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

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

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.

Trial Overview

Purpose

This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of tocilizumab (TCZ) in combination with standard of care (SOC) in hospitalized patients with severe COVID-19 pneumonia.

Comments

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.

Primary Endpoints

Safety : Incidence and severity of adverse events, change from baseline in clinical laboratory test results

Efficacy : 7 category ordinal scale

Other Endpoints

Efficacy : Time to clinical improvement
PK : TCZ PK profile
PD : Serum concentrations of IL-6, sIL-6R, and CRP [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -
COVID-19 pneumonia treatment severe

Subjects

  • Subject Type patients
  • Number

    Planned: 49

    Actual: 49

  • Sex male & female
  • Age Group ≥18 years; adult

Patient Inclusion Criteria

1) Age ≥18 years at time of signing Informed Consent Form2) Hospitalized with COVID-19 pneumonia confirmed per a positive PCR of any specimen (e.g., respiratory, blood, urine, stool, other bodily fluid) and evidenced by chest X-ray or CT scan3) SPO2 ≤ 93% or PaO2/FiO2 < 300 mmHg

Patient Exclusion Criteria

1) Known severe allergic reactions to TCZ or other monoclonal antibodies2) Active TB infection3) Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)4) Active chronic HBV or HCV5) Have received live vaccine or live attenuated vaccine within 4 weeks before screening6) In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments7) Have received oral anti-rejection or immunomodulatory drugs (including TCZ) within the past 3 months8) ALT or AST > 10 x ULN detected at screening9) ANC < 1000/microL at screening10) Platelet count < 50,000/microL at screening11) Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination12) Any serious medical condition that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study(Permitted Therapy)All patients will receive standard of care (eg. anti-viral treatment, low-dose steroids, and supportive care) per local practice for the treatment of COVID-19 pneumonia.If steroids are given, the Sponsor recommends a dose of no more than 1 mg/kg methylprednisolone or equivalent for no more than 5 days.

Trial Details

Identifiers

Identifier Owner
JapicCTI205270 Japan Pharmaceutical Information Center - Clinical Trials Information

Organisations

  • Sponsors Chugai Pharmaceutical
  • Affiliations Chugai Pharmaceutical

Trial Dates

  • Initiation Dates

    Planned : 25 May 2020

  • End Dates

    Planned : 31 Mar 2021

Other Details

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

Interventions

Drugs Route Formulation
TocilizumabPrimary Drug Intravenous Infusion

Intervention Name: tocilizumab

INN of investigational material: tocilizumab
Investigational material:medicine:therapeutic category code: 639 / other biological preparations
Dosage and administration for investigational material: Participants will receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg. Up to 1 additional dose may be given 8-24 hours after the initial infusion if the clinical signs or symptoms worsen or do not improve.

Results

Adverse events

COVID-19 pneumonia: 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 [2]

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
24 Mar 2022 Other trial event Last checked against Japan Pharmaceutical Information Center - Clinical Trials Information: Updated 24 Mar 2022
21 Jan 2022 Other trial event 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. Updated 27 Jan 2022
24 Dec 2021 Other trial event New source identified and integrated( Japan Pharmaceutical Information Center - Clinical Trials Information:JapicCTI205270). Updated 24 Dec 2021
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. Japan Pharmaceutical Information Center - Clinical Trials Information. Trial-Reg 2016;.

    Available from: URL: http://www.clinicaltrials.jp/user/cteSearch_e.jsp
  2. Chugai Pharmaceutical. Results of Phase III Clinical Study in Japan for Actemra in COVID-19 Associated Pneumonia. Media-Rel 2021;.

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

    Media Release
  4. Chugai Pharmaceutical. Chugai's Actemra Approved for Additional Indication of SARS-CoV-2 Pneumonia in Japan. Media-Rel 2022;.

    Media Release
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