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CoVIg 19

Drug Profile

CoVIg 19

Alternative Names: anti-coronavirus hIVIG - Takeda; Anti-coronavirus hyperimmune intravenous immunoglobulin - Takeda; Anti-COVID-19 Hyperimmune Globulin - Takeda; Anti-SARS-CoV-2 polyclonal H-IG - Takeda; Anti-SARS-CoV-2 polyclonal hyperimmune globulin - Takeda; COVID-19 H-IG - Takeda; CoVIg-19; TAK-888

Latest Information Update: 27 Apr 2022

At a glance

  • Originator Takeda
  • Developer Takeda; University of Minnesota
  • Class Antivirals; Immunoglobulins; Polyclonal antibodies
  • Mechanism of Action Virus internalisation inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes
  • Available For Licensing Yes - COVID 2019 infections

Highest Development Phases

  • Phase III COVID 2019 infections

Most Recent Events

  • 25 Apr 2022 Biotest AG has been acquired by Grifols
  • 21 May 2021 University of Minnesota completes a phase III ITAC trial in the treatment of COVID-2019 infections in the US, Greece, UK, Denmark, Japan, Germany, Indonesia, Israel, Argentina, Nigeria and Spain (NCT04546581)
  • 08 Oct 2020 Phase-III clinical trials in COVID-2019 infections in Denmark, Japan, Germany, Nigeria, Spain (IV) (EudraCT2020-002542-16) (NCT04546581)

Development Overview

Introduction

CoVIg 19 (formerly TAK 888) is an anti-SARS-CoV-2 polyclonal hyperimmune globulin (H-Ig), being developed by Takeda, for the treatment of COVID-2019 infections. The hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) is derived from the plasma of individuals who recover and develop neutralising antibodies. Clinical development is ongoing in the US, Greece, the UK, Denmark, Japan, Germany, Indonesia, Israel, Argentina, Nigeria and Spain.

As of March 2019, Takeda is in discussions with multiple national health and regulatory agencies and health care partners in the US, Asia, and Europe for the development of CoVIg 19 [1] .

In April 2022, Biotest AG was acquired by Grifols [2] .

Company Agreements

In April 2020, Biotest, Bio Products Laboratory (BPL), LFB, and Octapharma joined an alliance formed by CSL Behring and Takeda Pharmaceutical to develop a potential plasma-derived therapy for the treatment of COVID-19. The collaboration leads to the development of an unbranded anti-SARS-CoV-2 polyclonal hyperimmune immunoglobulin medicine with the potential to treat individuals with serious complications from COVID-19. The collaboration will leverage leading-edge expertise and work that the companies already have underway. Experts from the alliance will begin collaborating across key aspects such as plasma collections, clinical trial development and manufacturing. Liminal Biosciences, through its subsidiary, Prometic Plasma Resources, has also joined the alliance. [3] [4]

Key Development Milestones

In May 2021, the University of Minnesota, the National Institute of Allergy and Infectious Diseases (NIAID), and the National Institutes of Health (NIH), completed a phase III ITAC trial of CoVIg 19 in the treatment of COVID 2019 infections. Earlier, in September 2020, the University of Minnesota, the National Institute of Allergy and Infectious Diseases (NIAID), and the National Institutes of Health (NIH), initiated a phase III ITAC trial to evaluate the safety, tolerability and efficacy of anti-coronavirus hyperimmune intravenous immunoglobulin (hIVIG) versus placebo, along with remdesivir [see adis profile 800043325] as standard of care, in adult patients hospitalised for COVID-19 and have had symptoms for 12 days or fewer without life-threatening organ dysfunction or end-organ failure (INSIGHT013; EudraCT2020-002542-16; INSIGHT 013; NCT04546581). The Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) trial is a double-blind, placebo-controlled, randomised, adaptive enrolled 593 patients in the US, Greece, the UK, Denmark, Japan, Germany, Indonesia, Israel, Argentina, Nigeria and Spain. The primary outcome of the trial is to compare the health status of participants in each group on day seven, based on an ordinal outcome with seven mutually exclusive categories ranging from no limiting symptoms due to COVID-19, to death [5] . Emergent BioSolutions [see adis profile 800057829], Grifols [see adis profile 800057941] and, CSL Behring with Takeda will provide anti-coronavirus hIVIG for the trial. The CoVIg 19 will be provided by CSL Behring and Takeda on behalf of the CoVIg-19 Plasma Alliance. In October 2020, the first patient was enrolled in the study and primary analysis was planned after all participants finish 28 days of follow-up. An independent data and safety monitoring board (DSMB) will review interim safety and efficacy data to ensure patient well-being and safety as well as study integrity [6] [7] . In April 2021, Takeda announced that, top-line data from this trial demonstrated that the trial did not met its endpoint. However, no safety signals were observed [8] .

In March 2020, early research for CoVIg 19 (TAK 888) was conducted in Japan [1] .

Financing information

As of October 2020, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, was sponsoring and funding the phase III ITAC trial [see above] [7] .

Drug Properties & Chemical Synopsis

  • Route of administration IV
  • Formulation Infusion
  • Class Antivirals, Immunoglobulins, Polyclonal antibodies
  • Target Virus internalisation
  • Mechanism of Action Virus internalisation inhibitors
  • WHO ATC code

    J06B-C (Antibacterial monoclonal antibodies)

  • EPhMRA code

    J6H (Specific Immunoglobulins - Antiviral)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - - Phase III Argentina, Denmark, Germany, Greece, Indonesia, Israel, Japan, Nigeria, Spain, USA, United Kingdom IV / Infusion Takeda, University of Minnesota 08 Oct 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
Takeda Originator Japan
Takeda Owner Japan
Liminal BioSciences Collaborator Canada
Octapharma Collaborator Switzerland
LFB Collaborator France
National Institutes of Health (USA) Collaborator USA
Biotest AG Collaborator Germany
CSL Behring Collaborator USA
National Institute of Allergy and Infectious Diseases Collaborator USA
Bio Products Laboratory Collaborator United-Kingdom
University of Minnesota Collaborator USA

Licensing Availability

Licensing Organisation Available Indication Available Phase Region Date
Takeda COVID 2019 infections Research Asia, Europe, USA 04 Mar 2020

Development History

Event Date Update Type Comment
25 Apr 2022 Company Involvement Biotest AG has been acquired by Grifols Updated 27 Apr 2022
21 May 2021 Trial Update University of Minnesota completes a phase III ITAC trial in the treatment of COVID-2019 infections in the US, Greece, UK, Denmark, Japan, Germany, Indonesia, Israel, Argentina, Nigeria and Spain (NCT04546581) Updated 13 Oct 2023
08 Oct 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections in Denmark, Japan, Germany, Nigeria, Spain (IV) (EudraCT2020-002542-16) (NCT04546581) Updated 22 Feb 2021
30 Sep 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections in Israel, Indonesia, Argentina (IV) (EudraCT2020-002542-16) Updated 13 Oct 2023
30 Sep 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections in USA, United Kingdom (IV) (EudraCT2020-002542-16) [6] Updated 13 Oct 2020
29 Sep 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections in Greece (IV) (EudraCT2020-002542-16) Updated 30 Oct 2020
06 Aug 2020 Licensing Status Liminal Biosciences (through its subsidiary, Prometic Plasma Resources) joins the alliance for the development of the CoVIg-19 therapy [4] Updated 12 Aug 2020
03 Aug 2020 Trial Update Takeda plans a registration-enabling clinical trial in COVID-2019 infections Updated 06 Aug 2020
07 Apr 2020 Licensing Status Takeda collaborates with Biotest, Bio Products Laboratory (BPL), LFB, Octapharma and CSL Behring to develop an anti-SARS-CoV-2 polyclonal hyperimmune immunoglobulin therapeutic for COVID-2019 [3] Updated 13 Apr 2020
04 Mar 2020 Licensing Status TAK 888 is available for licensing in Asia, Europe, USA as of 04 Mar 2020. https://www.takeda.com/ Updated 09 Mar 2020
04 Mar 2020 Phase Change Early research in COVID-2019 infections in Japan (Parenteral) before March 2019 [1] Updated 09 Mar 2020

References

  1. Takeda Initiates Development of a Plasma-Derived Therapy for COVID-19.

    Media Release
  2. Grifols completes the acquisition of Biotest: a strategic and transformational transaction to accelerate growth and innovation.

    Media Release
  3. Global Plasma Leaders Collaborate to Accelerate Development of Potential COVID-19 Hyperimmune Therapy.

    Media Release
  4. Liminal Biosciences to Present at Canaccord 40th Annual Growth Conference.

    Media Release
  5. An International Multicenter, Adaptive, Randomized Double-Blind, Placebo-Controlled Trial of the Safety, Tolerability and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Hospitalized Patients at Onset of Clinical Progression of COVID-19

    ctiprofile
  6. First Patient Enrolled in NIH Phase 3 Trial to Evaluate Potential COVID-19 Hyperimmune Medicine.

    Media Release
  7. NIH clinical trial testing hyperimmune intravenous immunoglobulin plus remdesivir to treat COVID-19 Begins.

    Media Release
  8. CoVIg-19 Plasma Alliance Announces Topline Results from NIH-Sponsored Clinical Trial of Investigational COVID-19 Hyperimmune Globulin Medicine.

    Media Release
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