NK Cells Treatment for COVID-19
Primary Purpose
Novel Coronavirus Pneumonia
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
NK Cells
Sponsored by
About this trial
This is an interventional treatment trial for Novel Coronavirus Pneumonia
Eligibility Criteria
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
Sites / Locations
- The First Affiliated Hospital of Xinxiang Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
NK Cells Treatment Group
Conventional Control Group
Arm Description
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).
Participants will only receive conventional treatment.
Outcomes
Primary Outcome Measures
Improvement of clinical symptoms including duration of fever
Evaluation of pneumonia improvement
Improvement of clinical symptoms including respiratory frequency
Evaluation of pneumonia improvement
Number of participants with treatment-related adverse events evaluated with CTCAE,version 4.0
Safety evaluation
Secondary Outcome Measures
Time of virus nucleic acid test negative
Marker for 2019-nCoV
CD4+ and CD8+ T cell count
Marker of immunological function
Rate of mortality within 28-days
Marker for efficacy of treatment
Size of lesion area by thoracic imaging
Recovery of lung injury
Full Information
NCT ID
NCT04280224
First Posted
February 13, 2020
Last Updated
July 13, 2023
Sponsor
Xinxiang medical university
Collaborators
First Affiliated Hospital of Xinjiang Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04280224
Brief Title
NK Cells Treatment for COVID-19
Official Title
Clinical Investigation of Natural Killer Cells Treatment in Pneumonia Patients Infected With 2019 Novel Coronavirus
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xinxiang medical university
Collaborators
First Affiliated Hospital of Xinjiang Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Novel Coronavirus Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NK Cells Treatment Group
Arm Type
Experimental
Arm Description
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).
Arm Title
Conventional Control Group
Arm Type
No Intervention
Arm Description
Participants will only receive conventional treatment.
Intervention Type
Biological
Intervention Name(s)
NK Cells
Intervention Description
twice a week of NK cells (0.1-2*10E7 cells/kg body weight)
Primary Outcome Measure Information:
Title
Improvement of clinical symptoms including duration of fever
Description
Evaluation of pneumonia improvement
Time Frame
Measured from day 0 through day 28
Title
Improvement of clinical symptoms including respiratory frequency
Description
Evaluation of pneumonia improvement
Time Frame
Measured from day 0 through day 28
Title
Number of participants with treatment-related adverse events evaluated with CTCAE,version 4.0
Description
Safety evaluation
Time Frame
Measured from day 0 through day 28
Secondary Outcome Measure Information:
Title
Time of virus nucleic acid test negative
Description
Marker for 2019-nCoV
Time Frame
Measured from day 0 through day 28
Title
CD4+ and CD8+ T cell count
Description
Marker of immunological function
Time Frame
Measured from day 0 through day 28
Title
Rate of mortality within 28-days
Description
Marker for efficacy of treatment
Time Frame
Day 28
Title
Size of lesion area by thoracic imaging
Description
Recovery of lung injury
Time Frame
Measured from day 0 through day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ZHU, Professor
Phone
00863733029089
Email
wulingzhu@xxmu.edu.cn
Facility Information:
Facility Name
The First Affiliated Hospital of Xinxiang Medical University
City
Xinxiang
State/Province
Henan
ZIP/Postal Code
453000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GUO, Professor
Phone
00863734402517
Email
guomh@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
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NK Cells Treatment for COVID-19
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