Prevention of Infection and Incidence of COVID-19 in Medical Personnel Assisting Patients With New Coronavirus Disease

Increased Risk of SARS-CoV-2 Infection Clinical Trial

Official title:

Prevention of Infection and Incidence of COVID-19 in Medical Personnel Assisting Patients With New Coronavirus Disease: a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04405999
• Other study ID #: 05-20-02-?
• Status: Completed
• Phase: Phase 4
• Start date: May 14, 2020
• Est. completion date: August 31, 2020

Study information

• Verified date: March 2022
• Source: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 31, 2020
• Est. primary completion date: August 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age of 18 years or more;

2. Negative test (PCR) for SARS-CoV-2 infection;

3. The absence of clinical manifestations of a respiratory infection;

4. Contact with patients with laboratory and / or clinically confirmed SARS-CoV-2 infection;

5. Signed informed consent to participate in the study.

Exclusion Criteria:

1. Intolerance to Bromhexine hydrochloride;

2. Work out of contact with SARS-CoV-2 infection;

3. Non-compliance with the rules for the use of personal protective equipment when working with SARS-CoV-2 infection (the rules for the use of personal protective equipment in accordance with the recommendations of the Ministry of Health of Russia and the internal orders of the Director General of Almazov NMRC, relevant to the dates of research);

4. Pregnancy and the period of breastfeeding;

5. Other circumstances that the researcher considers inappropriate to participate in this study

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Increased Risk of SARS-CoV-2 Infection
• Infections

Intervention

Drug:
• Bromhexine Hydrochloride
Medical personnel at risk for COVID-19 infection will receive study medication for 14 days

Locations

Country	Name	City	State
Russian Federation	Almazov National Medical Research Centre	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks after randomization
Secondary	Number of Participants With Asymptomatic SARS-CoV-2 Infection	Number of Participants with Asymptomatic SARS-CoV-2 Infection	14 days after last contact
Secondary	Number of Participants With Mild, Moderate and Severe COVID-19 Disease	number of participants with mild, moderate and severe COVID-19 disease	14 days after last contact
Secondary	Number of Participants With Adverse Events	Number of Participants with Adverse Events	14 days after last contact