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| Name | Class |
|---|---|
| First Affiliated Hospital of Xinjiang Medical University | OTHER |
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Since december 2019, acute respiratory disease due to 2019 novel coronavirus (2019-nCoV) emerged in Wuhan city and rapidly spread throughout China. There is no confirmed antivirus therapy for 2019-nCoV infection. Natural killer (NK) cells are innate lymphocytes that may serve as useful effectors against danger infection. The purpose of this clinical investigation is to evaluate the safety and efficiency of NK Cells in combination with standard therapy for pneumonia patients infected with 2019-nCoV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NK Cells Treatment Group | Experimental | Conventional treatment plus NK cells. Participants will receive conventional treatment plus twice a week of NK cells (0.1-2*10E7 NK cells/kg body weight). |
|
| Conventional Control Group | No Intervention | Participants will only receive conventional treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NK Cells | Biological | twice a week of NK cells (0.1-2*10E7 cells/kg body weight) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of clinical symptoms including duration of fever | Evaluation of pneumonia improvement | Measured from day 0 through day 28 |
| Improvement of clinical symptoms including respiratory frequency | Evaluation of pneumonia improvement | Measured from day 0 through day 28 |
| Number of participants with treatment-related adverse events evaluated with CTCAE,version 4.0 | Safety evaluation | Measured from day 0 through day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Time of virus nucleic acid test negative | Marker for 2019-nCoV | Measured from day 0 through day 28 |
| CD4+ and CD8+ T cell count | Marker of immunological function |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xinxiang Medical University | Xinxiang | Henan | 453000 | China |
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| Measured from day 0 through day 28 |
| Rate of mortality within 28-days | Marker for efficacy of treatment | Day 28 |
| Size of lesion area by thoracic imaging | Recovery of lung injury | Measured from day 0 through day 28 |