A Compassionate Use Study of Namilumab (IZN-101) in the Treatment of Patients with Rapidly Worsening COVID-19
Latest Information Update: 07 Apr 2020
At a glance
- Drugs Namilumab (Primary)
- Indications COVID 2019 infections
- Focus Expanded access; Therapeutic Use
- 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.
Most Recent Events
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 |
-
|
Namilumab (IZN-101)
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
-
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 -
Ergomed. Ergomed Announces Provision of Clinical Research Services for Second COVID-19 Clinical Development Programme. Media-Rel 2020;.
Media Release
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