COVID-19: Providers
Monoclonal Antibodies and Other Outpatient Therapeutics
There are several COVID-19 oral antivirals under development, but anti-SARS-CoV-2 monoclonal antibodies are currently the only therapeutic authorized for:
- Treatment of non-hospitalized patients with mild to moderate COVID-19 who are at high risk of progressing to severe disease.
- Post-exposure prophylaxis (PEP) for people at high risk of progressing to severe COVID-19.
Monoclonal antibodies are made in a laboratory and work as substitute antibodies that can help fight an infection before the body mounts its own immune response. The antibodies are directed against specific targets on the spike protein of SARS-CoV-2, blocking viral entry into cells. They are recommended by the National Institutes of Health COVID-19 Treatment Guidelines for outpatient treatment of COVID-19 and post-exposure prophylaxis (PEP).
If you start treatment soon after the onset of symptoms, monoclonal antibodies can decrease the risk of hospitalization and death due to COVID-19 by as much as 70% to 85% and reduce hospital length of stay and emergency department visits.
As PEP, the antibodies can reduce the risk of developing symptomatic COVID-19 by 80%.
Providers should refer all eligible symptomatic patients for this treatment, regardless of a patient's vaccination status.
- Visual Abstract: Refer Patients for Monoclonal Antibody Therapy for COVID-19 (PDF, September 2021)
Eligibility
Monoclonal antibody therapy is authorized for people who have a medical condition or other factors that increase their risk for severe illness.
We recommend you consider race and ethnicity when assessing individual risk. A patient may have been impacted by longstanding systemic health and social inequities that put them at increased risk of getting sick and dying from COVID-19.
Specific Criteria for Treatment and PEP Therapy
For treatment, patients must meet all of these criteria:
- Age 2 years and older
- Test positive for SARS-CoV-2 on a nucleic acid amplification test or antigen test
- Have mild to moderate COVID-19 symptoms
- Be within 10 days of symptom onset
- Not be hospitalized or receiving oxygen therapy due to COVID-19
For PEP, patients must meet all of these criteria:
- Not fully vaccinated or expected to have an adequate immune response to COVID-19 vaccination due to immunocompromise or other factors
- Either they have been exposed to a person with COVID-19 or they live in an institutional setting where others have COVID-19 (such as a nursing home or correctional facility)
Available Products
There are currently three products that have received emergency use authorization.
Bamlanivimab and etesivimab
- Indication: Treatment or PEP
- Administration: IV infusion
- FDA Documentation:
Casirivimab and imdevimab (REGEN-COV)
- Indication: Treatment or PEP
- Administration: For treatment, IV infusion (strongly recommended) or sub-cutaneous. For PEP, IV infusion or sub-cutaneous
- FDA Documentation:
Sotrovimab
- Indication: Treatment
- Administration: IV infusion
- FDA Documentation:
Clinical Considerations
To decide if monoclonal antibody therapy is appropriate for a patient, refer to the Monoclonal Antibody Therapy Decision Support Tool for Health Care Providers (PDF).
Treatment is most effective when given soon after symptom onset and should be considered for eligible patients, regardless of vaccination status.
For PEP, there is no optimal timing stated in the emergency use authorization. Clinical trials evaluating their efficacy included patients within 96 hours of exposure.
Referring or Offering Monoclonal Antibody Therapy
Referring for Therapy
Here are some resources to help you find a referral site:
- Health Information Tool for Empowerment: Monoclonal Antibody Treatment Site Locator
- NYC Health + Hospitals: ExpressCare; 212-COVID19 (212-268-4319)
- U.S. Department of Health and Human Services (HHS): Therapeutics Distribution Locations
Offering Therapy
The following websites have information for providers interested in offering monoclonal antibody therapy:
- HHS: Administering Monoclonal Antibody Treatments for COVID-19 in Your Facility (PDF)
- HHS: Outpatient Cost and Coverage for Monoclonal Antibody Treatments (PDF)
- HHS: Monoclonal Antibody Playbook for Outpatient Administration
- New York State: Ordering COVID-19 Monoclonal Antibody Therapeutics: Information for Providers
Patient Education
People at increased risk of severe COVID-19 and their caregivers should be advised:
- About the benefits of prompt monoclonal antibody therapy to reduce the risk of hospitalization and death
- To immediately get tested if they develop COVID-19 symptoms
- To contact their provider right away if they test positive or suspect they were exposed to COVID-19
Resources for Patients
- COVID-19: Treatments
- Monoclonal Antibody Treatment for COVID-19 (PDF, August 20)
Other Languages: Español | Русский | 繁體中文 | 简体中文 | Kreyòl ayisyen | 한국어 | বাংলা | Italiano | Polski | ײִדיש |العربية | Français | اردو - Palm Card: Monoclonal Antibody Treatment for COVID-19 (PDF, September 21)
- NYC Health + Hospitals: Monoclonal Antibody Eligibility Screening Tool
Additional Resources
- Letter to Providers: Updates on COVID-19 Monoclonal Antibody Treatment in the Outpatient Setting (PDF, August 20)
- Note: Ordering information and the emergency use authorization for bamlanivimab/etesevimab have been updated.
- COVID-19 Monoclonal Antibody Treatment in the Outpatient Setting (PDF, March 30)
- HHS: Monoclonal Antibody Treatment Resources for Clinicians and Patients
- HHS: COVID-19 Monoclonal Antibody Therapeutics Digital Toolkit
- NIH: COVID-19 Treatment Guidelines
- Infectious Diseases Society of America: COVID-19 Treatment Guidelines