Investigational antibody treatment medications bamlanivimab, a monoclonal antibody; and casirivimab and imdevimab, a polyclonal antibody, are now available at Door County Medical Center for the treatment of SARS-CoV-2 coronavirus disease (COVID-19). The drugs have received an Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA).
Receiving bamlanivimab or casirivimab and imdevimab may reduce complications and mitigate hospitalization or emergency room visits for certain people with COVID-19.
The drugs are administered intravenously when someone who has tested positive for COVID-19 is experiencing mild to moderate symptoms (within 10 days of symptom onset), weighs 88 pounds (40 kg) or more, is over 12 years of age and is at high risk for progressing to severe COVID-19 and developing a need for hospitalization. Patients only receive the treatment at their own discretion.
These treatments are allocated to the states by the federal government, and then to hospitals throughout Wisconsin based on an algorithm the state uses to determine the number of doses each site is eligible to receive. Door County Medical Center has received allocations of both products based on that algorithm.
There is a team of clinicians at DCMC that calls positive COVID-19 results to patients. This team screens these patients for eligibility to receive the antibody treatments based on the criteria set forth in the Emergency Use Authorization, and when calling the results gives them the information about the antibody treatment. If the patient chooses to receive treatment they are then scheduled.
Within days of receiving the first shipment of antibody therapy, an unused area of the hospital was repurposed into an antibody infusion center. It took a team effort to accomplish this in such a short period of time.
"Everyday our knowledge about COVID-19 grows and with that comes new preventative and treatment options. We are relieved to have access to this antibody treatment and hope that it mitigates risk of severe cases of COVID-19 for people in Door County," says Dr. James Heise, Chief Medical Officer at Door County Medical Center.
If you are concerned about exposure to or symptoms of COVID-19 should visit dcmedical.org/covid19 to fill out an online form. Upon submission, patients will be contacted by Door County Medical Center staff as soon as possible Monday-Friday 8 a.m. to 4:30 p.m. to discuss their case and potentially schedule a COVID-19 test.
For more information on these drugs and COVID-19 treatment options, ask your healthcare provider or visit www.covid19treatmentguidelines.nih.gov.
About Emergency Use Authorization
These drugs are under an Emergency Use Authorization (EUA), meaning they are investigational, or still being studied. There is limited information known about the safety or effectiveness of using the medications to treat people with COVID-19. The drugs have not undergone the same type of review as an Food and Drug Administration (FDA) approved or cleared product. The FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, and available alternatives. In addition, the FDA decision is based on the totality of scientific evidence available showing that it is reasonable to believe that the product meets certain criteria for safety, performance, and labeling and may be effective in treatment of patients during the COVID-19 pandemic. All of these criteria must be met to allow for the product to be used in the treatment of patients during the COVID-19 pandemic.
The EUA is in effect for the duration of the COVID-19 declaration justifying emergency use of these products, unless terminated or revoked (after which the product may no longer be used).
Clinical trials were conducted before issuing the Emergency Use Authorization.
About Door County Medical Center
For more than 75 years, Door County Medical Center (DCMC) has been the leader in health and wellness for Door and Kewaunee counties. Our integrated medical center provides a wide range of specialties, including Primary Care, General Surgery, the Women’s and Children’s Center, the Door Orthopedic Center, Behavioral Health, the Door County Cancer Center, a skilled nursing facility, and rehabilitation services facilities among others. With its main campus in Sturgeon Bay and satellite clinics and rehabilitation services facilities in other smaller communities, DCMC provides expert care, close to home. More than 175 physicians serve on the medical staff. Visit www.dcmedical.org for more information.