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Long Term Outcomes of Coronavirus Disease-19 (COVID-19)

Sponsor
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04715919
Collaborator
Turkish Respiratory Society (Other)
70
Enrollment
1
Location
4.5
Actual Duration (Months)
15.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators hypothese that lung involvement due to COVID-19 may cause structural changes in the lung in the long term. In this study the effects of structural changes in the lung on pulmonary function tests, exercise capacity and quality of life will be examined.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Chest Computed Tomography
  • Diagnostic Test: Pulmonary Function Tests
  • Other: Six Minutes Walk Test
  • Other: Quality of Life

Detailed Description

Coronavirus disease-19 (COVID-19) has a clinical spectrum ranging from asymptomatic cases to severe cases requiring intensive care hospitalization due to respiratory failure. The disease mostly infects the lower respiratory tract. Typical computed tomography findings of lung involvement are bilateral, peripherally located ground glass density and consolidations. There is a close relationship between tomography findings and clinical severity. It is not known whether there will be complete recovery in the lungs.

Investigators will evaluate pulmonary structures with chest computed tomography, respiratory capacity with pulmonary function tests (PFTs), exercise capacity with six minutes walk test and quality of life with short form-36 (SF-36) im patients who survivors of COVID-19 at least 6 months after hospital discharge.

Study Design

Study Type:
Observational
Actual Enrollment :
70 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Long Term Outcomes in Patients With Coronavirus Disease-19 (COVID-19) on Pulmonary Functions, Exercise Capacity, Lung Structure and Quality of Life
Actual Study Start Date :
Jan 15, 2021
Actual Primary Completion Date :
Jun 1, 2021
Actual Study Completion Date :
Jun 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Patients in ICU

ICU patients with COVID-19

Diagnostic Test: Chest Computed Tomography
Evaluation of Lung Structure

Diagnostic Test: Pulmonary Function Tests
Respiratory Capacity

Other: Six Minutes Walk Test
Exercise Capacity

Other: Quality of Life
Physical disability assessment tool
Other Names:
  • SF-36

    		•
    Patients in Hospital Ward

    Patients with COVID-19 in hospital wards

    Diagnostic Test: Chest Computed Tomography
    Evaluation of Lung Structure

    Diagnostic Test: Pulmonary Function Tests
    Respiratory Capacity

    Other: Six Minutes Walk Test
    Exercise Capacity

    Other: Quality of Life
    Physical disability assessment tool
    Other Names:
  • SF-36

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Structural Change in Lung [up to 6 months after discharge]

      Chest Computed Tomography

    Secondary Outcome Measures

    1. Carbon monoxide diffusion capacity (DLCO) [up to 6 months after discharge]

      Carbon monoxide diffusion capacity of the lung

    2. Exercise Capacity [up to 6 months after discharge]

      Six Minutes Walking Test

    3. Short Form Health Survey Score (SF-16) [up to 6 months after discharge]

      A 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients who were ≥18 years

    • COVID-19 confirmed by Real-Time PCR

    • At least 6 months after discharge

    Exclusion Criteria:

    • Patients who were < 18 years

    • Pregnancy

    • Become bedridden after discharge

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 1University of Health Sciences Turkey, Dr Suat Seren Chest Diseases and Chest Surgery Training and Research Hospital, Intensive Care Unit İzmir Turkey 35110

    Sponsors and Collaborators

    • Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
    • Turkish Respiratory Society

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cenk Kirakli, M.D., Professor Doctor, Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT04715919
    Other Study ID Numbers:
    • 195/ADF14
    First Posted:
    Jan 20, 2021
    Last Update Posted:
    Sep 14, 2021
    Last Verified:
    Sep 1, 2021
    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
    Keywords provided by Cenk Kirakli, M.D., Professor Doctor, Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
    Covid19
    Long term outcomes
    Chest computed comography
    Pulmonary functional tests
    Exercise capacity
    Quality of life
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Sep 14, 2021