Losartan for Outpatients on COVID-19
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 20-002948
NCT ID: NCT04311177
About this study
This is a multicenter randomized controlled trial comparing losartan vs placebo for outpatients with COVID. Every patient that is tested in the ED and drive through clinic will receive a brochure with information about the study. COVID positive will be called, and will receive supplies (medication, thermometer and swabs) at home.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- Positive laboratory test for COVID-19 based on local laboratory standard.
- Age greater than or equal to 18 years of age.
- At least one symptom of coronavirus as utilized by the CDC within 24 hours of enrollment (https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html). [Currently those symptoms include: Fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or running nose, nausea or vomiting, or diarrhea].
- Age less than 18 years.
- 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.
- Women 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 women of child bearing age 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 m^2 (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:
- 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
|Mayo Clinic Location
Mayo Clinic principal investigator
Nathan Cummins, M.D.
Closed for enrollment
Publications are currently not available
Study Results Summary
Not yet available
Supplemental Study Information
Not yet available