Real-World Evidence of the Neutralizing Monoclonal Antibody Sotrovimab for Preventing Hospitalization and Mortality in COVID-19 Outpatients
Aggarwal et al.,
Real-World Evidence of the Neutralizing Monoclonal Antibody Sotrovimab for Preventing Hospitalization and..,
medRxiv, doi:10.1101/2022.04.03.22273360 (Preprint)
Retrospective 522 sotrovimab patients and matched controls in the USA, showing significantly lower hospitalization and mortality with treatment.
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 US EUA has been revoked.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, 88.9% lower, RR 0.11, p = 0.048, treatment 0 of 522 (0.0%), control 15 of 1,563 (1.0%), NNT 104, adjusted per study, odds ratio converted to relative risk, propensity score matching, multivariable, day 28.
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risk of hospitalization, 61.6% lower, RR 0.38, p = 0.002, treatment 11 of 522 (2.1%), control 89 of 1,563 (5.7%), NNT 28, adjusted per study, odds ratio converted to relative risk, propensity score matching, multivariable, day 28.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Aggarwal et al., 5 Apr 2022, retrospective, USA, preprint, 14 authors, study period 1 October, 2021 - 11 December, 2021.
Abstract: medRxiv preprint doi: https://doi.org/10.1101/2022.04.03.22273360; this version posted April 5, 2022. The copyright holder for this preprint
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
All rights reserved. No reuse allowed without permission.
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Real World Evidence of the Neutralizing Monoclonal Antibody Sotrovimab
for Preventing Hospitalization and Mortality in COVID-19 Outpatients
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Neil R. Aggarwal, MD, MHSca*; Laurel E. Beaty, MSb*; Tellen D. Bennett, MD, MS c,e; Nichole
E. Carlson, PhD, MSb,e; Christopher B. Davis, MDd; Bethany M. Kwan, PhD, MSPHd,e,f; David
A. Mayer, BSb; Toan C. Ong, PhDc; Seth Russell, MSc; Jeffrey Steele, RNg; Adane F. Wogu,
PhDb; Matthew K. Wynia, MD, MPHa,h,i; Richard D. Zane, MDd; Adit A. Ginde, MD, MPHd,e
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Department of Medicine, University of Colorado School of Medicine, Aurora, 80045, USA
Department of Biostatistics and Informatics, Colorado School of Public Health, Aurora, 80045,
USA
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See Supplement for a full list of Contributors.
Section of Informatics and Data Science, Department of Pediatrics, University of Colorado
School of Medicine, Aurora, 80045, USA
Department of Emergency Medicine, University of Colorado School of Medicine, Aurora,
80045, USA
Colorado Clinical and Translational Sciences Institute, University of Colorado Anschutz
Medical Campus, Aurora, 80045, USA
Department of Family Medicine, University of Colorado School of Medicine, Aurora, 80045,
USA
Research Informatics, Children’s Hospital Colorado, Aurora, 80045, USA
Center for Bioethics and Humanities, University of Colorado, Anschutz Medical Campus,
Aurora, 80045, USA
Department of Health Systems Management and Policy, Colorado School of Public Health,
Aurora, 80045, USA
Contributed equally to this manuscript
Corresponding author:
Neil R. Aggarwal, MD, MHSc
Department of Medicine
University of Colorado School of Medicine
12700 E. 19th Ave, Mail Stop C-272
Aurora, CO 80045, USA
Phone: +1-303-724-6038
Email: neil.aggarwal@cuanschutz.edu
Running title: Sotrovimab for COVID-19 Outpatients
Word counts: Abstract: 199, Manuscript text: 2944
NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.
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medRxiv preprint doi: https://doi.org/10.1101/2022.04.03.22273360; this version posted April 5, 2022. The copyright holder for this preprint
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
All rights reserved. No reuse allowed without permission.
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ABSTRACT
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Background: It is not known whether sotrovimab, a neutralizing monoclonal antibody (mAb)
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treatment authorized for early symptomatic COVID-19 patients, is effective against the SARS-
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CoV-2 Delta variant to prevent progression to severe disease and mortality.
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Methods: Observational cohort study of non-hospitalized adult patients with SARS-CoV-2
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infection from October 1st 2021 - December 11th 2021, using electronic health records from a
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statewide health system plus state-level vaccine and mortality data. We used propensity
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matching to select 3 patients not receiving mAbs for each patient who received outpatient
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sotrovimab treatment. The primary..
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