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A Phase 3 clinical trial of VIR-7831 for the prevention of symptomatic COVID-19 infections

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Trial Profile

A Phase 3 clinical trial of VIR-7831 for the prevention of symptomatic COVID-19 infections

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 16 Aug 2022

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At a glance

  • Drugs Sotrovimab (Primary)
  • Indications COVID 2019 infections
  • Focus Therapeutic Use
  • Acronyms COMET-STAR

    • Most Recent Events

    • 09 Aug 2022 According to a Vir Biotechnology media release, due to the evolving COVID-19 landscape and based on discussions with the US Food and Drug Administration (FDA), the Company and GSK do not plan to file a Biologics License Application for sotrovimab at this time and do not intend to pursue the US-based Phase 3 COMET-STAR prophylaxis trial.
    • 24 Feb 2022 According to a Vir Biotechnology media release, Vir in collaboration with GSK is expecting this trial to start in the second quarter of 2022, the analysis of the primary endpoint of COMET-STAR will be event driven, and could be as early as the second half of 2022.
    • 21 May 2021 According to a GlaxoSmithKline media release, this Phase 3 trial is expected to begin in the third quarter of 2021.

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