NK Cells Treatment for COVID-19

February 6, 2024 updated by: Xinxiang medical university

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Xinxiang, Henan, China, 453000
        • The First Affiliated Hospital of Xinxiang Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of clinical symptoms including duration of fever
Time Frame: Measured from day 0 through day 28
Evaluation of pneumonia improvement
Measured from day 0 through day 28
Improvement of clinical symptoms including respiratory frequency
Time Frame: Measured from day 0 through day 28
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
Time Frame: Measured from day 0 through day 28
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
Time Frame: Measured from day 0 through day 28
Marker for 2019-nCoV
Measured from day 0 through day 28
CD4+ and CD8+ T cell count
Time Frame: Measured from day 0 through day 28
Marker of immunological function
Measured from day 0 through day 28
Rate of mortality within 28-days
Time Frame: Day 28
Marker for efficacy of treatment
Day 28
Size of lesion area by thoracic imaging
Time Frame: Measured from day 0 through day 28
Recovery of lung injury
Measured from day 0 through day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinxiang medical university

Collaborators

First Affiliated Hospital of Xinjiang Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2020

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

February 13, 2020

First Submitted That Met QC Criteria

February 20, 2020

First Posted (Actual)

February 21, 2020

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NK-COVID19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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