Trial Outcomes & Findings for Prevention of Infection and Incidence of COVID-19 in Medical Personnel Assisting Patients With New Coronavirus Disease (NCT NCT04405999)
NCT ID: NCT04405999
Last Updated: 2022-04-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
4 weeks after randomization
Results posted on
2022-04-13
Participant Flow
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.
No subjects were excluded from the study before assignment to groups.
Participant milestones
| Measure |
Treatment Group
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
|
Control Group
medical personnel at risk for COVID-19 infection without oral administration of Bromhexine hydrochloride
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prevention of Infection and Incidence of COVID-19 in Medical Personnel Assisting Patients With New Coronavirus Disease
Baseline characteristics by cohort
| Measure |
Bromhexine Hydrochloride Group
n=25 Participants
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
|
Control Group
n=25 Participants
medical personnel at risk for COVID-19 infection without oral administration of Bromhexine hydrochloride
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.7 years
STANDARD_DEVIATION 6.9 • n=99 Participants
|
39.5 years
STANDARD_DEVIATION 8.2 • n=107 Participants
|
40.6 years
STANDARD_DEVIATION 7.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Russia
|
25 participants
n=99 Participants
|
25 participants
n=107 Participants
|
50 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 4 weeks after randomizationNumber 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.
Outcome measures
| Measure |
Treatment Group
n=25 Participants
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
|
Control Group
n=25 Participants
medical personnel at risk for COVID-19 infection without oral administration of Bromhexine hydrochloride
|
|---|---|---|
|
Negative Polymerase Chain Reaction (PCR)
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 14 days after last contactNumber of Participants with Asymptomatic SARS-CoV-2 Infection
Outcome measures
| Measure |
Treatment Group
n=25 Participants
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
|
Control Group
n=25 Participants
medical personnel at risk for COVID-19 infection without oral administration of Bromhexine hydrochloride
|
|---|---|---|
|
Number of Participants With Asymptomatic SARS-CoV-2 Infection
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 14 days after last contactnumber of participants with mild, moderate and severe COVID-19 disease
Outcome measures
| Measure |
Treatment Group
n=25 Participants
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
|
Control Group
n=25 Participants
medical personnel at risk for COVID-19 infection without oral administration of Bromhexine hydrochloride
|
|---|---|---|
|
Number of Participants With Mild, Moderate and Severe COVID-19 Disease
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 14 days after last contactNumber of Participants with Adverse Events
Outcome measures
| Measure |
Treatment Group
n=25 Participants
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
|
Control Group
n=25 Participants
medical personnel at risk for COVID-19 infection without oral administration of Bromhexine hydrochloride
|
|---|---|---|
|
Number of Participants With Adverse Events
|
2 Participants
|
0 Participants
|
Adverse Events
Bromhexine Hydrochloride Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bromhexine Hydrochloride Group
n=25 participants at risk
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
|
Control Group
n=25 participants at risk
medical personnel at risk for COVID-19 infection without oral administration of Bromhexine hydrochloride
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Flash hot
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected over 8 weeks.
Overall number of participants affected by one or more Serious Adverse Events, for each arm/group.
|
0.00%
0/25 • Adverse event data were collected over 8 weeks.
Overall number of participants affected by one or more Serious Adverse Events, for each arm/group.
|
|
Respiratory, thoracic and mediastinal disorders
Acute cough
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected over 8 weeks.
Overall number of participants affected by one or more Serious Adverse Events, for each arm/group.
|
0.00%
0/25 • Adverse event data were collected over 8 weeks.
Overall number of participants affected by one or more Serious Adverse Events, for each arm/group.
|
Additional Information
Evgeny Mikhaylov
Almazov National Medical Research Centre
Phone: +7(812)7023764
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place