Clinical Impact of Monoclonal Antibodies in the Treatment of High-Risk Patients with SARS-CoV-2 Breakthrough Infections: The ORCHESTRA Prospective Cohort Study
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 t...
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MDPI AG
2022-08-01
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| Series: | Biomedicines |
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| Online Access: | https://www.mdpi.com/2227-9059/10/9/2063 |
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| author | Alessia Savoldi Matteo Morra Alessandro Castelli Massimo Mirandola Matilda Berkell Mathias Smet Angelina Konnova Elisa Rossi Salvatore Cataudella Pasquale De Nardo Elisa Gentilotti Akshita Gupta Daniele Fasan Enrico Gibbin Filippo Cioli Puviani Jan Hasenauer Roy Gusinow Adriana Tami Samir Kumar-Singh Surbhi Malhotra-Kumar mAb ORCHESTRA Working Group Evelina Tacconelli |
| author_facet | Alessia Savoldi Matteo Morra Alessandro Castelli Massimo Mirandola Matilda Berkell Mathias Smet Angelina Konnova Elisa Rossi Salvatore Cataudella Pasquale De Nardo Elisa Gentilotti Akshita Gupta Daniele Fasan Enrico Gibbin Filippo Cioli Puviani Jan Hasenauer Roy Gusinow Adriana Tami Samir Kumar-Singh Surbhi Malhotra-Kumar mAb ORCHESTRA Working Group Evelina Tacconelli |
| author_sort | Alessia Savoldi |
| collection | DOAJ |
| description | 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 (<i>p</i> < 0.001). aOR for hospitalization was significantly lower for breakthrough infection (aOR 0.12, 95%CI: 0.05–0.27, <i>p</i> < 0.001) and higher for immunocompromised status (aOR:2.35, 95%CI:1.08–5.08, <i>p</i> = 0.003), advanced age (aOR:1.06, 95%CI: 1.03–1.08, <i>p</i> < 0.001), and male gender (aOR:1.97, 95%CI: 1.04–3.73, <i>p</i> = 0.037). Among the breakthrough infection group, the median SARS-CoV-2 anti-spike IgGs was lower (<i>p</i> < 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. |
| first_indexed | 2024-03-10T00:40:34Z |
| format | Article |
| id | doaj.art-ab6fcac758a4487c8de36256b61565fa |
| institution | Directory Open Access Journal |
| issn | 2227-9059 |
| language | English |
| last_indexed | 2024-03-10T00:40:34Z |
| publishDate | 2022-08-01 |
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| series | Biomedicines |
| spelling | doaj.art-ab6fcac758a4487c8de36256b61565fa2023-11-23T15:08:31ZengMDPI AGBiomedicines2227-90592022-08-01109206310.3390/biomedicines10092063Clinical Impact of Monoclonal Antibodies in the Treatment of High-Risk Patients with SARS-CoV-2 Breakthrough Infections: The ORCHESTRA Prospective Cohort StudyAlessia Savoldi0Matteo Morra1Alessandro Castelli2Massimo Mirandola3Matilda Berkell4Mathias Smet5Angelina Konnova6Elisa Rossi7Salvatore Cataudella8Pasquale De Nardo9Elisa Gentilotti10Akshita Gupta11Daniele Fasan12Enrico Gibbin13Filippo Cioli Puviani14Jan Hasenauer15Roy Gusinow16Adriana Tami17Samir Kumar-Singh18Surbhi Malhotra-Kumar19mAb ORCHESTRA Working GroupEvelina Tacconelli20Division of Infectious Diseases, Department of Diagnostics and Public Health, University of Verona, P.le L.A. Scuro 10, 37134 Verona, ItalyDivision of Infectious Diseases, Department of Diagnostics and Public Health, University of Verona, P.le L.A. Scuro 10, 37134 Verona, ItalyDivision of Infectious Diseases, Department of Diagnostics and Public Health, University of Verona, P.le L.A. Scuro 10, 37134 Verona, ItalyDivision of Infectious Diseases, Department of Diagnostics and Public Health, University of Verona, P.le L.A. Scuro 10, 37134 Verona, ItalyLab of Medical Microbiology, Vaccine & Infectious Disease Institute, University of Antwerp, 2610 Antwerp, BelgiumLab of Medical Microbiology, Vaccine & Infectious Disease Institute, University of Antwerp, 2610 Antwerp, BelgiumMolecular Pathology Group, Cell Biology & Histology, Faculty of Medicine and Health Sciences, University of Antwerp, 2610 Antwerp, BelgiumCINECA—Interuniversity Consortium, Via Magnanelli 6/3, Casalecchio di Reno, 40033 Bologna, ItalyCINECA—Interuniversity Consortium, Via Magnanelli 6/3, Casalecchio di Reno, 40033 Bologna, ItalyDivision of Infectious Diseases, Department of Diagnostics and Public