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

• 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: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
• Information provided by (Responsible Party): Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Increased Risk of SARS-CoV-2 Infection
• Intervention: Drug: Bromhexine Hydrochloride
• Enrollment: 50

Participant Flow

Recruitment Details	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.
Pre-assignment Details	No subjects were excluded from the study before assignment to groups.

Arm/Group Title	Treatment Group	Control Group
Arm/Group Description	medical personnel at risk for COVID-19 infection with oral administration of Bromhexine hydrochloride Bromhexine Hydrochloride: Medical personnel at risk for COVID-19 infection will receive study medication for 14 days	medical personnel at risk for COVID-19 infection without oral administration of Bromhexine hydrochloride
Period Title: Overall Study
Started	25	25
Completed	25	25
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Bromhexine Hydrochloride Group	Control Group	Total
Arm/Group Description		medical personnel at risk for COVID-19 infection with oral administration of Bromhexine hydrochloride Bromhexine Hydrochloride: Medical personnel at risk for COVID-19 infection will receive study medication for 14 days	medical personnel at risk for COVID-19 infection without oral administration of Bromhexine hydrochloride	Total of all reporting groups
Overall Number of Baseline Participants		25	25	50
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	25 participants	25 participants	50 participants
		41.7 (6.9)	39.5 (8.2)	40.6 (7.2)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	25 participants	25 participants	50 participants
	Female	14 56.0%	15 60.0%	29 58.0%
	Male	11 44.0%	10 40.0%	21 42.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	25 participants	25 participants	50 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%
	White	25 100.0%	25 100.0%	50 100.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
Russia	Number Analyzed	25 participants	25 participants	50 participants
		25	25	50

Outcome Measures

1. Primary Outcome

Title	Negative Polymerase Chain Reaction (PCR)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Group	Control Group
Arm/Group Description:	medical personnel at risk for COVID-19 infection with oral administration of Bromhexine hydrochloride Bromhexine Hydrochloride: Medical personnel at risk for COVID-19 infection will receive study medication for 14 days	medical personnel at risk for COVID-19 infection without oral administration of Bromhexine hydrochloride
Overall Number of Participants Analyzed	25	25
Measure Type: Count of Participants; Unit of Measure: Participants
	2 8.0%	7 28.0%

2. Secondary Outcome

Title	Number of Participants With Asymptomatic SARS-CoV-2 Infection
Description	Number of Participants with Asymptomatic SARS-CoV-2 Infection
Time Frame	14 days after last contact

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Group	Control Group
Arm/Group Description:	medical personnel at risk for COVID-19 infection with oral administration of Bromhexine hydrochloride Bromhexine Hydrochloride: Medical personnel at risk for COVID-19 infection will receive study medication for 14 days	medical personnel at risk for COVID-19 infection without oral administration of Bromhexine hydrochloride
Overall Number of Participants Analyzed	25	25
Measure Type: Count of Participants; Unit of Measure: Participants
	2 8.0%	2 8.0%

3. Secondary Outcome

Title	Number of Participants With Mild, Moderate and Severe COVID-19 Disease
Description	number of participants with mild, moderate and severe COVID-19 disease
Time Frame	14 days after last contact

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Group	Control Group
Arm/Group Description:	medical personnel at risk for COVID-19 infection with oral administration of Bromhexine hydrochloride Bromhexine Hydrochloride: Medical personnel at risk for COVID-19 infection will receive study medication for 14 days	medical personnel at risk for COVID-19 infection without oral administration of Bromhexine hydrochloride
Overall Number of Participants Analyzed	25	25
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	5 20.0%

4. Secondary Outcome

Title	Number of Participants With Adverse Events
Description	Number of Participants with Adverse Events
Time Frame	14 days after last contact

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Group	Control Group
Arm/Group Description:	medical personnel at risk for COVID-19 infection with oral administration of Bromhexine hydrochloride Bromhexine Hydrochloride: Medical personnel at risk for COVID-19 infection will receive study medication for 14 days	medical personnel at risk for COVID-19 infection without oral administration of Bromhexine hydrochloride
Overall Number of Participants Analyzed	25	25
Measure Type: Count of Participants; Unit of Measure: Participants
	2 8.0%	0 0.0%

Adverse Events

Time Frame	Adverse event data were collected over 8 weeks.
Adverse Event Reporting Description	Overall number of participants affected by one or more Serious Adverse Events, for each arm/group.
Arm/Group Title	Bromhexine Hydrochloride Group		Control Group
Arm/Group Description	medical personnel at risk for COVID-19 infection with oral administration of Bromhexine hydrochloride Bromhexine Hydrochloride: Medical personnel at risk for COVID-19 infection will receive study medication for 14 days		medical personnel at risk for COVID-19 infection without oral administration of Bromhexine hydrochloride
All-Cause Mortality
	Bromhexine Hydrochloride Group		Control Group
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/25 (0.00%)		0/25 (0.00%)
Serious Adverse Events
	Bromhexine Hydrochloride Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0.00%)		0/25 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Bromhexine Hydrochloride Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/25 (8.00%)		0/25 (0.00%)
Respiratory, thoracic and mediastinal disorders
Acute cough * 1 [1]	1/25 (4.00%)	1	0/25 (0.00%)	0
Skin and subcutaneous tissue disorders
Flash hot * 1 [2]	1/25 (4.00%)	1	0/25 (0.00%)	0
1 Term from vocabulary, MedDRA; * Indicates events were collected by non-systematic assessment; [1] Transient cough without sequelae. Drug treatment was not interrupted.; [2] A short period of hot flashes at treatment initiation without sequelae. Treatment was not interrupted.

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Evgeny Mikhaylov
• Organization: Almazov National Medical Research Centre
• Phone: +7(812)7023764
• EMail: e.mikhaylov@almazovcentre.ru

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

Mikhaylov EN, Lyubimtseva TA, Vakhrushev AD, Stepanov D, Lebedev DS, Vasilieva EY, Konradi AO, Shlyakhto EV. Bromhexine Hydrochloride Prophylaxis of COVID-19 for Medical Personnel: A Randomized Open-Label Study. Interdiscip Perspect Infect Dis. 2022 Jan 29;2022:4693121. doi: 10.1155/2022/4693121. eCollection 2022.

• 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 Submitted: May 18, 2020
• First Posted: May 28, 2020
• Results First Submitted: March 21, 2022
• Results First Posted: April 13, 2022
• Last Update Posted: April 13, 2022