Losartan for Patients With COVID-19 Not Requiring Hospitalization

University of Minnesota (UMN)

Status and phase: Completed; Phase 2

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

Treatments: Other: Placebo; Drug: Losartan

Study type: Interventional

Funder types: Other

Identifiers

NCT04311177

SURG-2020-28683

Details and patient eligibility

About

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).

Enrollment: 117 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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:

  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 (must be have been measured within 1 month of enrollment)
  4. 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:

  1. Cirrhosis
  2. History of hepatitis B or C
  3. Other liver disease that in the opinion of the investigator, would affect losartan clearance
  4. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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117 participants in 2 patient groups, including a placebo group

Losartan

Experimental group

Description:

Participants in this arm will receive the study drug, Losartan.

Treatment:

Drug: Losartan

Placebo

Placebo Comparator group

Description:

Participants in this arm will receive a placebo treatment.

Treatment:

Other: Placebo