Sotrovimab in Hospitalized Patients with SARS-CoV-2 Omicron Variant Infection: a Propensity Score-Matched Retrospective Cohort Study

doi:10.1128/spectrum.04103-22

. 2023 Feb 14;11(1):e0410322.

doi: 10.1128/spectrum.04103-22. Epub 2022 Dec 8.

Sotrovimab in Hospitalized Patients with SARS-CoV-2 Omicron Variant Infection: a Propensity Score-Matched Retrospective Cohort Study

Marcel S Woo^#^{1

2}, Thomas Theo Brehm^#^{3

4}, Marlene Fischer⁵, Andreas Heyer³, Dominic Wichmann⁵, Sabine Jordan³, Dominik Nörz⁶, Marc Lütgehetmann^{4

6}, Marylyn M Addo^{3

4

7}, Ansgar W Lohse^{3

4}, Stefan Schmiedel^{3

4}, Stefan Kluge^#⁵, Julian Schulze Zur Wiesch^#^{3

4}

Affiliations

¹ Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
² Institute of Neuroimmunology and Multiple Sclerosis (INIMS), Center for Molecular Neurobiology Hamburg (ZMNH), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
³ I. Department of Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
⁴ German Center for Infection Research (DZIF), University Medical Center Hamburg-Eppendorf, Lübeck-Borstel-Riems, Hamburg, Germany.
⁵ Department of Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
⁶ Institute of Medical Microbiology, Virology and Hygiene, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
⁷ Institute of Infection Research and Vaccine Development (IIRVD), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

^# Contributed equally.

PMID: 36475890
PMCID: PMC9927465
DOI: 10.1128/spectrum.04103-22

Sotrovimab in Hospitalized Patients with SARS-CoV-2 Omicron Variant Infection: a Propensity Score-Matched Retrospective Cohort Study

Marcel S Woo et al. Microbiol Spectr. 2023.

. 2023 Feb 14;11(1):e0410322.

doi: 10.1128/spectrum.04103-22. Epub 2022 Dec 8.

Authors

Affiliations

¹ Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
² Institute of Neuroimmunology and Multiple Sclerosis (INIMS), Center for Molecular Neurobiology Hamburg (ZMNH), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
³ I. Department of Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
⁴ German Center for Infection Research (DZIF), University Medical Center Hamburg-Eppendorf, Lübeck-Borstel-Riems, Hamburg, Germany.
⁵ Department of Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
⁶ Institute of Medical Microbiology, Virology and Hygiene, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
⁷ Institute of Infection Research and Vaccine Development (IIRVD), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

^# Contributed equally.

PMID: 36475890
PMCID: PMC9927465
DOI: 10.1128/spectrum.04103-22

Abstract

In vitro data suggest the monoclonal antibody sotrovimab may have lost inhibitory capability against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variant. We aimed to provide real-life data on clinical outcomes in hospitalized patients. We retrospectively analyzed patients who were treated at the University Medical Center Hamburg-Eppendorf, Germany, between December 2021 and June 2022. Out of all 1,254 patients, 185 were treated with sotrovimab: 147 patients received sotrovimab monotherapy, and 38 received combination treatment with sotrovimab and remdesivir. We compared in-hospital mortality for the different treatment regimens for patients treated on regular wards and the intensive care unit separately and performed propensity score matching by age, sex, comorbidities, immunosuppression, and additional dexamethasone treatment to select patients who did not receive antiviral treatment for comparison. No difference in in-hospital mortality was observed between any of the treatment groups and the respective control groups. These findings underline that sotrovimab adds no clinical benefit for hospitalized patients with SARS-CoV-2 Omicron variant infections. IMPORTANCE This study shows that among hospitalized patients with SARS-CoV-2 Omicron variant infection at risk of disease progression, treatment with sotrovimab alone or in combination with remdesivir did not decrease in-hospital mortality. These real-world clinical findings in combination with previous in vitro data about lacking neutralizing activity of sotrovimab against SARS-CoV-2 Omicron variant do not support sotrovimab as a treatment option in these patients.

Keywords: COVID-19; Omicron; Omicron variant; SARS-CoV-2; monoclonal antibodies; remdesivir; sotrovimab.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

**FIG 1**
In-hospital mortality in hospitalized patients with SARS-CoV-2 Omicron variant infections. (A and B) Patients included in the analysis who were treated in a normal ward (A) and in the intensive care unit (B) by date of SARS-CoV-2 infection. In-hospital mortality is shown for the following treatment groups and respective propensity score-matched control groups who did not receive antiviral treatment (NT): patients who were treated with sotrovimab alone in a normal ward (C), patients who were treated with sotrovimab alone in the intensive care unit (D), patients who were treated with combination therapy with sotrovimab and remdesivir in a normal ward (E), and patients who were treated with combination therapy with sotrovimab and remdesivir in the intensive care unit (F). “Number at risk” refers to the number of patients who were still hospitalized at the respective time after SARS-CoV-2 infection.

