Bromhexine Hydrochloride Prophylaxis of COVID-19 for Medical Personnel: A Randomized Open-Label Study
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...
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| Format: | Article |
| Language: | English |
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Wiley
2022-01-01
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| Series: | Interdisciplinary Perspectives on Infectious Diseases |
| Online Access: | http://dx.doi.org/10.1155/2022/4693121 |
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| author | Evgeny N. Mikhaylov Tamara A. Lyubimtseva Aleksandr D. Vakhrushev Dmitry Stepanov Dmitry S. Lebedev Elena Yu. Vasilieva Alexandra O. Konradi Evgeny V. Shlyakhto |
| author_facet | Evgeny N. Mikhaylov Tamara A. Lyubimtseva Aleksandr D. Vakhrushev Dmitry Stepanov Dmitry S. Lebedev Elena Yu. Vasilieva Alexandra O. Konradi Evgeny V. Shlyakhto |
| author_sort | Evgeny N. Mikhaylov |
| collection | DOAJ |
| description | 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). |
| format | Article |
| id | doaj-art-21eddf886de14b3ab3ece3b19c48e302 |
| institution | Kabale University |
| issn | 1687-7098 |
| language | English |
| publishDate | 2022-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Interdisciplinary Perspectives on Infectious Diseases |
| spelling | doaj-art-21eddf886de14b3ab3ece3b19c48e3022025-02-03T01:12:53ZengWileyInterdisciplinary Perspectives on Infectious Diseases1687-70982022-01-01202210.1155/2022/4693121Bromhexine Hydrochloride Prophylaxis of COVID-19 for Medical Personnel: A Randomized Open-Label StudyEvgeny N. Mikhaylov0Tamara A. Lyubimtseva1Aleksandr D. Vakhrushev2Dmitry Stepanov3Dmitry S. Lebedev4Elena Yu. Vasilieva5Alexandra O. Konradi6Evgeny V. Shlyakhto7Almazov National Medical Research CentreAlmazov National Medical Research CentreAlmazov National Medical Research CentreDepartment of AnesthesiologyAlmazov National Medical Research CentreAlmazov National Medical Research CentreAlmazov National Medical Research CentreAlmazov National Medical Research CentreBackground. 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).http://dx.doi.org/10.1155/2022/4693121 |
| spellingShingle | Evgeny N. Mikhaylov Tamara A. Lyubimtseva Aleksandr D. Vakhrushev Dmitry Stepanov Dmitry S. Lebedev Elena Yu. Vasilieva Alexandra O. Konradi Evgeny V. Shlyakhto Bromhexine Hydrochloride Prophylaxis of COVID-19 for Medical Personnel: A Randomized Open-Label Study Interdisciplinary Perspectives on Infectious Diseases |
| title | Bromhexine Hydrochloride Prophylaxis of COVID-19 for Medical Personnel: A Randomized Open-Label Study |
| title_full | Bromhexine Hydrochloride Prophylaxis of COVID-19 for Medical Personnel: A Randomized Open-Label Study |
| title_fullStr | Bromhexine Hydrochloride Prophylaxis of COVID-19 for Medical Personnel: A Randomized Open-Label Study |
| title_full_unstemmed | Bromhexine Hydrochloride Prophylaxis of COVID-19 for Medical Personnel: A Randomized Open-Label Study |
| title_short | Bromhexine Hydrochloride Prophylaxis of COVID-19 for Medical Personnel: A Randomized Open-Label Study |
| title_sort | bromhexine hydrochloride prophylaxis of covid 19 for medical personnel a randomized open label study |
| url | http://dx.doi.org/10.1155/2022/4693121 |
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