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    Summary
    EudraCT Number:2020-001841-38
    Sponsor's Protocol Code Number:Col-VID
    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:2020-05-26
    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 number2020-001841-38
    A.3Full title of the trial
    Colchicine for the Treatment of Hyperinflammation associated with Pneumonia due to COVID-19
    Colchicina para el Tratamiento de la Hiperinflamación asociada a la Neumonía por COVID-19.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Colchicine for the Treatment of Hyperinflammation associated with Pneumonia due to COVID-19
    Colchicina para el Tratamiento de la Hiperinflamación asociada a la Neumonía por COVID-19.
    A.4.1Sponsor's protocol code numberCol-VID
    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 SponsorSociedad Española de Cardiología
    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 supportSociedad Española de Cardiología
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSociedad Española de Cardiología
    B.5.2Functional name of contact pointAlberto Cecconi
    B.5.3 Address:
    B.5.3.1Street AddressCalle Diego de León, 62
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28006
    B.5.3.4CountrySpain
    B.5.4Telephone number+34915202272
    B.5.6E-mailalberto.cecconi@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.2.1.2Country 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 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 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 typerange
    D.3.10.3Concentration number0.5 to 1
    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
    Hyperinflammation associated with Pneumonia due to COVID19
    Hiperinflamación asociada a la Neumonía por COVID19.
    E.1.1.1Medical condition in easily understood language
    Hyperinflammation associated with Pneumonia due to COVID19
    Hiperinflamación asociada a la Neumonía por COVID19.
    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 determine whether the use of colchicine in patients hospitalized for COVID-19 pneumonia and with hyperinflammation data reduces the start of non-invasive ventilation (CPAP / BiPAP), admission to the ICU, start of invasive ventilation or death.
    Determinar si el uso de colchicina en paciente hospitalizado por neumonía por COVID19 y con datos de hiperinflamación reduce el inicio de ventilación no invasiva (CPAP/BiPAP), ingreso en UCI, inicio de ventilación invasiva o muerte.
    E.2.2Secondary objectives of the trial
    - To determine if the use of colchicine in a hospitalized patient due to COVID-19 pneumonia and hyperinflammation data is capable of limiting the overproduction of inflammatory cytokines while maintaining a good safety profile for the patient.
    - To determine if the use of colchicine in a patient hospitalized for COVID-19 pneumonia and hyperinflammation data reduces the days of hospitalization.
    - To determine if the use of colchicine in a hospitalized patient due to COVID19 pneumonia and hyperinflammation data reduces myocardial damage.
    - Determinar si el uso de colchicina en paciente hospitalizado por neumonía por COVID19 y datos de hiperinflamación es capaz de limitar la sobre-producción de citoquinas inflamatorias manteniendo un buen perfil de seguridad para el paciente.
    - Determinar si el uso de colchicina en paciente hospitalizado por neumonía por COVID19 y datos de hiperinflamación reduce los días de hospitalización.
    - Determinar si el uso de colchicina en paciente hospitalizado por neumonía por COVID19 y datos de hiperinflamación reduce el daño miocárdico.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient hospitalized for COVID pneumonia19 (microbiological confirmation and chest X-ray compatible with pneumonia are required).
    2. Hyperinflammation.
    3. Verbal informed consent (written consent on paper would carry a risk of contagion for healthcare personnel) (Model consent is attached). The patient's consent will be noted in the patient's medical record.
    1. Paciente hospitalizado por neumonía por COVID19 (se exige confirmación microbiológica y Rx tórax compatible con neumonía).
    2.Hiperinflamación.
    3. Consentimiento informado verbal (el consentimiento escrito en papel conllevaría riesgo de contagio para el personal sanitario) (Se adjunta modelo de consentimiento). El consentimiento del paciente quedará anotado en la historia clínica del paciente.
