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A study on the clinical characteristics including severity of pulmonary fibrosis by COVID-19

Status Approved

  • First Submitted Date

    2021/06/07

  • Registered Date

    2021/07/02

  • Last Updated Date

    2021/06/22

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number    		 KCT0006312
    Unique Protocol ID 2021-0769
    Public/Brief Title A study on the clinical characteristics including severity of pulmonary fibrosis by COVID-19
    Scientific Title A study on the clinical characteristics including severity of pulmonary fibrosis by COVID-19
    Acronym Pulmonary fibrosis by COVID-19 infection
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable

  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 2021-0769
    Approval Date 2021-05-25
    Institutional Review Board Name Asan Medical Center Institutional Review Board
    Institutional Review Board Address 88, Olympic-ro 43-gil, Songpa-gu, Seoul
    Institutional Review Board Telephone 02-3010-7166
    Data Monitoring Committee No

  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Jinwoo Song
    Title Professor
    Telephone +82-2-3010-8532
    Affiliation Asan Medical Center
    Address 88, Olympic-ro 43-gil, Songpa-gu, Seoul
    Contact Person for Public Queries
    Name Junghyun Kim
    Title Medical Doctor
    Telephone +82-2-2276-2140
    Affiliation National Medical Center
    Address 245, Eulji-ro, Jung-gu, Seoul
    Contact Person for Updating Information
    Name Subin Hwang
    Title Clinical Research Coordinator
    Telephone +82-2-3010-5453
    Affiliation Asan Medical Center
    Address 245, Eulji-ro, Jung-gu, Seoul

  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 8
    Overall Recruitment Status Not yet recruiting
    Date of First Enrollment 2021-06-14 Anticipated
    Target Number of Participant 100
    Primary Completion Date 2021-12-31 , Anticipated
    Study Completion Date 2021-12-31 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Asan Medical Center
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2021-06-15 ,
    Recruitment Status by Participating Study Site 2
    Name of Study National Medical Center
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2021-06-15 ,
    Recruitment Status by Participating Study Site 3
    Name of Study Seoul National University Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2021-06-15 ,
    Recruitment Status by Participating Study Site 4
    Name of Study Seoul National University Bundang Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2021-06-21 ,
    Recruitment Status by Participating Study Site 5
    Name of Study Ulsan Univeristy Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2021-06-21 ,
    Recruitment Status by Participating Study Site 6
    Name of Study Samsung Medical Center
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2021-06-16 ,
    Recruitment Status by Participating Study Site 7
    Name of Study Chung-Ang Univerisity Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2021-06-21 ,
    Recruitment Status by Participating Study Site 8
    Name of Study Soon Chun Hyang University Hospital Bucheon
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2021-06-21 ,

  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Korea Disease Control and Prevention Agency
    Organization Type Government
    Project ID 2021040CAAA - 00

  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Asan Medical Center
    Organization Type Medical Institute

  • 7. Study Summary

    Study Summary Information
    Lay Summary 
    Purpose
-To investigate the incidence and severity of pulmonary fibrosis according to the timing of intubation in patients with severe COVID-19 infection. 
-To provide guidelines for minimizing intubation and ventilator-related complications in patients with severe respiratory failure

Methods
- Study population : patients infected with COVID-19 who require a mechanical ventilation 
- Contents
 ·This study is a prospective study to evaluate association between the  timing of intubation and the extent of pulmonary fibrosis on chest CT.
 ·Tests: Chest CT, Pulmonary function test including forced vital capacity (FVC), diffusing capacity for carbon dioxide (DLCO), and total lung capacity (TLC), Serologic test such as rheumatoid factor, antinuclear antibody (ANA)
 ·Collection of clinical data including incidence, and severity of pulmonary fibrosis
 ·Collection of specimens for analyzing the clinical characteristics of COVID-19 : respiratory specimens (upper and lower airway), blood sample,etc.
 ·Analysis of virological and serological characteristics of COVID-19.

Expected Contribution
- Confirmation of pulmonary fibrosis frequency and risk factors in patients with COVID-19 in South Korea
- Confirmation of complications and risk factors related to tracheal intubation in patients with COVID-19 in South Korea
- Providing a guideline for clinical management in intensive care unit
- a basis for estimating the health care budget and establishing infrastructure for severe COVID-19 patients in Korea

  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Cohort
    Time Perspective Prospective  
    Target Number of Participant 100
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    patients with severe COVID-19 infection

    Cohort/Group Description

    patients with severe COVID-19 infection requiring intubation

A prospective study to monitor the timing of intubation and the extent of pulmonary fibrosis on chest CT.
Examination : 

1. At registration 
-Chest CT
-Serologic test such as rheumatoid factor, antinuclear antibody (ANA)
-Clinical characteristics including incidence, severity, etc.
-Collecting specimens for analyzing the clinical characteristics of COVID-19 
: Respiratory specimens(at registration), blood sample(at registration, after 1wk)
-Analysis of virological and serological characteristics of COVID-19.

2. Outpatient visit after 1 month
-Chest CT
-Pulmonary function test including forced vital capacity (FVC), diffusing capacity for carbon dioxide (DLCO), and total lung capacity (TLC)
    Biospecimen
    Collection & Archiving    		 
    : DNA Collect & Archive: Sample without DNA
    Biospecimen Description 
    Whole blood, serum, sputum

  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description 
    Patients with severe COVID-19 infection requiring intubation
    Sampling Method 
    Not applicable
    Condition(s)/Problem(s) * (U00-U99)Codes for special purposes 
       (U07.1)Coronavirus disease 2019, virus identified [COVID-19, virus identified] 

    COVID-19, Infections, Pulmonary Fibrosis
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~No Limit

    Description

    Patients aged over 19 who admitted to ICU and needed mechanical ventilation due to COVID-19 infection
Patients who were confirmed pneumonia by radiological imaging
Patients with severe or critical status based on COVID-19 WHO clinical classification
    Exclusion Criteria 
    Patients who were previously diagnosed with interstitial lung disease
Patients who had been intubated in other hospitals and refered to study hospital
    Healthy Volunteers No

  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Not applicable
    Primary Outcome(s) 1
    Outcome 
    Pulmonary fibrosis
    Timepoint 
    Chest CT performed in outpatient clinic after 1 month
    Secondary Outcome(s) 1
    Outcome 
    Not applicable
    Timepoint 
    Not applicable

  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No

  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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