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References

1. WHO. 2022. WHO coronavirus (COVID-19) dashboard. https://covid19.who.int.
1. Dejnirattisai W, Huo J, Zhou D, Zahradník J, Supasa P, Liu C, Duyvesteyn HME, Ginn HM, Mentzer AJ, Tuekprakhon A, Nutalai R, Wang B, Dijokaite A, Khan S, Avinoam O, Bahar M, Skelly D, Adele S, Johnson SA, Amini A, Ritter TG, Mason C, Dold C, Pan D, Assadi S, Bellass A, Omo-Dare N, Koeckerling D, Flaxman A, Jenkin D, Aley PK, Voysey M, Costa Clemens SA, Naveca FG, Nascimento V, Nascimento F, Fernandes da Costa C, Resende PC, Pauvolid-Correa A, Siqueira MM, Baillie V, Serafin N, Kwatra G, Da Silva K, Madhi SA, Nunes MC, Malik T, Openshaw PJM, Baillie JK, Semple MG, ISARIC4C Consortium , et al. 2022. SARS-CoV-2 Omicron-B.1.1.529 leads to widespread escape from neutralizing antibody responses. Cell 185:467–484.e15. doi:10.1016/j.cell.2021.12.046. - DOI - PMC - PubMed
1. Cao Y, Wang J, Jian F, Xiao T, Song W, Yisimayi A, Huang W, Li Q, Wang P, An R, Wang J, Wang Y, Niu X, Yang S, Liang H, Sun H, Li T, Yu Y, Cui Q, Liu S, Yang X, Du S, Zhang Z, Hao X, Shao F, Jin R, Wang X, Xiao J, Wang Y, Xie XS. 2022. Omicron escapes the majority of existing SARS-CoV-2 neutralizing antibodies. Nature 602:657–663. doi:10.1038/s41586-021-04385-3. - DOI - PMC - PubMed
1. Brehm TT, Pfefferle S, von Possel R, Karolyi M, Zoufaly A, Wichmann D, Kobbe R, Emmerich P, Nörz D, Aepfelbacher M, Schulze Zur Wiesch J, Addo MM, Schmiedel S, Lütgehetmann M. 2022. Clinical efficacy and in vitro neutralization capacity of monoclonal antibodies for severe acute respiratory syndrome coronavirus 2 delta and omicron variants. J Med Virol 94:5038–5043. doi:10.1002/jmv.27916. - DOI - PMC - PubMed
1. Takashita E, Yamayoshi S, Simon V, van Bakel H, Sordillo EM, Pekosz A, Fukushi S, Suzuki T, Maeda K, Halfmann P, Sakai-Tagawa Y, Ito M, Watanabe S, Imai M, Hasegawa H, Kawaoka Y. 2022. Efficacy of antibodies and antiviral drugs against Omicron BA.2.12.1, BA.4, and BA.5 subvariants. N Engl J Med 387:468–470. doi:10.1056/NEJMc2207519. - DOI - PMC - PubMed

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[1] WHO. 2022. WHO coronavirus (COVID-19) dashboard. https://covid19.who.int.

[2] WHO. 2022. WHO coronavirus (COVID-19) dashboard. https://covid19.who.int.

[3] Dejnirattisai W, Huo J, Zhou D, Zahradník J, Supasa P, Liu C, Duyvesteyn HME, Ginn HM, Mentzer AJ, Tuekprakhon A, Nutalai R, Wang B, Dijokaite A, Khan S, Avinoam O, Bahar M, Skelly D, Adele S, Johnson SA, Amini A, Ritter TG, Mason C, Dold C, Pan D, Assadi S, Bellass A, Omo-Dare N, Koeckerling D, Flaxman A, Jenkin D, Aley PK, Voysey M, Costa Clemens SA, Naveca FG, Nascimento V, Nascimento F, Fernandes da Costa C, Resende PC, Pauvolid-Correa A, Siqueira MM, Baillie V, Serafin N, Kwatra G, Da Silva K, Madhi SA, Nunes MC, Malik T, Openshaw PJM, Baillie JK, Semple MG, ISARIC4C Consortium , et al. 2022. SARS-CoV-2 Omicron-B.1.1.529 leads to widespread escape from neutralizing antibody responses. Cell 185:467–484.e15. doi:10.1016/j.cell.2021.12.046. - DOI - PMC - PubMed

