NK Cells Treatment for COVID-19

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Investigation of Natural Killer Cells Treatment in Pneumonia Patients Infected With 2019 Novel Coronavirus

Conditions
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Novel Coronavirus Pneumonia

Intervention / Treatment
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* Biological: NK Cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Male or female, aged at 18 years-65 years old 2. Pneumonia that is judged by chest radiograph or computed tomography 3. Laboratory confirmation of NCP infection by reverse-transcription polymerase chain reaction(RT-PCR) from any diagnostic sampling source Exclusion Criteria: 1. Pregnancy or breastfeeding 2. Known HIV, HBV or HCV infection 3. Patients with malignant tumor, other serious systemic diseases and psychosis 4. Patients who are participating in other clinical trials 5. Inability to provide informed consent or to comply with test requirements

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NK Cells Treatment Group<br>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). | Biological: NK Cells<br>* twice a week of NK cells (0.1-2*10E7 cells/kg body weight)<br>|
| No Intervention: Conventional Control Group<br>Participants will only receive conventional treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |