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. 2022 Oct;94(10):5038-5043.
doi: 10.1002/jmv.27916. Epub 2022 Jun 11.

Clinical efficacy and in vitro neutralization capacity of monoclonal antibodies for severe acute respiratory syndrome coronavirus 2 delta and omicron variants

Thomas Theo Brehm  1   2 , Susanne Pfefferle  2   3   4 , Ronald von Possel  3   5 , Mario Karolyi  6 , Alexander Zoufaly  6   7 , Dominic Wichmann  8 , Robin Kobbe  1 , Petra Emmerich  3   5 , Dominik Nörz  4 , Martin Aepfelbacher  4 , Julian Schulze Zur Wiesch  1   2 , Marylyn M Addo  1   2   9 , Stefan Schmiedel  1   2 , Marc Lütgehetmann  2   4
Affiliations

Clinical efficacy and in vitro neutralization capacity of monoclonal antibodies for severe acute respiratory syndrome coronavirus 2 delta and omicron variants

Thomas Theo Brehm et al. J Med Virol. 2022 Oct.

Abstract

We aimed to provide in vitro data on the neutralization capacity of different monoclonal antibody (mAb) preparations against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) delta and omicron variant, respectively, and describe the in vivo RNA kinetics of coronavirus disease 2019 (COVID-19) patients treated with the respective mAbs. Virus neutralization assays were performed to assess the neutralizing effect of the mAb formulations casirivimab/imdevimab and sotrovimab on the SARS-CoV-2 delta and omicron variant. Additionally, respiratory tract SARS-CoV-2 RNA kinetics are provided for 25 COVID-19 patients infected with either delta variant (n = 18) or omicron variant (n = 7) treated with the respective mAb formulations during their hospital stay. In the virus neutralization assay, sotrovimab exhibits neutralizing capacity at therapeutically achievable concentrations against the SARS-CoV-2 delta and omicron variant. In contrast, casivirimab/imdevimab had neutralizing capacity against the delta variant but failed neutralization against the omicron variant except for a very high concentration above the currently recommended therapeutic dosage. In patients with delta variant infections treated with casivirimab/imdevimab, we observed a rapid decrease of respiratory viral RNA at day 3 after mAb therapy. In contrast, no such prompt decline was observed in patients with delta variant or omicron variant infections receiving sotrovimab.

Keywords: COVID-19; SARS-CoV-2; casirivimab/imdevimab; delta variant; monoclonal antibodies; omicron variant; sotromivab; virus neutralization assay.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Virus neutralization and clinical efficacy by monoclonal antibody formulations. The percentage of neutralization of the severe acute respiratory syndrome coronavirus‐2 (SARS‐CoV‐2) delta variant (A: red; B: yellow) or omicron variant (blue) by casivirimab/imdivimab (A) or sotrovimab (B) or combined monoclonal antibody (mAB) formulations (C–E) at the indicated concentrations is illustrated. (C) Sotrovimab was added to a final concentration of 100 µg/ml >10 min after initial incubation of the virus variants with casivirimab/imdevimab at the indicated concentrations. (D) A fixed concentration of casirivimab/imdevimab (240/240 µg/ml) was added, sotrovimab was assessed at indicated concentrations (E) Serial dilutions of both casivirimab/imdevimab and sotrovimab were combined. For each mAB concentration tested, triplicate dilutions were incubated with the respective variant isolate in virus neutralization assay. Kinetics of nasopharyngeal SARS‐CoV‐2 RNA loads of patients with delta variant infections treated with casirivimab/imdevimab (F) and sotrovimab (G), respectively and of patients with omicron variant infections treated with sotrovimab (dark blue) or sequential treatment with casirivimab/imdevimab and sotrovimab (light blue).
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