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Evaluation of the effects of Losartan in patients with corona virus disease 2019

Protocol summary

Study aim
To evaluate the safety and efficacy of losartan in COVID-19
Design
One-hundred patients with COVID-19 after taking informed consent including 50 patients in the case group and 50 patients in the control group will be conducted parallel in the trial.
Settings and conduct
This clinical trial study will be performed in Tabriz Emam Reza hospital on patients with coronavirus disease 2019 (COVID-19). Losartan (25mg/BID) in one group and amlodipine (5mg/daily) in another group will be administered for 14 days. Also, all patients will receive routine treatment protocol of COVID-19. Lab tests and clinical features will be obtained and documented and in the end, by using the computer software (SPSS Version 24) the data will be analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: laboratory (RT-PCR) confirmed COVID-19, stable hemodynamic condition, blood pressure ≥130/85 mmHg. Exclusion criteria: patient's critical condition, cough exacerbation after initiating losartan, increasing blood potassium levels or high baseline potassium levels, new anemia, shock or decreasing blood pressure ≤ 90/60 mmHg after losartan initiating, angioedema, acute hepatic failure, acute renal failure, bilateral renal artery stenosis, bilateral renal artery stenosis, history of uncontrolled hypertension, pregnancy and lactation, history of treatment with ACE inhibitors and ARB inhibitors, treatment with phenobarbital, rifampin and fluconazole
Intervention groups
In the case group, patients will receive 25 mg losartan tablets two times daily and in the control group, patients will receive 5 mg amlodipine daily.
Main outcome variables
28 days mortality, length of hospitalizationو changes of laboratory and clinical findings, the performance of patients

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180802040678N4
Registration date: 2020-04-01, 1399/01/13
Registration timing: registered_while_recruiting

Last update: 2020-04-01, 1399/01/13
Update count: 0
Registration date
2020-04-01, 1399/01/13
Registrant information
Name
Masoud Nouri-Vaskeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3325 9778
Email address
mnvaskeh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-31, 1399/01/12
Expected recruitment end date
2020-04-30, 1399/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of Losartan in patients with corona virus disease 2019
Public title
Evaluation of the effects of Losartan in patients with corona virus disease 2019
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Laboratory (RT-PCR of oropharyngeal swab) confirmed COVID-19 Stable hemodynamic condition Blood pressure ≥130/85 mmHg
Exclusion criteria:
Patient's critical condition Cough exacerbation after initiating Losartan Increasing blood potassium levels or high baseline potassium levels New anemia Shock or decreasing blood pressure ≤ 90/60 mmHg after Losartan initiating Angioedema Acute hepatic failure Acute renal failure Bilateral renal artery stenosis History of uncontrolled hypertension Pregnancy and lactation History of treatment with ACE inhibitors and ARB inhibitors Treatment with phenobarbital, rifampin and fluconazole
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomizing by computer software
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
Golgasht Ave.
City
Tabriz
Province
West Azarbaijan
Postal code
5166/15731
Approval date
2020-03-16, 1398/12/26
Ethics committee reference number
IR.TBZMED.REC.1399.002

Health conditions studied

1

Description of health condition studied
Corona virus disease 2019 (COVID-19)
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified

Primary outcomes

1

Description
Mortality
Timepoint
28 days
Method of measurement
Number of death

2

Description
Performance of patients
Timepoint
Primary and 14 days after
Method of measurement
Sequential Organ Failure Assessment (SOFA) Respiratory Score

3

Description
Length of hospitalization
Timepoint
28 days
Method of measurement
Days between admission to discharge

4

Description
Laboratory Findings
Timepoint
Primary and 14 days after
Method of measurement
Laboratory methods

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the case group, patients will receive 25 mg losartan tablets two times daily.
Category
Treatment - Drugs

2

Description
Intervention group: Patients will receive 5 mg amlodipine daily.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz Emam Reza Hospital
Full name of responsible person
Akbar Sharifi
Street address
Golgasht Ave.
City
Tabriz
Province
West Azarbaijan
Postal code
5166/15731
Phone
+98 41 3337 3966
Email
ak.sharif1349@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
Golgasht Ave.
City
Tabriz
Province
West Azarbaijan
Postal code
5166/15731
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
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
Armin Sadeghi
Position
Clinical Fellow
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Golgasht Ave.
City
Tabriz
Province
West Azarbaijan
Postal code
5166/15731
Phone
+98 41 3335 7311
Email
arm.sad@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Akbar Sharifi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Golgasht Ave.
City
Tabriz
Province
West Azarbaijan
Postal code
5166/15731
Phone
+98 41 3336 4901
Email
ak.sharif1349@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masoud Nouri-Vaskeh
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Golgasht Ave.
City
Tabriz
Province
West Azarbaijan
Postal code
5166/15731
Phone
+98 41 3336 9331
Email
mnvaskeh@tbzmed.ac.ir

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
Information about the study is available upon approval by the University's Ethics Committee.
When the data will become available and for how long
Starting access 6 months after publication of data
To whom data/document is available
Everybody
Under which criteria data/document could be used
Using is not authorized
From where data/document is obtainable
Applicants must send their request to the author
What processes are involved for a request to access data/document
Sending the request via e-mail
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