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

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Other: Quality of Life; Diagnostic test: Chest Computed Tomography; Diagnostic test: Pulmonary Function Tests; Other: Six Minutes Walk Test

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 Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey, 35110
    • 1University of Health Sciences Turkey, Dr Suat Seren Chest Diseases and Chest Surgery Training and Research Hospital, Intensive Care Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Survivors of COVID-19 aged over 18 years old who had been admitted in University of Health Sciences, Dr. Suat Seren Chest Disease and Surgery Training and Research Hospital for COVID-19 patients in İzmir, Turkey.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients in ICU; ICU patients with COVID-19	Other: Quality of Life; Physical disability assessment tool; Other Names: SF-36; Diagnostic test: Chest Computed Tomography; Evaluation of Lung Structure; Diagnostic test: Pulmonary Function Tests; Respiratory Capacity; Other: Six Minutes Walk Test; Exercise Capacity
Patients in Hospital Ward; Patients with COVID-19 in hospital wards	Other: Quality of Life; Physical disability assessment tool; Other Names: SF-36; Diagnostic test: Chest Computed Tomography; Evaluation of Lung Structure; Diagnostic test: Pulmonary Function Tests; Respiratory Capacity; Other: Six Minutes Walk Test; Exercise Capacity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Structural Change in Lung	Chest Computed Tomography	up to 6 months after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Carbon monoxide diffusion capacity (DLCO)	Carbon monoxide diffusion capacity of the lung	up to 6 months after discharge
Exercise Capacity	Six Minutes Walking Test	up to 6 months after discharge
Short Form Health Survey Score (SF-16)	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	up to 6 months after discharge

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: December 28, 2020
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (Actual): January 20, 2021

Study Record Updates

• Last Update Posted (Actual): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 13, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Covid19; Quality of life; Exercise capacity; Long term outcomes; Chest computed comography; Pulmonary functional tests
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 195/ADF14

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