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OpenTrials
Completed

NCT Number: NCT04715919

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

1University of Health Sciences Turkey, Dr Suat Seren Chest Diseases and Chest Surgery Training and Research Hospital, Intensive Care Unit

Izmir, 35110, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chest Computed Tomography

Diagnostic Test

Evaluation of Lung Structure

Pulmonary function tests

Diagnostic Test

Respiratory Capacity

Six minutes walk test

Other

Exercise Capacity

Quality of life

Other

Physical disability assessment tool

Other names: SF-36

Primary outcomes

  1. Structural Change in Lung

    Time frame: up to 6 months after discharge

    Chest Computed Tomography

Secondary outcomes

  1. Carbon monoxide diffusion capacity (DLCO)

    Time frame: up to 6 months after discharge

    Carbon monoxide diffusion capacity of the lung

  2. Exercise Capacity

    Time frame: up to 6 months after discharge

    Six Minutes Walking Test

  3. Short Form Health Survey Score (SF-16)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital

Other

Collaborators

  • Turkish Respiratory Society

Registry information

Official study title

Long Term Outcomes in Patients With Coronavirus Disease-19 (COVID-19) on Pulmonary Functions, Exercise Capacity, Lung Structure and Quality of Life

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 20, 2021
Registry last updated
Sep 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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