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Disaster Med Public Health Prep ; : 1-32, 2022 Jan 14.
Article in English | MEDLINE | ID: covidwho-1625403


Monoclonal antibody therapeutics to treat COVID-19 have been authorized by the U.S. Food and Drug Administration under Emergency Use Authorization (EUA). Many barriers exist when deploying a novel therapeutic during an ongoing pandemic, and it is critical to assess the needs of incorporating monoclonal antibody infusions into pandemic response activities. We examined the monoclonal antibody infusion site process during the COVID-19 pandemic and conducted a descriptive analysis using data from three sites at medical centers in the U.S. supported by the National Disaster Medical System. Monoclonal antibody implementation success factors included engagement with local medical providers, therapy batch preparation, placing the infusion center in proximity to emergency services, and creating procedures resilient to EUA changes. Infusion process challenges included confirming patient SARS-CoV-2 positivity, strained staff, scheduling, and pharmacy coordination. Infusion sites are effective when integrated into pre-existing pandemic response ecosystems and can be implemented with limited staff and physical resources.

Open Forum Infect Dis ; 8(8): ofab398, 2021 Aug.
Article in English | MEDLINE | ID: covidwho-1364829


BACKGROUND: Monoclonal antibodies (mAbs) against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are a promising treatment for limiting the progression of coronavirus disease 2019 (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 US Department of Health and Human Services' National Disaster Medical System. Patients who received mAbs were compared with 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 (ED) 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 thirty-one patients (39%) were Hispanic. Among treated patients, 5/270 (1.9%) presented to the ED or required hospitalization within 30 days of a positive SARS-CoV-2 test, compared with 39/328 (12%) untreated patients (P < .001). After adjusting for age, gender, and comorbidities, the risk of ED visit or hospitalization was 82% lower in mAb-treated patients compared with untreated patients (95% CI, 56%-94%). CONCLUSIONS: In this diverse, real-world COVID-19 patient population, mAb treatment significantly decreased the risk of subsequent ED 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.