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    Summary
    EudraCT Number:2020-001511-25
    Sponsor's Protocol Code Number:IMIB-COLVID-2020-03
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-04-15
    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 number2020-001511-25
    A.3Full title of the trial
    Randomized open-blind controlled trial to study the benefit of Colchicine in Patients with COVID-19
    Estudio aleatorizado, abierto y controlado para valorar el beneficio de Colchicina en pacientes con enfermedad COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized open-blind controlled trial to study the benefit of Colchicine in Patients with COVID-19
    Estudio aleatorizado, abierto y controlado para valorar el beneficio de Colchicina en pacientes con enfermedad COVID-19
    A.3.2Name or abbreviated title of the trial where available
    COL-COVID
    COL-COVID
    A.4.1Sponsor's protocol code numberIMIB-COLVID-2020-03
    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 SponsorFFIS
    B.1.3.4CountrySpain
    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 supportISCarlos iii
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFFIS
    B.5.2Functional name of contact pointSPONSOR
    B.5.3 Address:
    B.5.3.1Street AddressLUIS FONTES PAGAN 9
    B.5.3.2Town/ cityMURCIA
    B.5.3.3Post code30003
    B.5.3.4CountrySpain
    B.5.4Telephone number34968359763
    B.5.6E-mailLola.serna@carm.es
    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 COLCHICINE
    D.2.1.1.2Name of the Marketing Authorisation holderSEID, S.A. Carretera de Sabadell a Granollers Km. 15 08185 LLIÇA DE VALL - Barcelona- ESPAÑA
    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.3.1Product nameCOLCHIMAX
    D.3.2Product code M04AX
    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.3.8INN - Proposed INNCOLCHICINA
    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 number.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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COVID19
    COVID19
    E.1.1.1Medical condition in easily understood language
    COVID19
    COVID19
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    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 study whether the administration of colchicine, compared to a control group, improves the clinical evolution of patients and prevents the inflammatory response.
    1. Changes in the clinical status of patients on the 7-point ordinal scale (WHO R&D Blueprint expert group) (34) at 7, 14 and 28 days:
    2. Change in IL-6 concentrations up to 28 days.
    Estudiar si la administración de colchicina, respecto a un grupo control, mejora la evolución clínica de los pacientes y previene la respuesta inflamatoria
    1. Cambios del estado clínico de los pacientes en la escala ordinal de 7 puntos (OMS R&D Blueprint expert group)(34) a los 7, 14 y 28 días:
    2. Cambio en las concentraciones de IL-6 hasta los 28 días.
    E.2.2Secondary objectives of the trial
    1. Improvement of clinical status defined as time to reduction of at least 2 points on the WHO 7-point ordinal scale.
    2. Changes in the Sequential Organ Failure Scale (SOFA,) during hospitalization and time to 50% reduction with respect to randomization.
    3. Changes in NEWS severity scale score (33) during hospitalization and time to NEWS score ≤2 or 50% reduction from randomization.
    4. Number of days in invasive mechanical ventilation or ECMO
    5. Number of days with oxygen at high flow.
    6. Changes of other inflammatory markers: C-reactive protein, TNF-alpha, GDF-15, IL-1β up to 28 days with respect to randomization.
    7. Changes in severity markers: D-dimer, leukocytes, lymphocytes, platelets, LDH and ferritin up to 28 days with respect to randomization.
    8. Changes in markers of myocardial damage: hsTnT and NT-proBNP up to 28 days with respect to randomization.
    9. Time to viral negative by RT-PCR
    10. Duration in days of hospital stay
    11. ICU income
    12. Mortality from causes
    1. Mejora del estado clínico definida como tiempo hasta la reducción de al menos 2 puntos en la escala ordinal de 7 puntos de la OMS.
    2. Cambios en la puntuación de la escala de fallo secuencial de órganos
    3. Cambios en la puntuación de la escala de gravedad NEWS(33) durante la hospitalización y tiempo hasta una puntuación NEWS ≤2 o reducción del 50% respecto a la randomización.
    4. Número de días en ventilación mecánica invasiva o ECMO
    5. Número de días con oxígeno a alto flujo.
    6. Cambios de otros marcadores inflamatorios: proteína C reactiva, TNF-alfa, GDF-15, IL-1β hasta 28 días respecto a la randomización.
    7. Cambios en marcadores de severidad: dimero D, leucocitos, linfocitos, plaquetas, LDH y ferritina hasta 28 días respecto a la randomización.
    8. Cambios en marcadores de daño miocárdico: hsTnT y NT-proBNP hasta 28 días respecto a la randomización.
    9. Tiempo hasta negativización vírica por RT-PCR
    10. Duración en días de la estancia hospitalaria
    11. Ingresos en UCI
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Infection confirmed by SARS-CoV-2 by RT-PCR.
