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NK Cells Treatment for Novel Coronavirus Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04280224
Recruitment Status : Recruiting
First Posted : February 21, 2020
Last Update Posted : February 21, 2020
Sponsor:
Collaborator:
First Affiliated Hospital of Xinjiang Medical University
Information provided by (Responsible Party):
Xinxiang medical university

Tracking Information
First Submitted Date  ICMJE February 13, 2020
First Posted Date  ICMJE February 21, 2020
Last Update Posted Date February 21, 2020
Estimated Study Start Date  ICMJE February 20, 2020
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2020)
  • Improvement of clinical symptoms including duration of fever [ Time Frame: Measured from day 0 through day 28 ]
    Evaluation of pneumonia improvement
  • Improvement of clinical symptoms including respiratory frequency [ Time Frame: Measured from day 0 through day 28 ]
    Evaluation of pneumonia improvement
  • Number of participants with treatment-related adverse events evaluated with CTCAE,version 4.0 [ Time Frame: Measured from day 0 through day 28 ]
    Safety evaluation
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2020)
  • Time of virus nucleic acid test negative [ Time Frame: Measured from day 0 through day 28 ]
    Marker for 2019-nCoV
  • CD4+ and CD8+ T cell count [ Time Frame: Measured from day 0 through day 28 ]
    Marker of immunological function
  • Rate of mortality within 28-days [ Time Frame: Day 28 ]
    Marker for efficacy of treatment
  • Size of lesion area by thoracic imaging [ Time Frame: Measured from day 0 through day 28 ]
    Recovery of lung injury
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NK Cells Treatment for Novel Coronavirus Pneumonia
Official Title  ICMJE Clinical Investigation of Natural Killer Cells Treatment in Pneumonia Patients Infected With 2019 Novel Coronavirus
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Novel Coronavirus Pneumonia
Intervention  ICMJE Biological: NK Cells
twice a week of NK cells (0.1-2*10E7 cells/kg body weight)
Study Arms  ICMJE
  • Experimental: NK Cells Treatment Group
    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).
    Intervention: Biological: NK Cells
  • No Intervention: Conventional Control Group
    Participants will only receive conventional treatment.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 20, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ZHU, Professor 00863733029089 wulingzhu@xxmu.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04280224
Other Study ID Numbers  ICMJE xinxiangM
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Xinxiang medical university
Study Sponsor  ICMJE Xinxiang medical university
Collaborators  ICMJE First Affiliated Hospital of Xinjiang Medical University
Investigators  ICMJE Not Provided
PRS Account Xinxiang medical university
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP