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Savoldi, A.* ; Morra, M.* ; Castelli, A.* ; Mirandola, M.* ; Berkell, M.* ; Smet, M.* ; Konnova, A.* ; Rossi, E.* ; Cataudella, S.* ; De Nardo, P.* ; Gentilotti, E.* ; Gupta, A.* ; Fasan, D.* ; Gibbin, E.* ; Puviani, F.C.* ; Hasenauer, J. ; Gusinow, R. ; Tami, A.* ; Kumar-Singh, S.* ; Malhotra-Kumar, S.* ; Tacconelli, E.*

Clinical impact of monoclonal antibodies in the treatment of high-risk patients with SARS-CoV-2 breakthrough infections: The ORCHESTRA prospective cohort study.

Biomedicines 10:2063 (2022)

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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 (aOR:2.35, 95%CI:1.08–5.08, p = 0.003), advanced age (aOR:1.06, 95%CI: 1.03–1.08, p < 0.001), and male gender (aOR:1.97, 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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Publication type Article: Journal article

Document type Scientific Article

Corresponding Author

Keywords Anti-spike Monoclonal Antibodies ; Covid-19 Breakthrough Infection ; Covid-19 Early Treatment

ISSN (print) / ISBN 2227-9059

e-ISSN 2227-9059

Journal Biomedicines

Quellenangaben Volume: 10, Issue: 9, Article Number: 2063

Publisher MDPI

Publishing Place Basel, Switzerland

Non-patent literature Publications

Reviewing status Peer reviewed

Institute(s) Institute of Computational Biology (ICB)