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Clinical Impact of Monoclonal Antibodies in the Treatment of High-Risk Patients with SARS-CoV-2 Breakthrough Infections: The ORCHESTRA Prospective Cohort Study.
Savoldi, Alessia; Morra, Matteo; Castelli, Alessandro; Mirandola, Massimo; Berkell, Matilda; Smet, Mathias; Konnova, Angelina; Rossi, Elisa; Cataudella, Salvatore; De Nardo, Pasquale; Gentilotti, Elisa; Gupta, Akshita; Fasan, Daniele; Gibbin, Enrico; Puviani, Filippo Cioli; Hasenauer, Jan; Gusinow, Roy; Tami, Adriana; Kumar-Singh, Samir; Malhotra-Kumar, Surbhi; Tacconelli, Evelina.
  • Savoldi A; Division of Infectious Diseases, Department of Diagnostics and Public Health, University of Verona, P.le L.A. Scuro 10, 37134 Verona, Italy.
  • Morra M; Division of Infectious Diseases, Department of Diagnostics and Public Health, University of Verona, P.le L.A. Scuro 10, 37134 Verona, Italy.
  • Castelli A; Division of Infectious Diseases, Department of Diagnostics and Public Health, University of Verona, P.le L.A. Scuro 10, 37134 Verona, Italy.
  • Mirandola M; Division of Infectious Diseases, Department of Diagnostics and Public Health, University of Verona, P.le L.A. Scuro 10, 37134 Verona, Italy.
  • Berkell M; School of Health Sciences, University of Brighton, Brighton BN2 4AT, UK.
  • Smet M; Lab of Medical Microbiology, Vaccine & Infectious Disease Institute, University of Antwerp, 2610 Antwerp, Belgium.
  • Konnova A; Molecular Pathology Group, Cell Biology & Histology, Faculty of Medicine and Health Sciences, University of Antwerp, 2610 Antwerp, Belgium.
  • Rossi E; Lab of Medical Microbiology, Vaccine & Infectious Disease Institute, University of Antwerp, 2610 Antwerp, Belgium.
  • Cataudella S; Molecular Pathology Group, Cell Biology & Histology, Faculty of Medicine and Health Sciences, University of Antwerp, 2610 Antwerp, Belgium.
  • De Nardo P; CINECA-Interuniversity Consortium, Via Magnanelli 6/3, Casalecchio di Reno, 40033 Bologna, Italy.
  • Gentilotti E; CINECA-Interuniversity Consortium, Via Magnanelli 6/3, Casalecchio di Reno, 40033 Bologna, Italy.
  • Gupta A; Division of Infectious Diseases, Department of Diagnostics and Public Health, University of Verona, P.le L.A. Scuro 10, 37134 Verona, Italy.
  • Fasan D; Division of Infectious Diseases, Department of Diagnostics and Public Health, University of Verona, P.le L.A. Scuro 10, 37134 Verona, Italy.
  • Gibbin E; Molecular Pathology Group, Cell Biology & Histology, Faculty of Medicine and Health Sciences, University of Antwerp, 2610 Antwerp, Belgium.
  • Puviani FC; Division of Infectious Diseases, Department of Diagnostics and Public Health, University of Verona, P.le L.A. Scuro 10, 37134 Verona, Italy.
  • Hasenauer J; Division of Infectious Diseases, Department of Diagnostics and Public Health, University of Verona, P.le L.A. Scuro 10, 37134 Verona, Italy.
  • Gusinow R; Division of Infectious Diseases, Department of Diagnostics and Public Health, University of Verona, P.le L.A. Scuro 10, 37134 Verona, Italy.
  • Tami A; Helmholtz Center Munich-Germany Research Center for Environmental Heath, Institute for Computational Biology, 85764 Neuherberg, Germany.
  • Kumar-Singh S; Life and Medical Sciences Institute, University of Bonn, 53115 Bonn, Germany.
  • Malhotra-Kumar S; Helmholtz Center Munich-Germany Research Center for Environmental Heath, Institute for Computational Biology, 85764 Neuherberg, Germany.
  • mAb Orchestra Working Group; Life and Medical Sciences Institute, University of Bonn, 53115 Bonn, Germany.
  • Tacconelli E; Department of Medical Microbiology & Infection Prevention, University Medical Center Groningen, 9713 AV Groningen, The Netherlands.
Biomedicines ; 10(9)2022 Aug 24.
Article in English | MEDLINE | ID: covidwho-1997515
ABSTRACT
The clinical impact of anti-spike monoclonal antibodies (mAb) in Coronavirus Disease 2019 (COVID-19) breakthrough infections is unclear. We present the results of an observational prospective cohort study assessing and comparing COVID-19 progression in high-risk outpatients receiving mAb according to primary or breakthrough infection. Clinical, serological and virological predictors associated with 28-day COVID-19-related hospitalization were identified using multivariate logistic regression and summarized with odds ratio (aOR) and 95% confidence interval (CI). A total of 847 COVID-19 outpatients were included 414 with primary and 433 with breakthrough infection. Hospitalization was observed in 42/414 (10.1%) patients with primary and 8/433 (1.8%) patients with breakthrough infection (p < 0.001). aOR for hospitalization was significantly lower for breakthrough infection (aOR 0.12, 95%CI 0.05-0.27, p < 0.001) and higher for immunocompromised status (aOR2.35, 95%CI1.08-5.08, p = 0.003), advanced age (aOR1.06, 95%CI 1.03-1.08, p < 0.001), and male gender (aOR1.97, 95%CI 1.04-3.73, p = 0.037). Among the breakthrough infection group, the median SARS-CoV-2 anti-spike IgGs was lower (p < 0.001) in immunocompromised and elderly patients >75 years compared with that in the immunocompetent patients. Our findings suggest that, among mAb patients, those with breakthrough infection have significantly lower hospitalization risk compared with patients with primary infection. Prognostic algorithms combining clinical and immune-virological characteristics are needed to ensure appropriate and up-to-date clinical protocols targeting high-risk categories.
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Full text: Available Collection: International databases Database: MEDLINE Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study Topics: Vaccines Language: English Year: 2022 Document Type: Article Affiliation country: Biomedicines10092063

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study Topics: Vaccines Language: English Year: 2022 Document Type: Article Affiliation country: Biomedicines10092063