Implementation and outcomes of monoclonal antibody infusion for COVID-19 in an inner-city safety net hospital: A South-Bronx experience

Abstract

Background Monoclonal antibody therapy (MAT) is recommended in mild to moderate Coronavirus disease 2019 (COVID-19) patients who are at risk of progressing to severe disease. Due to limited data on its outcomes and the logistic challenges in administering the drug, MAT has not been widely used in the United States (US) despite of emergency use authorization (EUA) approval by the Food and Drug Administration (FDA). Aim We aim to study the outcomes of MAT in patients predominantly from ethnic minority groups and the challenges we experienced in implementing the infusion therapy protocol in an inner-city safety-net-hospital in the South Bronx. Methods and results We conducted a retrospective observational study of 49 patients who were offered MAT as per EUA protocol of FDA. Patient who met the criteria for MAT and received therapy were included in treatment group ( n = 38) and the remaining ( n = 11) who declined treatment were included in the control group. A majority of patients (76%) in the study group reported symptomatic improvement, the day after infusion. There was statistically significant reduction in COVID-19 related hospitalizations (7.8 vs 54.5%, P = < 0.001) mortality (0 vs 18.1%, P value = 0.008) in the treatment group. Conclusion MAT reduced both hospitalization and mortality in this predominantly Hispanic patient population with mild to moderate COVID-19 with high risk factors for disease progression.

COVID-19 therapeutics and outcomes among solid organ transplant recipients during the Omicron BA.1 era

“…Sotrovimab, as with other monoclonal antibody therapies authorized for use in patients with COVID‐19, requires intravenous administration, and thus coordinating timely care can be difficult, particularly in areas with limited resources and drug supply. 16 NR use in SOTR poses the specific challenge of managing drug–drug interactions with commonly used immunosuppressive medications. 9 Although the previously published NYPH protocol can effectively help manage the ritonavir‐related drug interactions, this protocol requires intensive therapeutic drug monitoring and should not be followed if drug levels cannot be adequately measured over time.…”

Real-world Effectiveness of Casirivimab and Imdevimab in Patients With COVID-19 in the Ambulatory Setting: An Analysis of Two Large US National Claims Databases

“…While multiple studies have reported on the real-world effectiveness of CAS+IMD [4][5][6][7][8][9][10][11][12][13][14][15][16], most only included a small number of CAS+IMD-treated patients, generally evaluating the early experience with monoclonal antibodies (mAbs), were single-center, and did not have sufficient sample size to assess effectiveness of CAS+IMD across various patient subgroups. Studies leveraging large databases with sufficient counts to assess the effectiveness of CAS+IMD in subgroups of patients at higher risk of poor outcomes are needed.…”

Real-World Effectiveness of Casirivimab and Imdevimab Among Patients Diagnosed With COVID-19 in the Ambulatory Setting: A Retrospective Cohort Study Using a Large Claims Database

“…[10][11][12] In vitro studies suggested that CAS+IMD retains neutralization activity against most VOC including Delta but with the exception of Omicron (B.1.1.529). 5,[13][14][15][16][17] Most real-world studies assessing the effectiveness of CAS+IMD for treating COVID-19 [18][19][20][21][22][23][24][25][26][27][28][29][30] were conducted prior to Delta, and those that did overlap with the emergence of the Delta variant were single-center and of small sample size. 19,30,31 Furthermore, with the introduction of COVID-19 vaccines, an improved understanding of vulnerable groups, and the emergence of the Delta variant, it became important to evaluate the effectiveness of CAS+IMD across these patient subgroups.…”