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Randomized Controlled Trial
. 2020 Apr-Jun;37(2):356-360.
doi: 10.17843/rpmesp.2020.372.5546. Epub 2020 Aug 28.

Respuestas rápidas a la pandemia de COVID-19 a través de la ciencia y la colaboración global: el ensayo clínico Solidaridad

[Article in Spanish]
Affiliations
Randomized Controlled Trial

Respuestas rápidas a la pandemia de COVID-19 a través de la ciencia y la colaboración global: el ensayo clínico Solidaridad

[Article in Spanish]
Alonso Soto et al. Rev Peru Med Exp Salud Publica. 2020 Apr-Jun.

Abstract

COVID-19 represents a global crisis. Rapidly conducting a clinical trial with the rigor necessary to obtain reliable results requires the collaboration of various participants involved in the development, evaluation and authorization of clinical trials (CT) such as the trial sponsor, researchers, regulatory authority and the ethics committee (EC). Carrying out these studies is not only scientifically appropriate, but an ethical and moral obligation to guarantee our patients effective treatment. SOLIDARITY is a mega clinical trial that recruited thousands of subjects with moderate to severe disease, who were randomly assigned to one of the treatment groups under evaluation, including hydroxychloroquine, lopinavir/ritonavir associated or not with interferon; or remdesivir compared to standard therapy. Peru has joined the list of countries where the trial will be reproduced, through which it will be possible to quickly identify if any of these drugs offers a real benefit to patients.

La COVID-19 representa una crisis global. La realización rápida de un ensayo clínico con la rigurosidad necesaria para obtener resultados confiables requiere la colaboración de diversos actores que participan en el desarrollo, evaluación y autorización de los ensayos clínicos (EC), como el patrocinador del ensayo, los investigadores, la autoridad regulatoria y el comité de ética (CE). Llevar a cabo estos estudios no solo es científicamente apropiado, sino una obligación ética y moral para ofrecer a las personas infectadas con COVID-19 un tratamiento efectivo. Solidaridad es un megaensayo clínico que reclutará miles de sujetos de investigación con enfermedad moderada a grave, a quienes se les asignará aleatoriamente a uno de los grupos de tratamiento en evaluación incluyendo hidroxicloroquina, lopinavir/ritonavir asociado o no a interferón; o remdesivir en comparación con el manejo estándar. El Perú se ha sumado a la lista de países donde se reproducirá el ensayo, mediante el cual se podrá identificar rápidamente si alguno de estos fármacos ofrece un beneficio real a los pacientes.

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