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    Summary
    EudraCT Number:2020-001475-33
    Sponsor's Protocol Code Number:COLVID-19
    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:2020-06-24
    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 number2020-001475-33
    A.3Full title of the trial
    Treatment with COLchicine of patients affected by COVID-19: a Pilot Study
    Treatment with COLchicine of patients affected by COVID-19: a Pilot Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment with COLchicine of patients affected by coronavirus disease (COVID-19): a Pilot Study
    Trattamento con COLchicina di pazienti affetti da malattia da coronavirus (COVID-19): uno studio pilota
    A.3.2Name or abbreviated title of the trial where available
    Colchicine in COVID-19: a Pilot study
    Colchicine in COVID-19: a Pilot study
    A.4.1Sponsor's protocol code numberCOLVID-19
    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 SponsorDIPARTIMENTO DI MEDICINA, UNIVERSITà DI PERUGIA
    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 supportSocietà Italiana di Reumatologia
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationReumatologia, Dipartimento di Medicina, Università degli Studi di Perugia,
    B.5.2Functional name of contact pointCarlo Perricone
    B.5.3 Address:
    B.5.3.1Street AddressPiazzale Menghini, 1
    B.5.3.2Town/ cityPERUGIA
    B.5.3.3Post code06129
    B.5.3.4CountryItaly
    B.5.4Telephone number0755783573
    B.5.5Fax number0755783944
    B.5.6E-mailcarlo.perricone@unipg.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 LIRCA - 1 MG COMPRESSE 60 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderACARPIA - SERVICOS FARMACEUTICOS LDA
    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 LIRCA
    D.3.2Product code [009964038]
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor code.
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    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 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 Yes
    D.3.11.13.1Other medicinal product typefarmaco antigottoso in grado di ridurre l’infiammazione
    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
    Study population: patients with COVID-19 pneumonia with oxygen saturation deficiency and requiring hospitalization assistance.
    Popolazione in studio: pazienti con polmonite da COVID-19 con deficit di saturazione
    dell’ossigeno e che richiedono assistenza in regime di ricovero.
    E.1.1.1Medical condition in easily understood language
    SARS-CoV-2 virus infection that can cause pneumonia with fever, dry cough and require hospitalization in intensive care in 25% of patients and mortality rate of about 1-10%.
    infezione da virus SARS-CoV-2 che può causare polmonite con febbre, tosse secca e richiedere ricovero in terapia intensiva nel 25% dei pazienti e tasso di mortalità dell’1-10% circa.
    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.1.2 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 10021881 - Infections and infestations
    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 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
    The primary objective of the study is the one-month clinical worsening rate understood as a) respiratory failure that requires mechanical ventilation, b) the need for monitoring and treatment in intensive care for organ failure; c) mortality.
    L’obiettivo primario dello studio è il tasso ad un mese di peggioramento clinico inteso come a) insufficienza respiratoria che richiede ventilazione meccanica, b) necessità di monitoraggio e trattamento in terapia intensiva per insufficienza d’organo; c) mortalità.
