María Luz Vila Méndez, Carmen Antón Sanz, Alicia del Rocío Cárdenas García, Amparo Bravo Malo, Francisco Javier Torres Martínez, José María Martín Moros, María Real Torrijos, José Francisco Javier Vendrell Covisa, Olga Guzmán Sierra, Verónica Molina Barcena, Nuria Viejo Pinero, Carlos Fernández Díaz, Purificación Arroyo Burguillo, Ana María Blanco Gallego, Carmen Guirao Sánchez, Aránzazu Montilla Bernabé, María del Pilar Villanueva Morán, Salvador Juárez Antón, Ángela Fernández Rodríguez, María Ángeles Somoza Calvo, Ernesto Cerrada Cerrada, Gemma Pérez Mañas, Antonio Sánchez Calso, Frida Vallejo Somohano, Carmen Cauqui Díaz, Gloria Viñas Fernández, Jesús Molina París, Marina González Godoy, Gonzalo Lumbreras García, Javier Rosado Martín, Aida Rodríguez Hernández, Sara López Antúñez, Gabriel Vázquez Perfecto, María Concepción Marcello Andrés, Nieves Marina Puente García, Carmen Gil, Ana Martínez, and Begoña Soler López
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.