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    Summary
    EudraCT Number:2020-001689-12
    Sponsor's Protocol Code Number:MHIPS-2020-001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-04-13
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2020-001689-12
    A.3Full title of the trial
    COLCHICINA TEST IN THE SARS-COV2 CORONAVIRUS (COLCORONA-COVID-19)
    ENSAYO DE COLCHICINA EN EL SARS-COV2 CORONAVIRUS (COLCORONA-COVID-19)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    COLCHICINA TEST IN THE SARS-COV2 CORONAVIRUS (COLCORONA-COVID-19)
    ENSAYO DE COLCHICINA EN EL SARS-COV2 CORONAVIRUS (COLCORONA-COVID-19)
    A.4.1Sponsor's protocol code numberMHIPS-2020-001
    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 SponsorMONTREAL HEART INSTITUTE
    B.1.3.4CountryCanada
    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 supportMONTREAL HEART INSTITUTE
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación investigación biomedica Hospital Universitario La Paz-UCICEC
    B.5.2Functional name of contact pointAlberto Borobia
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Castellana 261
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number34912071466
    B.5.5Fax number34912071466
    B.5.6E-mailalberto.borobia@salud.madrid.org
    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 SEID 0,5 mg comprimidos
    D.2.1.1.2Name of the Marketing Authorisation holderSEID, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form
    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 INNCOLCHICINE
    D.3.9.1CAS number 64-86-8
    D.3.9.3Other descriptive nameCOLCHICINE
    D.3.9.4EV Substance CodeSUB01420MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated 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
    Men and women over 40 years of age, with a diagnosis of COVID-19 infection and at least one high risk criterion.
    Hombres y mujeres mayores de 40 años de edad, con diagnóstico de infección COVID-19 y al menos un criterio de riesgo elevado.
    E.1.1.1Medical condition in easily understood language
    Men and women over 40 years of age, with a diagnosis of COVID-19 infection and at least one high risk criterion.
    Hombres y mujeres mayores de 40 años de edad, con diagnóstico de infección COVID-19 y al menos un criterio de riesgo elevado.
    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
    The main objective of this study is to determine if short-term treatment with colchicine reduces the mortality rate and lung complications related to COVID-19.
    El objetivo principal de este estudio es determinar si el tratamiento a corto plazo con colchicina reduce la tasa de mortalidad y las complicaciones pulmonares relacionadas con la COVID-19.
    E.2.2Secondary objectives of the trial
    The secondary objective is to determine the safety of colchicine treatment in this patient population.
    El objetivo secundario es determinar la seguridad del tratamiento con colchicina en esta población de pacientes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Man or woman over 40 years of age with the capacity and willingness to provide their informed consent.
    • Patient diagnosed with COVID-19 infection in the last 24 hours.
    • Outpatient (not currently hospitalized or pending decision on immediate hospitalization).
    • Patient presenting with at least one of the following high-risk criteria: Over 70 years of age, diabetes mellitus, uncontrolled hypertension (systolic blood pressure ≥ 150 mm Hg), known respiratory disease (including asthma and chronic obstructive pulmonary disease) known heart failure
    Known coronary heart disease, fever ≥ 38.4 ° C in the last 48 hours, dyspnea at presentation, bicytopenia, pancytopenia, or combination of high neutrophil count and low lymphocyte count.
    • Woman who is not fertile, defined as postmenopausal for at least 1 year or surgically sterile, or fertile woman who uses at least one contraceptive method, and preferably two complementary contraceptive methods including a barrier method (for example, male or female condom, spermicide, sponge, foam, gel, diaphragm, intrauterine device [IUD]) throughout the study and up to 30 days after the end of the study.
    • Patient with capacity and willingness to meet the requirements of this study protocol.
    • Hombre o mujer mayor de 40 años de edad con capacidad y disposición para proporcionar su consentimiento informado.
    • Paciente diagnosticado de infección COVID-19 en las últimas 24 horas.
    • Paciente ambulatorio (no hospitalizado actualmente ni pendiente de decisión sobre su hospitalización inmediata).
