Comparison of the effect of acetylcysteine and bromhexine on the improvement and prevention of hospitalization in outpatients
Design
One group of patients will be given oral acetylcysteine 600 mg twice daily for 5 days and another group will be given 8 mg bromhexine tablets three times daily for 5 days. Referral, on day 7 and day 14, patients' oxygen levels and hospitalization and death are checked.
Settings and conduct
This double-blind clinical trial is performed on 92 outpatients referred to Dibaj Municipal Services Center. The diagnosis of Covid-19 is debugged at the health service center and the patient enters the study after the test is confirmed. First, the blood oxygen level of the patients was measured with a pulse oximeter and from 92 patients, they were randomly assigned to group A and the rest to group B, and then to a group of patients taking oral acetylcysteine 600 mg twice daily. For 5 days, the other group is given 8 mg of bromhexine tablets three times a day for 5 days. Then, on day 7 and day 14, the patients are followed up and the patients' blood oxygen saturation level is measured and recorded with a pulse oximeter.
Participants/Inclusion and exclusion criteria
Inclusion criteria include:
• Adult patients aged 18 to 70 years referred to Dibaj Municipal Service Center
• Outpatients with Covid-19 symptoms after positive Covid-19 RT-PCR test
• Oxygen level 98-92%
Exclusion criteria:
• Pregnancy and lactation
.Patients taking nitroglycerin.
Intervention groups
This clinical trial is performed on outpatients Covid 19. One group of patients is given oral acetylcysteine 600 mg twice daily for 5 days and another group is given 8 mg bromhexine tablets three times daily for 5 days. On the day of referral, day 7 and day 14, patients' oxygen levels and their hospitalization and death are checked.
Main outcome variables
Duration of recovery, Duration of hospitalization, Death
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220302054167N1
Registration date:2022-04-29, 1401/02/09
Registration timing:registered_while_recruiting
Last update:2022-04-29, 1401/02/09
Update count:1
Registration date
2022-04-29, 1401/02/09
Registrant information
Name
Anahita Eslami-ghayour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3824 5383
Email address
anahitaeslami1995@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-10, 1400/12/19
Expected recruitment end date
2022-05-09, 1401/02/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of acetylcysteine and bromhexine on the rate of improvement and prevention of hospitalization in outpatients with Covid-19
Public title
The effect of acetylcysteine and bromhexine on the improvement and prevention of hospitalization in outpatients with Covid-19
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Outpatients with Covid-19 symptoms after positive Covid-19 RT-PCR test
Oxygen level 98-92%
Exclusion criteria:
• Dissatisfaction of the patient or their relatives to participate in the study
• Pregnancy and lactation
Evidence of pulmonary involvement and the need for hospitalization or referral to an infectious disease specialist
Prohibition of N-acetylcysteine and bromhexine as a history of allergy and anaphylactic shock
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
For this purpose, we will use the method of four random blocks (Block Randomization). For this purpose, we prepare four sheets of paper. On the two sheets, we write the letter I meaning "Intervention" and on the other two sheets we write the letter A meaning "Active Control". Mix the sheets together and place them in the desk drawer. When referring to any of the eligible patients, one of the sheets was randomly taken out, and based on this sheet, I or A was taken out and assigned to one of the two groups of intervention (NAC recipient) or comparison (bromhexine recipient). Will be given. It should be noted that the pulled-out sheets will not be returned to the drawer until all four sheets have been pulled out. After randomly pulling out all four sheets, all the sheets are returned to the drawer and the above procedure will be continued for the next four patients until the desired sample size (92 patients) is reached.
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
کمیته اخلاق دانشگاه علوم پزشکی همدان
Street address
Research Ethics Committee, Vice Chancellor for Research and Technology, Hamadan University of Medical Sciences,Shahid Fahmideh Blvd.
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Approval date
2022-03-04, 1400/12/13
Ethics committee reference number
IR.UMSHA.REC.1400.957
Health conditions studied
1
Description of health condition studied
covid-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
blood Oxygen
Timepoint
At the beginning of the study (before the intervention) and 7, 14 days
Method of measurement
pulse oximeter
2
Description
Cough
Timepoint
At the beginning of the study (before the intervention) and 7, 14 days
Method of measurement
questionnaire
3
Description
Shortness of breath
Timepoint
At the beginning of the study (before the intervention) and 7, 14 days
Method of measurement
questionnaire
4
Description
Sore throat
Timepoint
At the beginning of the study (before the intervention) and 7, 14 days
Method of measurement
questionnaire
Secondary outcomes
1
Description
Time to recover from the desired symptoms
Timepoint
daily
Method of measurement
questionnaire
2
Description
Duration of hospitalization
Timepoint
At the beginning of the study (before the intervention) and 7, 14 days
Method of measurement
questionnaire
3
Description
Death
Timepoint
At the beginning of the study (before the intervention) and 7, 14 days
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: The first group was a group of patients taking oral acetylcysteine(Hakim company) 600 mg twice daily for 5 days
Category
Treatment - Drugs
2
Description
Intervention group: The second method is for patients who take 8 mg of bromhexine tablets (Tolid Daroo) three times a day for 5 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
مرکز خدمات شهری دیباج
Full name of responsible person
محسن نوروزی
Street address
Kamalabad St., Dibaj Clinic
City
hamedan
Province
Hamadan
Postal code
6516768567
Phone
+98 81 3833 1024
Email
anahitaeslami1995@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
DR. Mhamad Khazaii
Street address
4th floor,University of Medical Sciences, Shahid Fahmideh St.,Research Square
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 0000
Email
it.amoozesh@umsha.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Anahita Eslami-Ghayour
Position
medical doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 25, Jihad Alley, 18 meters from Fajr, Ostadan St.
City
Hamedan
Province
Hamadan
Postal code
6516866818
Phone
+98 81 3824 5383
Email
anahitaeslami1995@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Fariba keramat
Position
medical doctor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Pasteur Crossroads, Farshchian Educational and Medical Center, Hamedan
City
hamedan
Province
Hamadan
Postal code
6516866818
Phone
+98 81 3827 4184
Email
keramat@ umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Fateme Shahbazi
Position
PhD student in epidemiology
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Research Square, Shahid Fahmideh St., hamedan University of Medical Sciences
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 0000
Email
shahbazif2017@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after unidentifiable individuals
When the data will become available and for how long
Six months after the results were published
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
For further research purposes and analysis
From where data/document is obtainable
Anahita Eslami Ghayour, Hamedan University of medical science
What processes are involved for a request to access data/document