E.1 Medical condition or disease under investigation |
E.1.1 | Medical 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. |
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E.1.1.1 | Medical 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. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main 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. |
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E.2.2 | Secondary 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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary 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. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial 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
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LVLS |
Última visita del último paciente |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |