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A Phase III, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Patients With Severe COVID-19 Pneumonia

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Trial Profile

A Phase III, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Patients With Severe COVID-19 Pneumonia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Apr 2023

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At a glance

  • Drugs Remdesivir (Primary) ; Tocilizumab (Primary)
  • Indications COVID-19 pneumonia
  • Focus Registrational; Therapeutic Use
  • Acronyms REMDACTA
  • Sponsors Genentech; Roche

    • Most Recent Events

    • 22 Feb 2023 Results assessing estimated dose exposure metrics of RDV and metabolites (GS-704277, GS-441524) in REDPINE (n=90) study compared to PINETREE (n=148) and REMDACTA(n=289) study participants presented at the 30th Conference on Retroviruses and Opportunistic Infections 2023
    • 04 Apr 2022 According to a Genentech media release, the U.S. FDA has accepted the company's supplemental Biologics License Application (sBLA) and has granted Priority Review for Actemra (tocilizumab) intravenous (IV) for the treatment of COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
    • 04 Apr 2022 According to a Genentech media release, a decision on U.S. FDA approval is expected in the second half of this year.
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