Antibodies are proteins created by certain cells in your immune system to recognize and destroy harmful microorganisms, such as bacteria or viruses. After fighting off the infection, the cells are able to remember the invaders, quickly recognize them and produce protective antibodies again. The FDA authorized emergency use of monoclonal antibodies to treat eligible COVID-19 patients. The treatment is given as an infusion and is available at some Froedtert & the Medical College of Wisconsin locations.
What Are Monoclonal Antibodies?
Monoclonal antibodies are man-made versions of the antibody proteins made by the human body. Throughout the COVID-19 pandemic, clinicians and researchers have been working on a coronavirus cure. One effort has been to determine which antibodies can fight the COVID-19 virus, isolate them, replicate them in a lab setting and then mass produce them to use as treatment.
Is Monoclonal Antibody Therapy Effective Against COVID-19?
Clinical trials have shown that some monoclonal antibodies, such as bamlanivimab, used alone or with etesevimab and a combination of casirivimab and imdemivab, prevent hospitalizations and emergency room visits in people who have mild to moderate symptoms of COVID-19. The monoclonal antibodies stop the disease from progressing by quickly reducing the quantity of virus in the infected person’s blood. Studies are still ongoing, but the existing data prompted the FDA to issue emergency use authorizations to drug makers Eli Lilly and Company and Regeneron Pharmaceuticals.
How Does Monoclonal Antibody Therapy Work?
Bamlanivimab and esetevimab are produced by Eli Lilly, and the combination treatment of casirivimab and imdemivab is produced by Regeneron. The treatments are single infusions that are given in an outpatient setting. The infusions work by providing the body with a large quantity of monoclonal antibodies that attach to the virus particle that causes COVID-19, which prevents the virus from attaching to and entering cells in the body. The infusion should be given as soon as possible after a positive COVID-19 test and within 10 days of the onset of COVID symptoms.
“COVID-19 has two phases,” said Njeri Wainaina, MD, infectious disease specialist with the Froedtert & MCW health network. “The first phase is caused directly by the virus, and the second phase, which is more severe, is due to inflammation that is driven by the body’s immune response. The second phase can be avoided by treating the first phase. If we can block the virus from entering cells and reduce the extent of infection, we can effectively prevent severe COVID-19.”
Who Is Eligible for Monoclonal Antibody Therapy?
According to the authorizations from the FDA, only high-risk patients who have tested positive for COVID-19 and have mild to moderate COVID symptoms can receive monoclonal antibody therapy. Adults who meet at least one of the following criteria are defined as high risk by the FDA:
- Have a body mass index (BMI) over 35
- Have chronic kidney disease
- Have diabetes
- Have immunosuppressive disease
- Are currently receiving immunosuppressive treatment (for example, cancer patients or transplant patients)
- Are over the age of 65
- Are over 55 years of age and have one of the following:
- cardiovascular disease
- chronic obstructive pulmonary disease or other chronic respiratory diseases
People who have already been hospitalized due to COVID-19 or require oxygen due to COVID-19 are not eligible for monoclonal antibody therapy.
How Can I Get Monoclonal Antibody Therapy?
The U.S. Department of Health and Human Services is responsible for overseeing the distribution of supplies from Eli Lilly and Regeneron to individual states. Quantities allocated to individual states are determined based on each state’s percentage of confirmed COVID-19 cases and weekly COVID-19 hospitalization rate. In Wisconsin, a subcommittee of the State Disaster Medical Advisory Committee, a part of the Wisconsin Department of Health Services, was responsible for determining how these medications would be equitably distributed to local health systems.
The Froedtert & MCW health network offers monoclonal antibody therapy at its infusion clinics in three different locations. Eli Lily’s bamlanivimab infusion is available at Froedtert & MCW Froedtert Hospital and at the Froedtert & MCW Moorland Reserve Health Center. Regeneron’s casirivimab and imdemivab combination infusion is available at the Froedtert & MCW West Bend Health Center.
“We used the FDA’s criteria to determine which patients we would be able to offer the treatment to,” Dr. Wainaina said. “Then, we had to develop a process to identify these people in a timely manner.”
Mark Lodes, MD, a Froedtert & MCW internal medicine and pediatric physician and vice president and chief medical officer for Froedtert & MCW Population Health and Medical Education, worked with Dr. Wainaina to design the identification process.
“We used our internal databases to help us pinpoint eligible patients who get a positive COVID-19 test result at Froedtert & MCW test sites,” Dr. Lodes said. “When a person schedules a test, we gather the information we need on risk factors, based on the authorizations from the FDA that could qualify them for monoclonal antibody therapy. If their test is positive, this patient’s case is pulled into an internal registry. Our system generates a report for us each day of patients who have had positive COVID-19 tests, including which criteria they meet for the treatment.”
If, after a positive COVID-19 test, you are eligible for monoclonal antibody therapy, a nurse from the Froedtert & MCW virtual care team will proactively reach out to you to offer the treatment. The nurse will help you schedule your appointment to receive it. In January 2021, the Froedtert & MCW health network had infused more than 500 patients.
“We have developed a fast and efficient way to pinpoint which of our patients can benefit from this treatment,” Dr. Lodes said. “We are very encouraged by the results. Our early data is in line with the clinical trials that support the FDA authorizations. We are seeing an extremely low percentage of patients who have been treated with monoclonal antibody therapy needing to be hospitalized for further COVID-19 treatment.”
Froedtert & MCW’s patient identification process for monoclonal antibody therapy was a collaborative effort between Froedtert & MCW leadership and several teams, including infectious disease, population health, information technology, pharmacy, infusion clinic staff and the virtual care team through Inception Health, the hub for the Froedtert & MCW health network’s digital health services.
“Everyone put their best foot forward,” Dr. Wainaina said. “Figuring this out together felt like being a part of a winning Olympic team.”
Can I Get the COVID-19 Vaccine After Monoclonal Antibody Therapy?
It is still unclear how monoclonal antibody therapy could interfere with the COVID-19 vaccine. According to the Centers for Disease Control and Prevention (CDC), there is not enough data on the safety and efficacy of the vaccine in people who have received monoclonal antibody therapy. The CDC’s recommendation is to defer vaccination for 90 days as a precautionary measure.
Learn more about COVID-19 testing and care options.