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    Summary
    EudraCT Number:2020-001258-23
    Sponsor's Protocol Code Number:ColCOVID19
    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:2020-04-20
    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 number2020-001258-23
    A.3Full title of the trial
    COLCHICINE TO COUNTERACT INFLAMMATORY RESPONSE IN COVID-19 PNEUMONIA
    COLCHICINA PER CONTRASTARE LA RISPOSTA INFIAMMATORIA IN CORSO DI POLMONITE DA COVID 19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    COLCHICINE TO COUNTERACT INFLAMMATORY RESPONSE IN COVID-19 PNEUMONIA
    COLCHICINA PER CONTRASTARE LA RISPOSTA INFIAMMATORIA IN CORSO DI POLMONITE DA COVID 19
    A.3.2Name or abbreviated title of the trial where available
    ColCOVID19
    ColCOVID19
    A.4.1Sponsor's protocol code numberColCOVID19
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04322565
    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 SponsorAZIENDA OSPEDALIERO-UNIVERSITARIA DI PARMA
    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 supportAZIENDA OSPEDALIERO-UNIVERSITARIA DI PARMA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAZIENDA OSPEDALIERO-UNIVERSITARIA DI PARMA
    B.5.2Functional name of contact pointCORRADO CONFALONIERI Segreteria CE
    B.5.3 Address:
    B.5.3.1Street AddressVIA GRAMSCI
    B.5.3.2Town/ cityPARMA
    B.5.3.3Post code43126
    B.5.3.4CountryItaly
    B.5.4Telephone number00390521703013
    B.5.6E-mailcconfalonieri@ao.pr.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 COLCHICINA
    D.2.1.1.2Name of the Marketing Authorisation holderACARPIA Farmaceutici S.r.l.
    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 nameCOLCHICINA
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 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 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
    patients with COVID-19 infection with pneumonia and stable conditions.
    infezione da COVID-19 con polmonite e condizioni clinicamente stabili
    E.1.1.1Medical condition in easily understood language
    patients with COVID-19 infection with pneumonia and stable conditions.
    infezione da COVID-19 con polmonite e condizioni clinicamente stabili
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    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 clinical efficacy of colchicine relative to the control arm in adult patients hospitalized for COVID-19 with pneumonia and clinically stable conditions
    Valutare l'efficacia clinica della colchicina relativamente al trattamento standard in pazienti adulti ospedalizzati con polmonite da COVID-19 e in condizioni clinicamente stabili
    E.2.2Secondary objectives of the trial
    - Clinical efficacy of colchicine compared to the control arm by clinical severity
    - Duration of predefined symptoms and signs (if applicable)
    - Duration of supplemental oxygen dependency (if applicable)
    - Incidence of new mechanical ventilation use during the study
    - Duration of new mechanical ventilation use during the Study
    - Need for admission into intensive care unit (ICU)
    - Evaluate duration of hospitalization (days)
    - Evaluate the 28-day mortality rate
    - Efficacia clinica della colchicina confrontata con il braccio di controllo in base alla severità clinica
    - Durata di sintomi e segni predefiniti (se applicabile)
    -Durata della dipendenza da supplementazione di ossigeno (se applicabile)
    - Incidenza dell'uso di nuova ventilazione meccanica durante lo studio
    - Durata dell'uso di nuova ventilazione meccanica durante lo studio
    - Necessità di ricovero in unità di terapia intensiva
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients aged 18 years or above
    - Belonging to the low- to intermediate-risk strata according to the criteria of the Emilia-Romagna Region, Italy (PG/2020/0240975 del 21 marzo 2020 “Protocollo terapeutico per la terapia antivirale per I pazienti con infezione da Covid19”, Scenario 2 and 3A, in a scale of increased levels of severity) and to the SIMIT guidelines (http://www.simit.org/IT/formazione/linee-guida.xhtml)), that is patients in stable medical conditions (MEWS<3, see Table below) with the following characteristics:

    -Pauci-symptomatic with positive nasopharyngeal swab for COVID-19 + age ≥70 years and/or clinical risk factors for poor outcome (clinically relevant chronic lung disease, diabetes and/or heart disease) + even minimal CT scan findings (>5% of lung parenchima) suggestive of viral pneumonia (ground-glass opacities and/or patchy consolidation, and/or interstitial changes with a peripheral distribution)

    - Symptomatic (temperature ≥38°C and/or intensive cough and/or shortness of breath), + CT imaging showing typical findings of viral pneumonia (ground-glass opacities, multifocal patchy consolidation, and/or interstitial changes with a peripheral distribution) and positive or pending pharyngo-nasal swab for COVID-19.
    Pazienti di età uguale o maggiore di 18 anni
    Appartenenti al gruppo di rischio basso-intermedio, in base ai criteri della Regione Emilia-Romagna, Italia (PG/2020/0240975 del 21 marzo 2020 "Protocollo terapeutico per la terapia antivirale per I pazienti con infezione da Covid19", Scenario 2 e 3A, in una scala di livelli aumentati di gravità) e alle linee guida SIMIT (http://www.simit.org/IT/formazione/linee-guida.xhtml), cioè pazienti in condizioni mediche stabili (MEWS<3) con le seguenti caratteristiche:
    - Pauci-sintomatici con tampone nasofaringeo positivo per COVID-19 + età ?70 anni e/o fattori di rischio clinico per outcome mediocre (malattia polmonare cronica clinicamente rilevante, diabete e /o cardiopatia) + reperti alla TC anche minimi (>5% di parenchima polmonare) suggestivi di polmonite virale
    - Sintomatici (temperatura ?38°C e/o tosse persistente e/o dispnea), + immagini alla TC che mostrano reperti tipici di polmonite virale e tampone faringonasale positivo per COVID-19 o in attesa di conferma.
    E.4Principal exclusion criteria
    - Unstable clinical conditions (MEWS≥3)
    - Respiratory rate > 30 rpm, PaO2/FiO2 < 200mmHg
    - Pregnant or breast feeding
    - Hepatic failure Child-Pugh C
    - Enrollment in other pharmacological studies
    Treatment with
    - Chronic treatment with colchicine
    - Ongoing treatment with antiviral drugs that include ritonavir or cobicistat (Previous treatment with antiviral drugs that include ritonavir or cobicistat is NOT an exclusion criteria)
    - Any medical condition or disease which in the opinion of the Investigator may place the patient at unacceptable risk for study participation.
    - Condizioni cliniche instabili (MEWS≥3)
    - Frequenza respiratoria > 30 rpm, PaO2/FiO2 < 200mmHg
    - In gravidanza o in allattamento
    - Insufficienza epatica Child-Pugh C
    - Arruolamento in altri studi farmacologici
    In trattamento con
    - Terapia cronica con colchicina
    - Terapia in atto con farmaci antivirali comprendente ritonavir o cobicistat (la terapia pregressa con farmaci antivirali comprendente ritonavir o cobicistat non è un criterio di esclusione)
    - Qualunque condizione medica o patologia che, secondo il Ricercatore potrebbe mettere il paziente a rischio inaccettabile per la partecipazione allo studio.
    E.5 End points
    E.5.1Primary end point(s)
    Time to clinical improvement: defined as time from randomization to an improvement of two points from the status at randomization on a seven-category ordinary scale (cfr 7.5.2) or live discharge from the hospital (whatever comes first) as recommended by Coronavirus Disease (COVID – 2019) R&D Geneva World Health Organization http://www.who.int/
    Tempo al miglioramento clinico: definito come tempo dalla randomizzazione a un miglioramento di due punti rispetto allo stato al momento della randomizzazione su una scala ordinale di sette categorie, o come dimissione dall'ospedale di paziente in vita (il caso che si verifica per primo) come raccomandato dal Coronavirus Disease (COVID - 2019) R&D Geneva World Health Organization http://www.who.int/
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days
    28 giorni
    E.5.2Secondary end point(s)
    1. Clinical status as assessed with 7-category ordinal scale on days 7 and 14
    2. Mortality at day 28
    3. Duration of mechanical ventilation
    4. Duration of hospitalization in survivors
    5. Time in days from treatment initiation to death
    6. Time for negativeization of two consecutive pharyngo-nasal swab 24-72 hrs apart
    7. Time to remission of fever in patients with T>37.5°C at enrollment
    1. valutazione della scala ordinale a 7 e 14 giorni
    2. mortalità a 28 giorni
    3. durata di ventilazione meccanica
    4. durata di ospedalizzazione nei sopravvissuti
    5. Tempo in giorni dall'inizio della terapia alla morte
    6. Tempo di negativizzazione di due tamponi naso-faringei consecutivi a distanza di 24-72 ore
    7. Tempo di remissione della febbre in pazienti con T> 37,5 ° C al momento dell'arruolamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 days
    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 No
    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 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 Yes
    E.8.2.3.1Comparator description
    SOC 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 concerned6
    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 No
    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
    Ultima visita dell'ultimo paziente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 No
    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
    for the severity of the clinical condition or in the case of legal representative of the patient
    per la severità della condizione clinica o nel caso di tutore legale
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state310
    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)
    SOC Standard of care
    Trattamento Standrd
    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 Decision2020-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-20
    P. End of Trial
    P.End of Trial StatusOngoing
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