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.
Drug: Losartan
Losartan; 50 mg daily; oral administration
Other Name: Cozaar
Other: Placebo
Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration
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
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