Background: Clinical data to support the use of bamlanivimab for the treatment of outpatients with mild to moderate coronavirus disease-19 (COVID-19) is needed.Methods: 2,335 patients who received single-dose bamlanivimab infusion between November 12, 2020 to February 17, 2021 were compared with a propensity-matched control of 2,335 untreated patients with mild to moderate COVID-19 at Mayo Clinic facilities across 4 states.The primary outcome was the rate of hospitalization at days 14, 21 and 28. Results:The median age of the population was 63 years-old; 47.3% of the bamlanivimabtreated cohort were ≥65 years; 49.3% were female. High-risk characteristics included hypertension (54.2%), body mass index ≥35 (32.4%), diabetes mellitus (26.5%), chronic lung disease (25.1%), malignancy (16.6%), and renal disease (14.5%). Patients who received bamlanivimab had lower all-cause hospitalization rates at days 14 (1.5% vs 3.5%; Risk Ratio [RR], 0.41), 21 (1.9% vs 3.9%; RR, 0.49), and 28 (2.5% vs 3.9%; RR, 0.63). Secondary exploratory outcomes included lower intensive care unit admission rates at days 14 (0.14% vs 1%; RR, 0.14), 21 (0.25% vs 1%; RR: 0.25) and 28 (0.56% vs 1.1%; RR: 0.51), and lower allcause mortality at days 14 (0% vs 0.33%), 21 (0.05% vs 0.4%; RR,0.13) and 28 (0.11% vs 0.44%; RR, 0.26). Adverse events were uncommon with bamlanivimab, occurring in 19/2355, most commonly fever (n=6), nausea (n=5), and lightheadedness (n=3).Conclusions: Among high-risk patients with mild to moderate COVID-19, treatment with bamlanivimab was associated with a statistically significant lower rate of hospitalization, ICU admission and mortality, compared with usual care.
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.
The effectiveness of bebtelovimab in real-world settings has not been assessed. In this retrospective cohort study of 3,607 high-risk patients, bebtelovimab was used more commonly than nirmatrelvir-ritonavir for treatment of COVID-19 among older patients, immunosuppressed patients, and those with multiple comorbidities. Despite its use in highly comorbid patients, the rates of progression to severe disease after bebtelovimab (1.4%; 95% confidence interval: 1.2, 1.7) was not significantly different from nirmatrelvir-ritonavir treatment (1.2%; 95% confidence interval: 0.8, 1.5). Our findings support the emergency use authorization of bebtelovimab for treatment of COVID-19 during the Omicron epoch dominated by BA.2 and subvariants.
Consultation with key physicians regarding the proposed percent reduction resulted in a 10% dose reduction for all cases when utilizing these three agents. Implementation of a dose rounding protocol for bevacizumab, trastuzumab, and cetuximab represents a potentially substantial cost savings at this institution.
Background Residents of nursing homes and long‐term care facilities are at increased risk for severe coronavirus disease‐19 (COVID‐19) but may not be able to access monoclonal antibody therapies offered at outpatient infusion centers due to frailty and logistical issues. We describe a mobile monoclonal antibody infusion program for patients with COVID‐19 in skilled nursing facilities and provide descriptive data on its outcomes. Design Retrospective cohort study. Setting Collaboration between Mayo Clinic and skilled nursing facilities in Southeast Minnesota was developed to administer anti‐spike monoclonal antibodies under the FDA Emergency Use Authorization. Participants Seventy five residents of skilled nursing facilities at high risk of COVID‐19 complications. Exposure Emergency use treatment with bamlanivimab and casirivimab–imdevimab. Measurements Hospitalization and medically attended visits. Results The mobile infusion unit, staffed by Mayo Clinic Infusion Therapy registered nurses and supported by the skilled nursing facility staff, infused anti‐spike monoclonal antibodies to 45 of 75 patients (average age, 77.8 years) in December 2020. The infusions occurred at an average of 4.3 days after COVID‐19 diagnosis. Fourteen days after infusion, there were no deaths, two emergency department visits, and three hospitalizations, for a combined event rate of 11.1%. There was one reported adverse event. Conclusion The implementation of a mobile infusion unit embedded in a collaborative process resulted in rapid infusion of monoclonal antibodies to high‐risk COVID‐19 patients in skilled nursing facilities, who would otherwise be unable to access the novel therapies. The therapies were well tolerated and appear beneficial. Further study is warranted to explore the scalability and efficacy of this program.
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