A parallel-group, multicenter randomized, double-blinded, placebo-controlled, phase 2/3, clinical trial to test the effi
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(2020) 20:765
STUDY PROTOCOL
Open Access
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-CoV2 infection: the Pyridostigmine In Severe COvid-19 (PISCO) trial protocol Sergio Fragoso-Saavedra1,2†, David A. Iruegas-Nunez2,3†, Alejandro Quintero-Villegas4, H. Benjamín García-González4, Isaac Nuñez4, Sergio L. Carbajal-Morelos4, Belem M. Audelo-Cruz2, Sarahi Arias-Martínez2, Yanink Caro-Vega5, Juan José Calva5, Verónica Luqueño-Martínez5, Alejandra González-Duarte2, Brenda Crabtree-Ramírez5, José C. Crispín6†, Juan Sierra-Madero5†, Pablo F. Belaunzarán-Zamudio5,7† and Sergio I. Valdés-Ferrer2,5,8*†
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 (Continued on next page)
* Correspondence: [email protected] † 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 © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made avai
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