Clinical Trial of renin-angiotensin-aldosterone system inhibitors with halting their administration and the effect on clinical outcomes of patients with coronavirus disease-2019 (COVID-19) referring to Sina and Imam-Khomeini Hospitals in 2020
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Protocol summary
The randomized clinical trial study will be performed in Sina Hospital, with triple-blinding of data recruiter, patients, and the data analyzer
The randomized clinical trial study will be performed in Sina and Imam-Khomeini Hospitals with triple-blinding of data recruiter, patients, and the data analyzer
The randomized clinical trial study will be performed in Sina Hospital,and Imam-Khomeini Hospitals with triple-blinding of data recruiter, patients, and the data analyzer
مطالعه کلینیکال تریال تصادفی شده در بیمارستان سینا و با سه سویه کور بودن فرد جمع آوری کننده داده ها، بیمار و آنالیزور داده ها انجام می گیرد.
مطالعه کلینیکال تریال تصادفی شده در بیمارستان های سینا و امام خمینی و با سه سویه کور بودن فرد جمع آوری کننده داده ها، بیمار و آنالیزور داده ها انجام می گیرد.
مطالعه کلینیکال تریال تصادفی شده در بیمارستان های سینا و امام خمینی و با سه سویه کور بودن فرد جمع آوری کننده داده ها، بیمار و آنالیزور داده ها انجام می گیرد.
General information
empty
To add Imam-Khomeini Hospital in conducting the study
To add Imam-Khomeini Hospital in conducting the study
empty
اضافه کردن بیمارستان امام خمینی برای اجرای طرح
اضافه کردن بیمارستان امام خمینی برای اجرای طرح
Clinical Trial of renin-angiotensin-aldosterone system inhibitors with halting their administration and the effect on clinical outcomes of patients with corona virus disease-2019 (COVID-19) referring to Sina Hospital in 2020
Clinical Trial of renin-angiotensin-aldosterone system inhibitors with halting their administration and the effect on clinical outcomes of patients with coronavirus disease-2019 (COVID-19) referring to Sina and Imam-Khomeini Hospitals in 2020
Clinical Trial of renin-angiotensin-aldosterone system inhibitors with halting their administration and the effect on clinical outcomes of patients with corona viruscoronavirus disease-2019 (COVID-19) referring to Sina Hospitaland Imam-Khomeini Hospitals in 2020
کلینیکال تریال مقایسه مصرف کنندگان مهارکننده های سیستم رنین-آنژیوتانسین-آلدوسترون با قطع مصرف آن و تعیین پیشامدهای بالینی بیماران مبتلا به بیماری کرونا ویروس-2019 (کووید-19) مراجعه کننده به بیمارستان سینا در سال 1399
کلینیکال تریال مقایسه مصرف کنندگان مهارکننده های سیستم رنین-آنژیوتانسین-آلدوسترون با قطع مصرف آن و تعیین پیشامدهای بالینی بیماران مبتلا به بیماری کرونا ویروس-2019 (کووید-19) مراجعه کننده به بیمارستان های سینا و امام خمینی در سال 1399
کلینیکال تریال مقایسه مصرف کنندگان مهارکننده های سیستم رنین-آنژیوتانسین-آلدوسترون با قطع مصرف آن و تعیین پیشامدهای بالینی بیماران مبتلا به بیماری کرونا ویروس-2019 (کووید-19) مراجعه کننده به بیمارستان های سینا و امام خمینی در سال 1399
Clinical Trial of renin-angiotensin-aldosterone system inhibitors with halting their administration and the effect on clinical outcomes of patients with corona virus disease-2019 (COVID-19) referring to Sina Hospital in 2020
Clinical Trial of renin-angiotensin-aldosterone system inhibitors with halting their administration and the effect on clinical outcomes of patients with coronavirus disease-2019 (COVID-19) referring to Sina and Imam-Khomeini Hospitals in 2020