    • Paciente que presente al menos uno de los siguientes criterios de riesgo elevado: Mayor de 70 años de edad, diabetes mellitus, hipertensión no controlada (tensión arterial sistólica ≥ 150 mm Hg), enfermedad respiratoria conocida (incluidas asma y enfermedad pulmonar obstructiva crónica), insuficiencia cardiaca conocida,
    enfermedad coronaria conocida, fiebre ≥ 38,4 °C en las últimas 48 horas, disnea en el momento de la presentación, bicitopenia, pancitopenia o combinación de alto recuento de neutrófilos y bajo recuento de linfocitos.
    • Mujer que no sea fértil, definida como posmenopáusica durante al menos 1 año o quirúrgicamente estéril, o mujer fértil que utiliza al menos un método anticonceptivo, y preferiblemente dos métodos anticonceptivos complementarios incluido un método de barrera (por ejemplo, preservativo masculino o femenino, espermicida, esponja, espuma, gel, diafragma, dispositivo intrauterino [IUD]) durante todo el estudio y hasta 30 días después de finalizar el estudio.
    • Paciente con capacidad y disposición para cumplir los requisitos de este protocolo de estudio.
    E.4Principal exclusion criteria
    • Hospitalized patient or pending decision on immediate hospitalization.
    • Patient in shock or with hemodynamic instability.
    • Patient with inflammatory bowel disease (Crohn's disease or ulcerative colitis) or with chronic diarrhea;
    • Patient with pre-existing progressive neuromuscular disease.
    • Cut-off point of estimated glomerular filtration rate (eGFR) with the MDRD equation <30 m / min / 1.73 m2 in all patients considered for inclusion.
    • Patient with a history of cirrhosis, active chronic hepatitis or severe liver disease.
    • Pregnant or lactating woman, or who is considering becoming pregnant during the study or in the 6 months following the last dose of study medication.
    • Patient who is already taking colchicine for other indications (the main chronic indications are familial Mediterranean fever and gout). Patients who have received colchicine treatment and discontinued it prior to inclusion do not require a period of pharmacological cleansing.
    • Patient with a history of allergic reaction or hypersensitivity to colchicine.
    • Patient receiving chemotherapy to treat cancer.
    • Patient who, for whatever reason, the researcher considers to be not a suitable candidate for the study.
    • Paciente hospitalizado o pendiente de decisión sobre su hospitalización inmediata.
    • Paciente en choque o con inestabilidad hemodinámica.
    • Paciente con enfermedad inflamatoria intestinal (enfermedad de Crohn o colitis ulcerosa) o con diarrea crónica;
    • Paciente con enfermedad neuromuscular progresiva preexistente.
    • Punto de corte de tasa de filtración glomerular estimada (TFGe) con la ecuación MDRD < 30 m/min/1,73 m2 en todos los pacientes considerados para su inclusión.
    • Paciente con antecedentes de cirrosis, hepatitis crónica activa o enfermedad hepática grave.
    • Mujer embarazada o en periodo de lactancia, o que está sopesando quedarse embarazada durante el estudio o en los 6 meses siguientes a la última dosis de medicación del estudio.
    • Paciente que ya está tomando colchicina para otras indicaciones (las indicaciones crónicas principales son la fiebre mediterránea familiar y la gota). Los pacientes que hayan recibido tratamiento con colchicina y lo hayan suspendido antes de la inclusión no requieren someterse a un periodo de limpieza farmacológica.
    • Paciente con antecedentes de reacción alérgica o hipersensibilidad a la colchicina.
    • Paciente que recibe quimioterapia para el tratamiento de un cáncer.
    • Paciente que, por cualquier motivo, el investigador considere que no es un candidato adecuado para el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be a composite endpoint of death or need for hospitalization from COVID-19 infection within 30 days of randomization.
    El criterio de valoración principal será un criterio compuesto de muerte o necesidad de hospitalización por infección COVID-19 en los 30 días siguientes a la aleatorización.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days
    30 días
    E.5.2Secondary end point(s)
    Secondary endpoints will be the components of the composite primary endpoint and the need for mechanical ventilation within 30 days of randomization.
    Los criterios de valoración secundarios serán los componentes del criterio de valoración principal compuesto y la necesidad de ventilación mecánica en los 30 días siguientes a la aleatorización.
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days
    30 días
    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 No
    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 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 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 concerned8
    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 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
    Última visita del último paciente
    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 months10
    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: 500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 500
    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 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 state1000
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 6000
    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)
    None
    Ninguno
    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 Decision2020-04-11
    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 StatusCompleted
    P.Date of the global end of the trial2021-01-11
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