ALPS-COVID: Participate in COVID-19 Research

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By participating in a COVID-19 research study, you can be part of tomorrow’s medical breakthroughs.

CONTACT 
Phone: 612-624-4373  | E-mail: COVID19TRIAL@umn.edu

 

ALPS-COVID:  Angiotensin receptor blocker based Lung Protective Strategy for COVID-19

The University of Minnesota Medical School is currently performing clinical research trials to find treatments for the COVID-19. One of the studies examines a blood pressure medication, losartan, to see if it can help alleviate the severity of the disease. Research focuses on two patient groups: patients admitted to the hospital and patients with mild disease who self-isolate at home.

This is a multi-center (M Health Fairview and Hennepin County Medical Center), double-blinded study of COVID-19 infected patients who will be randomized 1:1 to daily losartan or placebo for 10 days or until treatment failure, which is when a patient needs to be admitted to the hospital.

WHAT IS COVID-19?

COVID-19 is a viral respiratory disease that is currently affecting over 14,000 people in the U.S. and over 260,000 worldwide, as of March 20, 2020. Symptoms of the disease include fever, cough and shortness of breath. In most people, the virus causes only mild symptoms, but in some, it can cause severe pneumonia and can even lead to death. Because this is a new disease, there is no vaccine or specific treatment available at the moment.

CURRENT TREATMENTS FOR COVID-19?

COVID-19 is closely related to the severe acute respiratory syndrome coronavirus (SARS-CoV), which caused an outbreak of disease (SARS) in 2003. Attempts to develop a vaccine since SARS have been unsuccessful. The development of new vaccines takes time and may or may not be effective for this or future coronavirus pandemics.
Health officials are focused on screening, identification and containment to combat the spread of COVID-19. Given its rapid spread, patients with COVID-19 would greatly benefit from treatments with an established safety profile readily available for immediate use if the treatment is effective.

ABOUT THE TRIAL

The high blood pressure drug, losartan, is one drug that has an established safety profile readily available for immediate use and may be effective as a treatment.
Researchers theorize that the use of losartan will reduce how aggressive and deadly a COVID-19 infection is by disrupting how the virus binds to the body at the molecular level. COVID-19 uses a protein on the surface of lung cells to enter the cell. This protein is important to protect the lung from a circulating hormone. COVID-19 blocks this protein and damages the lungs. This study will determine if losartan, which can block this lung-damaging hormone, helps reduce the severity of breathing problems in those recovering from COVID-19.

Patients in Home Isolation

Patients participating in this trial who self-isolate at home will:

  • Participate in this clinical research study for up to 90 days

  • Receive a study drug for 10 days or until admitted to the hospital, whichever comes first

  • Take their temperature daily (a thermometer will be provided)

  • Provide oral mouth swabs every two days (with a kit provided)

  • Answer daily questions about symptoms or side effects by phone for 10 days and take study medication daily. Additional phone calls from study staff will happen on days 15, 28 and 90. 

  • Be randomly assigned to receive either losartan or a placebo (a pill that looks just like losartan but doesn’t have any medicine in it). Participants have a 50:50 chance of taking either pill during this study, like flipping a coin. Neither the patient nor their doctors or nurses will know if participants are taking losartan or a placebo, but they can find out if they need to.

Note: Women capable of becoming pregnant will be required to take a urine pregnancy test before participation.

Hospitalized Patients

Patients participating in this trial who are hospitalized will:

  • Participate in this clinical research study for up to 90 days

  • Receive a study drug for 10 days or until they leave the hospital, whichever comes first 

  • Be asked to have a physical exam, provide blood samples, mouth swab samples and take study medication daily.

  • Receive phone call check-ins from study staff on days 15, 28 and 90 after the start of the study.

  • Be randomly assigned to receive either losartan or a placebo (a pill that looks just like losartan but doesn’t have any medicine in it). There is a 50:50 chance of taking either pill during this study, like flipping a coin. Neither the patient nor their doctors or nurses will know if participants are taking losartan or a placebo, but they can find out if they need to.

  • Why Participate?
  • Am I Eligible?
  • Why Participate?

    Benefits

    We cannot promise any benefits to you or others from your taking part in this research. However, if you receive losartan and if this medication works, you might need less oxygen or mechanical ventilation. Additionally, if this medication works, it can potentially help a large number of patients.

    Risks

    Losartan is a very well-studied medication that has been prescribed for patients with hypertension for over 20 years. However, there are side effects that can be caused by losartan. Some of these are:

    • Feeling tired or weak
    • Diarrhea
    • Chest pain
    • Low red blood cell count
    • Worsening kidney function
    • Abnormal levels of electrolytes
    • Allergic reaction

    You should not take losartan if you are pregnant, trying to get pregnant or breastfeeding.

    For patients in the hospital only: Blood draws may cause pain, bleeding or bruising where the needle pokes your skin. There is a small risk of infection at the needle site, and sometimes, people feel lightheaded or faint during a blood draw. The team will try to draw your blood from IVs you already have but might need to perform a needle stick.

  • Am I Eligible?

    You are eligible if you:

    • Have a positive laboratory test for COVID-19
    • Are age 18 or older

    You are NOT eligible if:

    • More than 72 hours have passed since the positive COVID-19 test result
    • More than 7 days have passed since your fever started
    • You are currently taking an Angiotensin converting enzyme inhibitor (ACE-inhibitor) or Angiotensin receptor blocker (ARB)
    • You are currently taking Aliskiren
    • You had a prior reaction or intolerance to an ARB or ACE inhibitor, including but not limited to, angioedema
    • You are pregnant, trying to get pregnant or breastfeeding
    • Some kidney and liver diseases (please contact us to see if you are eligible).