Neiva Huila Colombia 25 Ensayos anti COVID-19 en Colombia INVIMA molécula Covid-19-001-USRCOVID-19 clínicos medicamentos covid-19

25 ensayos anti COVID-19 en Colombia

Actualidad Salud / Cuidado personal

Un total de 25 ensayos clínicos se han autorizado en Colombia, encaminados a encontrar medicamento que reduzca la afectación del. COVID-19 en la población civil.

En ese sentido el Instituto Nacional de Vigilancia de Medicamentos y Alimentos – Invima, advierte que aprobó iniciar la fase II del ensayo clínico con “la molécula Covid-19-001-USR” compuesta por Ivermectina y Dexametasona, la cual es una de las etapas fundamentales requeridas para determinar la eficacia y seguridad en el desarrollo de medicamentos, previo a su autorización de comercialización.

El ensayo clínico en mención fue autorizado el pasado 24 de diciembre de 2020 y consiste en la administración del producto Covid-19-001-USR, por nebulizaciones que incluyen la combinación de dos compuestos (Ecomectin 1% – Ivermectina y Dexametasona Fosfato 8mg/2mL) a pacientes con infección leve y/o moderada de Sars-CoV-2, buscando demostrar la seguridad, eficacia en la disminución de la carga viral en pacientes con la enfermedad COVID-19. 

«Este es uno de los veinticinco ensayos clínicos autorizados por Invima, que se encuentran en desarrollo en el país y que pretenden recopilar información de seguridad y eficacia como posibles tratamientos o profilácticos contra COVID-19». Anota la coordinadora del Grupo de Investigación Clínica del Invima, Sindy Pahola Pulgarín.

La investigación en cabeza del Dr. Carlos Riveros, debe completar las fases II y III antes de que se pueda realizar cualquier evaluación de cara a la obtención del registro sanitario que permita la comercialización del medicamento en Colombia. 

El uso de la molécula compuesta por Ivermectina y Dexametasona se encuentra estrictamente restringido al ámbito clínico y en ninguna circunstancia se autorizó su publicidad, comercialización o distribución con otros fines. Adicionalmente, el ensayo únicamente puede ser desarrollado en el Centro de Investigación Médico Asistencial S.A.S. – CIMEDICAL S.A.S, ubicado en la ciudad de Barranquilla. 

Todos los ensayos clínicos con medicamentos para COVID-19 que han sido autorizados por Invima, pueden consultarse en la página web del Instituto, www.invima.gov.co, en el siguiente enlace

El Invima reitera que, hasta la fecha no existe ningún tratamiento o medicamento que haya demostrado ser seguro y eficaz para curar la enfermedad generada por el Sars-CoV-2.

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