A multicenter, randomized controlled trial for the efficacy and safety of tocilizumab in the treatment of new coronavirus pneumonia (COVID-19)
Latest Information Update: 17 Jun 2020
At a glance
- Drugs Tocilizumab (Primary)
- Indications COVID 2019 infections
- Focus Therapeutic Use
- 11 Mar 2020 New trial record
Most Recent Events
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
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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 |
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|
control group:conventional therapy;Experience group:conventional therapy+tocilizumab;
Trial Centres
Centres
Centre Name | Location | Trial Centre Country |
---|---|---|
Department of science and technology of Anhui Province |
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|
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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 |
---|---|---|
17 Jun 2020 | Other trial event | Last checked against China Clinical Trials Register record. Updated 17 Jun 2020 |
11 Mar 2020 | New trial record | New trial record Updated 11 Mar 2020 |
References
-
Chinese Clinical Trial Register. Trial-Reg 2021;.
Available from: URL: http://www.chictr.org -
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;.
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