Status:
COMPLETED
Losartan for Patients With COVID-19 Not Requiring Hospitalization
Lead Sponsor:
University of Minnesota
Conditions:
Corona Virus Infection
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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).
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT04311177
Start Date
April 9 2020
End Date
February 1 2021
Last Update
May 4 2022
Active Locations (4)
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1
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
2
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
3
University of Minnesota
Minneapolis, Minnesota, United States, 55455
4
Mayo Clinic Health System
Rochester, Minnesota, United States, 55415