Pneumonia, Ventilator-Associated, Pneumonia, Viral
Conditions
Keywords
2019-nCOV infection, UC-MSCs Treatment
Brief summary
Serious Pneumonia and Critical Pneumonia caused by the 2019-nCOV infection greatly threats patients' life, UC-MSCs treatment has been proved to play a role in curing multiple diseases. And this study is conducted to find out whether or not it will function in 2019-nCOV infection Pneumonia.
Detailed description
Serious Pneumonia and Critical Pneumonia caused by the 2019-nCOV infection greatly threats patients' life, UC-MSCs treatment has been proved to play a role in curing multiple diseases. And this study is conducted to find out whether or not it will function in 2019-nCOV infection Pneumonia. And we are going to get the permission of the enrolled patients. Besides the present clinical treatment, UC-MSCs treatment will be applied to those fulfilling the enrollment. After a period of UC-MSCs treatment, the analysis of UC-MSCs treatment will be completed from related aspects.
Interventions
BIOLOGICALUC-MSCs
After enrollment, each subject will receive UC-MSCs infusion intravenously on day 1, day 3, day 5, and day 7.
Sponsors
Tuohua Biological Technology Co. Ltd
ZhiYong Peng
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
reaching the criteria of pneumonia according to Diagnosis and Clinical Management of Pneumonia caused by 2019-nCoV Infection(Trial Version 4)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 18-80 years old ,no gender restriction * According to Diagnosis and Clinical Management of Pneumonia caused by 2019-nCoV infection(Trial Version 6), patients are diagnosed with severe or critical 2019-nCoV pneumonia * Women of childbearing age should have a negative blood pregnancy test before the start of dosing and agree to take effective contraceptive measures during the trial until the last follow-up (28 days) * Previous detection of Nucleotide or antibody of 2019-nCoV pneumonia was positive * Voluntarily participate in this clinical study and sign a written informed consent. If the patient cannot obtain informed consent, he can authorize his legal representative.
Exclusion criteria
* Liver SOFA score of more than 3 points; * HIV positive * Highly allergic constitution or history of severe allergies; * Pregnant and lactating women; * Patients with malignant tumors; * Patients with previous history of pulmonary embolism; * Participating in clinical trials of other drugs within 3 months before enrollment. * be thought by researchers to be inappropriate to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygenation index | on the day 14 after enrollment | partial arterial oxygen pressure (PaO2) / oxygen concentration (FiO2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital stay | up to 6 months | days of the patients in hospital |
| 2019-nCoV antibody test | on the day 7,14,28 after enrollment | whether or not the 2019-nCoV antibody is positive |
| 2019-nCoV nucleic acid test | on the day 7,14,28 after enrollment | whether or not the 2019-nCoV nucleic acid test is positive |
| Improvement of lung imaging examinations | on the day 7,14,28 after enrollment | whether lung imaging examinations show the improvement of the pneumonia |
| White blood cell count | on the day 7,14,28 after enrollment | counts of white blood cell in a litre of blood |
| Lymphocyte count | on the day 7,14,28 after enrollment | counts of lymphocyte in a litre (L) of blood |
| Procalcitonin | on the day 7,14,28 after enrollment | procalcitonin in microgram(ug)/L |
| interleukin(IL)-2 | on the day 7,14,28 after enrollment | IL-2 in picogram(pg)/millilitre(mL) |
| 28 day mortality | on the day 28 after enrollment | whether the patient survives |
| IL-6 | on the day 7,14,28 after enrollment | IL-6 in pg/mL |
| IL-10 | on the day 7,14,28 after enrollment | IL-10 in pg/mL |
| tumor necrosis factor(TNF)-α | on the day 7,14,28 after enrollment | TNF-α in nanogram(ng)/L |
| γ-interferon(IFN) | on the day 7,14,28 after enrollment | γ-IFN in a thousand unit (KU)/L |
| C-reactive protein(CRP) | on the day 7,14,28 after enrollment | CRP in microgram（μg）/L |
| CD4+ T-Lymphocytopenia | on the day 7,14,28 after enrollment | counts of CD4+ T-Lymphocytopenia in litre |
| CD8+ T-Lymphocytopenia | on the day 7,14,28 after enrollment | counts of CD8+ T-Lymphocytopenia in a litre |
| natural killer cell(NK) | on the day 7,14,28 after enrollment | counts of NK in a litre |
| IL-4 | on the day 7,14,28 after enrollment | IL-4 in pg/mL |
Countries
China
Contacts
Primary ContactXingHuan Wang, professor
Backup ContactZhiYong Peng, professor
Outcome results
None listed