The effect of bromhexine on the course of clinical signs in patients with COVID-19 will be Evaluated.
Design
A clinical trial with a control group, with parallel groups, simple-randomly assigned to intervention and control groups, Phase 3, 60 patients
Settings and conduct
This study will be performed in Imam Reza Hospital, Tabriz, Iran. 60 patients will be divided into two groups (30 in each group) by simple randomization. Patients in the control group will be prescribed a standard regimen. The intervention group will receive Bromhexine 8 mg tablets every 8 hours for 14 days from the beginning of hospitalization. Lungs' CT scan, hospitalization period, need to intubation and mortality rate will be assessed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with PCR-positive for COVID-19 with mild to moderate pneumonia; 18 Years to 80 Years; both genders. Exclusion criteria: Pregnant or lactating women; patients with an active thrombotic event; severe respiratory failure.
Intervention groups
Intervention group: will receive a standard regimen for COVID-19 plus Bromhexine. Control group: will receive a standard regimen for COVID-19.
Main outcome variables
Symptoms of the disease; mortality rate; hospitalization period
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200317046797N4
Registration date:2020-04-14, 1399/01/26
Registration timing:prospective
Last update:2020-04-14, 1399/01/26
Update count:0
Registration date
2020-04-14, 1399/01/26
Registrant information
Name
Sepideh Zununi Vahed
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 9331
Email address
sepide.zununi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-18, 1399/01/30
Expected recruitment end date
2020-05-19, 1399/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Bromhexine Hydrochloride on clinical improvement and outcome of COVID-19-induced pneumonia
Public title
Effect of Bromhexine Hydrochloride on patients with COVID-19
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with COVID-19-induced pneumonia confirmed with PCR
Patients or authorized family members volunteered to participate in this study and signed informed consent.
Both genders
18 to 80 years old
Exclusion criteria:
Patients who are participating in other drug clinical trials
Pregnant or lactating women
Patient with active thrombotic event
Patients with severe respiratory failure
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization will be generated with a computer from 1 to 60. The computer will divide the digits between the two groups. According to the sequences of admission, they will go to the control or the intervention group regarding the computerized random list.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2020-04-05, 1399/01/17
Ethics committee reference number
IR.TBZMED.REC.1399.013
Health conditions studied
1
Description of health condition studied
Patients with COVID-2019
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
2
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Hospitalization days
Timepoint
At baseline and discharge time
Method of measurement
Counting the days
2
Description
Need for mechanical ventilation
Timepoint
From baseline to discharge time
Method of measurement
Observation and documents
3
Description
Condition of discharge (death or recovery)
Timepoint
End of hospitalization
Method of measurement
Observation and documents
4
Description
Period of mechanical ventilation
Timepoint
End of hospitalization
Method of measurement
Documents of hospitalization
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:30 patients with COVID-19 in addition to a standard regimen will receive Bromhexine 8 mg tablets every 8 hours for 14 days from the beginning of hospitalization
Category
Treatment - Drugs
2
Description
Control group: 30 patients will receive only standard regimen of COVID-2019
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Immamreza Hospita of Tabriz
Full name of responsible person
Dr Khalil Ansarin
Street address
Imamreza Hospital, Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
imamreza@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammad Samiei
Street address
3th floor of Tabriz University of Medical Sciences Central Building, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Email
Samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Khalil Ansarin
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Daneshgah Street, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2898
Email
dr.ansarin@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammadreza Ardalan
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 9331
Email
ardalan34@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sepideh Zununi Vahed
Position
Assistant Prof.
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 9331
Email
sepide.zununi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available