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Fluvoxamina versus placebo y deterioro clínico en pacientes ambulatorios con síntomas de COVID-19: un ensayo clínico
Eric J Lenze1, Caline Mattar2, Charles F Zorumski1
1Department of Psychiatry, School of Medicine, Washington University in St Louis, St Louis, Missouri.
JAMA
|November 12, 2020
Resumen
La fluvoxamina puede reducir el deterioro clínico en pacientes con enfermedad por coronavirus 2019 (COVID-19) leve. Este estudio encontró una menor probabilidad de deterioro en los pacientes tratados con fluvoxamina en comparación con el placebo.
Área de la Ciencia:
- Enfermedades infecciosas
- Farmacología
- Medicina de cuidados intensivos
Sus antecedentes:
- La enfermedad por coronavirus 2019 (COVID-19) puede causar enfermedades graves debido a una respuesta inmune hiperactiva.
- La fluvuvoxamina, un inhibidor selectivo de la recaptación de serotonina, puede modular la respuesta inmune mediante la estimulación del receptor sigma-1, lo que podría regular la producción de citoquinas.
Objetivo del estudio:
- Investigar la eficacia de la fluvoxamina en la prevención del deterioro clínico en adultos no hospitalizados con COVID-19 leve.
- Evaluar si el tratamiento precoz con fluvoxamina reduce la gravedad de la enfermedad.
Principales métodos:
- Se realizó un ensayo doble ciego, aleatorizado y controlado con placebo a distancia.
- Se inscribieron 152 participantes con infección confirmada por SARS-CoV-2 y aparición de síntomas dentro de los 7 días.
- Los participantes recibieron fluvoxamina (100 mg tres veces al día) o placebo durante 15 días.
Principales resultados:
- El deterioro clínico se produjo en 0 de los 80 pacientes que recibieron fluvoxamina frente a 6 de los 72 pacientes que recibieron placebo en un plazo de 15 días.
- La diferencia en el deterioro clínico fue estadísticamente significativa (log-rank P = .009).
- Se informaron menos eventos adversos graves en el grupo de fluvoxamina en comparación con el grupo de placebo.
Conclusiones:
- El tratamiento con fluvoxamina se asoció con una menor probabilidad de deterioro clínico en pacientes ambulatorios con COVID-19 sintomático.
- El estudio sugiere un papel potencial para la fluvoxamina en el manejo del COVID-19 leve.
- Se necesitan ensayos más grandes con un seguimiento más prolongado para confirmar la eficacia clínica y los resultados definitivos.
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