    2. Hospital admission in the previous 48 hours for clinical involvement in groups 3, 4 or 5 of the WHO clinical scale.
    3. Age over 18 years.
    4. Granting of informed consent in writing.
    1. Infección confirmada por SARS-CoV-2 mediante RT-PCR.
    2. Ingreso hospitalario en las 48 horas previas por afectación clínica en los grupos 3, 4 o 5 de la escala clínica de la OMS.
    3. Edad mayor de 18 años.
    4. Otorgamiento de consentimiento informado por escrito.
    E.4Principal exclusion criteria
    1. Need for invasive ventilatory support
    2. Limitation of therapeutic effort due to poor vital prognosis
    3. Inflammatory bowel disease (Crohn's disease or ulcerative colitis), chronic diarrhea or malabsorption.
    4. Previous neuromuscular disease
    5. Different disease with estimated life prognosis less than 1 year.
    6. Severe kidney failure (glomerular filtration rate <30 mL / m in / 1.73m2)
    7. History of cirrhosis, active chronic hepatitis, or severe liver disease defined by GOT (AST) or GPT (ALT) values ​​that exceed 3 x upper limit of normality
    8. Patient who is taking colchicine for other indications (mainly chronic prescriptions for family Mediterranean fever or gout) (No washout period will be required for patients who have been treated with colchicine and have stopped treatment before randomization).
    9. Patient with a history of allergic reactions or significant sensitivity to colchicine.
    10. Treatment with immunosoppressants, corticosteroids, interleukin-1 antagonists in the 6 months prior to inclusion.
    11. Pregnant or lactating women, where pregnancy is defined as the state of a woman after conception and until the end of gestation, confirmed by a positive result in the analysis of human chorionic gonadotropin (hCG).
    12. Fertile, or postmenopausal female patient less than 1 year old, and not surgically sterilized. Women of childbearing potential who are using at least one contraceptive method and preferably two complementary methods of contraception, including a barrier method (male or female condoms, spermicides, sponges, foams, contraceptive gels, diaphragms, intrauterine device) may be included throughout the entire study and up to 30 days after the end of the study.
    13. Use of other investigational drugs at the time of enrollment, or during the 30 days prior to enrollment.
    1. Necesidad de soporte ventilatorio invasivo
    2. Limitación de esfuerzo terapéutico por mal pronóstico vital
    3. Enfermedad inflamatoria intestinal (enfermedad de Crohn o colitis ulcerosa), diarrea crónica o malabsorción.
    4. Enfermedad neuromuscular previa
    5. Enfermedad distinta con pronóstico vital estimado menor de 1 año.
    6. Insuficiencia renal grave (tasa de filtrado glomerular <30 mL/m in/1.73m2)
    7. Antecedentes de cirrosis, hepatitis crónica activa o enfermedad hepática severa definida por valores GOT (AST) o GPT (ALT) que superen 3 x límite superior de normalidad
    8. Paciente que se encuentre tomando colchicina para otras indicaciones (principalmente prescripciones crónicas para fiebre familiar del mediterráneo o gota) (No se requerirá periodo de lavado para pacientes que hayan sido tratados con colchicina y hayan dejado el tratamiento antes de la aleatorización).
    9. Paciente con antecedentes de reacciones alérgicas o sensibilidad significativa a la colchicina.
    10. Tratamiento con inmunosopresores, corticoides, antagonistas de la interleukina-1 en los 6 meses previos a la inclusión.
    11. Mujeres embarazadas o en periodo de lactancia, donde embarazo se define como el estado de una mujer después de la concepción y hasta que finalice la gestación, confirmado por un resultado positivo en la analítica de gonadotropina coriónica humana (hCG).
    12. Paciente femenino fértil, o posmenopáusica de menos de 1 año, y no esterilizada quirúrgicamente. Podrán incluirse mujeres en edad fértil que esté utilizando al menos un método anticonceptivo y preferentemente dos métodos complementarios de anticoncepción, incluyendo un método barrera (preservativos masculinos o femeninos, espermicidas, esponjas, espumas, geles anticonceptivos, diafragmas, dispositivo intrauterino) a lo largo de todo el estudio y hasta 30 días después de la finalización del mismo.
    13. Uso de otros fármacos en investigación en el momento de la inclusión, o durante los 30 días anteriores a la inclusión.
    E.5 End points
    E.5.1Primary end point(s)
    1. Ordinal 7-point clinical evaluation scale (WHO R&D Blueprint expert group (31).
    2. IL-6 concentrations, which together with the rest of the laboratory result variables will be measured together at the end of the study.
    1. Escala ordinal de evaluación clínica de 7 puntos (OMS R&D Blueprint expert group(31).
    2. Concentraciones de IL-6, que junto el resto de variables de resultado de laboratorio se medirán conjuntamente al final del estudio
    E.5.1.1Timepoint(s) of evaluation of this end point
    END OF STUDY
    FINAL ESTUDIO
    E.5.2Secondary end point(s)
    1. Sequential Organ Failure Assessment Scale for Organ Failure
    (https://www.mdcalc.com/sequential-organ-failure-assessment-sofa-score).

