跳至主要内容
临床试验/NCT05719038
NCT05719038尚未招募不适用

Construction of a Diagnostic and Prognostic Model of Pulmonary Fibrosis in Patients After COVID-19 Pneumonia and Study on Its Mechanism

Kunming Medical University2 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30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
试验地点
2
主要终点
change of pulmonary fibrosis

研究概览

简要总结

The infection of COVID-19 has caused serious threat to the life and health of all mankind and increased huge economic burden. According to the current statistics, the incidence of pulmonary fibrosis after COVID-19 infection is about 27.7% -87%, 81% of severe patients and 37% of moderate patients have residual lung lesions, and 53% of patients still have residual lung abnormalities one year after infection, resulting in restrictive pulmonary dysfunction and affecting the health and life of patients. Therefore, it is very important to study the diagnostic and prognostic markers of pulmonary fibrosis after infection of COVID-19. At present, relevant studies have been carried out on imagomics and serum proteomics of pulmonary fibrosis after COVID-19 infection, and serum biomarkers and imagomics marker models for diagnosing pulmonary fibrosis after COVID-19 pneumonia have been developed. However, there are few studies combining imageomics and serum proteomics, and the mechanism of pulmonary fibrosis after COVID-19 has not been fully clarified. In this study, it is planned to recruit patients with moderate, severe and critical COVID-19 pneumonia infection, collect venous blood from subjects, and perform chest HRCT follow-up. Blood samples were screened by proteomics and verified by expanded samples to screen diagnostic and prognostic markers of pulmonary fibrosis after COVID-19 infection. At the same time, based on deep learning technology, a model was developed to predict the occurrence and prognosis of pulmonary fibrosis after infection of COVID-19 combined with clinical characteristics, serum markers and AI imagomics, so as to provide ideas for further elucidating the mechanism of occurrence and development of pulmonary fibrosis after infection of 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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 18-90 years
  • novel coronavirus nucleic acid or antigen confirmed novel coronavirus infection
  • Meet the diagnostic criteria for moderate/severe/severe coronavirus infection in China (Trial Tenth Edition)
  • Chest CT showed that the extent of lung lesions was greater than 50%

排除标准

  • pregnant and lactating women
  • previous severe lung disease, such as known chronic lung disease: chronic obstructive pulmonary disease, asthma, interstitial lung disease, etc.
  • severe organ dysfunction: severe liver, kidney and heart dysfunction
  • severe epidemic defects (including tumors/severe rheumatism/organs, bone marrow transplantation/HIV, etc.)
  • inappropriate enrollment judged by the investigator

结局指标

主要结局

change of pulmonary fibrosis

时间窗: At the time of enrollment, The first month, the third month, the sixth month, the twelfth month

The change of pulmonary fibrosis were evaluated

次要结局

  • changes of Lung function(At the time of enrollment, the third month, the sixth month, the twelfth month)
  • change of protein in serum(At the time of enrollment, the third month)

研究者

发起方
Kunming Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuqi Cheng

Principal Investigator

Kunming Medical University

研究点 (2)

Loading locations...

相似试验