A Phase 4 interventional study of Bromhexine Hydrochloride in Increased Risk of SARS-CoV-2 Infection, sponsored by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health. Completed at 1 site in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-13.
Sponsored by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health · Phase 4, Interventional, and Prevention
This is a randomized controlled trial of the efficacy and safety evaluation of oral administration of Bromhexine hydrochloride for the prevention of SARS-CoV-2 infection and COVID-19 disease in medical personnel assisting patients with a new coronavirus disease
This study aims to evaluate the oral administration of Bromhexine hydrochloride for the prevention of SARS-CoV-2 infection and COVID-19 disease in medical personnel assisting patients with a new coronavirus disease. The aim of the study is to determine the preventive role of this drug in the framework of reducing the incidence of coronavirus infection in risk groups (medical personnel). Several studies show, that the acute respiratory syndrome coronavirus SARS-CoV uses endosomal cysteine proteases cathepsin B and L (CatB/L) and the transmembrane protease serine type 2 (TMPRSS2) for the priming of the viral S-protein. The new coronavirus SARS-CoV-2 penetrates into alveolar epithelial type two cells through a similar mechanism. In detail, viral S-protein binds to pneumocyte angiotensin-converting enzyme 2 (ACE2) and then undergoes cleaving by TMPRSS2 in S1- and S2-subunits. This leads to the release of a fusion peptide, which allows the virus to enter the cell via endocytosis. Therefore, the protease TMPRSS2 can serve as a target for pharmacological agents to prevent the penetration of the SARS-CoV-2 into the cell. Bromhexine blocks the TMPRSS2 ability to activate a zymogen precursor of tissue plasminogen activator in vitro. Interestingly, TMPRSS2 is blocked by much lower concentrations then required to inactivate other proteases in the cell culture. However, these data cannot be simply extended to the clinical practice: whether the concentration of bromhexine in the lung tissue of properly treated patients would be enough to prevent the virus entry through the TMPRSS2-inactivation remains unclear. A randomized study in people at risk for coronavirus infection will clarify the role of Bromhexine hydrochloride as a prevention of this disease.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 50 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health is the lead sponsor of 30 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
medical personnel at risk for COVID-19 infection with oral administration of Bromhexine hydrochloride
Drug: Bromhexine Hydrochloride
medical personnel at risk for COVID-19 infection without oral administration of Bromhexine hydrochloride
Medical personnel at risk for COVID-19 infection will receive study medication for 14 days
Negative Polymerase Chain Reaction (PCR)
Number of Participants with Negative PCR of SARS-CoV-2 and The Absence of Clinical Manifestations of COVID-19 Infection in individuals taking Bromhexine hydrochloride 4 weeks after randomization.
Time frame: 4 weeks after randomization
Number of Participants With Asymptomatic SARS-CoV-2 Infection
Number of Participants with Asymptomatic SARS-CoV-2 Infection
Time frame: 14 days after last contact
Number of Participants With Mild, Moderate and Severe COVID-19 Disease
number of participants with mild, moderate and severe COVID-19 disease
Time frame: 14 days after last contact
Number of Participants With Adverse Events
Number of Participants with Adverse Events
Time frame: 14 days after last contact
Recruitment was performed via the institution's electronic communication system and via personal contacts with healthcare providers. Following a general notification via an institutional electronic system, one hundred and fifty healthcare providers were contacted personally and 50 persons were included.
| Milestone | Treatment Group | Control Group |
|---|---|---|
| Started | 25 | 25 |
| Completed | 25 | 25 |
| Not completed | 0 | 0 |
Number of Participants with Negative PCR of SARS-CoV-2 and The Absence of Clinical Manifestations of COVID-19 Infection in individuals taking Bromhexine hydrochloride 4 weeks after randomization.
| Participants | Treatment Group | Control Group |
|---|---|---|
| Negative Polymerase Chain Reaction (PCR) | 2 | 7 |
Number of Participants with Asymptomatic SARS-CoV-2 Infection
| Participants | Treatment Group | Control Group |
|---|---|---|
| Number of Participants With Asymptomatic SARS-CoV-2 Infection | 2 | 2 |
number of participants with mild, moderate and severe COVID-19 disease
| Participants | Treatment Group | Control Group |
|---|---|---|
| Number of Participants With Mild, Moderate and Severe COVID-19 Disease | 0 | 5 |
Number of Participants with Adverse Events
| Participants | Treatment Group | Control Group |
|---|---|---|
| Number of Participants With Adverse Events | 2 | 0 |
Collected over Adverse event data were collected over 8 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bromhexine Hydrochloride Group | 0/25 (0%) | 0/25 (0%) | 2/25 (8%) |
| Control Group | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Event | Bromhexine Hydrochloride Group | Control Group |
|---|---|---|
| Flash hotSkin and subcutaneous tissue disorders | 1/25 | 0/25 |
| Acute coughRespiratory, thoracic and mediastinal disorders | 1/25 | 0/25 |
| Age, Continuous(years) | Bromhexine Hydrochloride Group | Control Group | Total |
|---|---|---|---|
| Mean | 41.7 ± 6.9 | 39.5 ± 8.2 | 40.6 ± 7.2 |
| Sex: Female, Male(Participants) | Bromhexine Hydrochloride Group | Control Group | Total |
|---|---|---|---|
| Female | 14 | 15 | 29 |
| Male | 11 | 10 | 21 |
| Race (NIH/OMB)(Participants) | Bromhexine Hydrochloride Group | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 25 | 25 | 50 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Bromhexine Hydrochloride Group | Control Group | Total |
|---|---|---|---|
| Russia | 25 | 25 | 50 |
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Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health