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. 2021 May;96(5):1250-1261.
doi: 10.1016/j.mayocp.2021.03.010. Epub 2021 Mar 9.

A Framework for Outpatient Infusion of Antispike Monoclonal Antibodies to High-Risk Patients with Mild-to-Moderate Coronavirus Disease-19: The Mayo Clinic Model

Raymund R Razonable  1 , Nicole C E Aloia  2 , Ryan J Anderson  3 , Gokhan Anil  4 , Lori L Arndt  5 , Richard F Arndt  6 , Sara E Ausman  6 , Sarah J Bell  7 , Dennis M Bierle  8 , Marcie L Billings  9 , Rachel K Bishop  10 , Carl H Cramer  11 , Tracy L Culbertson  12 , Ala S Dababneh  13 , Amber N Derr  14 , Kevin Epps  15 , Susan M Flaker  16 , Ravindra Ganesh  8 , Mary A Gilmer  17 , Eric Gomez Urena  18 , Christopher R Gulden  19 , Tamara L Haack  20 , Sara N Hanson  21 , Jenna R Herzog  22 , Alexander Heyliger  3 , Lex D Hokanson  23 , Laura H Hopkins  24 , Richard J Horecki  25 , Bipinchandra Hirisave Krishna  26 , W Charles Huskins  27 , Tammy A Jackson  28 , Ryan R Johnson  29 , Betty Jorgenson  30 , Cory Kudrna  31 , Brian D Kennedy  32 , Mary K Klingsporn  33 , Brian Kottke  30 , Jennifer J Larsen  7 , Sarah R Lessard  17 , Larry I Lutwick  5 , Edward J Malone 3rd  34 , Jennifer A Matoush  7 , Ivana N Micallef  35 , Darcie E Moehnke  7 , Muhanad Mohamed  5 , Colleena N Ness  36 , Shelly M Olson  37 , Robert Orenstein  38 , Raj Palraj  13 , Janki Patel  5 , Damian J Paulson  13 , David Phelan  13 , Margaret T Peinovich  6 , Wilford L Ramsey  39 , Taunya J Rau-Kane  36 , Kevin I Reid  40 , Karen J Reinschmidt  41 , Maria Teresa Seville  38 , Erin C Skold  42 , Jill M Smith  9 , Leigh L Speicher  43 , Laurie A Spielman  37 , Donna J Springer  13 , Perry W Sweeten  44 , Jennifer M Tempelis  17 , Sidna Tulledge-Scheitel  45 , Paschalis Vergidis  13 , Daniel C Whipple  41 , Caroline G Wilker  46 , Molly J Destro Borgen  39
Affiliations

A Framework for Outpatient Infusion of Antispike Monoclonal Antibodies to High-Risk Patients with Mild-to-Moderate Coronavirus Disease-19: The Mayo Clinic Model

Raymund R Razonable et al. Mayo Clin Proc. 2021 May.

Abstract

The administration of spike monoclonal antibody treatment to patients with mild to moderate COVID-19 is very challenging. This article summarizes essential components and processes in establishing an effective spike monoclonal antibody infusion program. Rapid identification of a dedicated physical infrastructure was essential to circumvent the logistical challenges of caring for infectious patients while maintaining compliance with regulations and ensuring the safety of our personnel and other patients. Our partnerships and collaborations among multiple different specialties and disciplines enabled contributions from personnel with specific expertise in medicine, nursing, pharmacy, infection prevention and control, electronic health record (EHR) informatics, compliance, legal, medical ethics, engineering, administration, and other critical areas. Clear communication and a culture in which all roles are welcomed at the planning and operational tables are critical to the rapid development and refinement needed to adapt and thrive in providing this time-sensitive beneficial therapy. Our partnerships with leaders and providers outside our institutions, including those who care for underserved populations, have promoted equity in the access of monoclonal antibodies in our regions. Strong support from institutional leadership facilitated expedited action when needed, from a physical, personnel, and system infrastructure standpoint. Our ongoing real-time assessment and monitoring of our clinical program allowed us to improve and optimize our processes to ensure that the needs of our patients with COVID-19 in the outpatient setting are met.

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Figures

Figure 1
Figure 1
Interaction among practice providers, patients, and other personnel in the workflow of allocation, education, consenting, infusion, and monitoring for spike monoclonal antibody therapies for mild-to-moderate COVID-19.
Figure 2
Figure 2
Simplified workflow for patient identification, clinical evaluation, and monoclonal antibody allocation to high-risk patients with mild-to-moderate COVID-19.
Figure 3
Figure 3
Weekly number of antispike monoclonal antibody infusions during the first 10 weeks of the Mayo Clinic Monoclonal Antibody Program across geographically diverse COVID-19–dedicated outpatient infusion centers.
See this image and copyright information in PMC

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