A Single-Arm Trial to Evaluate Tocilizumab (IL-6 Receptor Antibody) in Chinese COVID-19 Patients
Latest Information Update: 20 Mar 2020
At a glance
- Drugs Tocilizumab (Primary)
- Indications COVID 2019 infections
- Focus Therapeutic Use
- 20 Mar 2020 New trial record
- 16 Mar 2020 According to a Regeneron Pharmaceuticals media release, interleukin-6 (IL-6) may play a role in driving the overactive inflammatory response in the lungs of patients who are severely or critically ill with COVID-19.The role of IL-6 is supported by preliminary data from this single-arm study in China.Based on these preliminary data, China recently updated its COVID-19 treatment guidelines and approved the use of that IL-6 inhibitor to treat patients with severe or critical disease.
- 16 Mar 2020 Preliminary data (initial non-peer reviewed results) from this trial presented in a Regeneron Pharmaceuticals media release.
Most Recent Events
Trial Overview
Purpose
This single-arm study aims to evaluate an IL-6 receptor antibody (tocilizumab) in Chinese COVID-19 patients.
Comments
According to a Regeneron Pharmaceuticals media release, interleukin-6 (IL-6) may play a role in driving the overactive inflammatory response in the lungs of patients who are severely or critically ill with COVID-19.The role of IL-6 is supported by preliminary data from this single-arm study in China.Based on these preliminary data, China recently updated its COVID-19 treatment guidelines and approved the use of that IL-6 inhibitor to treat patients with severe or critical disease.
Other Endpoints
−Reduced fevers
−Reduction in need for supplemental oxygen within days of receiving a different IL-6 receptor antibody (tocilizumab). [1]
Diseases Treated
| Indication | Qualifiers | Patient Segments |
|---|---|---|
| COVID 2019 infections | treatment | - |
Subjects
- Subject Type patients
-
Number
Planned: 21
- Sex male & female
Patient Inclusion Criteria
−Chinese COVID-19 patients.
Trial Details
Trial Dates
Other Details
- Design prospective
- Phase of Trial Phase II
- Location China
- Focus Therapeutic Use
Interventions
| Drugs | Route | Formulation |
|---|---|---|
| TocilizumabPrimary Drug | Intravenous |
-
|
Tocilizumab (IL-6 Receptor Antibody)
Results
Publications
-
Regeneron Pharmaceuticals, Sanofi. Regeneron and Sanofi Begin Global Kevzara(R) (sarilumab) Clinical Trial Program in Patients with Severe COVID-19. Media-Rel 2020;.
Media Release
Trial History
| Event Date | Event Type | Comment |
|---|---|---|
| 20 Mar 2020 | New trial record | New trial record Updated 20 Mar 2020 |
| 16 Mar 2020 | Other trial event | According to a Regeneron Pharmaceuticals media release, interleukin-6 (IL-6) may play a role in driving the overactive inflammatory response in the lungs of patients who are severely or critically ill with COVID-19.The role of IL-6 is supported by preliminary data from this single-arm study in China.Based on these preliminary data, China recently updated its COVID-19 treatment guidelines and approved the use of that IL-6 inhibitor to treat patients with severe or critical disease. Updated 20 Mar 2020 |
| 16 Mar 2020 | Interim results | Preliminary data (initial non-peer reviewed results) from this trial presented in a Regeneron Pharmaceuticals media release. Updated 20 Mar 2020 |
References
-
Regeneron Pharmaceuticals, Sanofi. Regeneron and Sanofi Begin Global Kevzara(R) (sarilumab) Clinical Trial Program in Patients with Severe COVID-19. Media-Rel 2020;.
Media Release
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