Intranasal Versus Intravenous Dexamethasone to Treat Hospitalized COVID-19 Patients: A Randomized Multicenter Clinical Trial
Por:
Cárdenas G., Chávez-Canales M., Espinosa A.M., Jordán-Ríos A., Malagon D.A., Murillo M.F.M., Araujo L.V.T., Campos R.L.B., Wong-Chew R.M., González L.E.R., Cresencio K.I., Velázquez E.G., de la Cerda M.R., Leyva Y., Hernández-Ruiz J., Hernández-Medel M.L., León-Hernández M., Quero K.M., Monciváis A.S., Sarmiento E.B., Reynoso R.I.A., Reyes D.M., del Río Ambriz L.R., Hernández J.S.G., Cruz J., Ferrer S.I.V., Huerta L., Fierro N.A., Hernández M., Pérez-Tapia M., Meneses G., Rosas G., Hernández-Aceves J.A., Cervantes-Torres J., Valdez R.A., Rodríguez A.F., Espíndola-Arriaga E., Ortiz M., Salazar E.A., Barba C.C., Besedovsky H., Romano M.C., Jung H., Bobes R.J., Soldevila G., López-Alvarenga J.C., Fragoso G., Laclette J.P., Sciutto E.
Publicada:
1 ene 2024
Ahead of Print:
1 ene 2024
Resumen:
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. © 2024
Filiaciones:
Cárdenas G.:
Neurology Department, Instituto Nacional de Neurología y Neurocirugía, Mexico City, Mexico
Chávez-Canales M.:
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
Espinosa A.M.:
Clinical Pharmacology Unit, Hospital General de México Dr. Eduardo Liceaga, Mexico City, Mexico
Jordán-Ríos A.:
Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico
Malagon D.A.:
Clinical Pharmacology Unit, Hospital General de México Dr. Eduardo Liceaga, Mexico City, Mexico
Murillo M.F.M.:
Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico
Araujo L.V.T.:
Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico
Campos R.L.B.:
Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico
Wong-Chew R.M.:
Faculty of Medicine, Universidad Nacional Autónoma de Mexico, Mexico City, Mexico
González L.E.R.:
Temporary Unit COVID-19, Centro Citibanamex, Mexico City, Mexico
Cresencio K.I.:
Temporary Unit COVID-19, Centro Citibanamex, Mexico City, Mexico
Velázquez E.G.:
Temporary Unit COVID-19, Centro Citibanamex, Mexico City, Mexico
de la Cerda M.R.:
Temporary Unit COVID-19, Centro Citibanamex, Mexico City, Mexico
Leyva Y.:
Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico
Hernández-Ruiz J.:
Clinical Pharmacology Unit, Hospital General de México Dr. Eduardo Liceaga, Mexico City, Mexico
Hernández-Medel M.L.:
Clinical Pharmacology Unit, Hospital General de México Dr. Eduardo Liceaga, Mexico City, Mexico
León-Hernández M.:
Clinical Pharmacology Unit, Hospital General de México Dr. Eduardo Liceaga, Mexico City, Mexico
Quero K.M.:
Hospital Militar, Secretaría de la Defensa Nacional, Mexico City, Mexico
Monciváis A.S.:
Hospital Militar, Secretaría de la Defensa Nacional, Mexico City, Mexico
Sarmiento E.B.:
Hospital Militar, Secretaría de la Defensa Nacional, Mexico City, Mexico
Reynoso R.I.A.:
Hospital Militar, Secretaría de la Defensa Nacional, Mexico City, Mexico
Reyes D.M.:
Hospital Militar, Secretaría de la Defensa Nacional, Mexico City, Mexico
del Río Ambriz L.R.:
Hospital Militar, Secretaría de la Defensa Nacional, Mexico City, Mexico
Hernández J.S.G.:
Hospital Militar, Secretaría de la Defensa Nacional, Mexico City, Mexico
Cruz J.:
Neurology Department, Instituto Nacional de Neurología y Neurocirugía, Mexico City, Mexico
Ferrer S.I.V.:
Neurology and Psychiatry Department, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico
Huerta L.:
Inmunology Department, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Mexico City, Mexico
Fierro N.A.:
Inmunology Department, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Mexico City, Mexico
Hernández M.:
Clinical Pharmacology Unit, Hospital General de México Dr. Eduardo Liceaga, Mexico City, Mexico
Pérez-Tapia M.:
Bioprocess Development and Research Unit, Escuela Nacional de Ciencias Biológicas del Instituto Politécnico Nacional, Mexico City, Mexico
Meneses G.:
Instituto de Diagnóstico y Referencia Epidemiológicos Dr. Manuel Martinez Baez, Mexico City, Mexico
Rosas G.:
Faculty of Medicine, Universidad Autónoma del Estado de Morelos, Morelos, Cuernavaca, Mexico
Hernández-Aceves J.A.:
Inmunology Department, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Mexico City, Mexico
Cervantes-Torres J.:
Inmunology Department, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Mexico City, Mexico
Valdez R.A.:
Physiology, Biophysics and Neurosciences Department, Centro de Investigación y Estudios Avanzados del Instituto Politécnico Nacional, Mexico City, Mexico
Rodríguez A.F.:
National Flow Cytometry Laboratory, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Mexico
Espíndola-Arriaga E.:
National Flow Cytometry Laboratory, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Mexico
Ortiz M.:
National Flow Cytometry Laboratory, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Mexico
Salazar E.A.:
National Flow Cytometry Laboratory, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Mexico
Barba C.C.:
National Flow Cytometry Laboratory, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Mexico
Besedovsky H.:
Institute of Physiology and Pathophysiology, Marburg, Germany
Romano M.C.:
Physiology, Biophysics and Neurosciences Department, Centro de Investigación y Estudios Avanzados del Instituto Politécnico Nacional, Mexico City, Mexico
Jung H.:
Faculty of Chemistry, Universidad Nacional Autónoma de México, Mexico City, Mexico
Bobes R.J.:
Inmunology Department, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Mexico City, Mexico
Soldevila G.:
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, Mexico
López-Alvarenga J.C.:
School of Medicine, University of Texas Rio Grande Valley, TX, United States
Fragoso G.:
Inmunology Department, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Mexico City, Mexico
Laclette J.P.:
Inmunology Department, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Mexico City, Mexico
Sciutto E.:
Inmunology Department, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Mexico City, Mexico
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