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A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734) in Participants With Severe COVID-19

Trial Profile

A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734) in Participants With Severe COVID-19

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Oct 2020

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At a glance

  • Drugs Remdesivir (Primary)
  • Indications COVID-19 respiratory infection
  • Focus Registrational; Therapeutic Use
  • Acronyms SIMPLE; SIMPLE-severe
  • Sponsors Gilead Sciences
  • Most Recent Events

    • 22 Oct 2020 According to a Gilead Sciences media release, the U.S. Food and Drug Administration (FDA) has approved Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization, based on data from ACTT-1 and SIMPLE-Severe studies.
    • 10 Aug 2020 According to an Gilead Sciences media release, it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Veklury (remdesivir), an investigational antiviral for the treatment of patients with COVID-19.The filing is supported by data from ACTT and SIMPLE.
    • 23 Jul 2020 Status changed from active, no longer recruiting to completed.
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