Central Florida physicians can help their non-hospitalized COVID-19 patients avoid potential hospitalization, intubation and death by referring them for monoclonal antibody therapy treatments.
And the good news is, the criteria was recently updated to include almost anyone deemed appropriate by a physician. This includes patients 65 and older, anyone overweight or obese, those with hypertension or diabetes, patients who are pregnant, and many other medical conditions or factors (such as race or ethnicity).
“Monoclonal antibodies are an effective but underutilized therapy to reduce COVID-19 severity in high-risk patients,” explains AdventHealth infectious disease specialist Dr. Vincent Hsu. “Although somewhat overshadowed by the vaccine rollout, we have increasing evidence that these therapies work. As clinicians, we believe in doing everything we can to save lives from COVID-19, and with patients in our community still contracting the virus, we will need these treatments for the foreseeable future.”
Recent Phase III clinical trial evidence demonstrated that when given early to high-risk patients, monoclonal antibodies, which are designed to mimic the body’s natural immune response, decrease the viral load and slow the progression of COVID-19, reducing hospitalizations and deaths.
Locally, clinicians at AdventHealth are seeing similar results at infusion centers in Orange, Lake and Volusia counties. Of the 1,772 high-risk COVID-19 patients AdventHealth treated with monoclonal antibodies between January through April 2021, only 117 (6.6%) were later admitted as an inpatient.
In November 2020, the Food and Drug Administration (FDA) first approved monoclonal antibodies for emergency use authorization (EUA) in high risk COVID-19. Already used to treat other viruses like Ebola and rabies, a monoclonal antibody is created by exposing a white blood cell to a specific viral protein, which is then cloned to mass produce antibodies that target that particular virus. With COVID-19, monoclonal antibodies have been developed to bind to the spike protein on the surface of the SARS-CoV-2 virus, helping to prevent it from attaching and entering human cells.
AdventHealth currently uses combination agent monoclonal antibody therapies as recent clinical trial evidence has shown them to be more effective than single-agent therapies.
“This could be due to the emergence of new COVID-19 variants,” explains Hsu. “Combination antibodies, by definition, hit more targets on the spike protein.”
REGEN-COV (Casirivimab and Imdevimab) is the only monoclonal antibody therapy currently available at AdventHealth, as the use of bamlanivimab and etesevimab together was recently paused in Arizona, California, Florida, Indiana, Oregon and Washington due to the prevalence virus variants. See the full details in this joint May 26, 2021 announcement by the Assistant Secretary for Preparedness and Response (ASPR) and the Food and Drug Administration (FDA).
Who is a candidate?
Monoclonal antibody therapy is not for everyone, but a significant number of COVID-19 patients could benefit from this treatment.
The Food and Drug Administration (FDA) has authorized monoclonal antibodies for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (age 12-17 years, ≥ 40 kg) with positive results of COVID-19, and who are at risk for progressing to severe COVID-19 and/or hospitalization. This includes anyone who meets any of the following conditions or criteria:
- Older age (≥ 65 years)
- Obesity or overweight
- Cardiovascular disease (for example, high blood pressure)
- Chronic lung diseases
- Chronic kidney disease
- Immunosuppressive disease or treatment
- Sickle cell disease
- Neurodevelopmental disorders
- Medical-related technological dependence
- Other medical conditions or factors (for example, race or ethnicity)
How can I refer patients?
A physician order is required for patients to receive monoclonal antibody therapy. To refer patients to an AdventHealth monoclonal antibody clinic in Central Florida:
- Lake County’s Tavares location:
- All providers, including AdventHealth Medical Group and Centra Care, see the process for referral or call 352-253-3044.
- Orange County’s Orlando location:
- Community providers: Submit the physician order form or call 407-303-7197.
- AdventHealth Medical Group providers: send referrals through Athena
- Order name: Regeneron Infusion Therapy Referral AIC ORL
- AdventHealth Centra Care providers: send referrals through Cerner
- Order name: Referral for Monoclonal Antibody Infusion
- Volusia County’s Orange City location:
- All providers, including AdventHealth Medical Group and Centra Care, see the process for referral and the physician order form or call 386-917-7833.
On the horizon, researchers are exploring the possibility that combination monoclonal antibody therapies could be used as preventive treatment for household contacts of patients who have tested positive for COVID-19. However, the FDA has not yet approved this specific use. For the latest updates on monoclonal antibodies, go to coronavirusphysicianresource.com/MAB.
A board-certified internal medicine, infectious diseases and preventive medicine physician, Dr. Vincent Hsu has been helping guide AdventHealth’s response to the COVID-19 pandemic. An award-winning physician whose excellence has been recognized by the U.S. Public Health Service and other organizations, Hsu serves as Medical Director of Continuing Medical Education and Assistant Director of the Internal Medicine Residency Program at AdventHealth and is an assistant professor at the University of Central Florida College of Medicine.
Hsu is a graduate of the Loma Linda University College of Medicine in California and completed his residency training at Legacy Portland Hospital. He also undertook advanced fellowship training in infectious diseases at the University of Southern California Medical Center and holds a Master of Public Health from University of California, Los Angeles (UCLA).