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Phase III single arm Clinical Trial of Actemra (tocilizumab) for COVID-19 Pneumonia in Japan

Trial Profile

Phase III single arm Clinical Trial of Actemra (tocilizumab) for COVID-19 Pneumonia in Japan

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Feb 2021

At a glance

  • Drugs Tocilizumab (Primary)
  • Indications COVID 2019 infections; Pneumonia
  • Focus Registrational; Therapeutic Use
  • Acronyms J-COVACTA
  • Sponsors Chugai Pharmaceutical
  • Most Recent Events

    • 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.
    • 09 Feb 2021 According to a Chugai Pharmaceutical media release, the clinical trial notification was submitted on April 8, 2020 and 49 patients were enrolled in the study from May to October in 2020.

Trial Overview

Purpose

This phase III Clinical Trial will investigate efficacy and safety of the combination of tocilizumab (Actemra) and standard of care in hospitalized patients with severe COVID-19 associated pneumonia.

Comments

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.

Primary Endpoints

Other Endpoints

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -
Pneumonia treatment severe

Subjects

  • Subject Type patients
  • Number

    Planned: 49

  • Sex male & female

Patient Inclusion Criteria

Hospitalized patients with severe COVID19 pneumonia in Japan

Trial Details

Organisations

  • Sponsors Chugai Pharmaceutical
  • Affiliations Chugai Pharmaceutical

Trial Dates

Other Details

  • Design prospective
  • Phase of Trial Phase III
  • Location Japan
  • Focus Registrational; Therapeutic Use

Interventions

Drugs Route Formulation
TocilizumabPrimary Drug Intravenous Infusion

Tocilizumab (Actemra)

Patients will receive Actemra® Intravenous Infusion 80 mg, 200 mg, and 400 mg.

Results

Therapeutic efficacy

In the phase III J-COVACTA trial treatment tocilizumab at day 28 resulted in discharge of 35/48 (72.9%) patients from the hospital, while five (10.4%) patients suffered fatal outcomes. Improvement in at least one category was seen in (81.3%) patients on the 7-Category Ordinal scale at day 28 compared with the previous treatment. Six (12.5%) patients worsened in at least one category [1]

Adverse events

In the phase III J-COACTA trial, treatment with tocilizumab was found to be generally safe and well tolerated with no new safety signal identified [1]

Publications

  1. Chugai Pharmaceutical. Results of Phase III Clinical Study in Japan for Actemra in COVID-19 Associated Pneumonia. Media-Rel 2021;.

    Media Release

Authors

Author Total Publications First Author Last Author
Chugai Pharmaceutical 1 1 1

Trial Centres

Centres

Centre Name Location Trial Centre Country
Chugai pharmaceutical
-
-

Trial History

Event Date Event Type Comment
09 Feb 2021 Other trial event 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. Updated 16 Feb 2021
09 Feb 2021 Other trial event 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. Updated 16 Feb 2021
09 Feb 2021 Other trial event According to a Chugai Pharmaceutical media release, the clinical trial notification was submitted on April 8, 2020 and 49 patients were enrolled in the study from May to October in 2020. Updated 16 Feb 2021
09 Feb 2021 Results Results presented in the Chugai Pharmaceutical Media Release. Updated 16 Feb 2021
09 Apr 2020 New trial record New trial record Updated 09 Apr 2020
08 Apr 2020 Other trial event According to a Chugai Pharmaceutical media release, the company filed a clinical trial notification with the Pharmaceuticals and Medical Devices Agency today to conduct a Phase III clinical trial of Actemra for the treatment of hospitalized patients with severe COVID19 pneumonia in Japan. It is working to start enrolling as soon as possible after finalizing study details. Updated 09 Apr 2020

References

  1. Chugai Pharmaceutical. Results of Phase III Clinical Study in Japan for Actemra in COVID-19 Associated Pneumonia. Media-Rel 2021;.

    Media Release
  2. Chugai Pharmaceutical. Chugai Starts Phase III Clinical Trial of Actemra for COVID-19 Pneumonia in Japan. Media-Rel 2020;.

    Media Release
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