01/06/21: Due to the increase in cases of COVID-19 and the emergence of the Omicron variant,there is currently a low supply of COVID-19 therapeutics. The North Carolina Department of Health and Human Services has requested that treatments be limited to patients who meet the Tier 1, 2 or 3 criteria.
|1||Immunocompromised individuals not expected to mount an adequate immune response to COVID-19 vaccination or SARS-CoV-2 infection due to their underlying conditions, regardless of vaccine status (Immunocompromising Conditions); OR|
Unvaccinated individuals at the highest risk of severe disease (anyone aged ≥75 years or anyone aged ≥65 years with additional risk factors).
|2||Unvaccinated individuals at risk of severe disease not included in Tier 1 (anyone aged ≥65 years or anyone aged <65 years with clinical risk factors).|
|3||Vaccinated individuals at high risk of severe disease (anyone aged ≥75 years or anyone aged ≥65 years with clinical risk factors). Vaccinated individuals who have not received a COVID-19 vaccine booster dose are likely at higher risk for severe disease; tier 3 patients in this situation should be prioritized for treatment.|
People are considered to be moderately or severely immunocompromised if they have:
- Been receiving active cancer treatment for tumors or cancers of the blood
- Received an organ transplant and are taking medicine to suppress the immune system
- Received a stem cell transplant within the last 2 years or are taking medicine to suppress the immune system
- Moderate or severe primary immunodeficiency (such as DiGeorge syndrome, Wiskott-Aldrich syndrome)
- Advanced or untreated HIV infection
- Active treatment with high-dose corticosteroids or other drugs that may suppress your immune response
9/20/21:Due to changes in the federal and state processes for monoclonal antibody (mAb) treatments, high risk patients with positive COVID-19 test results will be given priority for infusions. A copy of the patient’s positive test results will be required—home tests not accepted. High risk patients who were exposed to COVID-19 but have not tested positive will be approved for mAb infusions on a very limited basis and will require a letter from their doctor along with the latest office notes indicating diagnoses (this does not guarantee approval).
To request a monoclonal antibody infusion, please fill out this form. The patient will be contacted within two business days to schedule an appointment.
As our phone lines are at maximum capacity, we ask that you please not call to confirm this request or schedule your appointment until this time period has passed. We appreciate your understanding as we work to serve our community.
Mercy Urgent Care is pleased to offer monoclonal antibody infusion to high-risk patients with COVID-19, as well as some individuals who have been exposed to COVID-19, even if they are not showing symptoms.
Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses. It’sused to treat mild to moderate symptoms of COVID-19 in non-hospitalized people who are at high risk for developing severe COVID-19 symptoms or the need for hospitalization. It is used for high-risk patients ages 12 and up, but Mercy Urgent Care will only provide infusions to ages 18 and older at this time.
Monoclonal Antibody Infusion Request Form
Who qualifies?Patients within 10 days of symptom onset, with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
The FDA has authorized the REGEN-COV monoclonal antibody (mAb) therapy for emergency use as post-exposure prophylaxis (prevention) in some individuals who have been exposed to COVID-19, even if they are not showing symptoms. Those who may qualify for this treatment include:
- Individuals who are not fully vaccinated
- Individuals who have immunocompromising conditions, including those taking immunosuppressive medications
- Individuals who have either been exposed to COVID-19 or are at high risk of exposure due to where they live or work
Please note that prevention against COVID-19 with monoclonal antibody therapy is not a substitute for vaccination against COVID-19 and is not authorized for pre-exposure prevention.
The following medical conditions or other factors may place patients at higher risk for progressing to severe COVID-19:
- Older age (for example, age ≥65 years of age)
- Obesity or being overweight (for example, BMI >25)
- Chronic kidney disease
- Immunosuppressive disease or immunosuppressive treatment
- Cardiovascular disease (including congenital heart disease) or hypertension
- Chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis and pulmonary hypertension)
- Sickle cell disease
- Neurodevelopmental disorders (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)
- Having a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID 19)) Other medical conditions or factors (for example, race or ethnicity) may also place individual patients at high risk for progressing to severe COVID-19 and authorization of REGEN-COV under the EUA is not limited to the medical conditions or factors listed above.
For additional information on medical conditions and factors associated with increased risk for progressing to severe COVID-19, see the CDC website. Healthcare providers should consider the benefit-risk for an individual patient.
Mercy Urgent Care is one of few providers in Western North Carolina that is currently providing monoclonal antibody infusions. Patients may request or receive a referral for the treatment, to be administered at Mercy Urgent Care West Asheville, from their regular health care providers. Patients will then be contacted to screen for and schedule the infusion, which is covered by insurance. The infusion isadministered via IV therapy and takes 21 minutes—or can be administered subcutaneously via 4 injections—followed by an hour of observation. Patients will be brought into the clinic through a separate entrance and kept in an area designated for infusions separate from the rest of the clinic’s urgent care services.
The United States FDA has made monoclonal antibody infusions available under an emergency access mechanism called an emergency use authorization (EUA). The EUA is supported by a Secretary of Health and Human Service (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic.
What are Monoclonal Antibody Infusions?
- Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses. It’sused to treat mild to moderate symptoms of COVID-19 in non-hospitalized adults who are at high risk for developing severe COVID-19 symptoms or the need for hospitalization
- The infusion is a IV therapy administered in an outpatient or hospital setting thatdirectly neutralizes the COVID-19 virus
- It takes 21 minutes to administer, followed by an hour of observation. Afterwards, you are sent home and should continue isolating
- It is important to receive the treatment as soon as possible following a positive test result and within 10 days of symptom onset
- In clinical trials, those who received this treatment soon after diagnosis experienced fewer symptoms and hospitalizations
Monoclonal Antibody Infusion Process
- Provider fills out request form for monoclonal antibody treatment
- Patient is contacted for screening and to set up infusion for that day or next
- Day of Infusion:
- Mercy provider will examine patient prior to infusion.
- Patient brought into clinic through a separate entrance and kept in an area designated for infusions separate from regular urgent care services. Patient will need to sign consent form.
- Baseline vitals taken and IV is placed. Patient will be constantly monitored and vitals taken before, during, and after infusion.
- After infusion or subcutaneous injections are complete, patient will remain under supervision for 1 hr.
- Follow-up telemedicine appointment scheduled for 7 days from infusion
Please check with your insurance before treatment to see if your policy fully covers the cost of this procedure. Insurance may or may not cover co-pays or cost share based on your own individual policy coverage. MUC will bill you for any portion not covered by insurance.
- “FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19” FDA.gov
- Centers for Medicare and Medicaid Services
- “Monoclonal Antibodies for COVID-19: What We Know So Far” — Medical News Today
- “Regeneron Antibody Cocktail May Reduce COVID-19 Hospitalization by 70%” — Healthline
- “Like Somebody Gave Me A Happy Pill” — USA Today