeno 12 mesi dopo la cessazione del trattamento ormonale esogeno e se i livelli di ormone follicolo-stimolante (Follicle Stimulating Hormone, FSH) rientrano nell’intervallo post-menopausale.
    • Le donne di età =50 anni saranno considerate essere in post-menopausa se amenorroiche da almeno 12 mesi dopo la cessazione dell’intero trattamento ormonale esogeno.
    Se, nel contesto della pandemia, l’uso di un metodo contraccettivo accettabile non è possibile, la decisione di arruolare una donna in età fertile deve essere basato sul rapporto rischio-beneficio per la paziente, che dovrebbe essere discusso con la paziente al momento del consenso informato.
    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-ß 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. Evidenza di infezione da SARS-CoV-2 in corso da più di 3 settimane, confermata da un test molecolare o un test per il rilevamento dell’antigene convalidato.
    2. Ventilazione non invasiva od ossigeno ad alto flusso (punteggio OSCI pari a 5).
    3. Ventilazione meccanica (CPAP continua o intermittente o intubazione) o ricovero in terapia intensiva (punteggio OSCI =6).
    4. Precedente infezione da SARS-CoV-2 confermata da un test molecolare o un test per il rilevamento dell’antigene convalidato.
    5. Qualsiasi condizione, compresi i risultati nell’anamnesi medica dei pazienti o nelle valutazioni pre-randomizzazione dello studio che, a giudizio dello sperimentatore, rappresenti un rischio o una controindicazione per la partecipazione del paziente allo studio o che potrebbe interferire con gli obiettivi, la conduzione o la valutazione dello studio.
    6. Partecipazione a sperimentazioni cliniche precedenti di SNG001.
    7. Attuale o precedente partecipazione a un’altra sperimentazione clinica in cui il paziente ha ricevuto una dose di un prodotto medicinale sperimentale (Investigational Medicinal Product, IMP) contenente molecole di piccole dimensioni nei 30 giorni o 5 emivite (a seconda di quale periodo sia più lungo) precedenti l’ingresso in questo studio o contenente elementi biologici nei 3 mesi precedenti l’ingresso in questo studio.
    8. Incapacità di utilizzare un nebulizzatore con un boccaglio.
    9. Incapacità di conformarsi con i requisiti per le condizioni di conservazione del farmaco dello studio a domicilio.
    10. Anamnesi di ipersensibilità a IFN-ß naturale o ricombinante, o ad uno qualsiasi degli eccipienti presenti nella preparazione del farmaco.
    11. Soggetti di sesso femminile che stiano allattando al seno, in gravidanza o che intendono iniziare una gravidanza.
    12. Precedente vaccinazione contro 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.
    Tempo alla dimissione dall’ospedale, definito come punteggio OSCI pari o inferiore a 2, senza recidiva alle valutazioni successive.
    Tempo al recupero, laddove il recupero è definito come punteggio OSCI pari o inferiore a 1, senza recidiva alle valutazioni successive.
    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.
    Le valutazioni OSCI saranno condotte quotidianamente tra il giorno 1 e il giorno 35.
    Il tempo per il recupero sarà valutato nei primi 28 giorni del periodo di studio. Le valutazioni OSCI dopo il giorno 28 verranno utilizzate solo per valutare la ricaduta.
    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.
    Endpoint secondari chiave:
    a. Progressione a malattia grave o decesso, definito come punteggio OSCI pari o superiore a 5 entro 35 giorni dalla prima dose.
    b. Progressione a intubazione o decesso, definito come punteggio OSCI pari o superiore a 6 entro 35 giorni dalla prima dose.
    c. Decesso entro 35 giorni dalla prima dose.
    End point secondari:
    a. Recupero, laddove il recupero è definito come punteggio OSCI pari o inferiore a 1, senza recidiva alle valutazioni successive, nei Giorni 7, 14, 21 e 28.
    b. Tempo alla dimissione dall’ospedale ai Giorni 7, 14, 21 e 28.
    c. Miglioramento in tutto l’OSCI ai Giorni 7, 14, 21 e 28.
    d. Variazioni dei punteggi della Scala della dispnea, tosse ed espettorato (Breathlessness, Cough and Sputum Scale, BCSS) durante il periodo dello studio, inclusi i punteggi disaggregati di dispnea e tosse.
    e. Variazioni nel Punteggio nazionale dei livelli di allerta precoce 2 (National Early Warning Score 2, NEWS2) durante il periodo di ricovero ospedaliero.
    f. Valutazione giornaliera dei sintomi di COVID-19 e limitazione delle attività abituali.
    g. Qualità della vita misurata utilizzando il questionario EQ-5D-5L [European Questionnaire-5 Levels-5 Dimensions (Questionario europeo a 5 livelli e 5 dimensioni)].
    h. Sintomi a lungo termine di COVID-19.
    i. Sicurezza e tollerabilità: segni vitali, EA e farmaci concomitanti.
    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 postbaseline
    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.
    Endpoint secondari chiave
    La progressione alla malattia grave o alla morte sarà valutata utilizzando tutto il periodo successivo al basale con valutazioni OSCI fino al giorno 28.
    Il tempo necessario alla dimissione dall'ospedale sarà valutato nei primi 28 giorni del periodo di studio. Per la valutazione verranno utilizzate le valutazioni OSCI dopo il giorno 28 solo ricaduta.
    Per gli endpoint secondari i tempi per la valutazione sono indicati nel file
    formulazione dell'endpoint come da domande 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 concerned11
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Brazil
    Colombia
    India
    Israel
    Mexico
    Serbia
    United States
    Belgium
    France
    Italy
    Portugal
    Romania
    Spain
    United Kingdom
    Argentina
    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 years1
    E.8.9.1In the Member State concerned months16
    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 months16
    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 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: 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 state41
    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.
    Poiché questo farmaco in studio viene somministrato solo una volta al giorno per 14 giorni mentre i partecipanti sono arruolati nello studio e infettati con infezione da SARS-CoV-2, il farmaco in studio non sarà disponibile al termine della ricerca.
    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 States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-04-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-03
    P. End of Trial
    P.End of Trial StatusCompleted
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