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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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17 February 2020 |
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Main ID: |
ChiCTR2000029765 |
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Date of registration:
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2020-02-13 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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)
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Scientific title:
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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) |
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Date of first enrolment:
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2020-02-10 |
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Target sample size:
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control group:94;Experience group:94; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=49409 |
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Study type:
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Interventional study |
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Study design:
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Parallel
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Phase:
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4
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Countries of recruitment
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China
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Contacts
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Name:
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Dongsheng Wang
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Address:
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17 Lujiang Road, Luyang District, Hefei, Anhui, China
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Telephone:
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+86 15605519676 |
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Email:
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15605519676@163.com |
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Affiliation:
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The First Affiliated Hospital of University of science and technology of China (Anhui Provincial Hospital) |
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Name:
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Xiaoling Xu
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Address:
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17 Lujiang Road, Luyang District, Hefei, Anhui, China
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Telephone:
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+86 18963789002 |
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Email:
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xxlahh08@163.com |
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Affiliation:
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The First Affiliated Hospital of University of science and technology of China (Anhui Provincial Hospital) |
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Key inclusion & exclusion criteria
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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.
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.
Age minimum:
18
Age maximum:
85
Gender:
Both
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Health Condition(s) or Problem(s) studied
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new coronavirus pneumonia
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Intervention(s)
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control group:conventional therapy;Experience group:conventional therapy+tocilizumab;
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Primary Outcome(s)
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cure rate;
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Secondary Outcome(s)
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mortality;Ventilator utilization;Hospitalization day;
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Source(s) of Monetary Support
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Department of science and technology of Anhui Province
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Ethics review
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Status: Approved
Approval date: 11/02/2020
Contact:
Meinan Chen
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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