Diagnostic and Prognostic Model of Pulmonary Fibrosis After COVID-19 Pneumonia and Mechanism Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Pulmonary Fibrosis, COVID-19

Intervention / Treatment
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* Diagnostic Test: observational study


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy control group<br> | Diagnostic Test: observational study<br>* observational study<br>|
| Pulmonary fibrosis after COVID-19 Pneumonia<br> | Diagnostic Test: observational study<br>* observational study<br>|
| No pulmonary fibrosis after COVID-19 Pneumonia<br> | Diagnostic Test: observational study<br>* observational study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of pulmonary fibrosis | The change of pulmonary fibrosis were evaluated | At the time of enrollment, The first month, the third month, the sixth month, the twelfth month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of protein in serum | Changes in plasma proteins over time | At the time of enrollment, the third month | 
| changes of Lung function | Lung function over time | At the time of enrollment, the third month, the sixth month, the twelfth month |