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    The EU Clinical Trials Register currently displays   39572   clinical trials with a EudraCT protocol, of which   6487   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-002458-25
    Sponsor's Protocol Code Number:INTERCOP
    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 number2020-002458-25
    A.3Full title of the trial
    Randomized, controlled, open label, phase 2 clinical trial of Interferon-ß-1a (IFNß-1a) in COVID-19 patients.
    Studio randomizzato, controllato, in aperto, di fase 2 con Interferone-ß-1a (IFNß-1a) in pazienti con COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study for the treatment with Interferon-ß-1a (IFNß-1a) of COVID-19 patients: randomized, controlled, open label
    Studio per il trattamento con Interferone-ß-1a (IFNß-1a) di pazienti con COVID-19: randomizzato, controllato, in aperto
    A.3.2Name or abbreviated title of the trial where available
    Clinical study for the treatment with Interferon-ß-1a (IFNß-1a) of COVID-19 patients
    Studio per il trattamento con Interferone-ß-1a (IFNß-1a) di pazienti con COVID-19
    A.4.1Sponsor's protocol code numberINTERCOP
    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 SponsorOSPEDALE SAN RAFFAELE
    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 supportMerck Serono S.p.A
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS Ospedale San Raffaele
    B.5.2Functional name of contact pointUnità di Medicina Generale, Diabete
    B.5.3 Address:
    B.5.3.1Street AddressVia Olgettina, 60
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20132
    B.5.3.4CountryItaly
    B.5.4Telephone number+390226432818
    B.5.5Fax number+390226432827
    B.5.6E-mailbosi.emanuele@hsr.it
    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 REBIF - 44 MCG(12 MILIONI UI) -SOLUZ INIETTABILE- USO SOTTOCUTANEO-PENNA PRERIEMPITA 0.5 ML (24 MILIONI UI/ML) 1 PENNA PRERIEMPITA
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SERONO EUROPE LIMITED
    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 nameInterferone-ß-1a
    D.3.2Product code [IFNß-1a]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINTERFERONE BETA 1A
    D.3.9.2Current sponsor codeIFNß-1a
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number44
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    SARS-Cov-2 infection (COVID-19)
    Infezione da SARS-Cov-2 (COVID-19)
    E.1.1.1Medical condition in easily understood language
    SARS-Cov-2 infection (COVID-19)
    Infezione da SARS-Cov-2 (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 determine the efficacy of IFNß-1a as time to negative conversion of SARS-Cov-2 nasopharyngeal swab in hospitalized COVID-19 patients
    Valutare l’efficacia di IFNß-1a nel ridurre il tempo alla negativizzazione di tamponi nasofaringei per infezione da SARS-CoV-2 in pazienti Covid-19.
    E.2.2Secondary objectives of the trial
    I. To determine the efficacy of IFNß-1a to improve the clinical status and respiratory functions in hospitalized COVID-19 patients.
    II. To determine the efficacy of IFNß-1a to reduce mortality in COVID-19 patients
    III. To determine the efficacy of IFNß-1a to improve the chest CT scan picture in hospitalized COVID-19 patients.
    IV. To determine the efficacy of IFNß-1a to reduce the time of hospitalization in hospitalized COVID-19 patients.
    V. To determine the efficacy of IFNß-1a to reduce the viral load of SARS-CoV-2 measured on plasma
    VI. To determine the safety of the use of IFNß-1a in hospitalized COVID-19 patients.
    I. Valutare la efficacia di IFNß-1a nel migliorare lo stato clinico e la funzionalità respiratoria in pazienti ospedalizzati per COVID-19
    II. Valutare la efficacia di IFNß-1a nel ridurre la mortalità in pazienti ospedalizzati per COVID-19
    III. Valutare l’efficacia di IFNß-1a nel migliorare il quadro radiologico TC dei pazienti ospedalizzati per COVID-19
    IV. Valutare l’efficacia di IFNß-1a nel ridurre la durata dell’ospedalizzazione dei pazienti ospedalizzati per COVID-19
    V. Valutare l’efficacia di IFNß-1a nel ridurre la carica virale di SARS-CoV-2 nel plasma
    VI. Valutare la sicurezza dell’uso di IFNß-1a in pazienti ospedalizzati per COVID-19
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. Informed consent signed
    b. Patients hospitalized with confirmed swab RT-PCR detection of SARS-CoV-2
    c. X-ray and/or TC diagnosed pneumonia
    d. Age >=18 years
    e. Clinical status defined as 3, 4 or 5 on the 7-point ordinal scale
    a. Consenso informato firmato
    b. Pazienti ospedalizzati con tampone nasofaringeo positivo a SARS-CoV-2 confermato tramite test su acido nucleico (RT-PCR)
    c. Diagnosi di polmonite tramite radiografia tradizionale e/o TC
    d. Età >=18 anni
    e. Stato clinico definito come 3, 4, o 5 secondo la scala a sette punti
    E.4Principal exclusion criteria
    a. Known allergy or hypersensitivity to IFNß-1a or IFNß-1b
    b. Presence of severe concomitant illnesses/medical conditions that in the physician opinion do not allow participation to the stud
    c. Pregnant or lactating females
    d. History of major depression disorder or suicidal attempt or suicidal ideation
    e. Spontaneous blood ALT/AST levels > 5 times the upper limit of normal
    f. Clinical status defined as 1, 2, or 6 on the 7-point ordinal scale
    a. Allergia o ipersensibilità nota a IFNß-1a o IFNß-1b.
