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    Summary
    EudraCT Number:2020-001517-21
    Sponsor's Protocol Code Number:I4V-MC-KHAA
    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:2020-09-09
    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 number2020-001517-21
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Study of Baricitinib in Patients with COVID-19 Infection
    Studio di fase 3 randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli su Baricitinib in pazienti con infezione da COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Baricitinib in Patients with COVID-19 Infection
    Baricitinib in pazienti con infezione da COVID-19
    A.3.2Name or abbreviated title of the trial where available
    COV-BARRIER
    COV-BARRIERA
    A.4.1Sponsor's protocol code numberI4V-MC-KHAA
    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 SponsorELI LILLY & COMPANY, LILLY CORPORATE CENTER
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center, DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 Olumiant
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ, Utrecht, the Netherlands
    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 nameOlumiant
    D.3.2Product code [LY3009104]
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBARICITINIB
    D.3.9.1CAS number 1187594-09-7
    D.3.9.2Current sponsor codeLY3009104
    D.3.9.4EV Substance CodeSUB180983
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 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 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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COVID-19 infection
    Infezione da COVID-19
    E.1.1.1Medical condition in easily understood language
    COVID-19 infection
    Infezione da COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10053983
    E.1.2Term Corona virus infection
    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
    To evaluate the effect of baricitinib 4 mg once daily (QD) compared to placebo on disease progression in patients with COVID-19 infection
    Valutare l'effetto di baricitinib 4 mg una volta al giorno (QD) rispetto al placebo sulla progressione della malattia nei pazienti con infezione da COVID-19
    E.2.2Secondary objectives of the trial
    To evaluate the effect of baricitinib 4 mg QD compared to placebo on clinical outcomes in patients with COVID-19 infection
    Valutare l'effetto di baricitinib 4 mg QD rispetto al placebo sugli esiti clinici in pazienti con infezione da COVID-19
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Hospitalized with coronavirus (SARS-CoV-2) infection, confirmed by polymerase chain reaction (PCR) test or other commercial or public health assay in any specimen, as documented by either of the following:
    • PCR positive in sample collected <72 hours prior to randomization; OR
    • PCR positive in sample collected =72 hours prior to randomization (but no more than 14 days prior to randomization), documented inability to obtain a repeat sample (for example, due to lack of testing supplies, limited testing capacity, results taking >24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 infection.
    - Have evidence of pneumonia (SpO2 <94 or PaO2/FiO2 [or SpO2/FiO2] ratio <300 mmHg or chest imaging findings consistent with pneumonia), OR have evidence of active COVID infection (with clinical symptoms including any of the following: fever, vomiting, diarrhea, dry cough, tachypnea defined as respiratory rate >24 breaths/minute).
    - Have indicators of risk of progression: at least 1 inflammatory markers >upper limit of normal (ULN) (C reactive protein [CRP], D dimer, lactate dehydrogenase [LDH], ferritin) with at least 1 instance of elevation>ULN within 2 days before study entry.
    Ricoverato in ospedale con infezione da coronavirus (SARS-CoV-2), confermato dal test di reazione a catena della polimerasi (PCR) o da altri test di salute pubblica o commerciale in qualsiasi campione, come documentato da uno dei seguenti:
    • PCR positivo nel campione raccolto <72 ore prima alla randomizzazione; OPPURE
    • PCR positivo nel campione raccolto =72 ore prima della randomizzazione (ma non piu' di 14 giorni prima della randomizzazione), incapacità documentata di ottenere un campione ripetuto (ad esempio, a causa della mancanza di materiali di prova, capacità di test limitata, risultati che richiedono> 24 ore, ecc.) E malattia progressiva che suggerisce una infezione continuata da SARS-CoV-2.
    - Avere evidenza di polmonite (rapporto SpO2 <94 o PaO2 / FiO2 [o SpO2 / FiO2] <300 mmHg o reperti di imaging toracico coerenti con la polmonite), O avere evidenza di infezione da COVID attiva (con sintomi clinici tra cui uno dei seguenti: febbre, vomito, diarrea, tosse secca, tachipnea definita come frequenza respiratoria> 24 respiri / minuto).