Clinical Trial of renin-angiotensin-aldosterone system inhibitors with halting their administration and the effect on clinical outcomes of patients with corona viruscoronavirus disease-2019 (COVID-19) referring to Sina Hospitaland Imam-Khomeini Hospitals in 2020
کلینیکال تریال مقایسه مصرف کنندگان مهارکننده های سیستم رنین-آنژیوتانسین-آلدوسترون با قطع مصرف آن و تعیین پیشامدهای بالینی بیماران مبتلا به بیماری کرونا ویروس-2019 (کووید-19) مراجعه کننده به بیمارستان سینا در سال 1399
کلینیکال تریال مقایسه مصرف کنندگان مهارکننده های سیستم رنین-آنژیوتانسین-آلدوسترون با قطع مصرف آن و تعیین پیشامدهای بالینی بیماران مبتلا به بیماری کرونا ویروس-2019 (کووید-19) مراجعه کننده به بیمارستان های سینا و امام خمینی در سال 1399
کلینیکال تریال مقایسه مصرف کنندگان مهارکننده های سیستم رنین-آنژیوتانسین-آلدوسترون با قطع مصرف آن و تعیین پیشامدهای بالینی بیماران مبتلا به بیماری کرونا ویروس-2019 (کووید-19) مراجعه کننده به بیمارستان های سینا و امام خمینی در سال 1399
Secondary outcomes
#1
3 months
6 months
36 months
3 ماه
6 ماه
36 ماه
Recruitment centers
#1
Name of recruitment center - English: Imam-Khomeini hospital
Name of recruitment center - Persian: بیمارستان امام خمینی
Full name of responsible person - English: Maryam Bahreini
Full name of responsible person - Persian: مریم بحرینی
Street address - English: Keshavarz blv.
Street address - Persian: بلوار کشاورز
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1416753955
Phone: +98 21 6690 4848
Fax:
Email: Imamhospital@tums.ac.ir
Web page address:
Name of recruitment center - English: Imam-Khomeini hospital Name of recruitment center - Persian: بیمارستان امام خمینی Full name of responsible person - English: Maryam Bahreini Full name of responsible person - Persian: مریم بحرینی Street address - English: Keshavarz blv. Street address - Persian: بلوار کشاورز City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1416753955 Phone: +98 21 6690 4848 Fax: Email: Imamhospital@tums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Maryam Bahreini
Full name of responsible person - Persian: مریم بحرینی
Street address - English: Keshavarz Blv., Tehran, Iran
Street address - Persian: تهران، خیابان کشاورز
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1417653761
Phone: +98 21 6649 2271
Fax:
Email: ic-research@tums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mohammad Ali Sahraian
Full name of responsible person - Persian: محمد علی صحراییان
Street address - English: Keshavarz Blv., Tehran, Iran
Street address - Persian: تهران، خیابان کشاورز
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1417653761
Phone: +98 21 6649 2271
Fax:
Email: ic-research@tums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Maryam BahreiniMohammad Ali Sahraian Full name of responsible person - Persian: مریم بحرینیمحمد علی صحراییان Street address - English: Keshavarz Blv., Tehran, Iran Street address - Persian: تهران، خیابان کشاورز City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1417653761 Phone: +98 21 6649 2271 Fax: Email: ic-research@tums.ac.ir Web page address:
Protocol summary
Study aim
The comparison of the clinical outcomes of patients with COVID -19 consuming renin-angiotensin-aldosterone system inhibitors with ceasing their consumption for whom calcium channel blockers with or without beta-blockers are prescribed according to the blood pressure and medication dosage.
