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    Summary
    EudraCT Number:2020-001185-11
    Sponsor's Protocol Code Number:BREATH
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-08-10
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-001185-11
    A.3Full title of the trial
    A proof-of concept study of the use of Janus Kinase 1 and 2 Inhibitor, Baricitinib, in the treatment of COVID-19-related pneumonia: a two-step phase II clinical trial
    Baricitinib per la polmonite da Corona virus: sperimentazione terapeutica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Baricitinib for coRona virus pnEumonia: a THerapeutic trial (BREATH trial)
    Baricitinib per la polmonite da Corona virus: sperimentazione terapeutica
    A.3.2Name or abbreviated title of the trial where available
    BREATH Trial
    BREATH Trial
    A.4.1Sponsor's protocol code numberBREATH
    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 SponsorFONDAZIONE I.R.C.C.S. POLICLINICO SAN MATTEO
    B.1.3.4CountryItaly
    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 supportFondazione IRCCS Policlinico San Matteo
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione IRCCS Policlinico San Matteo
    B.5.2Functional name of contact pointU.O.C. Reumatologia
    B.5.3 Address:
    B.5.3.1Street AddressPiazzale Golgi 19
    B.5.3.2Town/ cityPavia
    B.5.3.3Post code27100
    B.5.3.4CountryItaly
    B.5.4Telephone number3491874209
    B.5.6E-mailsara.saramonti@gmail.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 Baricitinib
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameBaricitinib
    D.3.2Product code [---]
    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 codeBaricitinib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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.IMP: 2
    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 Baricitinib
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameBaricitinib
    D.3.2Product code [---]
    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 codeBaricitinib
    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
    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 Covid-19
    E.1.1.1Medical condition in easily understood language
    Covid-19 infection
    Infezione 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 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 assess the efficacy and safety of Baricitinib in the management of patients admitted for COVID-19 pneumonia
    Valutare l’efficacia e la sicurezza di Baricitinib nel trattamento dei pazienti con polmonite nel contesto di COVID-19
    E.2.2Secondary objectives of the trial
    1. To quantify the rate of each of: moderate or severe oxygenation impairment within 8 days
    2. To quantify the mortality within 8 days
    3. Peripheral capillary oxygen saturation (SpO2)
    4. PaO2/FiO2
    5. To assess the rate of patients admitted to the ICU
    6. To measure the length of hospital stay
    7. To quantify 28-day mortality
    8. To quantify the rate of re-admission within 28 days
    9. To quantify the cumulative incidence and severity of adverse events
    1. Quantificare il tasso di ciascuno tra: alterazione moderata (100<PaO2/FiO2<=200) o severa (PaO2/FiO2<=100) dell’ossigenazione entro 8 giorni
    2. Quantificare la mortalità entro 8 giorni
    3. Saturazione periferica (SpO2)
    4. PaO2/FiO2
    5. Valutare il tasso di pazienti ricoverati in ICU
    6. Misurare la durata della degenza
    7. Quantificare la mortalità a 28 giorni
    8. Quantificare il tasso di ulteriore ricovero entro 28 giorni
    9. Quantificare l’incidenza cumulativa e la severità degli eventi avversi
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Ability to obtain informed patient consent noting the limitations of existing knowledge regarding Baricitinib’s efficacy and the labeled warning and precautions as the proposed use is outside the approved indication, as well as the presence of known risk of being treated with Baricitinib while the subject of an active infection
    - informed Consent as documented by signature
    - patients with a confirmed SARS-CoV-2 pneumonia
    - adult patients aged 18-74 years old
    - infiltrates at chest radiography
    - = 48 hours from admission
    - c-reactive protein level greater than 10 mg/dl or ferritin level > 900 ug/L
    - Lymphocyte count less than 1500/mmc
    - 200 < PaO2/FiO2 = 300
    Pazienti adulti (18-74 anni) con diagnosi confermata di polmonite con SARS-CoV-2 con infiltrati alla radiografia del torace e con fattori di attivazione flogistica sistemica insorti o peggiorati nonostante la terapia standard ad almeno 48 ore dalla prima valutazione.
