Monoclonal Antibody Therapy
Newman Regional Health provides COVID-19 monoclonal antibody therapy (mAb) to eligible patients in accordance with the Food & Drug Administration (FDA) Emergency Use Authorization (EUA) criteria. Monoclonal antibody therapy may be available to patients meeting specific criteria and with a provider order only.
What is Monoclonal Antibody therapy
Monoclonal antibody (mAb) therapy, also called monoclonal antibody infusion treatment, is a way of treating COVID-19. The goal of this therapy is to help prevent hospitalizations, reduce viral loads and lessen symptom severity.
Monoclonal antibodies are mass-produced in a laboratory, resemble your natural antibodies, and are designed to recognize the spike protein on your cell’s outer shell.
These specific antibodies interfere with the virus’s ability to attach and gain entry into human cells, thus assisting your natural immune system to mount its own response.
This therapy can be extremely effective but is not a replacement for vaccination.
Monoclonal antibodies, or mAbs, are made in a laboratory to fight a particular infection—in this case, SARS-CoV-2—and are given to patients directly with an infusion.
How is monoclonal antibody therapy administered?
Monoclonal antibody therapy is given through an intravenous (IV) under the direction of a medical professional.
These infusions are administered over about an hour, followed by an hour of observation and monitoring.
Monoclonal antibody treatment may be available to patients who meet all of the following criteria:
- Are high risk for developing severe COVID-19
- Have a laboratory confirmed positive direct SARS-CoV-2 test
- Have not yet been admitted to the hospital
- Are 12 years of age or older (and at least 88 pounds)
- Treatment must begin within the first 10 days of symptoms
Patients must also meet one or more of the FDA’s EUA high risk criteria:
- Have a body mass index ≥35;
- Have chronic kidney disease;
- Have diabetes;
- Have immunosuppressive disease;
- Are currently receiving immunosuppressive treatment;
- Are ≥65 years of age;
- Are ≥55 years of age AND have cardiovascular disease, OR hypertension OR chronic obstructive pulmonary disease/other chronic respiratory disease;
- Are 12–17 years of age AND have BMI ≥85th percentile for their age and gender based on CDC growth charts, OR sickle cell disease, OR congenital or acquired heart disease, OR neurodevelopmental disorders, for example, cerebral palsy, OR a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19), OR asthma, reactive airway or other chronic respiratory disease that requires daily medication for control.