COMET-ICE

Incomplete

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.
PubMed • Full text • PDF

Clinical Question

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

Bottom Line

There are too many va

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

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

Criticisms

• Causes of death were not specified

Funding

• Vir Biotechnology and GlaxoSmithKline