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

Trials 23, 148 (2022)

Autores: 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

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.gov NCT04513184. 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.

Cite this article

Cárdenas, G., Chávez-Canales, M., Espinosa, A.M. et al. Intranasal dexamethasone: a new clinical trial for the control of inflammation and neuroinflammation in COVID-19 patients. Trials 23, 148 (2022). https://doi.org/10.1186/s13063-022-06075-5

Vía: Trials