Intranasal Versus Intravenous Dexamethasone to Treat Hospitalized COVID-19 Patients: A Randomized Multicenter Clinical Trial.

Neurology Department, Instituto Nacional de Neurología y Neurocirugía, Mexico City, Mexico. Research Unit Universidad Autónoma de Mexico, Instituto Nacional de Cardiología Ignacio Chávez and Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Mexico City, Mexico. Clinical Pharmacology Unit, Hospital General de México Dr. Eduardo Liceaga, Mexico City, Mexico. Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico. Faculty of Medicine, Universidad Nacional Autónoma de México, Mexico City, Mexico. Temporary Unit COVID-19, Centro Citibanamex, Mexico City, Mexico. Hospital Militar, Secretaría de la Defensa Nacional, Mexico City, Mexico. Neurology and Psychiatry Department, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico. Inmunology Department, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Mexico City, Mexico. Bioprocess Development and Research Unit, Escuela Nacional de Ciencias Biológicas del Instituto Politécnico Nacional, Mexico City, Mexico. Instituto de Diagnóstico y Referencia Epidemiológicos Dr. Manuel Martínez Báez, Mexico City, Mexico. Faculty of Medicine, Universidad Autónoma del Estado de Morelos, Cuernavaca, Morelos, Mexico. Physiology, Biophysics and Neurosciences Department, Centro de Investigación y Estudios Avanzados del Instituto Politécnico Nacional, Mexico City, Mexico. National Flow Cytometry Laboratory, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, México. Institute of Physiology and Pathophysiology, Marburg, Germany. Faculty of Chemistry, Universidad Nacional Autónoma de México, Mexico City, Mexico. Inmunology Department, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Mexico City, Mexico; National Flow Cytometry Laboratory, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, México. School of Medicine, University of Texas Rio Grande Valley, Texas, USA. Inmunology Department, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Mexico City, Mexico. Electronic address: edda@unam.mx.

Archives of medical research. 2024;(2):102960
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Abstract

BACKGROUND SARS-CoV2 induces flu-like symptoms that can rapidly progress to severe acute lung injury and even death. The virus also invades the central nervous system (CNS), causing neuroinflammation and death from central failure. Intravenous (IV) or oral dexamethasone (DXM) reduced 28 d mortality in patients who required supplemental oxygen compared to those who received conventional care alone. Through these routes, DMX fails to reach therapeutic levels in the CNS. In contrast, the intranasal (IN) route produces therapeutic levels of DXM in the CNS, even at low doses, with similar systemic bioavailability. AIMS To compare IN vs. IV DXM treatment in hospitalized patients with COVID-19. METHODS A controlled, multicenter, open-label trial. Patients with COVID-19 (69) were randomly assigned to receive IN-DXM (0.12 mg/kg for three days, followed by 0.6 mg/kg for up to seven days) or IV-DXM (6 mg/d for 10 d). The primary outcome was clinical improvement, as defined by the National Early Warning Score (NEWS) ordinal scale. The secondary outcome was death at 28 d between IV and IN patients. Effects of both treatments on biochemical and immunoinflammatory profiles were also recorded. RESULTS Initially, no significant differences in clinical severity, biometrics, and immunoinflammatory parameters were found between both groups. The NEWS-2 score was reduced, in 23 IN-DXM treated patients, with no significant variations in the 46 IV-DXM treated ones. Ten IV-DXM-treated patients and only one IN-DXM patient died. CONCLUSIONS IN-DMX reduced NEWS-2 and mortality more efficiently than IV-DXM, suggesting that IN is a more efficient route of DXM administration.

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