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J Prim Care Community Health ; 12: 21501327211019282, 2021.
Article in English | MEDLINE | ID: covidwho-1242235


BACKGROUND: The clinical outcomes of patients who decline anti-spike monoclonal antibody therapies for coronavirus disease-2019 (COVID-19) is not known. Factors associated with the decision to accept or decline the offer for anti-spike monoclonal antibody therapies are not established. This study aimed to identify factors impacting the decision to consent for monoclonal antibody therapies and assess the differences in clinical outcomes of patients who accepted compared to those who declined these therapies. METHODS: This retrospective cohort study enrolled 2820 adult patients who were offered monoclonal antibody therapies, bamlanivimab and casirivimab-imdevimab, for COVID-19 at Mayo Clinic in the Midwest between 11/19/2020 and 12/31/2020. The primary endpoint is the decision to accept or decline monoclonal antibody treatment. Secondary endpoints were patient-level factors that could have impacted the decision to accept treatment (age, gender, race, ethnicity, primary language spoken, and medical comorbidities). The main clinical endpoint was hospitalization within 28 days of COVID-19 diagnosis. RESULTS: 59.1% (n = 1669) chose to accept monoclonal antibody therapy, and 40.9% (n = 1151) chose to decline the offer for treatment. Patients were more likely to accept treatment if they were non-Hispanic White, English speaking, identified a spouse or life partner, had a religious affiliation, and possessed more medical comorbidities. Overall, 28-day hospitalization rate was 2.6% (n = 72/2820) and was higher among those who declined (3.3%) than those who accepted monoclonal antibody therapy (2.0%; Rate Ratio = 0.62, 95% Confidence Interval, 0.39-0.98). CONCLUSIONS: Despite having more comorbidities, patients who accepted monoclonal antibody treatments had a lower rate of hospitalization compared to patients who declined treatment. Several social and cultural factors were associated with the decision to decline therapy, including race, language, ethnicity, and lack of social support. These findings can inform public health efforts to reduce social disparities in the treatment of COVID-19 and increase utilization of monoclonal antibody therapies in high risk populations.

Antibodies, Monoclonal , COVID-19 , Adult , Antibodies, Monoclonal/therapeutic use , COVID-19 Testing , Humans , Informed Consent , Retrospective Studies , SARS-CoV-2
Mayo Clin Proc ; 96(5): 1250-1261, 2021 05.
Article in English | MEDLINE | ID: covidwho-1219872


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.

Antiviral Agents/administration & dosage , COVID-19 , Critical Pathways , Home Infusion Therapy , SARS-CoV-2 , Spike Glycoprotein, Coronavirus , Antibodies, Monoclonal/administration & dosage , COVID-19/epidemiology , COVID-19/therapy , Clinical Protocols , Critical Pathways/organization & administration , Critical Pathways/trends , Efficiency, Organizational , Home Infusion Therapy/methods , Home Infusion Therapy/standards , Humans , Intersectoral Collaboration , Organizational Culture , Program Development/methods , SARS-CoV-2/immunology , SARS-CoV-2/isolation & purification , Severity of Illness Index , Spike Glycoprotein, Coronavirus/antagonists & inhibitors , Spike Glycoprotein, Coronavirus/immunology , United States/epidemiology