[4] Dejnirattisai W, Huo J, Zhou D, Zahradník J, Supasa P, Liu C, Duyvesteyn HME, Ginn HM, Mentzer AJ, Tuekprakhon A, Nutalai R, Wang B, Dijokaite A, Khan S, Avinoam O, Bahar M, Skelly D, Adele S, Johnson SA, Amini A, Ritter TG, Mason C, Dold C, Pan D, Assadi S, Bellass A, Omo-Dare N, Koeckerling D, Flaxman A, Jenkin D, Aley PK, Voysey M, Costa Clemens SA, Naveca FG, Nascimento V, Nascimento F, Fernandes da Costa C, Resende PC, Pauvolid-Correa A, Siqueira MM, Baillie V, Serafin N, Kwatra G, Da Silva K, Madhi SA, Nunes MC, Malik T, Openshaw PJM, Baillie JK, Semple MG, ISARIC4C Consortium , et al. 2022. SARS-CoV-2 Omicron-B.1.1.529 leads to widespread escape from neutralizing antibody responses. Cell 185:467–484.e15. doi:10.1016/j.cell.2021.12.046. - DOI - PMC - PubMed

[5] Cao Y, Wang J, Jian F, Xiao T, Song W, Yisimayi A, Huang W, Li Q, Wang P, An R, Wang J, Wang Y, Niu X, Yang S, Liang H, Sun H, Li T, Yu Y, Cui Q, Liu S, Yang X, Du S, Zhang Z, Hao X, Shao F, Jin R, Wang X, Xiao J, Wang Y, Xie XS. 2022. Omicron escapes the majority of existing SARS-CoV-2 neutralizing antibodies. Nature 602:657–663. doi:10.1038/s41586-021-04385-3. - DOI - PMC - PubMed

[6] Cao Y, Wang J, Jian F, Xiao T, Song W, Yisimayi A, Huang W, Li Q, Wang P, An R, Wang J, Wang Y, Niu X, Yang S, Liang H, Sun H, Li T, Yu Y, Cui Q, Liu S, Yang X, Du S, Zhang Z, Hao X, Shao F, Jin R, Wang X, Xiao J, Wang Y, Xie XS. 2022. Omicron escapes the majority of existing SARS-CoV-2 neutralizing antibodies. Nature 602:657–663. doi:10.1038/s41586-021-04385-3. - DOI - PMC - PubMed

[7] Brehm TT, Pfefferle S, von Possel R, Karolyi M, Zoufaly A, Wichmann D, Kobbe R, Emmerich P, Nörz D, Aepfelbacher M, Schulze Zur Wiesch J, Addo MM, Schmiedel S, Lütgehetmann M. 2022. Clinical efficacy and in vitro neutralization capacity of monoclonal antibodies for severe acute respiratory syndrome coronavirus 2 delta and omicron variants. J Med Virol 94:5038–5043. doi:10.1002/jmv.27916. - DOI - PMC - PubMed

[8] Brehm TT, Pfefferle S, von Possel R, Karolyi M, Zoufaly A, Wichmann D, Kobbe R, Emmerich P, Nörz D, Aepfelbacher M, Schulze Zur Wiesch J, Addo MM, Schmiedel S, Lütgehetmann M. 2022. Clinical efficacy and in vitro neutralization capacity of monoclonal antibodies for severe acute respiratory syndrome coronavirus 2 delta and omicron variants. J Med Virol 94:5038–5043. doi:10.1002/jmv.27916. - DOI - PMC - PubMed

[9] Takashita E, Yamayoshi S, Simon V, van Bakel H, Sordillo EM, Pekosz A, Fukushi S, Suzuki T, Maeda K, Halfmann P, Sakai-Tagawa Y, Ito M, Watanabe S, Imai M, Hasegawa H, Kawaoka Y. 2022. Efficacy of antibodies and antiviral drugs against Omicron BA.2.12.1, BA.4, and BA.5 subvariants. N Engl J Med 387:468–470. doi:10.1056/NEJMc2207519. - DOI - PMC - PubMed

[10] Takashita E, Yamayoshi S, Simon V, van Bakel H, Sordillo EM, Pekosz A, Fukushi S, Suzuki T, Maeda K, Halfmann P, Sakai-Tagawa Y, Ito M, Watanabe S, Imai M, Hasegawa H, Kawaoka Y. 2022. Efficacy of antibodies and antiviral drugs against Omicron BA.2.12.1, BA.4, and BA.5 subvariants. N Engl J Med 387:468–470. doi:10.1056/NEJMc2207519. - DOI - PMC - PubMed

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Sotrovimab in Hospitalized Patients with SARS-CoV-2 Omicron Variant Infection: a Propensity Score-Matched Retrospective Cohort Study

Affiliations

Sotrovimab in Hospitalized Patients with SARS-CoV-2 Omicron Variant Infection: a Propensity Score-Matched Retrospective Cohort Study

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