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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04405999
Recruitment Status : Completed
First Posted : May 28, 2020
Results First Posted : April 13, 2022
Last Update Posted : April 13, 2022
Sponsor:
Information provided by (Responsible Party):
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Increased Risk of SARS-CoV-2 Infection Drug: Bromhexine Hydrochloride Phase 4

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Infection and Incidence of COVID-19 in Medical Personnel Assisting Patients With New Coronavirus Disease: a Randomised Controlled Trial
Actual Study Start Date : May 14, 2020
Actual Primary Completion Date : August 9, 2020
Actual Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Bromhexine hydrochloride Group
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 will receive study medication for 14 days
No Intervention: Control Group
medical personnel at risk for COVID-19 infection without oral administration of Bromhexine hydrochloride


Outcome Measures
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Primary Outcome Measures :
  1. Negative Polymerase Chain Reaction (PCR) [ Time Frame: 4 weeks after randomization ]
    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.


Secondary Outcome Measures :
  1. Number of Participants With Asymptomatic SARS-CoV-2 Infection [ Time Frame: 14 days after last contact ]
    Number of Participants with Asymptomatic SARS-CoV-2 Infection

  2. Number of Participants With Mild, Moderate and Severe COVID-19 Disease [ Time Frame: 14 days after last contact ]
    number of participants with mild, moderate and severe COVID-19 disease

  3. Number of Participants With Adverse Events [ Time Frame: 14 days after last contact ]
    Number of Participants with Adverse Events


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04405999


Locations
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Russian Federation
Almazov National Medical Research Centre
Saint Petersburg, Russian Federation, 197341
Sponsors and Collaborators
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Investigators
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Study Director: Evgeny Mikhaylov, MD, PhD Almazov National Medical Research Centre
  Study Documents (Full-Text)

Documents provided by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health:
Study Protocol and Statistical Analysis Plan  [PDF] May 12, 2020

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
ClinicalTrials.gov Identifier: NCT04405999    
Other Study ID Numbers: 05-20-02-С
First Posted: May 28, 2020    Key Record Dates
Results First Posted: April 13, 2022
Last Update Posted: April 13, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
COVID-19
Disease Attributes
Pathologic Processes
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
 Virus Diseases
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Bromhexine
Expectorants
Respiratory System Agents