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Jensen, Tomas O; Grandits, Greg A; Jain, Mamta K; Murray, Thomas A; Grund, Birgit; Shaw-Saliba, Kathryn; Matthay, Michael A; Abassi, Mahsa; Ardelt, Magdalena; Baker, Jason V; Chen, Peter; Dewar, Robin L; Goodman, Anna L; Hatlen, Timothy J; Highbarger, Helene C; Holodniy, Mark; Lallemand, Perrine; Laverdure, Sylvain; Leshnower, Bradley G; Looney, David; Moschopoulos, Charalampos D; Mugerwa, Henry; Murray, Daniel D; Mylonakis, Eleftherios; [...]

Effect of Neutralizing Monoclonal Antibody Treatment on Early Trajectories of Virologic and Immunologic Biomarkers in Patients Hospitalized With COVID-19

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  • Medientyp: E-Artikel
  • Titel: Effect of Neutralizing Monoclonal Antibody Treatment on Early Trajectories of Virologic and Immunologic Biomarkers in Patients Hospitalized With COVID-19
  • Beteiligte: Jensen, Tomas O; Grandits, Greg A; Jain, Mamta K; Murray, Thomas A; Grund, Birgit; Shaw-Saliba, Kathryn; Matthay, Michael A; Abassi, Mahsa; Ardelt, Magdalena; Baker, Jason V; Chen, Peter; Dewar, Robin L; Goodman, Anna L; Hatlen, Timothy J; Highbarger, Helene C; Holodniy, Mark; Lallemand, Perrine; Laverdure, Sylvain; Leshnower, Bradley G; Looney, David; Moschopoulos, Charalampos D; Mugerwa, Henry; Murray, Daniel D; Mylonakis, Eleftherios; [...]
  • Erschienen: Oxford University Press (OUP), 2023
  • Erschienen in: The Journal of Infectious Diseases
  • Sprache: Englisch
  • DOI: 10.1093/infdis/jiad446
  • ISSN: 0022-1899; 1537-6613
  • Schlagwörter: Infectious Diseases ; Immunology and Allergy
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:title>Abstract</jats:title> <jats:sec> <jats:title>Background</jats:title> <jats:p>Neutralizing monoclonal antibodies (nmAbs) failed to show clear benefit for hospitalized patients with coronavirus disease 2019 (COVID-19). Dynamics of virologic and immunologic biomarkers remain poorly understood.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods</jats:title> <jats:p>Participants enrolled in the Therapeutics for Inpatients with COVID-19 trials were randomized to nmAb versus placebo. Longitudinal differences between treatment and placebo groups in levels of plasma nucleocapsid antigen (N-Ag), anti-nucleocapsid antibody, C-reactive protein, interleukin-6, and d-dimer at enrollment, day 1, 3, and 5 were estimated using linear mixed models. A 7-point pulmonary ordinal scale assessed at day 5 was compared using proportional odds models.</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>Analysis included 2149 participants enrolled between August 2020 and September 2021. Treatment resulted in 20% lower levels of plasma N-Ag compared with placebo (95% confidence interval, 12%–27%; P &amp;lt; .001), and a steeper rate of decline through the first 5 days (P &amp;lt; .001). The treatment difference did not vary between subgroups, and no difference was observed in trajectories of other biomarkers or the day 5 pulmonary ordinal scale.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions</jats:title> <jats:p>Our study suggests that nmAb has an antiviral effect assessed by plasma N-Ag among hospitalized patients with COVID-19, with no blunting of the endogenous anti-nucleocapsid antibody response. No effect on systemic inflammation or day 5 clinical status was observed.</jats:p> </jats:sec> <jats:sec> <jats:title>Clinical Trials Registration</jats:title> <jats:p>NCT04501978.</jats:p> </jats:sec>