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Clinical Trials/NCT05719038
NCT05719038
Not yet recruiting
Not Applicable

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

Kunming Medical University2 sites in 1 country200 target enrollmentJanuary 30, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Fibrosis
Sponsor
Kunming Medical University
Enrollment
200
Locations
2
Primary Endpoint
change of pulmonary fibrosis
Status
Not yet recruiting
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 30, 2023
End Date
December 30, 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Kunming Medical University
Responsible Party
Principal Investigator
Principal Investigator

Yuqi Cheng

Principal Investigator

Kunming Medical University

Eligibility Criteria

Inclusion Criteria

  • 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%

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

change of pulmonary fibrosis

Time Frame: At the time of enrollment, The first month, the third month, the sixth month, the twelfth month

The change of pulmonary fibrosis were evaluated

Secondary Outcomes

  • 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)

Study Sites (2)

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