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...

Full description

Saved in:
Bibliographic Details
Main Authors: Evgeny N. Mikhaylov, Tamara A. Lyubimtseva, Aleksandr D. Vakhrushev, Dmitry Stepanov, Dmitry S. Lebedev, Elena Yu. Vasilieva, Alexandra O. Konradi, Evgeny V. Shlyakhto
Format: Article
Language:English
Published: Wiley 2022-01-01
Series:Interdisciplinary Perspectives on Infectious Diseases
Online Access:http://dx.doi.org/10.1155/2022/4693121
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1832563689670049792
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
work_keys_str_mv AT evgenynmikhaylov bromhexinehydrochlorideprophylaxisofcovid19formedicalpersonnelarandomizedopenlabelstudy
AT tamaraalyubimtseva bromhexinehydrochlorideprophylaxisofcovid19formedicalpersonnelarandomizedopenlabelstudy
AT aleksandrdvakhrushev bromhexinehydrochlorideprophylaxisofcovid19formedicalpersonnelarandomizedopenlabelstudy
AT dmitrystepanov bromhexinehydrochlorideprophylaxisofcovid19formedicalpersonnelarandomizedopenlabelstudy
AT dmitryslebedev bromhexinehydrochlorideprophylaxisofcovid19formedicalpersonnelarandomizedopenlabelstudy
AT elenayuvasilieva bromhexinehydrochlorideprophylaxisofcovid19formedicalpersonnelarandomizedopenlabelstudy
AT alexandraokonradi bromhexinehydrochlorideprophylaxisofcovid19formedicalpersonnelarandomizedopenlabelstudy
AT evgenyvshlyakhto bromhexinehydrochlorideprophylaxisofcovid19formedicalpersonnelarandomizedopenlabelstudy