NK Cells Treatment for COVID-19

• Sponsor: Xinxiang medical university (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04280224
• Collaborator: First Affiliated Hospital of Xinjiang Medical University (Other)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 46.5
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Novel Coronavirus Pneumonia	Biological: NK Cells	Phase 1

Study Design

• Study Type: Interventional
• Anticipated 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: Feb 15, 2020
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Improvement of clinical symptoms including duration of fever [Measured from day 0 through day 28]

   Evaluation of pneumonia improvement

2. Improvement of clinical symptoms including respiratory frequency [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 [Measured from day 0 through day 28]

   Safety evaluation

Secondary Outcome Measures

1. Time of virus nucleic acid test negative [Measured from day 0 through day 28]

   Marker for 2019-nCoV

2. CD4+ and CD8+ T cell count [Measured from day 0 through day 28]

   Marker of immunological function

3. Rate of mortality within 28-days [Day 28]

   Marker for efficacy of treatment

4. Size of lesion area by thoracic imaging [Measured from day 0 through day 28]

   Recovery of lung injury

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 1. Male or female, aged at 18 years-65 years old
• 1. Pneumonia that is judged by chest radiograph or computed tomography
• 1. Laboratory confirmation of NCP infection by reverse-transcription polymerase chain reaction(RT-PCR) from any diagnostic sampling source

Exclusion Criteria:

• 1. Pregnancy or breastfeeding
• 1. Known HIV, HBV or HCV infection
• 1. Patients with malignant tumor, other serious systemic diseases and psychosis
• 1. Patients who are participating in other clinical trials
• 1. Inability to provide informed consent or to comply with test requirements

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Xinxiang Medical University	Xinxiang	Henan	China	453000

Sponsors and Collaborators

• Xinxiang medical university
• First Affiliated Hospital of Xinjiang Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xinxiang medical university
• ClinicalTrials.gov Identifier: NCT04280224
• Other Study ID Numbers: xinxiangM
• First Posted: Feb 21, 2020
• Last Update Posted: Feb 14, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pneumonia; Coronavirus Infections

Study Results

No Results Posted as of Feb 14, 2022