A parallel-group, multicenter randomized, double-blinded, placebo-controlled, phase 2/3, clinical trial to test the efficacy of pyridostigmine bromide at low doses to reduce mortality or invasive mechanical ventilation in adults with severe SARS-CoV- 2 in

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Les compartimos el artículo que publica el Dr. Sergio Fragoso-Saavedra publicado en conjunto con los siguientes doctores: Dr. David A. Iruegas-Nunez, Dr. Alejandro Quintero-Villegas, Dr. H. Benjamín García-González, Dr. Isaac Nuñez, Dr. Sergio L. Carbajal-Morelos, Dra. Belem M. Audelo-Cruz, Dra. Sarahi Arias-Martínez, Dra. Yanink Caro-Vega, Dr. Juan José Calva, Dra. Verónica Luqueño-Martínez, Dra. Alejandra González-Duarte, Dra. Brenda Crabtree-Ramírez, Dr. José C. Crispín, Dr. Juan Sierra-Madero, Dr. Pablo F. Belaunzarán-Zamudio and Sergio I. Valdés-Ferrer. Les compartimos el abstract del articulo, así como la liga donde podrá ser consultado en su totalidad
 
 

A parallel-group, multicenter randomized, double-blinded, placebo-controlled, phase 2/3, clinical trial to test the efficacy of pyridostigmine bromide at low doses to reduce mortality or invasive mechanical ventilation in adults with severe SARS-CoV- 2 infection: the Pyridostigmine In Severe COvid-19 (PISCO) trial protocol

Dr. Sergio Fragoso-Saavedra 1,2†, dr. David A. Iruegas-Nunez 2,3†, Dr. Alejandro Quintero-Villegas 4, Dr. H. Benjamín García-González 4, Dr. Isaac Nuñez 4, Dr. Sergio L. Carbajal-Morelos 4, Dra. Belem M. Audelo-Cruz 2, Dra. Sarahi Arias-Martínez 2, Dra. Yanink Caro-Vega 5, Dr. Juan José Calva 5, Dra. Verónica Luqueño-Martínez 5, Dra. Alejandra González-Duarte 2, Dra. Brenda Crabtree-Ramírez 5, Dr. José C. Crispín 6†, Dr. Juan Sierra-Madero 5†, Dr. Pablo F. Belaunzarán-Zamudio 5,7† and Sergio I. Valdés-Ferrer 2,5,8*†.

1* Correspondence: Esta dirección de correo electrónico está siendo protegida contra los robots de spam. Necesita tener JavaScript habilitado para poder verlo.
† Sergio Fragoso-Saavedra and David A. Iruegas-Núñez are co-first authors
† José C. Crispín, Juan Sierra-Madero, Pablo F. Belaunzarán-Zamudio and
Sergio I. Valdés-Ferrer are equal contributors.
2 Departamento de Neurología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico
5 Departamento de Infectología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico
Full list of author information is available at the end of the article
.

Originally published / october 16, 2020 / https://doi.org/10.1186/s12879-020-05485-7

Abstract

Background 

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, the causative agent of coronavirus disease 2019 (COVID-19), may lead to severe systemic inflammatory response, pulmonary damage, and even acute respiratory distress syndrome (ARDS). This in turn may result in respiratory failure and in death. Experimentally, acetylcholine (ACh) modulates the acute inflammatory response, a neuro-immune mechanism known as the inflammatory reflex. Recent clinical evidence suggest that electrical and chemical stimulation of the inflammatory reflex may reduce the burden of inflammation in chronic inflammatory diseases. Pyridostigmine (PDG), an ACh-esterase.

Methods

A parallel-group, multicenter, randomized, double-blinded, placebo-controlled, phase 2/3 clinical trial to test the efficacy of pyridostigmine bromide 60 mg/day P.O. to reduce the need for invasive mechanical ventilation and mortality in hospitalized patients with severe COVID-19.

Discussion

This study will provide preliminary evidence of whether or not -by decreasing systemic inflammation- addonThis study will provide preliminary evidence of whether or not -by decreasing systemic inflammation- addonPDG can improve clinical outcomes in patients with severe COVID-19.

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  2. A parallel group multicenter randomized double blinded placebo
 
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