Losartan for Patients With COVID-19 Requiring Hospitalization

Completed · Phase 2 · Has a placebo group

Conditions studied: Corona Virus Infection, Acute Respiratory Distress Syndrome, SARS-CoV Infection

In brief

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.

Key facts

Study ID

NCT04312009

Run by

University of Minnesota

People needed

205

Starts

2020-04-13

Expected to finish

2021-02-01

Last updated by the study team

2022-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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:
• Any history of dialysis
• History of chronic kidney disease stage IV
• 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:
• Cirrhosis
• History of hepatitis B or C
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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