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Regen COV (casirivimab and imdevimab) is not authorized for use in patients:

Who are hospitalized due to COVID-19
Who are require oxygen therapy due to COVID-19
Who require an increase in baseline oxygen flow rate due to COVID-19 in those chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.

Who may utilize Monoclonal Antibodies (MAbs)

MAbs may be used for the treatment of mild to moderate COVID-19 in adults and pediatric patients who meet all of the following:

Have a positive test for SARS-CoV-2 (molecular / PCR or antigen)
Are within 10 days of the start of their symptoms
Are at least 12 years of age or older and weigh at least 40 kgs
Are at a high risk for progressing to severe COVID-19 and / or hospitalization

Post- Exposure Prophylaxis (Exposure)

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, REGEN-COV (casirivimab and imdevimab) co-formulated.

Monoclonal

Antibodies

MAbs may be used for the treatment of mild to moderate COVID-19 in adults and pediatric patients