    E.2.2Secondary objectives of the trial
    1. White blood cell count trend
    2. Modification of the SOFA score
    3. Recovery rate of biochemical parameters (CK, ALT, ferritin)
    4. Disease remission rate
    5. Toxicity of colchicine
    1. Andamento della conta dei globuli bianchi
    2. Modifica del SOFA score
    3. Tasso di recupero dei parametri biochimici (CK, ALT, ferritina)
    4. Tasso di remissione della malattia
    5. Tossicità della colchicina
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Any gender
    2. >=18 years old
    3. Informed consent for participation in the study
    4. Virological diagnosis of SARS-CoV-2 infection (real-time PCR)
    5. Hospitalized due to clinical/instrumental diagnosis of pneumonia
    6. Oxygen saturation at rest in ambient air =94%
    7. PaO2/FiO2 ratio of 350 to 200
    1. Qualsiasi sesso
    2. >=18 anni
    3. Consenso informato per la partecipazione allo studio
    4. Diagnosi virologica dell'infezione da SARS-CoV-2 (RT-PCR)
    5. Ricovero ospedaliero con diagnosi clinica/strumentale di polmonite
    6. Saturazione di ossigeno a riposo in aria ambiente =94%
    7. Rapporto PaO2 / FiO2 da 350 a 200
    E.4Principal exclusion criteria
    1. Known hypersensitivity to colchicine or its excipients
    2. Severe diarrhea
    3. Patients who cannot take oral therapy
    4. Pregnant and lactating patients
    5. Patients with severe cardiac, renal insufficiency (creatinine clearance (CCL) <30 mL
    / min)
    6. Patients with kidney or liver damage [(AST or ALT> 5 times the normal limits in International Units (ULN)]; or are taking CYP3A4 enzyme - P glycoprotein inhibitors.
    7. Known other clinical condition that contraindicates colchicine and cannot be treated or solved according to the judgement of the clinician
    8. Neutrophils <1.000 / mmc
    9. Platelets <50.000 / mmc
    10. Bowel diverticulitis or perforation
    11. Patients already in ICU or requiring mechanical ventilation
    12. Patients receiving Tocilizumab
    13. Patients already enrolled in other clinical trials
    1. Ipersensibilità nota alla colchicina o ai suoi eccipienti
    2. Diarrea grave
    3. Pazienti che non possono assumere la terapia orale
    4. Pazienti in gravidanza e in allattamento
    5. Pazienti con grave insufficienza cardiaca, renale (clearance della creatinina (CCL)
    <30 mL/min)
    6. Pazienti con danno renale o epatico [(AST o ALT> 5 volte i limiti normali in unità internazionali (ULN)] o che assumono inibitori della glicoproteina-P e dell'enzima CYP3A4.
    7. Altre condizioni cliniche note che controindicano la colchicina e non possono essere trattate o risolte secondo il giudizio del medico
    8. Neutrofili <1.000 / mmc
    9. Piastrine <50.000 / mmc
    10. Diverticolite intestinale o perforazione
    11. Pazienti già in terapia intensiva o che richiedono ventilazione meccanica
    12. Pazienti trattati con Tocilizumab
    13. Pazienti già arruolati in altri studi clinici
    E.5 End points
    E.5.1Primary end point(s)
    One-month clinical worsening rate understood as a) respiratory failure that requires mechanical ventilation, b) the need for monitoring and treatment in intensive care for organ failure; c) mortality.
    Tasso ad un mese di peggioramento clinico inteso come a) insufficienza respiratoria che richiede ventilazione meccanica, b) necessità di monitoraggio e trattamento in terapia intensiva per insufficienza d’organo; c) mortalità.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 DAYS
    30 GIORNI
    E.5.2Secondary end point(s)
    1. White blood cell count trend
    2. Modification of the SOFA score
    3. Recovery rate of biochemical parameters (CK, ALT, ferritin)
    4. Disease remission rate
    5. Toxicity of colchicine
    1. Andamento della conta dei globuli bianchi
    2. Modifica del SOFA score
    3. Tasso di recupero dei parametri biochimici (CK, ALT, ferritina)
    4. Tasso di remissione della malattia
    5. Tossicità della colchicina
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 DAYS
    30 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 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
    solo terapia standard
    standard therapy only
    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 concerned9
    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 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 months3
    E.8.9.1In the Member State concerned days90
    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 days90
    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: 93
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 215
    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 state308
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 308
    F.4.2.2In the whole clinical trial 308
    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 followed up at home to evaluate their clinical progress by telephone interview.
    I pazienti verranno seguiti domiciliarmente per valutarne l’andamento clinico mediante
    intervista telefonica.
    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 Decision2020-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-10
    P. End of Trial
    P.End of Trial StatusOngoing
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