Bromhexine Hydrochloride Prophylaxis of COVID-19 for Medical Personnel: A Randomized Open-Label Study

https://www.medrxiv.org/content/10.1101/2021.03.03.21252855v1

NCT04405999- In a single-center randomized open-label study medical staff managing patients with suspected and confirmed COVID-19 were enrolled and followed-up for 8 weeks. 50 participants without a history of SARS-CoV-2 infection: 25 were assigned to bromhexine hydrochloride treatment (8 mg 3 times per day), and 25 were controls. The composite primary endpoint was a positive nasopharyngeal swab polymerase chain reaction (PCR) test to SARS-CoV-2 or the signs of clinical infection within 28 days and at week 8. Secondary endpoints included the symptomatic infection rate and positive nasopharyngeal swab (PCR) tests. The rate of the combined primary endpoint did not differ significantly between the active treatment group (2/25 [8%]) and control group (7/25 [28%]); P = 0.07. A fewer number of participants developed symptomatic infection (confirmed COVID-19) in the treatment group compared to controls (0/25 vs 5/25; P = 0.02). Bromhexine hydrochloride prophylaxis was associated with a reduced rate of symptomatic COVID-19. However, the prophylactic treatment was not associated with a lower combined primary endpoint rate, a positive swab PCR test and/or COVID-19.

Tags: