Verifying the effect of the bromhexine hydrochloride on the COVID19 disease compared to placebo
Design
Two patient groups receiving either the Bromhexine hydrochloride 8 mg or placebo every 8 hours for 16 days
Settings and conduct
EmamReza Hospital
Participants/Inclusion and exclusion criteria
COVID19 patients diagnoses according to three diagnostic criteria of this protocol and are 18 year of age or older
Intervention groups
Two patient groups receiving either the Bromhexine hydrochloride 8 mg or placebo every 8 hours for 16 days
Main outcome variables
ICU transfer, Intubation and Mechanical Ventilation, Survival/Mortality
General information
Reason for update
Acronym
BH8MGIRINT
IRCT registration information
IRCT registration number:IRCT20200818048444N2
Registration date:2020-12-31, 1399/10/11
Registration timing:registered_while_recruiting
Last update:2020-12-31, 1399/10/11
Update count:0
Registration date
2020-12-31, 1399/10/11
Registrant information
Name
Khalil Ansarin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 8093
Email address
dr.ansarin@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-14, 1399/08/24
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Bromhexine Hydrochloride versus Placebo on Clinical Outcomes of Patients with COVID-19 disease: a Randomized Controlled Trial
Public title
The Effect of Bromhexine Hydrochloride on Clinical Outcomes of Patients with COVID-19 disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
I-New laboratory confirmed diagnosis of SARS-CoV-2 via reverse transcriptase polymerase chain reaction as per the World Health Organization protocol, by nucleic acid based isothermal amplification, or by antigen testing OR II- Clinical suspicion of COVID-19 disease and acute onset (less than 10 days) and of AT LEAST ONE of the following conditions:• Loss of smell or taste• Cough or shortness of breath / dyspnea• Fever (body temperature > 38.5°)• PLUS Findings on chest-X ray or computer tomography suggestive of COVID-19 OR III- Clinical suspicion of COVID-19 disease and acute onset (less than 10 days) of AT LEAST TWO of the following conditions: • Chills or rigor • Conjunctivitis • Sore throat • Gastrointestinal symptoms • Headaches • Fatigue or malaise • Aches or pain PLUS Findings on chest-X ray or computer tomography suggestive of COVID-19
18 years and older
Informed consent from the patient (or legally authorized substitute decision maker).
Exclusion criteria:
The exclusion criteria are: 1) Admitted to the intensive care unit at the time of screening; 2) Imminent initiation or treatment with invasive mechanical ventilation at the time of screening; 3) Imminent death according to the judgement of the most responsible physician; 4) Receiving palliative care; 5) Known history of severe liver or kidney dysfunction; 6) On treatment with Bromhexine hydrochloride at the time of screening; 7) Known allergy to bromhexine hydrochloride; 8) Pregnancy or breastfeeding (including baby to breast, bottle feeding mother's expressed breast milk); 9) Previous enrollment in this trial (Enrollment in another clinical trial does not preclude enrollment in this trial )
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
400
Randomization (investigator's opinion)
Randomized
Randomization description
1:1 randomization, centralized web-based randomization and according to the entry and exit criteria, through random allocation by balanced block method, individuals are divided into two groups of control and experimental. Using Random Sequence Generator, groups are created and people are placed in one of these two groups based on the reference sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a two-way blind study. In this study, the subject and the researcher are both unaware of the drug used by individuals. The placebo and the main drug are placed in similar boxes with specific codes and are delivered to the patient by a third party. Medication information will not be visible to the therapist.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Regional Committee for Research Ethics(Human Subject Studies(91000001))
Street address
Third Floor / Tabriz University of Medical Sciences, Central Building No. 2/Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2020-12-21, 1399/10/01
Ethics committee reference number
IR.TBZMED.REC.1399.881
Health conditions studied
1
Description of health condition studied
COVID19
ICD-10 code
U07.1
ICD-10 code description
COVID19
Primary outcomes
1
Description
Survival
Timepoint
28 days after start of the treatment
Method of measurement
Follow up from hospital files and phone F/U in subjects who discharged earlier
2
Description
levels of CRP, LDH, Troponin, Ferritin
Timepoint
Day 1 and 28 days after treatment
Method of measurement
Standard laboratory hematology and biochemistry tests
3
Description
NLR (Neutrophil to Lymphocyte Ratio) and D-Dimer
Timepoint
Day 1 and 28 days after treatment
Method of measurement
Standard laboratory hematology and biochemistry tests
4
Description
ICU transfer rate
Timepoint
28 days after start of the treatment
Method of measurement
Follow up from hospital files and phone F/U in subjects who discharged earlier
5
Description
Intubation and Mechanical Ventilation
Timepoint
28 days after start of the treatment
Method of measurement
Follow up from hospital files and phone F/U in subjects who discharged earlier
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Bromhexine 8 mg every 8 hourly P O produced by Tolidaru.
Category
Treatment - Drugs
2
Description
Control group: Placebo as tablets that has been made similar to bromhexine and provided by the same drug company, Tolidaru, producing the bromhexine hydrochloride administered every 8 hourly p o for 16 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
EmamReza Hospital, Tabriz University of Medical Sciences
Full name of responsible person
Khalil Ansarin
Street address
Reza Hospital, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Fax
+98 41 3334 7054
Email
imamreza@tbzmed.ac.ir
Web page address
https://imamreza-en.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. M. Samiei
Street address
Central Building of University of Medical Sciences/ Golgasht St./ Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5142954481
Phone
+98 41 3335 7310
Fax
+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?
No
Title of funding source
Health Vice-Chancellor of Ministry of Health and Medical Education (MOHME)
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
Khalil Ansarin
Position
Professor of Medicine
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Daneshghah Avenue, Pashmineh Building, Tuberculosis and Lung Disease Research Center
City
Tabriz
Province
East Azarbaijan
Postal code
5142954481
Phone
+98 41 3337 8093
Fax
+98 41 3337 8093
Email
dr.ansarin@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Khalil Ansarin
Position
Professor of Medicine
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Daneshghah Ave, Pashmineh Building, Tuberculosis and Lung Disease Research Center
City
Tabriz
Province
East Azarbaijan
Postal code
5142954481
Phone
+98 41 3337 8093
Fax
+98 41 3337 8093
Email
Dr.ansarin@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Haleh Mikaeili
Position
Associate Professor of Medicine
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Daneshghah Avenue EmamReza Hospital Pulmonary FUnction Lab
City
Tabriz
Province
East Azarbaijan
Postal code
5142954481
Phone
+98 41 3335 2071
Fax
+98 41 3337 8093
Email
mikaiili@hotmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can potentially be shared after unidentified the individuals.
When the data will become available and for how long
Second quarter of 2021
To whom data/document is available
َAccess to data will be allowed for all researchers after submitting an access request and confirming it
Under which criteria data/document could be used
In order to use the data, researchers must first identify and send the required items and data upon request, after which the data will be delivered.
From where data/document is obtainable
By email dr.ansarin@gmail.com or postal code: 5142954481
What processes are involved for a request to access data/document
The researcher must state his request in a letter. Upon agreeing to his request, the data will be emailed to him in Excel or Spss.