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All Studies   Meta Analysis    Recent:   
0 0.5 1 1.5 2+ Mortality 89% Improvement Relative Risk Hospitalization 62% primary ED visit -11% Sotrovimab  Aggarwal et al.  EARLY TREATMENT Is early treatment with sotrovimab beneficial for COVID-19? PSM retrospective 10,036 patients in the USA (Oct - Dec 2021) Lower mortality (p=0.048) and hospitalization (p=0.0021) c19early.org Aggarwal et al., The J. Infectious Dis.., Apr 2022 Favors sotrovimab Favors control

Real-World Evidence of the Neutralizing Monoclonal Antibody Sotrovimab for Preventing Hospitalization and Mortality in COVID-19 Outpatients

Aggarwal et al., The Journal of Infectious Diseases, doi:10.1093/infdis/jiac206 (date from preprint)
Apr 2022  
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Sotrovimab for COVID-19
39th treatment shown to reduce risk in May 2023
 
*, now known with p = 0.0017 from 22 studies, recognized in 37 countries. Efficacy is variant dependent.
Lower risk for hospitalization.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
4,200+ studies for 70+ treatments. c19early.org
PSM retrospective 10,036 outpatients, 522 treated with sotrovimab, showing lower mortality and hospitalization with treatment.
Confounding by treatment propensity. This study analyzes a population where only a fraction of eligible patients received the treatment. Patients receiving treatment may be more likely to follow other recommendations, more likely to receive additional care, and more likely to use additional treatments that are not tracked in the data (e.g., nasal/oral hygiene c19early.org, c19early.org (B), vitamin D c19early.org (C), etc.) — either because the physician recommending sotrovimab also recommended them, or because the patient seeking out sotrovimab is more likely to be familiar with the efficacy of additional treatments and more likely to take the time to use them. Therefore, these kind of studies may overestimate the efficacy of treatments.
Efficacy is variant dependent. In Vitro studies predict lower efficacy for BA.1 Liu, Sheward, VanBlargan, BA.4, BA.5 Haars, XBB.1.9.3, XBB.1.5.24, XBB.2.9, CH.1.1 Pochtovyi, and no efficacy for BA.2 Zhou, ХВВ.1.9.1, XBB.1.16, BQ.1.1.45, and CL.1 Pochtovyi. US EUA has been revoked.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.
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, primary outcome.
ED visit, 11.0% higher, RR 1.11, p = 0.55, treatment 44 of 522 (8.4%), control 119 of 1,563 (7.6%), adjusted per study, odds ratio converted to relative risk, propensity score matching, multivariable, day 28.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Aggarwal et al., 5 Apr 2022, retrospective, USA, peer-reviewed, 14 authors, study period 1 October, 2021 - 11 December, 2021. Contact: neil.aggarwal@cuanschutz.edu.
This PaperSotrovimabAll
Real World Evidence of the Neutralizing Monoclonal Antibody Sotrovimab for Preventing Hospitalization and Mortality in COVID-19 Outpatients
MD, MHSc Neil R Aggarwal, MS Laurel E Beaty, MD Tellen D Bennett, PhD, MS Nichole E Carlson, MD d ; Christopher B Davis, PhD Bethany M Kwan, BS David A Mayer, PhD Toan C Ong, MS Seth Russell, RN g ; Jeffrey Steele, PhD Adane F Wogu, MD, MPH Matthew K Wynia, MD Richard D Zane, MD, MPH Adit A Ginde
doi:10.1101/2022.04.03.22273360
Background: It is not known whether sotrovimab, a neutralizing monoclonal antibody (mAb) treatment authorized for early symptomatic COVID-19 patients, is effective against the SARS-CoV-2 Delta variant to prevent progression to severe disease and mortality. Methods: Observational cohort study of non-hospitalized adult patients with SARS-CoV-2 infection from October 1 st 2021 -December 11 th 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 1,563 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% versus 5.7%; adjusted OR 0.37, 95% CI 0.19-0.66) and an 89% decrease in the odds of allcause 28-day mortality (raw rate 0% versus 1.0%; adjusted OR 0.11, 95% CI 0.0-0.79), and may reduce respiratory disease severity among those hospitalized. Conclusion: Real-world evidence demonstrated sotrovimab effectiveness in reducing hospitalization and all-cause 28-day mortality among COVID-19 outpatients during the Delta variant phase.
References
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Dougan, Nirula, Azizad, Bamlanivimab plus Etesevimab in Mild or Moderate Covid-19, N Engl J Med
Gupta, Gonzalez-Rojas, Juarez, Effect of Sotrovimab on Hospitalization or Death Among High-risk Patients With Mild to Moderate COVID-19: A Randomized Clinical Trial, JAMA
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Weinreich, Sivapalasingam, Norton, REGN-COV2, a Neutralizing Antibody Cocktail, in Outpatients with Covid-19, N Engl J Med
Wynia, Beaty, Bennett, Real World Evidence of Neutralizing Monoclonal Antibodies for Preventing Hospitalization and Mortality in COVID-19 Outpatients, medRxiv
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