Health, University of Verona, P.le L.A. Scuro 10, 37134 Verona, ItalyDivision of Infectious Diseases, Department of Diagnostics and Public Health, University of Verona, P.le L.A. Scuro 10, 37134 Verona, ItalyMolecular Pathology Group, Cell Biology & Histology, Faculty of Medicine and Health Sciences, University of Antwerp, 2610 Antwerp, BelgiumDivision of Infectious Diseases, Department of Diagnostics and Public Health, University of Verona, P.le L.A. Scuro 10, 37134 Verona, ItalyDivision of Infectious Diseases, Department of Diagnostics and Public Health, University of Verona, P.le L.A. Scuro 10, 37134 Verona, ItalyDivision of Infectious Diseases, Department of Diagnostics and Public Health, University of Verona, P.le L.A. Scuro 10, 37134 Verona, ItalyHelmholtz Center Munich—Germany Research Center for Environmental Heath, Institute for Computational Biology, 85764 Neuherberg, GermanyHelmholtz Center Munich—Germany Research Center for Environmental Heath, Institute for Computational Biology, 85764 Neuherberg, GermanyDepartment of Medical Microbiology & Infection Prevention, University Medical Center Groningen, 9713 AV Groningen, The NetherlandsMolecular Pathology Group, Cell Biology & Histology, Faculty of Medicine and Health Sciences, University of Antwerp, 2610 Antwerp, BelgiumLab of Medical Microbiology, Vaccine & Infectious Disease Institute, University of Antwerp, 2610 Antwerp, BelgiumDivision of Infectious Diseases, Department of Diagnostics and Public Health, University of Verona, P.le L.A. Scuro 10, 37134 Verona, ItalyThe 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 (<i>p</i> < 0.001). aOR for hospitalization was significantly lower for breakthrough infection (aOR 0.12, 95%CI: 0.05–0.27, <i>p</i> < 0.001) and higher for immunocompromised status (aOR:2.35, 95%CI:1.08–5.08, <i>p</i> = 0.003), advanced age (aOR:1.06, 95%CI: 1.03–1.08, <i>p</i> < 0.001), and male gender (aOR:1.97, 95%CI: 1.04–3.73, <i>p</i> = 0.037). Among the breakthrough infection group, the median SARS-CoV-2 anti-spike IgGs was lower (<i>p</i> < 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.https://www.mdpi.com/2227-9059/10/9/2063anti-spike monoclonal antibodiesCOVID-19 breakthrough infectionCOVID-19 early treatment |
| spellingShingle | Alessia Savoldi Matteo Morra Alessandro Castelli Massimo Mirandola Matilda Berkell Mathias Smet Angelina Konnova Elisa Rossi Salvatore Cataudella Pasquale De Nardo Elisa Gentilotti Akshita Gupta Daniele Fasan Enrico Gibbin Filippo Cioli Puviani Jan Hasenauer Roy Gusinow Adriana Tami Samir Kumar-Singh Surbhi Malhotra-Kumar mAb ORCHESTRA Working Group Evelina Tacconelli Clinical Impact of Monoclonal Antibodies in the Treatment of High-Risk Patients with SARS-CoV-2 Breakthrough Infections: The ORCHESTRA Prospective Cohort Study Biomedicines anti-spike monoclonal antibodies COVID-19 breakthrough infection COVID-19 early treatment |
| title | Clinical Impact of Monoclonal Antibodies in the Treatment of High-Risk Patients with SARS-CoV-2 Breakthrough Infections: The ORCHESTRA Prospective Cohort Study |
| title_full | Clinical Impact of Monoclonal Antibodies in the Treatment of High-Risk Patients with SARS-CoV-2 Breakthrough Infections: The ORCHESTRA Prospective Cohort Study |
| title_fullStr | Clinical Impact of Monoclonal Antibodies in the Treatment of High-Risk Patients with SARS-CoV-2 Breakthrough Infections: The ORCHESTRA Prospective Cohort Study |
| title_full_unstemmed | Clinical Impact of Monoclonal Antibodies in the Treatment of High-Risk Patients with SARS-CoV-2 Breakthrough Infections: The ORCHESTRA Prospective Cohort Study |
| title_short | Clinical Impact of Monoclonal Antibodies in the Treatment of High-Risk Patients with SARS-CoV-2 Breakthrough Infections: The ORCHESTRA Prospective Cohort Study |
| title_sort | clinical impact of monoclonal antibodies in the treatment of high risk patients with sars cov 2 breakthrough infections the orchestra prospective cohort study |
| topic | anti-spike monoclonal antibodies COVID-19 breakthrough infection COVID-19 early treatment |
| url | https://www.mdpi.com/2227-9059/10/9/2063 |
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