Change in Effectiveness of Sotrovimab for Preventing Hospitalization and Mortality for At-risk COVID-19 Outpatients During an Omicron BA.1 and BA.1.1-Predominant Phase
Aggarwal et al.,
Change in Effectiveness of Sotrovimab for Preventing Hospitalization and Mortality for At-risk COVID-19..,
International Journal of Infectious Diseases, doi:10.1016/j.ijid.2022.10.002 (date from earlier preprint)
Retrospective 30,247 outpatients in the USA, showing no significant differences with sotrovimab with omicron BA.1.
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 US EUA has been revoked.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, 38.0% lower, RR 0.62, p = 0.62, treatment 1 of 1,542 (0.1%), control 7 of 3,663 (0.2%), odds ratio converted to relative risk.
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risk of hospitalization, 17.5% lower, RR 0.82, p = 0.32, treatment 39 of 1,542 (2.5%), control 116 of 3,663 (3.2%), NNT 157, odds ratio converted to relative risk, primary outcome.
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risk of progression, 2.8% higher, RR 1.03, p = 0.83, treatment 93 of 1,542 (6.0%), control 224 of 3,663 (6.1%), NNT 1189, odds ratio converted to relative risk, ED visit.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Aggarwal et al., 18 Jun 2022, retrospective, USA, peer-reviewed, 10 authors, study period 26 December, 2021 - 10 March, 2022.
Contact:
neil.aggarwal@cuanschutz.edu.
Abstract: medRxiv preprint doi: https://doi.org/10.1101/2022.06.17.22276575; this version posted June 18, 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(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
It is made available under a CC-BY-NC-ND 4.0 International license .
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Change in Effectiveness of Sotrovimab for Preventing Hospitalization and
Mortality in COVID-19 Outpatients During the Omicron Phase
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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; Adit A. Ginde, MD, MPHd,e
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a Department of Medicine, University of Colorado School of Medicine, Aurora, 80045, USA
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c Section of Informatics and Data Science, Department of Pediatrics, University of Colorado
Department of Biostatistics and Informatics, Colorado School of Public Health, Aurora, 80045,
USA
School of Medicine, Aurora, 80045, USA
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e Colorado Clinical and Translational Sciences Institute, University of Colorado Anschutz
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* Contributed equally to this manuscript
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See Supplement for a full list of Contributors.
Department of Emergency Medicine, University of Colorado School of Medicine, Aurora,
80045, USA
Medical Campus, Aurora, 80045, USA
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: 2924
Summary: Real-world evidence demonstrates that the neutralizing monoclonal antibody
sotrovimab was not associated with lower 28-day hospitalization and mortality rates when
administered to high-risk outpatients recently infected with SARS-CoV-2 during the Omicron
variant phase, compared to a propensity-matched cohort of untreated outpatients.
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/10.1101/2022.06.17.22276575; this version posted June 18, 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.
It is made available under a CC-BY-NC-ND 4.0 International license .
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ABSTRACT
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Background: Sotrovimab, a neutralizing monoclonal antibody (mAb) treatment authorized for
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early symptomatic COVID-19 patients, was effective in preventing the progression of severe
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disease and mortality following SARS-CoV-2 Delta variant infection. It is not known whether
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sotrovimab is similarly effective for SARS-CoV-2 Omicron variant infection.
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Methods: Observational cohort study of non-hospitalized adult patients with SARS-CoV-2
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infection from December 26, 2021 to March 10, 2022 (>96% Omicron BA.1 variant), using
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electronic health records from a statewide health system linked to state-level vaccine and
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mortality data. We used propensity matching to select up to 3 patients not receiving mAbs or
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other authorized antivirals for each patient who received outpatient sotrovimab treatment. The
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primary outcome was 28-day hospitalization; secondary outcomes included mortality. To
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evaluate change in..
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