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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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9 March 2020 |
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Main ID: |
ChiCTR2000029580 |
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Date of registration:
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2020-02-05 |
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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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Severe novel coronavirus pneumonia (COVID-19) patients treated with ruxolitinib in combination with mesenchymal stem cells: a prospective, single blind, randomized controlled clinical trial
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Scientific title:
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Severe novel coronavirus pneumonia (COVID-19) patients treated with ruxolitinib in combination with mesenchymal stem cells: a prospective, single blind, randomized controlled clinical trial |
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Date of first enrolment:
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2020-01-31 |
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Target sample size:
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Experimental group:35;control group:35; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=49088 |
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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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0
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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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Cao Yang
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Address:
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1095 Jiefang Avenue, Qiaokou District, Wuhan, Hubei, China
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Telephone:
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+86 027 83665526 |
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Email:
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caoyangemma@163.com |
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Affiliation:
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Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology |
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Name:
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Jianfeng Zhou
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Address:
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1095 Jiefang Avenue, Qiaokou District, Wuhan, Hubei, China
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Telephone:
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+86 027 83665506 |
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Email:
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zhougene@medmail.com.cn |
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Affiliation:
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Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Aged >= 18 years and <= 75 years;
2. Patients clinically diagnosed as novel coronavirus infection; or with positive serum antibodies (IgM or IgG); or with novel coronavirus infection confirmed by PCR;
3. Severe/critical patients.
Exclusion criteria: 1. Patients with other malignant tumors requiring treatment;
2. Severe cardiovascular and metabolic diseases beyond the control of combination with other drugs
3. Patients with clinical symptoms of brain dysfunction or serious mental illness who cannot understand or follow the study protocol;
4. Endotracheal intubation with invasive ventilation;
5. Patients who cannot guarantee completion of necessary treatment plan and follow-up observation;
6. Women of child-bearing age who are positive in pregnancy test or do not stop breastfeeding in lactation period;
7. Patients with other infections at the time of enrollment;
8. Other circumstances that prevent the protocol from proceeding safely.
Age minimum:
18
Age maximum:
75
Gender:
Both
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Health Condition(s) or Problem(s) studied
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novel coronavirus pneumonia (COVID-19)
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Intervention(s)
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Experimental group:Ruxolitinib combined with mesenchymal stem cell;control group: Routine treatment;
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Primary Outcome(s)
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Safety;
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Source(s) of Monetary Support
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Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; Wuhan Bureau of Science and Technology; Huazhong University of Science and Technology
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Ethics review
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Status: Approved
Approval date: 30/01/2020
Contact:
Aihua Du
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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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