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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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21 April 2020 |
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Main ID: |
IRCT20180802040678N4 |
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Date of registration:
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2020-04-01 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of the effects of Losartan in patients with corona virus disease 2019
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Scientific title:
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Evaluation of the effects of Losartan in patients with corona virus disease 2019 |
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Date of first enrolment:
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2020-03-31 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://en.irct.ir/trial/46824 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomizing by computer software.
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Phase:
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3
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Armin Sadeghi
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Address:
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Golgasht Ave.
5166/15731
Tabriz
Iran (Islamic Republic of) |
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Telephone:
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+98 41 3335 7311 |
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Email:
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arm.sad@gmail.com |
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Affiliation:
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Tabriz University of Medical Sciences |
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Name:
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Akbar Sharifi
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Address:
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Golgasht Ave.
5166/15731
Tabriz
Iran (Islamic Republic of) |
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Telephone:
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+98 41 3336 4901 |
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Email:
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ak.sharif1349@gmail.com |
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Affiliation:
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Tabriz University of Medical Sciences |
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Key inclusion & exclusion criteria
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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 minimum:
18 years
Age maximum:
no limit
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Corona virus disease 2019 (COVID-19).
Coronavirus infection, unspecified
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B34.2
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Intervention(s)
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Intervention 1: Intervention group: In the case group, patients will receive 25 mg losartan tablets two times daily. Intervention 2: Intervention group: Patients will receive 5 mg amlodipine daily.
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Primary Outcome(s)
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Laboratory Findings. Timepoint: Primary and 14 days after. Method of measurement: Laboratory methods.
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Length of hospitalization. Timepoint: 28 days. Method of measurement: Days between admission to discharge.
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Mortality. Timepoint: 28 days. Method of measurement: Number of death.
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Performance of patients. Timepoint: Primary and 14 days after. Method of measurement: Sequential Organ Failure Assessment (SOFA) Respiratory Score.
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Source(s) of Monetary Support
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Tabriz University of Medical Sciences
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Ethics review
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Status: Approved
Approval date: 16/03/2020
Contact:
Ethics Committee of Tabriz University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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