NCT04715919

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2020

Completed
18 days until next milestone

Study Start

First participant enrolled

January 15, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

September 14, 2021

Status Verified

September 1, 2021

Enrollment Period

5 months

First QC Date

December 28, 2020

Last Update Submit

September 13, 2021

Conditions

Covid19

Keywords

Covid19Long term outcomesChest computed comographyPulmonary functional testsExercise capacityQuality of life

Outcome Measures

Primary Outcomes (1)

  • Structural Change in Lung

    Chest Computed Tomography

    up to 6 months after discharge

Secondary Outcomes (3)

  • Carbon monoxide diffusion capacity (DLCO)

    up to 6 months after discharge

  • Exercise Capacity

    up to 6 months after discharge

  • Short Form Health Survey Score (SF-16)

    up to 6 months after discharge

Study Arms (2)

Patients in ICU

ICU patients with COVID-19

Diagnostic Test: Chest Computed TomographyDiagnostic Test: Pulmonary Function TestsOther: Six Minutes Walk TestOther: Quality of Life

Patients in Hospital Ward

Patients with COVID-19 in hospital wards

Diagnostic Test: Chest Computed TomographyDiagnostic Test: Pulmonary Function TestsOther: Six Minutes Walk TestOther: Quality of Life

Interventions

Chest Computed TomographyDIAGNOSTIC_TEST

Evaluation of Lung Structure

Patients in Hospital WardPatients in ICU
Pulmonary Function TestsDIAGNOSTIC_TEST

Respiratory Capacity

Patients in Hospital WardPatients in ICU
Six Minutes Walk TestOTHER

Exercise Capacity

Patients in Hospital WardPatients in ICU
Quality of LifeOTHER

Physical disability assessment tool

Also known as: SF-36
Patients in Hospital WardPatients in ICU

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patients who were ≥18 years
  • COVID-19 confirmed by Real-Time PCR
  • At least 6 months after discharge

You may not qualify if:

  • Patients who were \< 18 years
  • Pregnancy
  • Become bedridden after discharge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Izmir, 35110, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Interventions

Respiratory Function TestsQuality of Life

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisHealth StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Doctor

Study Record Dates

First Submitted

December 28, 2020

First Posted

January 20, 2021

Study Start

January 15, 2021

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

September 14, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)