ENROLLMENT HAS ENDED FOR THIS STUDY.
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.
- Why Participate?
- Am I Eligible?
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.
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
• 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).