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A Phase II/III Randomized, Multi-center, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Monoclonal Antibody VIR-7831 for the Early Treatment of Coronavirus Disease 2019 (COVID-19) in Non-hospitalized Patients

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Trial Profile

A Phase II/III Randomized, Multi-center, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Monoclonal Antibody VIR-7831 for the Early Treatment of Coronavirus Disease 2019 (COVID-19) in Non-hospitalized Patients

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 08 Dec 2022

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At a glance

  • Drugs Sotrovimab (Primary)
  • Indications COVID 2019 infections
  • Focus First in man; Registrational; Therapeutic Use
  • Acronyms COMET-ICE
  • Sponsors Vir Biotechnology

    • Most Recent Events

    • 09 Nov 2022 Results assessing he cost-effectiveness of sotrovimab versus standard of care (SOC) as an outpatient treatment for patients in Italy with mild-to-moderate COVID-19 , by deriving Sotrovimab treatment effect from the COMET-ICE trial, presented at the 25th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research
    • 25 Aug 2022 New source identified and integrated (European Clinical Trials Database: EudraCT2020-002871-36).
    • 25 Mar 2022 According to a Vir Biotechnology media release, company intends to submit further data in support of a higher dose of sotrovimab for the Omicron BA.2 subvariant, to regulatory and health authorities around the world for discussion.
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