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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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16 March 2020 |
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Main ID: |
ChiCTR2000029817 |
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Date of registration:
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2020-02-14 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Cancelled by the investigator Clinical Study of Cord Blood NK Cells Combined with Cord Blood Mesenchymal Stem Cells in the Treatment of Acute Novel Coronavirus Pneumonia (COVID-19)
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Scientific title:
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Clinical Study of Cord Blood NK Cells Combined with Cord Blood Mesenchymal Stem Cells in the Treatment of Acute 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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High dose group:20;Conventional dose group:20;Preventive dose group:20; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=49384 |
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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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Contacts
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Name:
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Chao Xu
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Address:
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1 Fourth Nanyun Road, Hi-Tech District, Guangzhou, Guangdong, China
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Telephone:
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+86 15018720816 |
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Email:
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164972769@qq.com |
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Affiliation:
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Guangzhou reborn health management consultation co., LTD |
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Name:
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Chao Xu
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Address:
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1 Fourth Nanyun Road, Hi-Tech District, Guangzhou, Guangdong, China
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Telephone:
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+86 15018720816 |
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Email:
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164972769@qq.com |
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Affiliation:
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Guangzhou reborn health management consultation co., LTD |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients with confirmed new coronavirus-infected pneumonia;
2. Voluntarily sign written informed consent.
Exclusion criteria: 1. Extremely ill patients with shock, acute respiratory distress syndrome, and multiple organ failure;
2. Pregnant or lactating women;
3. In the opinion of the investigator, previous or present illnesses may affect patients' participation in the trial or influence the outcome of the study, including: malignant disease, autoimmune disease, liver and kidney disease, blood disease, neurological disease, and endocrine Disease; currently suffering from diseases that seriously affect the immune system, such as: human immunodeficiency virus (HIV) infection, or the blood system, or splenectomy, organ transplantation, etc .;
4. The investigator believes that the patient has other conditions that are not suitable for enrollment.
Age minimum:
18
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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novel coronavirus pneumonia (NCP)
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Intervention(s)
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High dose group:High-dose NK cells (>5x10^9)and mesenchymal stem cells(>5x10^9),Intravenous infusion once every two days for a total of five times;Conventional dose group:Conventional dose NK cells (>3x10^9)and mesenchymal stem cells(>3x10^9),Intravenous infusion once every two days for a total of three times;Preventive dose group:Preventive dose NK cells (>3x10^9)and mesenchymal stem cells(>3x10^9),Intravenous infusion once every week for a total of one time;
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Primary Outcome(s)
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Time to disease recovery;
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Secondary Outcome(s)
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Time and rate of coronavirus become negative;Clearance rate and time of main symptoms (fever, fatigue, cough);Exacerbation (transfer to RICU) time;Routine blood test;Biochemical Indicators;Immune indices;
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Source(s) of Monetary Support
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self-financing
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Ethics review
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Status: Not approved
Approval date: 26/08/2013
Contact:
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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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