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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

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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 Jun 2022

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At a glance

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

    • Most Recent Events

    • 24 Jun 2021 Results of an analysis assessing all cause mortality hazard ratios, overall and stratified by baseline oxygen ; data were used from this trial and compared with a study GS-US-540-5807 (EUPAS34303; a real-world retrospective longitudinal cohort study) presented at the World Microbe Forum 2021
    • 10 Mar 2021 Results assessing final comparative analysis from two studies: a prospective phase 3, randomized study of RDV (n=368; RDV cohort- final Day 28 (D28) analysis of NCT04292899) vs standard of care (SOC) (n= 1399; interim Day 14 [D14] analysis of a real-world retrospective cohort study of SOC (non-RDV cohort), presented at the 28th Conference on Retroviruses and Opportunistic Infections
    • 25 Oct 2020 Results (n=397) assessing regional differences in clinical outcomes of severe COVID-19 patients treated with RDV, presented at the IDWeek 2020

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