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A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-573) in Participants With Moderate COVID-19 Compared to Standard of Care Treatment

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Trial Profile

A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-573) in Participants With Moderate COVID-19 Compared to Standard of Care Treatment

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 Dec 2022

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At a glance

  • Drugs Remdesivir (Primary)
  • Indications COVID 2019 infections; COVID-19 pneumonia
  • Focus Registrational; Therapeutic Use
  • Acronyms SIMPLE; SIMPLE-moderate
  • Sponsors Gilead Sciences

    • Most Recent Events

    • 25 Oct 2020 Results presented at the IDWeek 2020
    • 25 Oct 2020 Results (n=584) assessing baseline characteristics associated with clinical improvement at day 14, presented at the IDWeek 2020
    • 28 Aug 2020 According to a Gilead Sciences media release, based on the SIMPLE-moderate (Study GS-US-540-5774) and ACTT-1 studies, the USA Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) use of the investigational antiviral Veklury (remdesivir) to treat all hospitalized patients with COVID-19, in addition to the previous authorization for patients hospitalized with severe COVID-19.
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