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A Compassionate Use Study of Namilumab (IZN-101) in the Treatment of Patients with Rapidly Worsening COVID-19

Trial Profile

A Compassionate Use Study of Namilumab (IZN-101) in the Treatment of Patients with Rapidly Worsening COVID-19

Status: Recruiting
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 07 Apr 2020

At a glance

  • Drugs Namilumab (Primary)
  • Indications COVID 2019 infections
  • Focus Expanded access; Therapeutic Use
  • Most Recent Events

    • 07 Apr 2020 New trial record
    • 06 Apr 2020 According to an Ergomed media release, the team working with Prof. Selmi will be coordinated locally by Dr. Amidio Testa and Dr. Giacomo Guidelli.
    • 06 Apr 2020 According to an Izana Bioscience media release, Ergomed plc, a CRO specialised in providing bespoke solutions and research services to the company, is facilitating this programme.

Trial Overview

Purpose

This study is designed to evaluate namilumab (IZN-101) in the treatment of patients with rapidly worsening COVID-19. The compassionate use programme will gather data from hospitalised, rapidly worsening COVID-19 patients, and has the overall objective of treating them before they are admitted to intensive care or require ventilation.

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Sex male & female

Patient Inclusion Criteria

−Patients with rapidly worsening COVID-19.

Trial Details

Organisations

  • Affiliations Izana Bioscience

Trial Dates

Other Details

  • Design multicentre; prospective
  • Phase of Trial Clinical Phase Unknown
  • Location Italy
  • Focus Expanded access; Therapeutic Use

Interventions

Drugs Route Formulation
NamilumabPrimary Drug Parenteral
-

Trial History

Event Date Event Type Comment
07 Apr 2020 New trial record New trial record Updated 07 Apr 2020
06 Apr 2020 Other trial event According to an Ergomed media release, the team working with Prof. Selmi will be coordinated locally by Dr. Amidio Testa and Dr. Giacomo Guidelli. Updated 09 Apr 2020
06 Apr 2020 Other trial event According to an Izana Bioscience media release, Ergomed plc, a CRO specialised in providing bespoke solutions and research services to the company, is facilitating this programme. Updated 07 Apr 2020
06 Apr 2020 Other trial event According to an Izana Bioscience media release, the study aims to support namilumab's future development for the treatment of COVID-19, and discussions with global regulatory authorities, including the UK, are in progress. Updated 07 Apr 2020
06 Apr 2020 Other trial event According to an Izana Bioscience media release, the study will take place in Bergamo and Milan, Italy. Updated 07 Apr 2020
06 Apr 2020 Other trial event According to an Izana Bioscience media release, the company announced the initiation of a two-centre compassionate use study of namilumab (IZN-101) in the treatment of patients with rapidly worsening COVID-19 in cooperation with the Humanitas research group, under the leadership of Professor Carlo Selmi, head of the Rheumatology and Clinical Immunology Unit at Humanitas Research Hospital and Associate Professor of Internal Medicine at Humanitas University. Updated 07 Apr 2020

References

  1. Izana Bioscience. Izana Bioscience: Initiation of two-centre compassionate use study involving namilumab in the treatment of individual patients with rapidly worsening COVID-19 infection in Italy. Media-Rel 2020;.

    Media Release
  2. Ergomed. Ergomed Announces Provision of Clinical Research Services for Second COVID-19 Clinical Development Programme. Media-Rel 2020;.

    Media Release
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