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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04715919
• Other study ID #: 195/ADF14
• Status: Completed
• Start date: January 15, 2021
• Est. completion date: June 1, 2021

Study information

• Verified date: September 2021
• Source: Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• Covid19

Intervention

Diagnostic Test:
• Chest Computed Tomography
Evaluation of Lung Structure
• Pulmonary Function Tests
Respiratory Capacity

Other:
• Six Minutes Walk Test
Exercise Capacity
• Quality of Life
Physical disability assessment tool

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital	Turkish Respiratory Society

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Structural Change in Lung	Chest Computed Tomography	up to 6 months after discharge
Secondary	Carbon monoxide diffusion capacity (DLCO)	Carbon monoxide diffusion capacity of the lung	up to 6 months after discharge
Secondary	Exercise Capacity	Six Minutes Walking Test	up to 6 months after discharge
Secondary	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