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A multicenter, randomized controlled trial for the efficacy and safety of tocilizumab in the treatment of new coronavirus pneumonia (COVID-19)

Trial Profile

A multicenter, randomized controlled trial for the efficacy and safety of tocilizumab in the treatment of new coronavirus pneumonia (COVID-19)

Status: Recruiting
Phase of Trial: Phase IV

Latest Information Update: 11 Mar 2020

At a glance

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

    • 11 Mar 2020 New trial record

Trial Overview

Purpose

This study is designed to evaluate the efficacy and safety of tocilizumab in treating regular patients with new coronavirus pneumonia (COVID-19) (including severe risk factors) and critical new coronavirus pneumonia (NCP) patients.

Primary Endpoints

−Cure rate

Other Endpoints

−Mortality
−Ventilator utilization
−Hospitalization day [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 188

  • Sex male & female
  • Age Group 18-85 years; adult; elderly

Patient Inclusion Criteria

1. The patients who were diagnosed with the common type of NCP (including severe risk factors) and severe cases of new coronavirus pneumonia;
2. Aged 18 to 85 years;
3. IL-6 elevated (using Elisa method, using the same company kit);
4. Patients or authorized family members volunteered to participate in this study and signed informed consent. Definition of Novel Coronavirus Pneumonia (NCP) clinical cases: 1. Regular patients with NCP (including severe risk factors): patients with dual pulmonary lesions based on common NCP clinical symptoms accompanied by fever or no fever; 2. Critical NCP patient: Refer to the "New Coronavirus Pneumonia Diagnosis and Treatment Plan (Fifth Edition)" formulated by the National Health Commission.

Patient Exclusion Criteria

1. Patients who are participating in other drug clinical trials;
2. Pregnant or lactating women;
3. ALT / AST> 5 ULN, neutrophils <0.5, platelets less than 50;
4. Definite diagnosis of rheumatic immune-related diseases;
5. Long-term oral anti-rejection or immunomodulatory drugs;
6. Hypersensitivity to tocilizumab or any excipients;
7. Patients with active pulmonary tuberculosis, with definite bacterial and fungal infections.

Trial Details

Identifiers

Identifier Owner
ChiCTR2000029765 Chinese Clinical Trial Register
2020-XG(H)-008 -

Organisations

  • Affiliations Roche

Trial Dates

  • Initiation Dates

    Actual : 10 Feb 2020

  • End Dates

    Planned : 10 May 2020

Other Details

  • Design multicentre; parallel; prospective; randomised
  • Phase of Trial Phase IV
  • Location China
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
TocilizumabPrimary Drug Intravenous
-

Qualified subjects were randomly assigned to the experimental group and the control group at a 1: 1 ratio in accordance with the chrono

Experience group: conventional therapy+tocilizumab

Control group: conventional therapy

Trial Centres

Centres

Centre Name Location Trial Centre Country
The First Affiliated Hospital of University of science and technology of China (Anhui Provincial Hospital)
17 Lujiang Road, Luyang District, Hefei, Anhui, China
show details
Hefei China

Trial History

Event Date Event Type Comment
11 Mar 2020 New trial record New trial record Updated 11 Mar 2020

References

  1. Chinese Clinical Trial Register. Trial-Reg 2016;.

    Available from: URL: http://www.chictr.org
  2. Can-Fite BioPharma. Can-Fite Updates on Clinical Milestone for its Phase III Rheumatoid Arthritis Study with Piclidenoson; Drugs Combating Rheumatoid Arthritis are Currently Introduced for the Treatment of the Coronavirus. Media-Rel 2020;.

    Media Release
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