Losartan for Patients With COVID-19 Not 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 randomized 1:1 to daily losartan or placebo for 10 days or treatment failure (hospital admission).

Key facts

Study ID

NCT04311177

Run by

University of Minnesota

People needed

117

Starts

2020-04-09

Expected to finish

2021-02-01

Last updated by the study team

2022-05-04

Who can join

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

You may qualify if…

• Positive laboratory test for COVID-19 based on local laboratory standard
• Age greater than or equal to 18 years of age
• One of the following: Upper respiratory symptoms (cough, rhinorrhea) or fever (>101.5) or loss of taste / smell

You may not qualify if…

• Randomization > 72 hours of meeting inclusion criteria
• Randomization > 7 days of symptom onset
• 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 women
• Females able to have children 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, condom use or abstinence during the study. All participants of child bearing potential enrolled in this fashion will be informed of the teratogenic risks.
• 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 (must be have been measured within 1 month of enrollment)
• Other kidney disease that in the opinion of the investigator, would affect losartan clearance
• Patient reported dehydration and significantly decreased urine output in the past 72 hours
• Most recent systolic blood pressure prior to enrollment <110 mmHg
• Patient reported history or electronic medical record history of severe liver disease, defined as:
• Cirrhosis
• History of hepatitis B or C
• Other liver disease that in the opinion of the investigator, would affect losartan clearance
• Documented AST or ALT > 3 times the upper limit of normal within 3 months of randomization (if available in electronic medical record)
• Potassium >5.0 mmol/L (must have been measured within 1 month) of enrollment
• Concurrent treatment with aliskiren
• Inability to obtain informed consent
• Enrollment in another blinded randomized clinical trial for COVID

Where it is running

• 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
• Mayo Clinic Health System — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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