    E.4Principal exclusion criteria
    - 18 years old< age <= 75 years old
    - concomitant bacterial infection
    - lymphopenia less than 200/mmc
    - hemoglobin < 8 g/dl
    - absolute neutrophil count < 1 x 109 cells/L
    - requiring continuous positive airway pressure (C-PAP) or mechanical ventilation
    - sudden clinical deterioration requiring ICU access or palliative care

    Exclusion criteria (Drug-related)
    - known hypersensitivity or allergy to the study drug
    - Creatinine clearance < 30 mL/min; if the creatinine clearance is between 30 and 60 mL/min the dose of Baricitinib should be reduced to 2 mg/daily
    - Severe hepatic impairment (no dose adjustment of Baricitinib is required in mild or moderate hepatic impairment)
    - Pregnant or breast-feeding
    - Active tuberculosis
    - Evidence of active HBV (HbsAg positive) or with detectable HCV-RNA, HIV
    - Ongoing, acute diagnosis of DVT/PE
    - Previous diagnosis of DVT/PE
    - 18 anni< età <=75 anni
    - Infezione batterica concomitante
    - Linfopenia < 200/mmc
    - Emoglobina < 8 g/dl
    - Conta assoluta dei neutrofili < 1 x 109 cellule/L
    - Necessità di ventilazione con pressione positiva continua (c-PAP) o ventilazione meccanica
    - Deterioramento clinico improvviso richiedente l’accesso in terapia intensiva o cure palliative

    Criteri di esclusione (legati al farmaco):
    - Nota ipersensibilità o allergia al farmaco sperimentale
    - Clearance della creatinina < 30 mL/min; se la clearance della creatinina è tra 30 e 60 mL/min, la dose di Baricitinib dovrà essere ridotta a 2 mg/die
    - Compromissione epatica severa (non è necessario un aggiustamento della dose di Baricitinib in caso di alterazione lieve o moderata)
    - In stato di gravidanza o di allattamento
    - Tubercolosi attiva
    - Evidenza di infezione attiva da HBV (HbsAg positività) o con HCV-RNA rilevabile, HIV
    - Diagnosi di trombosi venosa profonda/embolia polmonare acuta in corso
    - Precedente diagnosi di DVT/PE
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome of the study will be the response to treatment. A patient is consider responder in the absence of either moderate to severe oxygenation impairment according to Berlin criteria (24) or death, whichever occurs first, within 8 days from enrolment.
    La risposta al trattamento. Un paziente viene considerate come responsivo in assenza di un’alterazione moderata o severa dell’ossigenazione (misurata con il rapporto PaO2/FiO2 all’emogas-analisi arteriosa) ed in mancanza di morte, sulla base dell’evento che si verificherà per primo, entro 8 giorni dall’arruolamento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    8 days
    8 giorni
    E.5.2Secondary end point(s)
    1. To quantify the rate of each of: moderate or severe oxygenation impairment within 8 days
    2. To quantify the mortality within 8 days
    3. Peripheral capillary oxygen saturation (SpO2)
    4. PaO2/FiO2
    5. To assess the rate of patients admitted to the ICU
    6. To measure the length of hospital stay
    7. To quantify 28-day mortality
    8. To quantify the rate of re-admission within 28 days
    9. To quantify the cumulative incidence and severity of adverse events
    1. Quantificare il tasso di ciascuno tra: alterazione moderata (100<PaO2/FiO2<=200) o severa (PaO2/FiO2<=100) dell’ossigenazione entro 8 giorni
    2. Quantificare la mortalità entro 8 giorni
    3. Saturazione periferica (SpO2)
    4. PaO2/FiO2
    5. Valutare il tasso di pazienti ricoverati in ICU
    6. Misurare la durata della degenza
    7. Quantificare la mortalità a 28 giorni
    8. Quantificare il tasso di ulteriore ricovero entro 28 giorni
    9. Quantificare l’incidenza cumulativa e la severità degli eventi avversi
    E.5.2.1Timepoint(s) of evaluation of this end point
    8 and 28 days
    8 e 28 giorni
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    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 months3
    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 months3
    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: 7
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-08-10. Yes
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 13
    F.4.2.2In the whole clinical trial 13
    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)
    Patients will be continuously monitored daily until the resolution of COVID-19 infection, or the occurrence of death
    I pazienti verranno monitorati fino alla risoluzione dell'infezione da Covid-19 o alla morte
    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 Decision2020-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-30
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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