Real-world Effect of Monoclonal Antibody Treatment in COVID-19 Patients in a Diverse Population in the United States (preprint)

Background: Monoclonal antibodies (mAbs) against SARS-CoV-2 are a promising treatment for limiting the progression of COVID-19 and decreasing strain on hospitals. Their use, however, remains limited, particularly in disadvantaged populations. Methods: Electronic health records were reviewed from SARS-CoV-2 patients at a single medical center in the United States that initiated mAb infusions in January 2021 with the support of the U.S. Department of Health and Human Services' National Disaster Medical System. Patients who received mAbs were compared to untreated patients from the time period before mAb availability who met eligibility criteria for mAb treatment. We used logistic regression to measure the effect of mAb treatment on the risk of hospitalization or emergency department (E.D.) visit within 30 days of laboratory-confirmed COVID-19. Results: Of 598 COVID-19 patients, 270 (45%) received bamlanivimab and 328 (55%) were untreated. Two hundred and thirty-one patients (39%) were Hispanic. Among treated patients, 5/270 (1.9%) presented to the E.D. or required hospitalization within 30 days of a positive SARS-CoV-2 test, compared to 39/328 (12%) untreated patients (p<0.001). After adjusting for age, gender, and comorbidities, the risk of E.D. visit or hospitalization was 82% lower in mAb-treated patients compared to untreated patients (95% confidence interval [CI]: 66%-94%). Conclusions: In this diverse, real-world COVID-19 patient population, mAb treatment significantly decreased the risk of subsequent E.D. visit or hospitalization. Broader treatment with mAbs, including in disadvantaged patient populations, can decrease the burden on hospitals and should be facilitated in all populations in the United States to ensure health equity.

Implementation of SARS-CoV-2 monoclonal antibody infusion sites at three medical centers in the United States: Strengths and challenges assessment to inform COVID-19 pandemic and future public health emergency use (preprint)

Background: The COVID-19 pandemic caught the globe unprepared without targeted medical countermeasures, such as therapeutics, to target the emerging SARS-CoV-2 virus. However, in recent months multiple monoclonal antibody therapeutics to treat COVID-19 have been authorized by the U.S. Food and Drug Administration (FDA) under Emergency Use Authorization (EUA). Despite these authorizations and promising clinical trial efficacy results, monoclonal antibody therapies are currently underutilized as a treatment for COVID-19 across the U.S. Many barriers exist when deploying a new infused therapeutic during an ongoing pandemic with limited resources and staffing, and it is critical to better understand the process and site requirements of incorporating monoclonal antibody infusions into pandemic response activities. Methods: We examined the monoclonal antibody infusion site process components, resources, and requirements during the COVID-19 pandemic using data from three initial infusion sites at medical centers in the U.S. supported by the National Disaster Medical System. A descriptive analysis was conducted using process assessment metrics to inform recommendations to strengthen monoclonal antibody infusion site implementation. Results: The monoclonal antibody infusion sites varied in physical environment and staffing models due to state polices, infection control mechanisms, and underlying medical system structure, but exhibited a common process workflow. Sites operationalized an infusion process staffing model with at least two nurses per ten infusion patients. Monoclonal antibody implementation success factors included tailoring the infusion process to the patient community, strong engagement with local medical providers, batch preparing the therapy before patient arrival, placing the infusion center in proximity to emergency services, and creating procedures resilient to EUA changes. Infusion process challenges stemmed from confirming patient SARS-CoV-2 positivity, strained staff, scheduling needs, and coordination with the pharmacy for therapy preparation. Conclusions: Infusion site processes are most effective when integrated into the pre-existing pandemic response ecosystems and can be implemented with limited staff and physical resources. As the pandemic and policy tools such as EUAs evolve, monoclonal antibody infusion processes must also remain adaptable, as practice changes directly affect resources, staffing, timing, and workflows. Future use may be aided by incorporating innovative emergency deployment techniques, such as vehicle and home-based therapy administration, and by developing drug delivery mechanisms that alleviate the need for observed intravenous infusions by medically-accredited staff.