    - Avere indicatori di rischio di progressione: almeno 1 marker infiammatori> limite superiore normale (ULN) (C proteina reattiva [CRP], dimero D, lattato deidrogenasi [LDH], ferritina) con almeno 1 istanza di elevazione> ULN entro 2 giorni prima dell'ingresso nello studio.
    E.4Principal exclusion criteria
    - Are receiving cytotoxic or biologic treatments (such as tumor necrosis factor [TNF] inhibitors, anti-interleukin-1 [IL-1], anti-IL-6 [tocilizumab or sarilumab], T-cell or B-cell targeted therapies (rituximab), interferon, or Janus kinase (JAK) inhibitors for any indication at study entry. Note: A washout period 4 weeks (or 5 half-lives, whichever is longer) is required prior to screening.
    - Have ever received convalescent plasma or intravenous immunoglobulin [IVIg]) for COVID-19.
    - Have received high dose corticosteroids at doses >20 mg per day (or prednisone equivalent) administered for >=14 consecutive days in the month prior to study entry.
    - Strong inhibitors of OAT3 (such as probenecid) that cannot be discontinued at study entry.
    - Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening tests required).
    - Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product.
    - Have received any live vaccine within 4 weeks before screening, or intend to receive a live vaccine during the study. Note: Use of nonlive (inactivated) vaccinations is allowed for all participants.
    - Require invasive mechanical ventilation, including extracorporeal membrane oxygenation (ECMO) at study entry.
    - Current diagnosis of active malignancy that, in the opinion of the investigator, could constitute a risk when taking investigational product.
    - Have a history of venous thromboembolism (VTE) (deep vein thrombosis [DVT] and pulmonary embolism [PE]) within 12 weeks prior to randomization or have a history of recurrent (>1) VTE (DVT/PE).
    - Anticipated discharge from the hospital, or transfer to another hospital (or another unit), which is not a study site within 72 hours after study entry.
    - Have neutropenia (absolute neutrophil count <1000 cells/microliters)
    - Have lymphopenia (absolute lymphocyte count <200 cells/microliters)
    - Have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times ULN
    - Estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease [MDRD]) <30 milliliter/minute/1.73 meters squared.
    - Have a known hypersensitivity to baricitinib or any of its excipients.
    - Are currently enrolled in any other clinical study involving an investigation product or any other type of medical research judged not to be scientifically or medically compatible with this study.
    Note: The participant should not be enrolled (start) in another clinical trial for the treatment of COVID-19 or SARS CoV-2 through Day 28.
    - Are pregnant, or intend to become pregnant or breastfeed during the study.
    - Are using or will use extracorporeal blood purification (EBP) device to remove proinflammatory cytokines from the blood such as a cytokine absorption or filtering device, for example, CytoSorb®.
    - Are, in the opinion of the investigator, unlikely to survive for at least 48 hours after screening.
    - Ricevono trattamenti citotossici o biologici (come la necrosi tumorale inibitori del fattore [TNF], anti-interleuchina-1 [IL-1], anti-IL-6 [tocilizumab o sarilumab], terapie mirate a cellule T o cellule B (rituximab), interferone o Janus chinasi (JAK) per qualsiasi indicazione all'ingresso nello studio. Nota: prima dello screening è necessario un periodo di washout di 4 settimane (o 5 emivite, a seconda di quale è più lungo).
    - Hanno mai ricevuto plasma convalescente o immunoglobulina endovenosa [IVIg]) per COVID-19.
    - Hanno ricevuto corticosteroidi ad alte dosi a dosi> 20 mg al giorno (o equivalente di prednisone) somministrate per> = 14 giorni consecutivi nel mese prima dell'ingresso nello studio.
    - Inibitori forti di OAT3 (come probenecid) che non possono essere sospesi all'entrata nello studio.
    - Avere la diagnosi della tubercolosi attiva in corso (TB) o, se nota, TB latente in corso di trattamento per meno di 4 settimane con un'appropriata terapia anti-tubercolosi per locale linee guida (solo per la storia, nessun test di screening richiesto).
