Abstract
Background Bromhexine hydrochloride has been suggested as a TMPRSS2 protease blocker that precludes the penetration of SARS-CoV-2 into cells. We aimed to assess the preventive potential of regular bromhexine hydrochloride intake for COVID-19 risk reduction in medical staff actively involved in the evaluation and treatment of patients with confirmed or suspected SARS-CoV-2 infection. Methods In a single-centre randomized open-label study, medical staff managing patients with suspected and confirmed COVID-19 were enrolled and followed up for 8 weeks. The study began at the initiation of COVID-19 management in the clinic. The study was prematurely terminated after the enrollment of 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 for SARS-CoV-2 or signs of clinical infection within 28 days and at week 8. Secondary endpoints included time from the first contact with a person with COVID-19 to the appearance of respiratory infection symptoms; the number of days before a first positive SARS-CoV-2 test; the number of asymptomatic participants with a positive nasopharyngeal swab test; the number of symptomatic COVID-19 cases; and adverse events. Results 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 COVID-19 in the treatment group compared to controls (0/25 vs. 5/25; P=0.02). Conclusion Although the study was underpowered, it showed that Bromhexine hydrochloride prophylaxis was associated with a reduced rate of symptomatic COVID-19. The prophylactic treatment was not associated with a lower combined primary endpoint rate, a positive swab PCR test, or COVID-19 (ClinicalTrials.gov number, NCT04405999).
Highlights
Severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) is the cause of respiratory disease, COVID-19 [1].e fast SARS-CoV-2 distribution resulted in the pandemic, and the number of infected subjects keeps growing [2]
Interdisciplinary Perspectives on Infectious Diseases mechanism [8]. e viral S-protein is attached to angiotensin-converting enzyme 2 (ACE2) of pneumocytes. en, it adheres to TMPRSS2 in S1- and S2-subunits [2, 7,8,9,10,11,12], providing the possibility for the virus to enter the cell
We aimed to assess the preventive potential of regular bromhexine hydrochloride intake for reduction of the risk of COVID-19 in medical staff actively involved in the evaluation and treatment of patients with confirmed or suspected SARS-CoV-2 infection. e study was conducted in the period before any vaccine against COVID-19 became available
Summary
Severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) is the cause of respiratory disease, COVID-19 [1].e fast SARS-CoV-2 distribution resulted in the pandemic, and the number of infected subjects keeps growing [2]. Bromhexine hydrochloride has been suggested as a TMPRSS2 protease blocker that precludes the penetration of SARS-CoV-2 into cells. We aimed to assess the preventive potential of regular bromhexine hydrochloride intake for COVID-19 risk reduction in medical staff actively involved in the evaluation and treatment of patients with confirmed or suspected SARSCoV-2 infection. E study was prematurely terminated after the enrollment of 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. E prophylactic treatment was not associated with a lower combined primary endpoint rate, a positive swab PCR test, or COVID-19 (ClinicalTrials.gov number, NCT04405999) The study was underpowered, it showed that Bromhexine hydrochloride prophylaxis was associated with a reduced rate of symptomatic COVID-19. e prophylactic treatment was not associated with a lower combined primary endpoint rate, a positive swab PCR test, or COVID-19 (ClinicalTrials.gov number, NCT04405999)
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