There are several COVID-19 oral antivirals under development, but anti-SARS-CoV-2 monoclonal antibodies are currently the only therapeutic authorized for:
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.
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.
For treatment, patients must meet all of these criteria:
For PEP, patients must meet all of these criteria:
There are currently three products that have received emergency use authorization.
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
Here are some resources to help you find a referral site:
The following websites have information for providers interested in offering monoclonal antibody therapy:
People at increased risk of severe COVID-19 and their caregivers should be advised: