跳至主要内容
临床试验/NCT05669248
NCT05669248招募中不适用

A Follow-up Study of Immune Dysregulation in Patients With COVID-19

Qilu Hospital of Shandong University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
The number of immune cells(Th1/Th2 cell, Treg cell, MDSCs,etc.) in peripheral blood.

研究概览

简要总结

In order to detect the immunosuppression status of COVID-19 patients, this study collected blood samples of COVID-19 patients on the 10th, 20th and 30th days after the onset of symptoms, and detected the proinflammatory, anti-inflammatory factors,immunosuppressive marker,immune cells in the blood samples to evaluate the immunosuppression status of COVID-19 patients.

详细描述

After SARS-CoV-2 infection, the patient's immune system is overactivated. While the immune cells release a large number of proinflammatory factors, anti-inflammatory response starts at the same time. Anti-inflammatory factors such as IL-4, IL-10, and IL-37 will be compensated to resist the release of proinflammatory factors and prevent the further development of systemic inflammatory response. However, when the anti-inflammatory factor is excessively released, it will cause compensatory response syndrome, leading to immunosuppression. Whether the level of anti-inflammatory factors continues to rise, and whether it will lead to the persistence of later immunosuppression is unknown. Therefore, this study intends to recruit COVID-19 patients, detect the pro-inflammatory and anti-inflammatory factors,immunosuppressive marker,immune cells in 10 days, 20days, and 30days after the symptoms appear, and evaluate the immunosuppression status of patients with COVID-19

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participant is diagnosed with symptomatic COVID-19 by a positive PCR for SARS-CoV-2 or antigen quicktest.
  • Study participant is 18 years of age or older

排除标准

  • Patients with immunosuppression, including HIV infection, hematopoietic stem cell transplantation and high-dose immunosuppressant therapy
  • Pregnancy or breastfeeding
  • Patients receiving chemotherapy or other cancer treatment

结局指标

主要结局

The number of immune cells(Th1/Th2 cell, Treg cell, MDSCs,etc.) in peripheral blood.

时间窗: 10, 20, 30days

The concentration of inflammatory markers (IL-1β、IL-2、 IL-2R 、IL-4 、 IL-6 、 IL-8、 IL-10 、IFN-γ、TNF-α 、VEGF, etc.) in peripheral blood.

时间窗: 10, 20, 30days

The concentration of immunosuppression makers(HLA-DR, PD-1, TIM-3,etc.) in peripheral blood.

时间窗: 10, 20, 30days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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