Essentia Health is offering a new treatment for people diagnosed with mild to moderate COVID-19 who are at high risk for severe complications and hospitalization.
The drug, called bamlanivimab, is a monoclonal antibody recently authorized for emergency use by the U.S. Food and Drug Administration (FDA). It must be given within 10 days of the start of symptoms and as soon as possible after a positive COVID-19 test.
Patients must meet certain criteria set by the FDA to qualify for the treatment. There is a limited supply of bamlanivimab so it is being allocated by federal and state agencies.
More than 200 appointments are available each week across Essentia Health. The therapy is offered at these area locations:
• Brainerd: Essentia Health-St. Joseph’s Medical Center, 523 N. Third St.
• Deer River: Essentia Health-Deer River, 115 10th Ave. N.E.
• Detroit Lakes: Essentia Health-St. Mary’s Hospital, 1027 Washington Ave.
• Duluth: Essentia Health-St. Mary’s Medical Center, 407 E. Third St.
• Fargo: Essentia Health-32nd Avenue Clinic, 3000 32nd Ave. S.
People who have a positive COVID-19 test at any Essentia Health site are automatically screened for the FDA’s criteria. Those who were tested at other sites can call a toll-free hotline at 1-833-769-1524 to be screened. Hotline hours are 8:30 a.m. to 5 p.m. Monday-Friday. Health care providers can refer a patient by calling Essentia Health’s STAT Doc line.
Due to the limited supply of the drug, eligible patients are randomly chosen by a computer for treatment, says Dr. Amanda Noska, an Essentia Health infectious disease physician. Those patients are contacted by a registered nurse from Essentia Health and then scheduled for an exam and an intravenous infusion. Randomized selection is an ethical method for choosing who gets access to the treatment, said Dr. Noska.
Bamlanivimab treatment has been authorized by the FDA for patients age 12 or older who are at high risk for severe complications and/or hospitalization. Children must weigh at least 40 kilograms or 88 pounds.
Qualified patients include those who:
• Have the COVID-19 virus
• Are within 10 days of beginning mild to moderate symptoms and
• Meet at least one risk factor identified by the FDA
Monoclonal antibodies are lab-made proteins that help the body protect itself against viruses. Bamlanivimab is made specifically to act against the COVID-19 virus.
Like the COVID-19 vaccines, bamlanivimab is investigational. That means it is not yet approved by the FDA for any conditions and is still being tested in research studies. It has, however, been authorized by the FDA for use during the COVID-19 pandemic. The agency determined it is reasonable to believe bamlanivimab may be effective in certain patients. In one trial study, it was found to lower the possibility patients needing an emergency room or hospital visit.
The FDA defined high risk as patients who meet at least one of these criteria:
• Body mass index (BMI) of 35 or more
• Chronic kidney disease (consider hemodialysis patients)
• Immunosuppressive disease
• Currently receiving immunosuppressive treatment (e.g. rheumatology patients, patients with IBD on Humira or other immunosuppressive therapy)
• Age 65 or older
• Age 55 or older and have:
— Cardiovascular disease
— Chronic obstructive pulmonary disease/other chronic respiratory disease
• Ages 12-17 and have:
— BMI in 85th percentile or higher for age and gender based on CDC growth chart
— Sickle cell disease
— Congenital or acquired heart disease
— Neurodevelopmental disorders (e.g. cerebral palsy) OR
— Medical-related technological dependence not related to COVID-19 (e.g. tracheostomy, gastrostomy or positive-pressure ventilation)
— Asthma, reactive airway or other chronic respiratory disease that requires daily medication for control