Pulmonary FibrosisNCT05719038
Diagnostic and Prognostic Model of Pulmonary Fibrosis After COVID-19 Pneumonia and Mechanism Study
An observational study of Pulmonary Fibrosis and COVID-19, run by Kunming Medical University at 2 sites in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Fibrosis, COVID-19
- What is being tested?
- observational study
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- 30 Jan 2023to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650000
Yuqi Cheng, PhD, (86) 087165324888-2471 ext. Yuqi cheng, yuqicheng@126.com
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
Yuqi Cheng, PhD, +86-0871-65324888, yuqicheng@126.com
Yuqi Cheng, 13888122013, yuqicheng@126.com
About this study
Official title: 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.
- Conditions
- Pulmonary Fibrosis, COVID-19
- Being tested
- observational study
- Medical subject headings
- Pulmonary Fibrosis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyDiagnostic test
observational study
| Study group | Role | What they receive |
|---|---|---|
| Healthy control group | Not described Receives: Diagnostic Test: observational study | |
| Pulmonary fibrosis after COVID-19 Pneumonia | Not described Receives: Diagnostic Test: observational study | |
| No pulmonary fibrosis after COVID-19 Pneumonia | Not described Receives: Diagnostic Test: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of pulmonary fibrosis
The change of pulmonary fibrosis were evaluated
Measured: At the time of enrollment, The first month, the third month, the sixth month, the twelfth month
Secondary outcomes (2)
change of protein in serum
Changes in plasma proteins over time
Measured: At the time of enrollment, the third month
changes of Lung function
Lung function over time
Measured: At the time of enrollment, the third month, the sixth month, the twelfth month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start30 Jan 2023 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kunming Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuqi Cheng, Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719038
- Sponsor's protocol ID
- KunmingMC
- Status last verified
- Feb 2023
- First submitted
- 5 Feb 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. 2021 Apr 10;17(6):1565-1573. doi: 10.7150/ijbs.58825. eCollection 2021.
PubMed 33907520Li 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 patients with new corona virus pneumonia: a cohort study. Respir Res. 2021 Jul 9;22(1):203. doi: 10.1186/s12931-021-01798-6.
PubMed 34243776Yang 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.
PubMed 34272434Sardar 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.
PubMed 34093642Bazdyrev 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.
PubMed 34451904
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of a Diagnostic and Prognostic Model of Pulmonary Fibrosis in Patients After COVID-19 Pneumonia and Study on Its Mechanism
- ClinicalTrials.gov ID
- NCT05719038
- Acronym / sponsor ID
- KunmingMC
- Conditions
- Pulmonary Fibrosis, COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kunming Medical UniversityUniversity, hospital or other
- Study start
- 30 Jan 2023 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy control group | – | Diagnostic Test: observational study |
| Pulmonary fibrosis after COVID-19 Pneumonia | – | Diagnostic Test: observational study |
| No pulmonary fibrosis after COVID-19 Pneumonia | – | Diagnostic Test: observational study |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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%
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational studyobservational study | Diagnostic test | Healthy control group, No pulmonary fibrosis after COVID-19 Pneumonia, Pulmonary fibrosis after COVID-19 Pneumonia |
Primary outcome
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
2 secondary outcomes
change of protein in serum
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Results publication: PubMed 33907520Xue 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. 2021 Apr 10;17(6):1565-1573. doi: 10.7150/ijbs.58825. eCollection 2021.
- Results publication: PubMed 34243776Li 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 patients with new corona virus pneumonia: a cohort study. Respir Res. 2021 Jul 9;22(1):203. doi: 10.1186/s12931-021-01798-6.
- Results publication: PubMed 34272434Yang 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.
- Results publication: PubMed 34093642Sardar 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.
- Results publication: PubMed 34451904Bazdyrev 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Fibrosis and COVID-19, run by Kunming Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuqi Cheng, PhD ((86) 087165324888-2471, yuqicheng@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of pulmonary fibrosis (time frame: At the time of enrollment, The first month, the third month, the sixth month, the twelfth month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05719038, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.