    E.4Principal exclusion criteria
    1. Hemodynamic instability patient
    2. Patient already with invasive or non-invasive ventilation (CPAP / BiPAP).
    3. Pregnant, lactating or considering pregnancy in the following 6 months. In women with the possibility of undiagnosed pregnancy, pregnancy should be ruled out using a negative urine test
    4. Patients with indication of treatment with Kaletra.
    5. Patients included in other clinical trials.
    6. Patient with cirrhosis, active hepatitis or severe liver failure
    7. Patient with chronic inflammatory disease in active phase.
    8. Diarrhea that does not respond to diet or medication.
    9. Chronic immunosuppressive treatment Neutrophils <500 cell / mmc and / or platelets <50,000 cell / mmc.
    10. Severe renal failure (renal glomerular filtration <30ml / min / 1.7m2).
    11. Be already under treatment with colchicine.
    12. Under 18 years of age.
    1. Paciente con inestabilidad hemodinámica
    2. Paciente ya con ventilación invasiva o no invasiva (CPAP/BiPAP).
    3. Mujer embarazada, en periodo de lactancia o que esté considerando quedarse embarazada en los 6 meses sucesivos. En mujeres con posibilidad de embarazo no diagnósticado se deberá descartar embarazo mediante un test de orina negativo.
    4. Pacientes con indicación de tratamiento con Kaletra.
    5. Pacientes incluidos en otros ensayos clínicos.
    6. Paciente con cirrosis, hepatitis activa o fallo hepático grave
    7. Paciente con enfermedad crónica inflamatoria en fase activa.
    8. Diarrea que no responde a dieta o medicación.
    9. Tratamiento inmunosupresor crónico
    10. Neutrófilos < 500 cell/mmc y/o plaquetas <50000 cell/mmc
    11. Insuficiencia renal severa (filtrado glomerular renal < 30ml/min/1.7m2).
    12. Estar ya en tratamiento con colchicina.
    13. Menores de 18 años.
    E.5 End points
    E.5.1Primary end point(s)
    1. Support compound with CPAP / BiPAP, ICU admission, invasive ventilation or death.
    2. Cytokine levels (IL-6) and inflammatory parameters (PCR, ESR, ferritin, fibrinogen, blood count) at recruitment, at 48 hours and on the fifth day of treatment.
    3. Ultrasensitive troponin on the fifth day of treatment.
    1. Compuesto de soporte con CPAP/BiPAP, ingreso en UCI, ventilación invasiva o muerte.
    2. Niveles de citoquinas (IL-6) y parámetros inflamatorios (PCR, VSG, ferritina, fibrinógeno, hemograma) al reclutamiento, a las 48 horas y el quinto día de tratamiento.
    3. Troponina ultrasensible en el quinto día de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Hospitalization
    - At recruitment, at 48 hours and on the fifth day of treatment.
    - On the fifth day of treatment.
    - Durante el ingreso Hospitalario
    - Al reclutamiento, a las 48 horas y el quinto día de tratamiento.
    - En el quinto día de tratamiento
    E.5.2Secondary end point(s)
    No
    No
    E.5.2.1Timepoint(s) of evaluation of this end point
    No
    No
    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) 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 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
    The efficacy analysis of the trial will end at the moment of hospital discharge or the patient's exit.
    In order to complete the safety profile, patients will be followed up by telephone 60 days after hospital discharge to check the vital status and detect the presence of thrombotic complications (admission for venous or arterial thromboembolism).
    El análisis de eficacia del ensayo terminará en el momento del alta hospitalaria o del exitus del paciente.
    De cara a completar el perfil de seguridad, se realizará un seguimiento telefónico de los pacientes a los 60 días del alta hospitalaria para comprobar el status vital y detectar la presencia de complicaciones trombóticas (ingresos por tromboembolismo venoso o arterial).
    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 months4
    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: 240
    F.1.3Elderly (>=65 years) No
    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 2020-05-26. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    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 state240
    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
    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 Decision2020-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-19
    P. End of Trial
    P.End of Trial StatusOngoing
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