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A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Evaluating the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for COVID-19

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Trial Profile

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Evaluating the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for COVID-19

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 09 Jul 2024

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At a glance

  • Drugs Remdesivir (Primary)
  • Indications COVID 2019 infections; SARS-CoV-2 acute respiratory disease
  • Focus Registrational; Therapeutic Use
  • Acronyms REDPINE
  • Sponsors Gilead Sciences

    • Most Recent Events

    • 09 Mar 2024 The trial has been completed in Portugal (End Date: 24 May 2022), according to European Clinical Trials Database record.
    • 14 Jul 2023 According to a Gilead Sciences media release, based on results from a Phase 1 Pharmacokinetic study (GS-US-540-9015), as well as results from the Phase 3 REDPINE trial, the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for the use of Veklury (remdesivir) in COVID-19 patients with severe renal impairment, including those on dialysis.
    • 26 May 2023 According to a Gilead Sciences media release, based on results from a Phase 1 Pharmacokinetic study (GS-US-540-9015), as well as results from the Phase 3 REDPINE trial, he Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted a positive opinion for the use of Veklury (remdesivir) in COVID-19 patients with severe renal impairment, including those on dialysis. The European Commission (EC) will review the CHMP recommendation.

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