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NK Cells Treatment for COVID-19

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 : April 14, 2020
Sponsor:
Collaborator:
First Affiliated Hospital of Xinjiang Medical University
Information provided by (Responsible Party):
Xinxiang medical university

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.

Condition or disease Intervention/treatment Phase
Novel Coronavirus Pneumonia Biological: NK Cells Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Investigation of Natural Killer Cells Treatment in Pneumonia Patients Infected With 2019 Novel Coronavirus
Actual Study Start Date : February 15, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).
Biological: NK Cells
twice a week of NK cells (0.1-2*10E7 cells/kg body weight)

No Intervention: Conventional Control Group
Participants will only receive conventional treatment.



Primary Outcome Measures :
  1. Improvement of clinical symptoms including duration of fever [ Time Frame: Measured from day 0 through day 28 ]
    Evaluation of pneumonia improvement

  2. Improvement of clinical symptoms including respiratory frequency [ Time Frame: Measured from day 0 through day 28 ]
    Evaluation of pneumonia improvement

  3. 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


Secondary Outcome Measures :
  1. Time of virus nucleic acid test negative [ Time Frame: Measured from day 0 through day 28 ]
    Marker for 2019-nCoV

  2. CD4+ and CD8+ T cell count [ Time Frame: Measured from day 0 through day 28 ]
    Marker of immunological function

  3. Rate of mortality within 28-days [ Time Frame: Day 28 ]
    Marker for efficacy of treatment

  4. Size of lesion area by thoracic imaging [ Time Frame: Measured from day 0 through day 28 ]
    Recovery of lung injury



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04280224


Contacts
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Contact: ZHU, Professor 00863733029089 wulingzhu@xxmu.edu.cn

Locations
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China, Henan
The First Affiliated Hospital of Xinxiang Medical University Recruiting
Xinxiang, Henan, China, 453000
Contact: GUO, Professor    00863734402517    guomh@163.com   
Sponsors and Collaborators
Xinxiang medical university
First Affiliated Hospital of Xinjiang Medical University
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Responsible Party: Xinxiang medical university
ClinicalTrials.gov Identifier: NCT04280224    
Other Study ID Numbers: xinxiangM
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases