Real-World Evidence of the Neutralizing Monoclonal Antibody Sotrovimab for Preventing Hospitalization and Mortality in COVID-19 Outpatients. (16th May 2022)

• Record Type: Journal Article
• Authors: Aggarwal, Neil R; Beaty, Laurel E; Bennett, Tellen D; Carlson, Nichole E; Davis, Christopher B; Kwan, Bethany M; Mayer, David A; Ong, Toan C; Russell, Seth; Steele, Jeffrey; Wogu, Adane F; Wynia, Matthew K; Zane, Richard D; Ginde, Adit A
• Is Part Of: Journal of infectious diseases. Volume 226:Number 12(2022)
• Page Start: 2129
• Page End: 2136
• Publication Date: 2022-05-16
• Subjects: real-world evidence -- COVID-19 -- sotrovimab -- outpatients -- mortality; Communicable diseases -- Periodicals; Diseases -- Causes and theories of causation -- Periodicals; Medicine -- Periodicals; Communicable Diseases -- Periodicals; Electronic journals; 616.9
• DOI: 10.1093/infdis/jiac206
• Languages: English
• ISSNs: 0022-1899

Abstract

Abstract: Background: It is not known whether sotrovimab, a neutralizing monoclonal antibody (mAb) treatment authorized for early symptomatic coronavirus disease 2019 (COVID-19) patients, is also effective in preventing the progression of severe disease and mortality following severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Delta variant infection. Methods: In an observational cohort study of nonhospitalized adult patients with SARS-CoV-2 infection, 1 October 2021–11 December 2021, using electronic health records from a statewide health system plus state-level vaccine and mortality data, we used propensity matching to select 3 patients not receiving mAbs for each patient who received outpatient sotrovimab treatment. The primary outcome was 28-day hospitalization; secondary outcomes included mortality and severity of hospitalization. Results: Of 10 036 patients with SARS-CoV-2 infection, 522 receiving sotrovimab were matched to 1563 not receiving mAbs. Compared to mAb-untreated patients, sotrovimab treatment was associated with a 63% decrease in the odds of all-cause hospitalization (raw rate 2.1% vs 5.7%; adjusted odds ratio [aOR], 0.37; 95% confidence interval [CI], .19–.66) and an 89% decrease in the odds of all-cause 28-day mortality (raw rate 0% vs 1.0%; aOR, 0.11; 95% CI, .0–.79), and may reduce respiratory disease severity among those hospitalized. Conclusions: Real-world evidence demonstrated sotrovimab effectiveness in reducing hospitalization and all-cause 28-day mortality among COVID-19 outpatients during the Delta variant phase. Abstract : Real-world evidence demonstrates that sotrovimab, a neutralizing monoclonal antibody (mAb), significantly reduces 28-day hospitalization and mortality rates when administered to high-risk outpatients recently infected with SARS-CoV-2 during the Delta variant phase, compared to a propensity-matched cohort of mAb-untreated outpatients.