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Gupta A, et al. "Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab". The New England Journal of Medicine. 2021. 385:1941-1950.
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Clinical Question

In patients with mild to moderate COVID-19 will Sotrovimab reduce hospitalization or mortality

Bottom Line

There are too many va

Major Points

Guidelines

Design

  • Multicenter, Double-blind, Phase 3 trial, Placebo group

Population

Inclusion Criteria

  • 18 years of age or older and at high risk of progression of Covid-19 based on at least one risk factor
    • diabetes
    • obesity
    • chronic kidney disease
    • congestive heart failure
    • chronic obstructive pulmonary disease
  • 55 years of age or older
  • positive SARS-CoV-2 test result
  • oxygen saturation of 94% and more on room air
  • Covid-19 symptoms
    • fever
    • chills
    • cough
    • sore
    • throat
    • malaise
    • headache
    • joint
    • muscle pain
    • change in smell or taste
    • vomiting
    • diarrhea
    • shortness of breath on exertion
  • less than or equal to 5 days from onset of symptoms

Exclusion Criteria

  • Likely to require hospitalization in the next 24 hours
  • Symptoms consistent with severe Covid-19 as defined by shortness of breath at rest or respiratory distress or requiring supplemental oxygen
  • likely to die in the next 7 days
  • Pregnant
  • Breastfeeding
  • Known hypersensitivity to any constituent present in the investigational product
  • Previous anaphylaxis or hypersensitivity to a monoclonal antibody
  • Enrollment in any investigational vaccine study within the last 180 days or any other investigational drug study within 30 days prior to day 1 or within five half-lives of the investigational compound
  • Whichever is longer, enrollment in any trial of an investigational vaccine for SARS-CoV-2
  • Severely immunocompromised patients
  • Any vaccine within 48 hours prior to enrollment
  • Convalescent plasma from a recovered Covid-19 patient anti–SARS-CoV-2 monoclonal antibody within the last 3 months
  • Unlikely or unable to comply with the requirements of the protocol through day 29

Baseline Characteristics

Interventions

Outcomes

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Primary Outcomes

= hospitalization for more than 24 hours or died from any cause through day 29, alive and not hospitalized

Secondary Outcomes

Criticisms

  • Causes of death were not specified

Funding

  • Vir Biotechnology and GlaxoSmithKline

Further Reading