Official Title
Randomized Controlled Trial of Losartan for Patients With COVID-19 Requiring Hospitalization
Brief Summary

This is a multi-center, double-blinded study of COVID-19 infected patients requiring inpatient hospital admission randomized 1:1 to daily Losartan or placebo for 7 days or hospital discharge.

Completed
Corona Virus Infection
Acute Respiratory Distress Syndrome
SARS-CoV Infection

Drug: Losartan

Losartan; 50 mg daily; oral administration
Other Name: Cozaar

Other: Placebo

Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration

Eligibility Criteria

Inclusion Criteria:

- Presumptive positive laboratory test for Covid-19 based on local laboratory standard

- Age greater than or equal to 18 years of age

- Admission to the hospital with a respiratory SOFA >=1 and increased oxygen requirement
compared to baseline among those on home O2

- Randomization within 48 hours of presentation of hospital admission or within 48 hours
of a positive test result, whichever is later

Exclusion Criteria:

- Randomization > 48 hours of admission order or positive test result, whichever is
later

- Currently taking an angiotensin converting enzyme inhibitor (ACEi) or Angiotensin
receptor blocker (ARB)

- Prior reaction or intolerance to an ARB or ACE inhibitor, including but not limited to
angioedema

- Pregnant or breastfeeding

- Lack of negative urine or serum pregnancy test

- Not currently taking a protocol allowed version of contraception: intrauterine device,
Depo-formulation of hormonal contraception (e.g. medroxyprogesterone acetate /
Depo-Provera), subcutaneous contraceptive (e.g. Nexplanon), daily oral contraceptives
with verbalized commitment to taking daily throughout the study period; use of condoms
or agree to abstain from sexual intercourse during the study. All women of child
bearing age enrolled in this fashion will be informed of the teratogenic risks. If
enrolled under LAR, they will be informed of the risks after regaining capacity.

- Patient reported history or electronic medical record history of kidney disease,
defined as:

1. Any history of dialysis

2. History of chronic kidney disease stage IV

3. Estimated Glomerular Filtration Rate (eGFR) of < 30ml/min/1.73 m2 at the time of
randomization

- Severe dehydration at the time of enrollment in the opinion of the investigator or
bedside clinician

- Most recent mean arterial blood pressure prior to enrollment <65 mmHg

- Patient reported history or electronic medical record history of severe liver disease,
defined as:

1. Cirrhosis

2. History of hepatitis B or C

3. Documented AST or ALT > 3 times the upper limit of normal measured within 24
hours prior to randomization

- Potassium >5.0 within 24 hours prior to randomization unless a repeat value was <=5.0

- Treatment with aliskiren

- Inability to obtain informed consent from participant or legally authorized
representative

- Enrollment in another blinded randomized clinical trial for COVID

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

University of Florida Health Gainesville
Gainesville, Florida, United States

University of Florida Health Jacksonville
Jacksonville, Florida, United States

Grady Memorial Hospital
Atlanta, Georgia, United States

Henry Ford Hospital
Detroit, Michigan, United States

M Health Fairview Ridges Hospital
Burnsville, Minnesota, United States

M Health Fairview Southdale Hospital
Edina, Minnesota, United States

Hennepin County Medical Center
Minneapolis, Minnesota, United States

M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, United States

University of Minnesota
Minneapolis, Minnesota, United States

North Memorial Health Hospital
Robbinsdale, Minnesota, United States

University of Mississippi Medical Center
Jackson, Mississippi, United States

Cooper University Hospital
Camden, New Jersey, United States

University of Cincinnati Medical Center
Cincinnati, Ohio, United States

Bill and Melinda Gates Foundation
NCT Number
Keywords
Covid-19
Corona Virus
SARS-CoV-2
MeSH Terms
Infections
Communicable Diseases
Coronavirus Infections
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Losartan