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

February 7, 2023 updated by: Yuqi Cheng, Kunming Medical University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yuqi Cheng, PhD
  • Phone Number: (86) 087165324888-2471
  • Email: yuqicheng@126.com

Study Contact Backup

  • Name: Jianqing Zhang, PhD
  • Phone Number: (86) 18988272502
  • Email: ydyyzjq@163.com

Study Locations

  • China
    • Yunnan
      • Kunming, Yunnan, China, 650000
        • First Affiliated Hospital of Kunming Medical University
        • Contact:
          • Yuqi Cheng, PhD
          • Phone Number: Yuqi cheng (86) 087165324888-2471
          • Email: yuqicheng@126.com
      • Kunming, Yunnan, China, 650032
        • The First Affiliated Hospital of Kunming Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with newly diagnosed COVID-19 pneumonia were classified as moderate, severe and critical according to clinical classification, and underwent chest CT imaging follow-up and blood protein measurement. In the later stage, patients were divided into groups with pulmonary fibrosis and without pulmonary fibrosis according to whether pulmonary fibrosis occurred; Healthy people as healthy control groups.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: At the time of enrollment, the third month
Changes in plasma proteins over time
At the time of enrollment, the third month
changes of Lung function
Time Frame: At the time of enrollment, the third month, the sixth month, the twelfth month
Lung function over time
At the time of enrollment, the third month, the sixth month, the twelfth month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kunming Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 30, 2023

Primary Completion (ANTICIPATED)

December 30, 2024

Study Completion (ANTICIPATED)

December 30, 2024

Study Registration Dates

First Submitted

February 5, 2023

First Submitted That Met QC Criteria

February 7, 2023

First Posted (ACTUAL)

February 8, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KunmingMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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