Losartan for Patients With COVID-19 Not Requiring Hospitalization
Condition: Corona Virus Infection; Acute Respiratory Distress Syndrome; SARS-CoV Infection
MeSH terms: Infections; Communicable Diseases; Coronavirus Infections; Severe Acute Respiratory Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
Intervention: Losartan; Placebo
Intervention description: Losartan; 25 mg daily; oral administration; Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration
Intervention MeSH terms: Losartan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19; Corona Virus; SARS-COV-2

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 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