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A Single-Arm Trial to Evaluate Tocilizumab (IL-6 Receptor Antibody) in Chinese COVID-19 Patients

Trial Profile

A Single-Arm Trial to Evaluate Tocilizumab (IL-6 Receptor Antibody) in Chinese COVID-19 Patients

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 20 Mar 2020

At a glance

  • Drugs Tocilizumab (Primary)
  • Indications COVID 2019 infections
  • Focus Therapeutic Use
  • Most Recent Events

    • 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.

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
-

Results

Publications

  1. 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

Authors

Author Total Publications First Author Last Author
Regeneron Pharmaceuticals 1 1 -
Sanofi 1 - 1

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

  1. 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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