    - Sospetta infezione batterica, fungina, virale o di altro tipo (oltre a COVID-19) sospetta che, secondo l'opinione dello sperimentatore, potrebbe costituire un rischio durante l'assunzione di prodotti sperimentali. ha ricevuto un vaccino vivo entro 4 settimane prima dello screening o intende ricevere un vaccino vivo durante lo studio. Nota: è consentito l'uso di vaccinazioni non vive (inattivate) per tutti i partecipanti.
    - Richiede una ventilazione meccanica invasiva, inclusa l'ossigenazione extracorporea della membrana (ECMO) all'ingresso nello studio.
    - L'attuale diagnosi di malignità attiva che, secondo l'opinione dello sperimentatore, potrebbe costituire un rischio durante l'assunzione di prodotti sperimentali.
    - Avere una storia di tromboembolia venosa (TEV) (trombosi venosa profonda [TVP] ed embolia polmonare [PE]) entro 12 settimane prima della randomizzazione o avere una storia di TEV ricorrente (> 1) (TVP / PE) .
    - Dimissione anticipata dall'ospedale o trasferimento in un altro ospedale (o un'altra unità), che non è un sito di studio entro 72 ore dall'ingresso nello studio.
    - Avere neutropenia (conta assoluta dei neutrofili <1000 cellule / microlitri)
    - Linfopenia (conta dei linfociti assoluti <200 cellule / microlitri)
    - Avere alanina aminotransferasi (ALT) o aspartato aminotransferasi (AST)> 5 volte ULN
    - Velocità di filtrazione glomerulare stimata (eGFR) (Modifica della dieta nella malattia renale [MDRD]) <30 millilitri / minuto / 1,73 metri quadrati.
    - Avere un'ipersensibilità nota a baricitinib o ad uno qualsiasi dei suoi eccipienti.
    - Sono attualmente iscritti a qualsiasi altro studio clinico che coinvolge un prodotto di indagine o qualsiasi altro tipo di ricerca medica ritenuta non compatibile scientificamente o scientificamente con questo studio.
    Nota: i partecipanti non dovrebbero partecipare (iniziare) a un'altra sperimentazione clinica per il trattamento di COVID-19 o SARS CoV-2 fino al giorno 28.
    - Sono in gravidanza o intendono rimanere incinta o allattare durante lo studio.
    - Stanno usando o useranno un dispositivo di purificazione del sangue extracorporeo (EBP) per rimuovere citochine proinfiammatorie dal sangue come un dispositivo di assorbimento o filtraggio di citochine, ad esempio CytoSorb®.
    - È improbabile che l'investigatore sopravviva per almeno 48 ore dopo lo screening.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (including extracorporeal membrane oxygenation [ECMO]).
    Percentuale di partecipanti che muoiono o richiedono ventilazione non invasiva / ossigeno ad alto flusso o ventilazione meccanica invasiva (compresa l'ossigenazione extracorporea della membrana [ECMO]).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1 to Day 28
    Dal giorno 1 al giorno 28
    E.5.2Secondary end point(s)
    1.Percentage of Participants with at Least 1-Point Improvement on NIAID-OS or Live Discharge from Hospital. The National Institute of Allergy and Infectious Diseases ordinal scale (NIAID-OS) is an assessment of clinical status. The scale is as follows: Death; Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen; Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized, no limitations on activities.
