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A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia in Japan

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Trial Profile

A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia in Japan

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 24 Mar 2022

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At a glance

  • Drugs Tocilizumab (Primary)
  • Indications COVID 2019 infections; COVID-19 pneumonia
  • Focus Registrational; Therapeutic Use
  • Acronyms J-COVACTA
  • Sponsors Chugai Pharmaceutical

    • Most Recent Events

    • 21 Jan 2022 According to a Chugai Pharmaceutical media release, the company received regulatory approval from the Ministry of Health, Labour and Welfare for Actemra Intravenous Infusion 80 mg, 200 mg, and 400 mg for the additional indication of the treatment of SARS-CoV-2 pneumonia (limited to patients requiring oxygen intervention), based on results from COVACTA, EMPACTA, REMDACTA, J-COVACTA and RECOVERY studies.
    • 09 Feb 2021 According to a Chugai Pharmaceutical media release, further analysis of the study will be conducted, and the study results will be presented at a future medical meeting.
    • 09 Feb 2021 According to a Chugai Pharmaceutical media release, the company will discuss the filing for additional indication of Actemra for the treatment of COVID-19 associated pneumonia with Japanese health authority based on results from this and overseas studies including REMDACTA study.
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