Trial registration number
|
ChiCTR2000030088 |
Full text link
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
http://www.chictr.org.cn/showproj.aspx?proj=49902
|
First author
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Lianru Gao
|
Contact
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
lianru666@163.com
|
Registration date
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
2020-02-22
|
Recruitment status
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Not recruiting
|
Study design
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
RCT
|
Allocation
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Randomized
|
Design
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Parallel
|
Masking
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Not reported
|
Center
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
multi-center
|
Study aim
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Treatment
|
Inclusion criteria
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
1) age 18-80 years old, regardless of gender: 2) the diagnosis criteria of severe nCoV pneumonia in line with the 6th edition of China's new coronavirus pneumonia diagnosis scheme: a.B. Real-time fluorescence rt-pcr of respiratory tract specimens or blood samples was used to detect positive nCoV nucleic acid,3) critical cases of nCoV pneumonia: meet one of the following criteria: a. respiratory failure and mechanical ventilation required,B. shock,C. Combined with other organ failure, intensive care unit is required,4) patients with poor treatment response: that is, the above critically ill patients have undergone active modern medicine to fight against shock, correct acidosis, improve multi-organ function rescue and ECMO assisted breathing, and have not been improved by circulation assisted treatment and hormone application,5) those who signed the informed consent and agreed to participate in the initial clinical trial were selected.
|
Exclusion criteria
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
No
|
Number of arms
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
2
|
Funding
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
The Sixth Medical Center of PLA General Hospital
|
Inclusion age min
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
18
|
Inclusion age max
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
80
|
Countries
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
China
|
Type of patients
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Severe disease at enrollment
|
Severity scale
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
6: Severe disease at enrollment
|
Total sample size
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
40
|
primary outcome
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
The nucleic acid of the novel coronavirus is negative;CT scan of ground glass shadow disappeared;
|
Notes
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
| Declared number of arm (3.0)
differs from found arms (4.0)
|
Phase
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Phase 0
|
Arms
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
[{"arm_notes": "", "treatment_id": 787, "treatment_name": "Mesenchymal stem cells", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
|