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

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, EHR informatics, compliance, legal, medical ethics, engineering, administration and other critical areas. Clear communication and a culture where 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 COVID-19 patients in the outpatient setting are met.

Association of Intravenous Bamlanivimab Use with Reduced Hospitalization, Intensive Care Unit Admission, and Mortality in Patients with Mild to Moderate COVID-19

“…The details of this program have been reported. 12 A multidisciplinary team reviewed all patients identified from an electronic registry of positive SARS-CoV-2 PCR tests and self- and clinician-referred patients. Under the EUA, patients were eligible for bamlanivimab if they had mild to moderate COVID-19, were within 10 days of symptom onset, and had at least one of the following criteria: age ≥65 years, body mass index (BMI) ≥35, diabetes, chronic kidney disease, immunosuppressive medication use, or an immunocompromising condition.…”

“…Mayo Clinic developed dedicated infusion facilities and assembled multidisciplinary teams to coordinate monoclonal antibody infusions to patients with coronavirus disease-19 (COVID-19) who are eligible under the EUA. 12,13 This study was conducted to analyze the association of bamlanivimab monotherapy with clinical outcomes in high-risk patients with mild to moderate COVID-19.…”

Case Report: Severe COVID-19 in a Kidney Transplant Recipient Without Humoral Response to SARS-CoV-2 mRNA Vaccine Series

“… 34 While vaccines remain the cornerstone of COVID-19 prevention, passive immunotherapy using neutralizing monoclonal antibodies could potentially be used prophylactically or as therapeutic in certain vulnerable populations, including recipients who were recently transplanted within 3 mo. 35 , 36 Compared with the mass vaccination strategy, justification of alternative vaccine dosage or schedule and the prophylactic use of passive immunotherapy are still lacking scientific evidence. Nevertheless, this case report and the review of the vaccine immunogenicity studies in transplant recipients reinforce the importance of continuing precautions to reduce exposure such as masking and physical distancing, mass vaccination, and vaccination of close household contacts, or until further studies are available on vaccine efficacy in these vulnerable patients.…”

Early Experience With Neutralizing Monoclonal Antibody Therapy For COVID-19

“…5 Hesitancy may be related to questions of treatment effectiveness, logistical challenges, and staffing requirements during the pandemic. 9 In the 2.5 month period following the EUA, Northwell scaled up an ambulatory MAB infusion operation and successfully administered therapy to over 2,800 eligible patients with most patients receiving therapy within 1.8 days of referral. The operational success required close collaboration and coordination of clinical, operation, informatics, information technology, ambulatory, and population health leadership to ensure the appropriate requirements were in place.…”

“…The Mayo Clinic recently reported their implementation of a program across multiple facilities in different states, culminating in over 4,000 doses delivered. 9…”