Design
A randomized triple-blind clinical trial with parallel groups
Settings and conduct
The randomized clinical trial study will be performed in Sina and Imam-Khomeini Hospitals with triple-blinding of data recruiter, patients, and the data analyzer
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who have suggestive signs of COVID-19 in their chest computed tomography scan, reported by a radiologist. Patients consuming angiotensin-converting enzyme inhibitors or angiotensin receptor blockers
Exclusion criteria: Uncontrolled hypertension with systolic blood pressure more than 180 or diastolic more than 120; past history of congestive heart failure or arrhythmia with various severity; sensitivity to the newly prescribed medications; a history of severe asthma; a history of known depression; consuming medications with interactions such as lithium, antiepileptic drugs, chemotherapy; pregnancy; patient unwillingness to enter the study; patients whose prognosis is influenced by another disease
Intervention groups
1) Patients continuing to consume medications inhibiting renin-angiotensin-aldestrone system
2) Patients whose medication inhibiting renin-angiotensin-aldestrone system is discontinued and substituted by a calcium channel blocker with or without a beta blocker
Main outcome variables
Death; ICU admission
General information
Reason for update
To add Imam-Khomeini Hospital in conducting the study
Acronym
corona virus disease-2019 (COVID-19)
IRCT registration information
IRCT registration number:IRCT20151113025025N3
Registration date:2020-03-29, 1399/01/10
Registration timing:prospective
Last update:2020-07-06, 1399/04/16
Update count:1
Registration date
2020-03-29, 1399/01/10
Registrant information
Name
Maryam Bahreini
Name of organization / entity
Tehran University of Medical Sciences, Sina Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 6312 1413
Email address
m-bahreini@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-05, 1399/01/17
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial of renin-angiotensin-aldosterone system inhibitors with halting their administration and the effect on clinical outcomes of patients with coronavirus disease-2019 (COVID-19) referring to Sina and Imam-Khomeini Hospitals in 2020
Public title
Clinical Trial of renin-angiotensin-aldosterone system inhibitors with halting their administration and the effect on clinical outcomes of patients with coronavirus disease-2019 (COVID-19) referring to Sina and Imam-Khomeini Hospitals in 2020
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have suggestive signs of COVID-19 in their chest computed tomography scan, reported by a radiologist
Patients consuming angiotensin converting enzyme-inhibitors or angiotensin receptor blocker
Exclusion criteria:
Uncontrolled hypertension with systolic blood pressure more than 180 or diastolic more than 120
Past history of congested heart failure or arrhythmia with various severity
Sensitivity to the newly-prescribed medications
History of severe asthma
History of known depression
Consuming medications with interactions such as lithium, antiepileptic drugs, chemotherapy
Pregnancy
Patient unwillingness to enter the study
Patients whose prognosis is influenced by another disease
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients consuming renin-angiotensin-aldosterone system inhibitors are recruited in the study using computerized-sequence random codes in 2 groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The physicians recruiting patients' data and the statistician are blinded whether the antihypertensive medication will be continued or withheld.
A pharmacotherapist will consult with a cardiologist for the patient group whose antihypertensive medication should be changed. At the time of discharge, this medication will be prescribed by the cardiologist who is not blinded and not responsible for data gathering.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor in Research Affairs-Tehran University of Medical Sciences
Street address
Sina Hospital, Imam-Khomeini Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1136546911
Approval date
1985-06-17, 1364/03/27
Ethics committee reference number
IR.TUMS.VCR.REC.1399.028
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
corona virus disease 2019
Primary outcomes
1
Description
Death
Timepoint
3 months
Method of measurement
Number of deceased patients
Secondary outcomes
1
Description
ICU admission
Timepoint
6 months
Method of measurement
Number of deceased patients
Intervention groups
1
Description
Intervention group: Discontinuation of agents inhibiting renin-angiotensin-aldosterone system substituting by calcium channel blocker with or without beta-blocker
Category
Treatment - Drugs
2
Description
Control group: Continuation of renin-angiotensin-aldosterone inhibiting agents
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Maryam Bahreini
Street address
Sina Hospital, Imam-Khomeini Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1136546911
Phone
+98 21 6312 1413
Email
bahreinimaryam@gmail.com
Web page address
2
Recruitment center
Name of recruitment center
Imam-Khomeini hospital
Full name of responsible person
Maryam Bahreini
Street address
Keshavarz blv.
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 21 6690 4848
Email
Imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Keshavarz Blv., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6649 2271
Email
ic-research@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Maryam Bahreini
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Sina Hospital, Imam-Khomeini Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1136546911
Phone
+98 21 6312 1413
Email
bahreinimaryam@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Bahreini
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Sina Hospital, Imam-Khomeini Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1136546911
Phone
+98 21 6312 1413
Email
bahreinimaryam@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Bahreini
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Sina Hospital, Imam-Khomeini Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1136546911
Phone
+98 21 6312 1413
Email
bahreinimaryam@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
Yes - There is 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
Title and more details about the data/document
Data will be shared if a journal wants to.
When the data will become available and for how long
At the time of publishing the article
To whom data/document is available
Journal editor or reviewers
Under which criteria data/document could be used
In case of a request from journal reviewers or editors
From where data/document is obtainable
They can email me.
What processes are involved for a request to access data/document