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OpenTrials
Completed

NCT Number: NCT04280224

NK Cells Treatment for COVID-19

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.

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Key information

Conditions

Novel Coronavirus Pneumonia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, 453000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NK Cells

Biological

twice a week of NK cells (0.1-2*10E7 cells/kg body weight)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Henan Medical University

Other

Collaborators

  • First Affiliated Hospital of Xinjiang Medical University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 21, 2020
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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