NK Cells Treatment for COVID-19

Phase 1

Completed

• Conditions: Novel Coronavirus Pneumonia

• Registration Number: NCT04280224
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-13
• Study Start: 2020-02-15
• Study First Submitted QC: 2020-02-20
• Study First Posted: 2020-02-21
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events evaluated with CTCAE,version 4.0	Measured from day 0 through day 28	Safety evaluation
Improvement of clinical symptoms including duration of fever	Measured from day 0 through day 28	Evaluation of pneumonia improvement
Improvement of clinical symptoms including respiratory frequency	Measured from day 0 through day 28	Evaluation of pneumonia improvement

Secondary Outcome Measures

Name	Time	Method
CD4+ and CD8+ T cell count	Measured from day 0 through day 28	Marker of immunological function
Time of virus nucleic acid test negative	Measured from day 0 through day 28	Marker for 2019-nCoV
Rate of mortality within 28-days	Day 28	Marker for efficacy of treatment
Size of lesion area by thoracic imaging	Measured from day 0 through day 28	Recovery of lung injury

Trial Locations

Locations (1)

The First Affiliated Hospital of Xinxiang Medical University; 🇨🇳 Xinxiang, Henan, China