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A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Jul 2023

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At a glance

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

    • Most Recent Events

    • 24 May 2023 Results assessing effect of IL-6R blockade on key immune pathways associated with severe COVID-19, presented at the 119th International Conference of the American Thoracic Society
    • 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.
    • 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).
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