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01-12-2022 | COVID-19 | Study protocol

Intranasal dexamethasone: a new clinical trial for the control of inflammation and neuroinflammation in COVID-19 patients

Authors: Graciela Cárdenas, María Chávez-Canales, Ana María Espinosa, Antonio Jordán-Ríos, Daniel Anica Malagon, Manlio Fabio Márquez Murillo, Laura Victoria Torres Araujo, Ricardo Leopoldo Barajas Campos, Rosa María Wong-Chew, Luis Esteban Ramirez González, Karent Ibet Cresencio, Enrique García Velázquez, Mariana Rodriguez de la Cerda, Yoana Leyva, Joselin Hernández-Ruiz, María Luisa Hernández-Medel, Mireya León-Hernández, Karen Medina Quero, Anahí Sánchez Monciváis, Sergio Hernández Díaz, Ignacia Rosalia Zeron Martínez, Adriana Martínez-Cuazitl, Iván Noé Martínez Salazar, Eduardo Beltrán Sarmiento, Aldo Figueroa Peña, Patricia Saraí Hernández, Rafel Ignacio Aguilar Reynoso, Daniela Murillo Reyes, Luis Rodrigo del Río Ambriz, Rogelio Antonio Alfaro Bonilla, Jocelyn Cruz, Leonor Huerta, Nora Alma Fierro, Marisela Hernández, Mayra Pérez-Tapia, Gabriela Meneses, Erick Espíndola-Arriaga, Gabriela Rosas, Alberto Chinney, Sergio Rosales Mendoza, Juan Alberto Hernández-Aceves, Jaquelynne Cervantes-Torres, Anai Fuentes Rodríguez, Roxana Olguin Alor, Sandra Ortega Francisco, Evelyn Alvarez Salazar, Hugo Besedovsky, Marta C. Romano, Raúl J. Bobes, Helgi Jung, Gloria Soldevila, Juan López-Alvarenga, Gladis Fragoso, Juan Pedro Laclette, Edda Sciutto

Published in: Trials | Issue 1/2022

Abstract

Background

By end December of 2021, COVID-19 has infected around 276 million individuals and caused over 5 million deaths worldwide. Infection results in dysregulated systemic inflammation, multi-organ dysfunction, and critical illness. Cells of the central nervous system are also affected, triggering an uncontrolled neuroinflammatory response. Low doses of glucocorticoids, administered orally or intravenously, reduce mortality among moderate and severe COVID-19 patients. However, low doses administered by these routes do not reach therapeutic levels in the CNS. In contrast, intranasally administered dexamethasone can result in therapeutic doses in the CNS even at low doses.

Methods

This is an approved open-label, multicenter, randomized controlled trial to compare the effectiveness of intranasal versus intravenous dexamethasone administered in low doses to moderate and severe COVID-19 adult patients. The protocol is conducted in five health institutions in Mexico City. A total of 120 patients will be randomized into two groups (intravenous vs. intranasal) at a 1:1 ratio. Both groups will be treated with the corresponding dexamethasone scheme for 10 days. The primary outcome of the study will be clinical improvement, defined as a statistically significant reduction in the NEWS-2 score of patients with intranasal versus intravenous dexamethasone administration. The secondary outcome will be the reduction in mortality during hospitalization.

Conclusions

This protocol is currently in progress to improve the efficacy of the standard therapeutic dexamethasone regimen for moderate and severe COVID-19 patients.

Trial registration

ClinicalTrials.govNCT04513184. Registered November 12, 2020. Approved by La Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) with identification number DI/20/407/04/36. People are currently being recruited.

Graphical abstract

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Title: Intranasal dexamethasone: a new clinical trial for the control of inflammation and neuroinflammation in COVID-19 patients
Authors: Graciela Cárdenas
María Chávez-Canales
Ana María Espinosa
Antonio Jordán-Ríos
Daniel Anica Malagon
Manlio Fabio Márquez Murillo
Laura Victoria Torres Araujo
Ricardo Leopoldo Barajas Campos
Rosa María Wong-Chew
Luis Esteban Ramirez González
Karent Ibet Cresencio
Enrique García Velázquez
Mariana Rodriguez de la Cerda
Yoana Leyva
Joselin Hernández-Ruiz
María Luisa Hernández-Medel
Mireya León-Hernández
Karen Medina Quero
Anahí Sánchez Monciváis
Sergio Hernández Díaz
Ignacia Rosalia Zeron Martínez
Adriana Martínez-Cuazitl
Iván Noé Martínez Salazar
Eduardo Beltrán Sarmiento
Aldo Figueroa Peña
Patricia Saraí Hernández
Rafel Ignacio Aguilar Reynoso
Daniela Murillo Reyes
Luis Rodrigo del Río Ambriz
Rogelio Antonio Alfaro Bonilla
Jocelyn Cruz
Leonor Huerta
Nora Alma Fierro
Marisela Hernández
Mayra Pérez-Tapia
Gabriela Meneses
Erick Espíndola-Arriaga
Gabriela Rosas
Alberto Chinney
Sergio Rosales Mendoza
Juan Alberto Hernández-Aceves
Jaquelynne Cervantes-Torres
Anai Fuentes Rodríguez
Roxana Olguin Alor
Sandra Ortega Francisco
Evelyn Alvarez Salazar
Hugo Besedovsky
Marta C. Romano
Raúl J. Bobes
Helgi Jung
Gloria Soldevila
Juan López-Alvarenga
Gladis Fragoso
Juan Pedro Laclette
Edda Sciutto
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: COVID-19
Dexamethasone
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06075-5

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Intranasal dexamethasone: a new clinical trial for the control of inflammation and neuroinflammation in COVID-19 patients

Abstract

Background

Methods

Conclusions

Trial registration

Graphical abstract

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Conclusions

Trial registration

Graphical abstract

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