COVID-19 Therapeutic Monoclonal Antibody

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of COVID-19 Therapeutic Monoclonal Antibodies, for the treatment of mild to moderate COVID-19 in certain patients who are at high risk for progressing to severe COVID-19 and/or hospitalization. 

The following medical conditions or other factors may place adults and pediatric patients (age 12-17 years and weighing at least 40 kg) at higher risk for progressing to severe COVID-19:

• Older age (for example age ≥65 years of age)
• Obesity or being overweight (for example, adults with BMI >25 kg/m2, or if age 12-17, have BMI ≥85th percentile for their age and gender based on CDC growth charts
• Pregnancy
• Chronic kidney disease
• Diabetes
• 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 COVID-19 Therapeutic Monoclonal Antibodies 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.

LIMITATIONS OF AUTHORIZED USE- COVID-19 Therapeutic Monoclonal Antibodies is not authorized for use in patients:

• who are hospitalized due to COVID-19, OR
• who require oxygen therapy due to COVID-19, OR
• who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.

Benefit of treatment with COVID-19 Therapeutic Monoclonal Antibodies has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.

• Patient must meet the inclusion criteria
• Patient must have the following information readily available
  • Patient Name
  • DOB
  • Patient Mobile # (to initiate Virtual Care visit)
  • Patient Email
  • Date of + COVID-19 Result
  • Date of Symptom Onset
  • COVID Vaccination Status, including date of last shot (including booster)
• A health care provider can make also make a referral by calling 706-721-9449.

Provider Referral Form

Detailed instructions for infusion treatment will be provided upon scheduling.

Evusheld - Not Currently Authorized (Effective 1/26/2023)

Update: The FDA has suspended the use of Evusheld due to resistiant variants, once the suspension has lifted this treatment may be available again.

A long-acting monoclonal antibody drug called Evusheld  can help prevent COVID-19 infection in individuals who are severely immunocompromised. The preventive drug is delivered by intramuscular injections.

However, supplies are extremely limited. We are providing this therapy only to our severely immunocompromised patients, based on guidance from the National Institutes of Health (NIH) . We’ll continue our efforts to improve access to Evusheld, but are prioritizing its use to our highest-risk patient group for a while until supplies improve.

More information about this therapy.

Provider Referral Form