    2. NEWS (National Early Warning Score) severity scale (https://www.mdcalc.com/national-early-warning-score-news).
    3. Number of days in invasive mechanical ventilation or ECMO

    4. Number of days with oxygen at high flow.

    5. Concentrations of other inflammatory markers: C-reactive protein, TNF-alpha, IL-1beta, GDF-15, IL-1β.
    6. Concentrations of other severity markers: D-dimer, leukocytes, lymphocytes, platelets, LDH, ferritin.
    7. Concentrations of markers of myocardial damage: hsTnT and NT-proBNP

    8. Viral detection by RT-PCR

    9. Days of hospital stay

    10. ICU income

    11. Mortality by causes
    1. Escala de evaluación secuencial de fallo de órganos SOFA (Sequential Organ Failure Assessment)
    (https://www.mdcalc.com/sequential-organ-failure-assessment-sofa-score).

    2. Escala de gravedad NEWS (National Early Warning Score) (https://www.mdcalc.com/national-early-warning-score-news).
    3. Número de días en ventilación mecánica invasiva o ECMO

    4. Número de días con oxígeno a alto flujo.

    5. Concentraciones de otros marcadores inflamatorios: proteína C reactiva, TNF-alfa, IL-1beta, GDF-15, IL-1β.
    6. Concentraciones de otros marcadores de severidad: dimero D, leucocitos, linfocitos, plaquetas, LDH, ferritina.
    7. Concentraciones de marcadores de daño miocárdico: hsTnT y NT-proBNP
    8. Detección vírica por RT-PCR

    9. Días de estancia hospitalaria

    10. Ingresos en UCI

    11. Mortalidad por causas
    E.5.2.1Timepoint(s) of evaluation of this end point
    END OF STUDY
    FINAL ESTUDIO
    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 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) Yes
    E.8.2.2Placebo No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLV
    LVLV
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    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: 51
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 51
    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 state102
    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
    NONE
    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 Decision2020-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-13
    P. End of Trial
    P.End of Trial StatusOngoing
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