    2.Number of Ventilator-Free Days
    3.Time to Recovery (Recovery assessed by the NIAID-OS)
    4.Overall Improvement on the NIAID-OS
    5.Duration of Hospitalization
    6.Percentage of Participants with a Change in Oxygen Saturation from <94% to =94% from Baseline
    7.Mortality
    8.Duration of Stay in the Intensive Care Unit (ICU) in Days
    9.Time to Clinical Deterioration (one-category increase on the NIAID-OS)
    10.Time to Resolution of Fever, in Participants with Fever at Baseline
    11. Mean Change from Baseline on the National Early Warning Score (NEWS). The NEWS is used to detect and report changes in illness severity in participants with acute illness. The score is determined from six physiological parameters readily measured over time in hospitalized participants: Respiration rate; oxygen saturation; temperature; systolic blood pressure; heart (pulse) rate, and level of consciousness
    12.Time to Definitive Extubation
    13.Time to Independence from Non-Invasive Mechanical Ventilation
    14.Time to Independence from Oxygen Therapy in Days
    15.Number of Days with Supplemental Oxygen Use
    16.Number of Days of Resting Respiratory Rate <24 Breaths per Minute
    1.Percentuale di partecipanti con almeno 1 punto di miglioramento su NIAID-OS o dimissione dal vivo dall'ospedale. La scala ordinale dall'Istituto Nazionale per le allergie e le malattie infettive (NIAID-OS) è una valutazione dello stato clinico. La scala è la seguente: morte; ricoverato in ospedale, su ventilazione meccanica invasiva o ossigenazione extracorporea di membrana (ECMO); dispositivi ospedalieri, su ventilazione non invasiva o ossigeno ad alto flusso; ricoverato in ospedale, che richiede ossigeno supplementare; ricoverato in ospedale, non richiede ossigeno supplementare - richiede cure mediche in corso (correlate a COVID-19 o altro); ricoverato in ospedale, non richiede ossigeno supplementare - non richiede più cure mediche in corso; non ricoverato in ospedale, limitazione delle attività e / o che richiedono ossigeno a casa; non ricoverato in ospedale, nessuna limitazione sulle attività.
    2. Numero di giorni senza ventilazione
    3. Tempo di recupero (recupero valutato dal sistema operativo NIAID)
    4. Miglioramento generale del sistema operativo NIAID
    5. Durata del ricovero
    6. Percentuale di partecipanti con una variazione in Saturazione dell'ossigeno da <94% a =94% rispetto al basale
    7.Mortalità
    8.Durata di permanenza in terapia intensiva (ICU) in giorni
    9. Tempo al deterioramento clinico (aumento di una categoria sul sistema operativo NIAID)
    10. Tempo alla risoluzione di Febbre, in Partecipanti con febbre al basale
    11. Variazione media rispetto al basale del punteggio nazionale di allarme rapido (NEWS). La NEWS viene utilizzata per rilevare e segnalare i cambiamenti nella gravità della malattia nei partecipanti con malattia acuta. Il punteggio è determinato da sei parametri fisiologici prontamente misurati nel tempo nei partecipanti ospedalizzati: frequenza respiratoria; saturazione di ossigeno; temperatura; pressione sanguigna sistolica; frequenza cardiaca (pulsazioni) e livello di coscienza
    12.Tempo di estubazione definitiva
    13.Tempo di indipendenza dalla ventilazione meccanica non invasiva
    14.Tempo di indipendenza dalla terapia con ossigeno in giorni
    15.Numero di giorni con l'uso di ossigeno supplementare
    16.Numero di giorni di frequenza respiratoria a riposo <24 respiri al minuto
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary endpoints will be evaluated [Day 1 to Day 28], except: endpoint 1 and 6 [Day 10], endpoint 11 [Baseline, Day 1 to Day 28].
    Verranno valutati tutti gli endpoint secondari [dal giorno 1 al giorno 28], tranne: endpoint 1 e 6 [giorno 10], endpoint 11 [baseline, dal giorno 1 al giorno 28].
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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
    Argentina
    Brazil
    Germany
    Italy
    Mexico
    Russian Federation
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    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 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: 290
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 110
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Due to the severity of the patient's disease state subjects, limited to patients that may be too sick or confused.
    A causa della gravità dellai malattia del paziente, limitato a pazienti che potrebbero essere troppo malati o confusi.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 104
    F.4.2.2In the whole clinical trial 423
    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)
    Baricitinib will not be provided to participants following completion of the study.
    Baricitinib non verrà fornito ai partecipanti dopo il completamento dello studio.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-08-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-13
    P. End of Trial
    P.End of Trial StatusCompleted
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