    b. Presenza malattie o condizioni mediche concomitanti che secondo l’opinione del medico non permettono l’inclusione
    c. Gravidanza o allattamento
    d. Anamnesi indicativa di disturbo depressivo maggiore, tentativo di suicido o ideazione suicidaria
    e. Livelli basali di ALT o AST cinque volte il limite superiore di normalità.
    f. Stato clinico definito come 1, 2 o 6 nella scala a sette punti
    E.5 End points
    E.5.1Primary end point(s)
    Time to negative conversion of SARS-CoV-2 nasopharyngeal swab. Viral load will be measured by RT-PCR.
    Tempo alla negativizzazione per infezione da SARS-CoV-2 nei tamponi nasofaringei. La carica virale viene misurata tramite real-time PCR.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, days 3, 5, 7, 9, 11, 13, 15, 21, 29
    Baseline, giorni 3, 5, 7, 9, 11, 13, 15, 21, 29
    E.5.2Secondary end point(s)
    Changes from baseline in pulmonary TC; a. Improvement in clinical severity score, defined as percentage of subjects reporting each severity rating on a 7-point ordinal scale
    b. Improvement in clinical severity score, defined as the time to clinical improvement of two points from the time of randomization on a 7-category ordinal scale or live discharge from the hospital
    c. Incidence of new oxygen use, non-invasive ventilation, or high flow oxygen devices
    d. Oxygenation free days
    e. Ventilator free days
    f. Incidence of new mechanical ventilation use
    g. Number of patients transferred to Intensive Care Unit; Mortality rate; Duration of hospital stay expressed in days; Viral load measured on plasma with RT-PCR; a. Number of Serious adverse events and Adverse Drug Reaction (expected and un-expected)
    b. Changes from baseline in Hematological and biochemical blood parameters
    Cambiamenti rispetto al baseline nella scala di gravità di malattia polmonare alla TC; a. Miglioramento dello stato clinico, definito come percentuale di soggetti appartenenti a ciascuna delle categorie di una scala ordinale a sette punti
    b. Miglioramento dello stato clinico, definito come tempo al miglioramento di due punti sulla scala ordinale a sette punti, oppure tempo alla dimissione ospedaliera
    c. Incidenza di nuovo utilizzo di ossigeno, ventilazione non invasiva, o ossigeno ad alto flusso
    d. Numero di giorni liberi da ossigeno
    e. Numero di giorni liberi da ventilazione meccanica
    f. Incidenza di nuova ventilazione meccanica
    g. Numero di pazienti trasferiti ad unità di terapia; Mortalità totale; Durata della ospedalizzazione espressa in giorni; Misurazione del numero di copie del virus nel plasma mediante RT PCR; a. Numero di eventi avversi gravi e reazioni avverse al farmaco (attese e non-attese) fino alla dimissione ospedaliera per qualunque causa
    b. Variazione dei valori ematologici/biochimici rispetto al baseline
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, day 21; extra follow up at 90 days; From baseline to day 29; From baseline to day 29; From baseline to day 29; Baseline, days 3, 5, 7, 9, 11, 13, 15, 21, 29; From baseline to day 29
    Baseline, giorno 21 e giorno 90 (extra-followup); Da baseline al giorno 29; Da baseline al giorno 29; Da baseline al giorno 29; Baseline, giorni 3, 5, 7, 9, 11, 13, 15, 21, 29; Da baseline al giorno 29
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    Standard di cura
    Standard of Care
    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 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 months9
    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 months9
    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: 63
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 63
    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 Yes
    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 state126
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 126
    F.4.2.2In the whole clinical trial 126
    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)
    Clinical practice
    Normale pratica clinica
    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 Decision2020-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-23
    P. End of Trial
    P.End of Trial StatusOngoing
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