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U.S. Department of Health and Human Services

High-Risk Outpatients with COVID-19

High-Risk Individuals May Avoid Hospitalization with COVID-19 Monoclonal Antibody Treatment

Female asian physician counsels elderly patient


FDA Emergency Use Authorizations allow healthcare providers to administer COVID-19 monoclonal antibody (mAb) therapeutics to individuals who have been exposed to COVID-19 or individuals who have been infected and have mild to moderate symptoms.


Early Action Is Vital

High-risk COVID-19 outpatients must receive treatment within 10 days of symptom onset. Also, consider:

  • Discussing monoclonal antibodies, the importance of reporting symptoms, and COVID-19 testing with your high-risk patients during routine care appointments.
  • Pre-identifying patients who may be eligible for monoclonal antibody treatment.

Post-exposure prophylactic treatment of high-risk individuals should occur as soon as possible following exposure to SARS-CoV-2. Repeat dosing may be appropriate for individuals who have ongoing exposure to SARS-CoV-2 for longer than 4 weeks and who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination.


Eligibility

Protecting Patients
after a COVID-19 Exposure
Treating Individuals
with Mild to Moderate COVID-19 Symptoms

Healthcare providers can prescribe COVID-19 mAb therapeutics for post-exposure prophylaxis to individuals who have one or more of the high-risk factors and either:

  • are not fully vaccinated or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination, 
    OR
  • have been in close contact with an infected individual or are at high risk of continued exposure to an individual infected with SARS-CoV-2.

Note: Only one mAB product, REGEN-COV, is authorized for prophylactic use.

Outpatients can be prescribed COVID-19 mAb therapeutics if they have one or more of the high-risk factors and:

  • have experienced the onset of mild to moderate symptoms of COVID-19 in the last 10 days,
    AND
  • have tested positive for COVID-19.


High Risk Factors

Emergency Use Authorizations for COVID-19 mAbs provide latitude to healthcare providers to exercise their clinical judgment for both prophylactic use and use with individuals who have mild to moderate COVID-19 symptoms. These individuals may be eligible for monoclonal antibody treatment if they meet the following criteria for REGEN-COV TM (casirivimab with imdevimab), bamlanivimab and etesevimab, and sotrovimab:

  • Are an adult or pediatric (≥ 12 years of age and weighing at least 40 kg) patient; AND
  • Are at high risk for progressing to severe COVID-19 and/or hospitalization. High-risk factors include a medical condition or other factor, including race/ethnicity, that puts the outpatient at higher risk for progressing to severe COVID-19. Eligibility is not limited to the conditions and factors listed below.
    • ≥ 65 years of age
    • Obesity or being overweight based on CDC clinical growth charts
    • Pregnancy
    • Chronic kidney disease
    • Diabetes
    • Immunosuppressive disease or immunosuppressive treatment
    • Cardiovascular disease or hypertension
    • Chronic lung diseases
    • Sickle cell disease
    • Neurodevelopmental disorders
    • Having a medical-related technological dependence (for example: tracheostomy, gastrostomy, or positive pressure ventilation not related to COVID-19)

For additional information on medical conditions and factors associated with increased risk for progression to severe COVID-19, see the CDC’s information on ways that COVID-19 affects people with certain medical conditions.   

To guide outpatient treatment decisions:

  • See section 15 of the fact sheets from FDA’s Center for Drug Evaluation  on REGEN-COV TM (casirivimab with imdevimab), Bamlanivimab and Etesevimab, and Sotrovimab to learn more about antiviral resistance.
  • Refer to the CDC website, as well as information from state and local health authorities, for reports of viral variants in their region, and for current masking recommendations.

In addition to outpatient treatments, the FDA granted EUA for a recombinant humanized monoclonal antibody, Actemra (tocilizumab,) for certain hospitalized COVID-19 patients.


Administration Site Locations and Treatment Costs

Treatment can be provided by intravenous infusion or by subcutaneous injection. Subcutaneous injection is authorized by the FDA as an alternative route of administration when intravenous infusion is not feasible and would lead to delay in treatment. 

Because the federal government has purchased a supply of certain monoclonal antibody treatments, there is no cost to individuals for the monoclonal antibody products themselves; however, there may be costs incurred from administration of the product. Both Medicare and Medicaid/CHIP cover costs for infusion and subcutaneous routes of  administration.

 

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  • This page last reviewed: September 28, 2021