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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Losartan 		Participants in this arm will receive the study drug, Losartan.
  • Drug: Losartan
    Losartan; 50 mg daily; oral administration
    Other names:
    • Cozaar
Placebo Comparator
Placebo 		Participants in this arm will receive a placebo treatment.
  • Other: Placebo
    Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration

Recruiting Locations

More Details

NCT ID
NCT04312009
Status
Completed
Sponsor
University of Minnesota

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.