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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05719038
• Other study ID #: KunmingMC
• Status: Not yet recruiting
• Start date: January 30, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2023
• Source: Kunming Medical University
• Contact: Yuqi Cheng, PhD
• Phone: (86) 087165324888-2471
• Email: yuqicheng[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. age 18-90 years

2. novel coronavirus nucleic acid or antigen confirmed novel coronavirus infection

3. Meet the diagnostic criteria for moderate/severe/severe coronavirus infection in China (Trial Tenth Edition)

4. Chest CT showed that the extent of lung lesions was greater than 50%

Exclusion Criteria:

1. pregnant and lactating women

2. previous severe lung disease, such as known chronic lung disease: chronic obstructive pulmonary disease, asthma, interstitial lung disease, etc.

3. severe organ dysfunction: severe liver, kidney and heart dysfunction

4. severe epidemic defects (including tumors/severe rheumatism/organs, bone marrow transplantation/HIV, etc.)

5. inappropriate enrollment judged by the investigator

Related Conditions & MeSH terms

• COVID-19
• Fibrosis
• Pneumonia
• Pulmonary Fibrosis

Intervention

Diagnostic Test:
• observational study
observational study

Locations

Country	Name	City	State
China	First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	The First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan

Sponsors (1)

Lead Sponsor	Collaborator
Kunming Medical University

Country where clinical trial is conducted

China, 

References & Publications (5)

Bazdyrev E, Rusina P, Panova M, Novikov F, Grishagin I, Nebolsin V. Lung Fibrosis after COVID-19: Treatment Prospects. Pharmaceuticals (Basel). 2021 Aug 17;14(8):807. doi: 10.3390/ph14080807. — View Citation

Li X, Shen C, Wang L, Majumder S, Zhang D, Deen MJ, Li Y, Qing L, Zhang Y, Chen C, Zou R, Lan J, Huang L, Peng C, Zeng L, Liang Y, Cao M, Yang Y, Yang M, Tan G, Tang S, Liu L, Yuan J, Liu Y. Pulmonary fibrosis and its related factors in discharged patient — View Citation

Sardar R, Sharma A, Gupta D. Machine Learning Assisted Prediction of Prognostic Biomarkers Associated With COVID-19, Using Clinical and Proteomics Data. Front Genet. 2021 May 20;12:636441. doi: 10.3389/fgene.2021.636441. eCollection 2021. — View Citation

Xue M, Zhang T, Chen H, Zeng Y, Lin R, Zhen Y, Li N, Huang Z, Hu H, Zhou L, Wang H, Zhang XD, Sun B. Krebs Von den Lungen-6 as a predictive indicator for the risk of secondary pulmonary fibrosis and its reversibility in COVID-19 patients. Int J Biol Sci. — View Citation

Yang J, Chen C, Chen W, Huang L, Fu Z, Ye K, Lv L, Nong Z, Zhou X, Lu W, Zhong M. Proteomics and metabonomics analyses of Covid-19 complications in patients with pulmonary fibrosis. Sci Rep. 2021 Jul 16;11(1):14601. doi: 10.1038/s41598-021-94256-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	change of protein in serum	Changes in plasma proteins over time	At the time of enrollment, the third month
Secondary	changes of Lung function	Lung function over time	At the time of enrollment, the third month, the sixth month, the twelfth month

External Links

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