Objective: Little is known about deployment of SARS-CoV-2-neutralizing monoclonal antibodies (mab) in skilled nursing facilities (SNFs), a high-risk population for COVID-19-related complications. We assessed the utilization of mabs in SNFs and identified facility characteristics associated with effective use.
Design: Retrospective cohort study assessing the correlation of SNF characteristics with increasing mab use.
Setting And Participants: United States SNFs participating in Project ECHO (Extensions for Community Health Outcomes).
Methods: The primary outcome was percentage of total mabs per COVID-19 cases in SNFs. Facilities were divided into 3 groups based on the percentage of the administration of mabs per number of cases: 0%, >0% to 20%, >20%. Ordinal logistic regression was applied to assess whether facility characteristics-study group, state, location, type, size, rating at baseline, weekly average of residents vaccinated, weekly average of staff vaccinated, and total weeks short staffed-correlated with the primary outcome. A multivariable model was used to evaluate the independent effect of predictors.
Results: A total of 130 facilities were included. Between the weeks ending on May 30, 2021, and on May 29, 2022, mean mab use when accounting for the number of COVID-19 cases was 12.96% (±26.71%) and >50% of facilities administered 0 doses of mabs. Facility location was associated with mab use (P value .030), with micropolitan facilities having the highest percentage of facilities administering mabs (30.4% in >0% to 20%, and 39.1% in >20%, respectively). There was a nonsignificant trend toward increased mab use in facilities reporting fewer staffing shortages. When the multivariable ordinal logistic regression model was applied, location in a micropolitan vs metropolitan area was associated with higher odds [3.29 (1.30, 8.32), P value .012] of increasing percentage total mabs per cases.
Conclusions And Implications: COVID-19 mabs were underutilized in a high-risk population for COVID-19 hospitalization and death. Understanding the barriers to effective distribution is critical in shaping pandemic preparedness efforts for the future.
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http://dx.doi.org/10.1016/j.jamda.2023.10.003 | DOI Listing |
J Pharmacokinet Pharmacodyn
December 2024
Translational Medicine and Clinical Pharmacology, Boehringer Ingelheim Pharmaceuticals Inc., 900 Ridgebury Road, Ridgefield, CT, 06877, USA.
DZIF-10c (BI 767551) is a recombinant human monoclonal antibody of the IgG1 kappa isotype. It acts as a SARS-CoV-2 neutralizing antibody. DZIF-10c has been developed for both systemic exposure by intravenous infusion as well as for specific exposure to the respiratory tract by application as an inhaled aerosol generated by a nebulizer.
View Article and Find Full Text PDFFront Immunol
November 2024
Institute of Plant Biotechnology and Cell Biology, Department of Applied Genetics and Cell Biology, BOKU University, Vienna, Austria.
Despite the unique advantages of IgG3 over other IgG subclasses, such as mediating enhanced effector functions and increased flexibility in antigen binding due to a long hinge region, the therapeutic potential of IgG3 remains largely unexplored. This may be attributed to difficulties in recombinant expression and the reduced plasma half-life of most IgG3 allotypes. Here, we report plant expression of two SARS-CoV-2 neutralizing monoclonal antibodies (mAbs) that exhibit high (P5C3) and low (H4) antigen binding.
View Article and Find Full Text PDFAnal Chem
November 2024
School of Life Sciences, Zhengzhou University, Zhengzhou 450001, People's Republic of China.
The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) led to the global spread of coronavirus disease 2019 (COVID-19), creating an urgent need for updated methods to evaluate immune responses to vaccines and therapeutic strategies. In this study, we introduce a novel cell-free, virus-free SARS-CoV-2 neutralizing antibody ELISA (NAb-ELISA), which is based on competitive inhibition of the receptor binding domain (RBD) of spike protein binding to the angiotensin-converting enzyme 2 (ACE2) receptor. In this method, site-specific biotinylated hACE2-Fc-Avi recombinant protein is immobilized onto a 96-well plate for capture, and the RBD-Fc-vHRP recombinant proteins serve as detection probes.
View Article and Find Full Text PDFAppl Microbiol Biotechnol
October 2024
Department of Biochemical Science and Technology, College of Life Science, National Taiwan University, Taipei, 106, Taiwan.
Toxicol Res
October 2024
Research Institute of Pharmaceutical Sciences, College of Pharmacy, Chosun University, 309 Pilmun-Daero, Dong-gu, Gwangju, 61452 Republic of Korea.
The purpose of this study was to analyze the important medical events (IMEs) of anti-severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) monoclonal antibodies using the reports from the United States Food and Drug Administration (US FDA) adverse event reporting system (FAERS) and to detect safety signals. In this study, data from the FAERS from January 2020 to December 2022 were used to investigate signals associated with five monoclonal antibody products (bamlanivimab, bamlanivimab/etesevimab, bebtelovimab, casirivimab/imdevimab, sotrovimab) in coronavirus disease 2019 (COVID-19) patients and one monoclonal antibody product (tixagevimab/cilgavimab) in patients wherein COVID-19 vaccination was not recommended. Disproportionality analyses were conducted using the reporting odds ratio, and an information component to identify safety signals.
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