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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.
Register: ChiCTR
Last refreshed on: 2 March 2020
Main ID:  ChiCTR2000030261
Date of registration: 2020-02-26
Prospective Registration: Yes
Primary sponsor: Wuxi Fifth People's Hospital
Public title: A study for the key technology of mesenchymal stem cells exosomes atomization in the treatment of novel coronavirus pneumonia (COVID-19)
Scientific title: A study for the key technology of mesenchymal stem cells exosomes atomization in the treatment of novel coronavirus pneumonia (COVID-19)
Date of first enrolment: 2020-03-01
Target sample size: Exocrine group:13;Control group:13;
Recruitment status: Pending
URL:  http://www.chictr.org.cn/showproj.aspx?proj=49963
Study type:  Interventional study
Study design:  Parallel  
Phase:  0
Countries of recruitment
China
Contacts
Name: Yigang Chen   
Address:  68 Zhongshan Road, Wuxi, Jiangsu, China
Telephone: +86 13506187399
Email: imyigang@126.com
Affiliation:  Wuxi Second People's Hospital
Name: Meiping Chu   
Address:  1215 Guangrui Road, Wuxi, Jiangsu, China
Telephone: +86 15052103816
Email: chump1981@163.com
Affiliation:  Wuxi Fifth People's Hospital
Key inclusion & exclusion criteria
Inclusion criteria: Patients meet the diagnostic criteria "Diagnosis and treatment of novel coronavirus pneumonia (trial version fifth)"for suspected cases outside Hubei Province: combined with the following epidemiological and clinical manifestations: epidemiological history
1. Patients with travel or residence history in Wuhan and surrounding areas or other communities with case reports within 14 days before the onset of the disease;
2. Patients with a novel coronavirus infection (positive for nucleic acid detection) within 14 days before onset;,
3. Patients with fever or respiratory symptoms from Wuhan and surrounding areas or from the community with case report had been contacted within 14 days before the onset of the disease;
4. Clustering disease; clinical manifestations:
(1) fever and / or respiratory symptoms;
(2) having the above-mentioned imaging characteristics of pneumonia;
(3) normal or reduced leukocyte count or lymphocyte count in the early stage of the disease.
There is any one in the epidemiological history, and it is consistent with any two in the clinical manifestations.
If there is no clear epidemiological history, it is in line with 3 of the clinical manifestations.

Exclusion criteria: (1) Age < 18 or > 65;
(2) Patients with severe heart, brain, lung, kidney dysfunction, endocrine disease, hematopoiesis system disease or other serious diseases and psychosis;
(3) Pregnant and lactating women.


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Novel Coronavirus Pneumonia (COVID-19)
Intervention(s)
Exocrine group:Aerosol inhalation of exosomes;Control group:Blank;
Primary Outcome(s)
Lung CT;
Secondary Outcome(s)
Nucleic acid detection of pharyngeal test;Leukocytes and lymphocytes in blood routine;
Secondary ID(s)
Source(s) of Monetary Support
Wuxi novel coronavirus infection emergency control technology special project
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 13/02/2020
Contact:
Wubing Chen
Results
Results available:
Date Posted:
Date Completed:
URL:
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