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

Sponsor
Kunming Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05719038
Collaborator
(none)
200
2
23
100
4.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: observational study

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Construction of a Diagnostic and Prognostic Model of Pulmonary Fibrosis in Patients After COVID-19 Pneumonia and Study on Its Mechanism
Anticipated Study Start Date :
Jan 30, 2023
Anticipated Primary Completion Date :
Dec 30, 2024
Anticipated Study Completion Date :
Dec 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Healthy control group

Diagnostic Test: observational study
observational study

Pulmonary fibrosis after COVID-19 Pneumonia

Diagnostic Test: observational study
observational study

No pulmonary fibrosis after COVID-19 Pneumonia

Diagnostic Test: observational study
observational study

Outcome Measures

Primary Outcome Measures

  1. change of pulmonary fibrosis [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 Outcome Measures

  1. change of protein in serum [At the time of enrollment, the third month]

    Changes in plasma proteins over time

  2. changes of Lung function [At the time of enrollment, the third month, the sixth month, the twelfth month]

    Lung function over time

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 First Affiliated Hospital of Kunming Medical University Kunming Yunnan China 650000
2 The First Affiliated Hospital of Kunming Medical University Kunming Yunnan China 650032

Sponsors and Collaborators

  • Kunming Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Yuqi Cheng, Principal Investigator, Kunming Medical University
ClinicalTrials.gov Identifier:
NCT05719038
Other Study ID Numbers:
  • KunmingMC
First Posted:
Feb 8, 2023
Last Update Posted:
Feb 8, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 8, 2023