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

Completed

• Conditions: Covid19
• Interventions: Diagnostic Test: Chest Computed Tomography; Diagnostic Test: Pulmonary Function Tests; Other: Six Minutes Walk Test; Other: Quality of Life

• Registration Number: NCT04715919
• Lead Sponsor: Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital

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.

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 Timeline

• Study First Submitted: 2020-12-28
• Study Start: 2021-01-15
• Study First Submitted QC: 2021-01-19
• Study First Posted: 2021-01-20
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-13
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients in Hospital Ward	Chest Computed Tomography	Patients with COVID-19 in hospital wards
Patients in ICU	Chest Computed Tomography	ICU patients with COVID-19
Patients in ICU	Six Minutes Walk Test	ICU patients with COVID-19
Patients in Hospital Ward	Pulmonary Function Tests	Patients with COVID-19 in hospital wards
Patients in ICU	Pulmonary Function Tests	ICU patients with COVID-19
Patients in ICU	Quality of Life	ICU patients with COVID-19
Patients in Hospital Ward	Six Minutes Walk Test	Patients with COVID-19 in hospital wards
Patients in Hospital Ward	Quality of Life	Patients with COVID-19 in hospital wards

Primary Outcome Measures

Name	Time	Method
Structural Change in Lung	up to 6 months after discharge	Chest Computed Tomography

Secondary Outcome Measures

Name	Time	Method
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
Carbon monoxide diffusion capacity (DLCO)	up to 6 months after discharge	Carbon monoxide diffusion capacity of the lung
Exercise Capacity	up to 6 months after discharge	Six Minutes Walking Test

Trial Locations

Locations (1)

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