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Efficacy of Bromhexine versus Standard of Care in Reducing Viral Load in Patients with Mild-to-Moderate COVID-19 Disease Attended in Primary Care: A Randomized Open-Label Trial.

María Luz Vila MéndezCarmen Antón SanzAlicia Del Rocío Cárdenas GarcíaAmparo Bravo MaloFrancisco Javier Torres MartínezJosé María Martín MorosMaría Real TorrijosJosé Francisco Javier Vendrell CovisaOlga Guzmán SierraVerónica Molina BarcenaNuria Viejo PineroCarlos Fernández DíazPurificación Arroyo BurguilloAna María Blanco GallegoCarmen Guirao SánchezAránzazu Montilla BernabéMaría Del Pilar Villanueva MoránSalvador Juárez AntónÁngela Fernández RodríguezMaría Ángeles Somoza CalvoErnesto Cerrada CerradaGemma Pérez MañasAntonio Sánchez CalsoFrida Vallejo SomohanoCarmen Cauqui DíazGloria Viñas FernándezJesús MolinaMarina González GodoyGonzalo Lumbreras GarcíaJavier Rosado MartínAida Rodríguez HernándezSara López AntúñezGabriel Vázquez PerfectoMaría Concepción Marcello AndrésNieves Marina Puente GarcíaCarmen GilAna MartinezBegoña Soler-López
Published in: Journal of clinical medicine (2022)
A 28-day randomized open-label multicenter study was conducted to assess the efficacy of bromhexine plus standard of care (SOC) (n = 98) vs. SOC alone (n = 93) in 191 outpatients with mild-to-moderate COVID-19 in the primary health care setting. Bromhexine three daily doses of 10 mL (48 mg/day) were administered for seven days. The primary efficacy endpoint was the reduction of viral load estimated as the cycle thresholds (Ct) to detect ORF1ab, N Protein, and S Protein genes by RT-qPCR in saliva samples on day 4 as compared with baseline. Ct values of the three genes increased from baseline throughout days 4 to 14 (p < 0.001) but significant differences between the study groups were not found. Differences in the percentages of patients with low, medium, and high viral loads at 4, 7, and 14 days were not found either. In summary, treatment with bromhexine plus SCO was associated with a viral load reduction of ORF1ab, N Protein, and S Protein genes at day 4, which was not significantly different than similar viral load reductions observed with SOC alone. The present findings do not seem to favor the use of bromhexine as an antiviral in patients with COVID-19.
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