NK Cells Treatment for COVID-19

Novel Coronavirus Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04280224
• Other study ID #: NK-COVID19
• Status: Completed
• Phase: Phase 1
• Start date: February 15, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2024
• Source: Xinxiang medical university
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• Novel Coronavirus Pneumonia
• Pneumonia

Intervention

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Xinxiang Medical University	Xinxiang	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Xinxiang medical university	First Affiliated Hospital of Xinjiang Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of clinical symptoms including duration of fever	Evaluation of pneumonia improvement	Measured from day 0 through day 28
Primary	Improvement of clinical symptoms including respiratory frequency	Evaluation of pneumonia improvement	Measured from day 0 through day 28
Primary	Number of participants with treatment-related adverse events evaluated with CTCAE,version 4.0	Safety evaluation	Measured from day 0 through day 28
Secondary	Time of virus nucleic acid test negative	Marker for 2019-nCoV	Measured from day 0 through day 28
Secondary	CD4+ and CD8+ T cell count	Marker of immunological function	Measured from day 0 through day 28
Secondary	Rate of mortality within 28-days	Marker for efficacy of treatment	Day 28
Secondary	Size of lesion area by thoracic imaging	Recovery of lung injury	Measured from day 0 through day 28