COVID-19 monoclonal antibody infusions: A multidisciplinary initiative to operationalize EUA novel treatment options

Abstract

Objective: To develop and implement a process for administering COVID-19 monoclonal antibody infusions for outpatients with mild or moderate COVID-19 at high risk for hospitalization, using multidisciplinary collaboration, US Food and Drug Administration (FDA) guidance, and infection prevention standards. Methods: When monoclonal antibody therapy became available for mild or moderate COVID-19 outpatients via Emergency Use Authorization (EUA), our institution sought to provide this therapy option to our patients. We describe the process for planning, implementing, and maintaining a successful program for administering novel therapies based on FDA guidance and infection prevention standards. Keys components of our implementation process were multidisciplinary planning involving decision makers and stakeholders; setting realistic goals in the process; team communication; and measuring and reporting quality improvement on a regular basis. Results: A total of 790 COVID-19 monoclonal antibody infusions were administered from November 20, 2020 to March 5, 2021. Steps to minimize the likelihood of adverse drug reactions were implemented and a low incidence (< 1%) has occurred. There has been no concern from staff regarding infection during the process. Rarely, patients have raised cost-related concerns, typically due to incomplete communication regarding billing prior to the infusion. Patients, families, nursing staff, physicians, pharmacy, and hospital administration have expressed satisfaction with the program. Conclusion: This process can provide a template for other hospitals or health care delivery facilities to provide novel therapies to patients with mild or moderate COVID-19 in a safe and effective manner.