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

Trial Profile

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

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 09 Apr 2020

At a glance

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

    • 09 Apr 2020 New trial record
    • 08 Apr 2020 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.

Trial Overview

Purpose

This phase III Clinical Trial will investigate tocilizumab (Actemra) in patients with severe COVID-19 Pneumonia in Japan.

Diseases Treated

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

Subjects

  • Subject Type patients
  • 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.

Trial Centres

Centres

Centre Name Location Trial Centre Country
Chugai pharmaceutical
-
-

Trial History

Event Date Event Type Comment
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. Chugai Starts Phase III Clinical Trial of Actemra for COVID-19 Pneumonia in Japan. Media-Rel 2020;.

    Media Release
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