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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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2 March 2020 |
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Main ID: |
ChiCTR2000030196 |
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Date of registration:
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2020-02-25 |
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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, single arm, open label trial for the efficacy and safety of CMAB806 in the treatment of cytokine release syndrome of novel coronavirus pneumonia (COVID-19)
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Scientific title:
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A multicenter, single arm, open label trial for the efficacy and safety of CMAB806 in the treatment of cytokine release syndrome of novel coronavirus pneumonia (COVID-19) |
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Date of first enrolment:
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2020-02-20 |
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Target sample size:
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Case series:60; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=49883 |
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Study type:
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Interventional study |
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Study design:
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Single arm
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Phase:
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2
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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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Yingjun Pan
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Address:
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1 Jinyu Street, Sha-Er-Qin Industrial Park, Economic and Technological Development Zone, Hohhot, the Inner Mongolia Autonomous Region, China
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Telephone:
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+86 18686008763 |
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Email:
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panyingjun@jinyubaoling.com.cn |
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Affiliation:
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JinYu Bio-Technology Co.,LTD. |
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Name:
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Zhiyong Peng
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Address:
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169 Donghu Road, Wuchang District, Wuhan, Hubei, China
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Telephone:
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+86 18672396028 |
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Email:
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Pengzy5@hotmail.com |
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Affiliation:
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Central South Hospital, Wuhan University |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients volunteered to sign the informed consent;
2. Patients who were diagnosed with the common type of NCP and severe cases of new coronavirus pneumonia, Referring to the New Coronavirus Pneumonia Diagnosis and Treatment Plan, with elevation of IL-6, and grade 2-3 CRS.In the case of atypical signs of CRS, he or she should be judged by the investigator;
3. Aged >=18 years.
Exclusion criteria: 1. People with serious or uncontrolled concomitant diseases, including sensory, vascular, heart, liver, kidney, gastric, intestinal, endocrine, etc.;
2. Having received Vaccine in the 4 weeks before entry or Planning to receive vaccine during the study;
3. Hypersensitivity to tocilizumab;
4. Pregnant or positive of the pregnancy test, lactating women;
5. Other reasons to exclude from the study.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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cytokine release syndrome of new coronavirus pneumonia (COVID-19)
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Intervention(s)
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Case series:conventional therapy+tocilizumab;
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Primary Outcome(s)
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the relive of CRS;
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Secondary Outcome(s)
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including AE, SAE, laboratory findings, symptoms, vital signs, ECG, Physical examination.;The time to relive;The recurrence of CRS;The change of IL-1, IL-6, IFN-gama, TNF-alpha;
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Source(s) of Monetary Support
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funds raised by oneself
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Ethics review
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Status: Approved
Approval date: 20/02/2020
Contact:
Lei Zheng
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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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