COVID-19 Monoclonal Antibody Therapy Clinical Decision Tool

Since a November 2020 Federal Drug Administration Emergency Use Authorization (EUA), patients who test positive for COVID-19, have mild to moderate disease and are at risk for progression to severe disease have been eligible to receive a single intravenous (or subcutaneous) dose of therapeutic monoclonal antibodies (mAbs) against SARS CoV-2. Patients who are admitted to the hospital for reasons other than COVID-19, and who have mild-moderate COVID-19, may also receive these therapies. Just as human insulin is produced in large quantities in a laboratory, therapeutic monoclonal antibodies against SARS CoV-2 are produced by pharmaceutical companies. The products are effective with a low side-effect profile. Their approval was based on analyses of outpatient randomized controlled trials, which showed a reduction in COVID-19 related hospitalization or emergency room visits with their use. On July 30, 2021, the EUA was updated to add an indication for post-exposure prophylaxis of COVID-19 in certain individuals who are at high risk for progression to severe COVID-19. Post-exposure prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19. REGEN-COV is not authorized for pre-exposure prophylaxis for prevention of COVID-19.

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