Sotrovimab in Hospitalized Patients with SARS-CoV-2 Omicron Variant Infection: a Propensity Score-Matched Retrospective Cohort Study
et al., Microbiology Spectrum,
Sotrovimab in Hospitalized Patients with SARS-CoV-2 Omicron Variant Infection: a Propensity Score-Matched..
, Microbiology Spectrum, doi:10.1128/spectrum.04103-22
PSM retrospective 1,254 hospitalized patients in Germany, 147 treated with sotrovimab, showing higher mortality with sotrovimab, without statistical significance.Efficacy is variant dependent. In Vitro studies predict lower efficacy for BA.1 [Liu, Sheward, VanBlargan] and a lack of efficacy for BA.2 [Zhou]. US EUA has been revoked.
risk of death, 140.0% higher, RR 2.40, p = 0.12, treatment 4 of 60 (6.7%), control 10 of 360 (2.8%), non-ICU, propensity score matching.
risk of death, 50.0% higher, RR 1.50, p = 0.08, treatment 36 of 87 (41.4%), control 24 of 87 (27.6%), ICU, propensity score matching.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Woo et al., 8 Dec 2022, retrospective, Germany, peer-reviewed, 13 authors.
Abstract: RESEARCH ARTICLE
Sotrovimab in Hospitalized Patients with SARS-CoV-2 Omicron
Variant Infection: a Propensity Score-Matched Retrospective
Marcel S. Woo,a,b Thomas Theo Brehm,c,d Marlene Fischer,e Andreas Heyer,c Dominic Wichmann,e Sabine Jordan,c Dominik Nörz,f
Marc Lütgehetmann,d,f Marylyn M. Addo,c,d,g Ansgar W. Lohse,c,d Stefan Schmiedel,c,d Stefan Kluge,e Julian Schulze zur Wieschc,d
Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Institute of Neuroimmunology and Multiple Sclerosis (INIMS), Center for Molecular Neurobiology Hamburg (ZMNH), University Medical Center Hamburg-Eppendorf,
I. Department of Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
German Center for Infection Research (DZIF), University Medical Center Hamburg-Eppendorf, Lübeck-Borstel-Riems, Hamburg, Germany
Department of Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Institute of Medical Microbiology, Virology and Hygiene, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Institute of Infection Research and Vaccine Development (IIRVD), University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Marcel S. Woo, Thomas Theo Brehm, Stefan Kluge, and Julian Schulze zur Wiesch contributed equally to this article. Author order was determined in order of increasing seniority.
In vitro data suggest the monoclonal antibody sotrovimab may have lost
inhibitory capability against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) 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
KEYWORDS SARS-CoV-2, COVID-19, Omicron, sotrovimab, remdesivir, monoclonal
antibodies, Omicron variant
s of September 2022, more than 6.4 million people have died from coronavirus disease
2019 (COVID-19) worldwide (1). The severe acute respiratory syndrome coronavirus
type 2 (SARS-CoV-2) Omicron variant (B.1.1.529) emerged in November 2021 and quickly
replaced the Delta variant..
is less effective
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