An observational study in Covid19, sponsored by Koc University Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by Koc University Hospital · Observational
Coronavirus disease 2019 (COVID-19) is a respiratory tract infection caused by a newly emergent coronavirus (SARS-CoV-2) that can progress to severe multiorgan disease requiring hospitalization. The medium and long-term impact in survivors of COVID-19 on lung function, imaging by thoracic CT, exercise capacity, and health-related quality of life and the relation of these parameters remains to be determined.
Aim: To evaluate medium to late (visit 1: 6-12 months after hospital discharge) effects of COVID-19 on lung function, exercise capacity, thoracic CT findings, symptoms and HRQoL in patients with confirmed diagnosis of SARS-CoV-2 infection and the relation between these parameters.
Material and methods: Prospective cohort of subjects with laboratory and/or thoracic CT confirmed COVID-19 who were treated as inpatients. Participants will perform spirometry, lung diffusion capacity of carbon monoxide, 6-minute walk test (6MWT) and cardiopulmonary exercise testing (CPET) after 6-12 months (Visit 1) of COVID-19. Clinical, laboratory and chest image data during the COVID-19 hospitalization will be obtained from medical records.
The minimum sample size was estimated as 37 participants.
7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 28 is below the median of 260 across 3,135 observational studies indexed under COVID-19.
Browse COVID-19 studies →Koc University Hospital is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults with Covid-19 diagnosis
Exclusion Criteria:
Patients with laboratory and/or thoracic CT confirmed COVID-19 pneumonia ; older than18 years of age; treated as inpatients; evaluated at 6-12 months after hospital discharge in outpatient clinic
Diagnostic Test: spirometry, thoracic CT, CPET, 6 minute walking test, SF-36 questionnaire
Participants will perform spirometry, lung diffusion capacity of carbon monoxide, 6-minute walk test (6MWT), Short form-36 (SF-36) questionnaire and cardiopulmonary exercise testing (CPET) after 6-12 months (Visit 1) of COVID-19. Clinical, laboratory and chest image data during the COVID-19 hospitalization will be obtained from medical records.
Forced vital capacity (FVC)
in ml
Time frame: at 6-12 months after discharge
Lung diffusion capacity for carbon monoxide (DLCO)
DLCO (%predicted); DLCO/alveolar volume- DLCO/VA (%predicted)
Time frame: at 6-12 months after discharge
6-minute walk test distance
m
Time frame: at 6-12 months after discharge
Short-form 36 questionnaire (SF-36)
scores range between 0 and 100 with higher scores indicating a better HRQoL
Time frame: at 6-12 months after discharge
Oxygen uptake at peak exercise
from incremental Cardiopulmonary exercise test (% of predicted)
Time frame: at 6-12 months after discharge
Minute-ventilation/carbon dioxide output during exercise
from incremental Cardiopulmonary exercise test (L/L)
Time frame: at 6-12 months after discharge
Dyspnea during exercise
from incremental Cardiopulmonary exercise test (measured with 10-point categorical Borg scale
Time frame: at 6-12 months after discharge
Thoracic CT findings
lung parenchymal abnormalities as percentage of occupied lung
Time frame: in the first week of pneumonia and at 6-12 months after discharge
Forced expiratory volume in 1 second
in ml and %predicted
Time frame: at 6-12 months after discharge
FEV1/FVC ratio
in %
Time frame: at 6-12 months after discharge
Forced vital capacity %predicted (FVC%)
in %
Time frame: at 6-12 months after discharge
Signs and symptoms
Recorded separately as present or absent) mortality (recorded as present or absent)
Time frame: in the first week of pneumonia and at 6-12 months after discharge
Time to hospital discharge
in days
Time frame: in hospital
ICU discharge
in days
Time frame: in hospital
Weaning from intubation
in days
Time frame: in the period of intensive care
Weaning from supplemental oxygen
in days
Time frame: in hospital
Weaning from noninvasive mechanical ventilation
in days
Time frame: in hospital
Mortality
recorded as present or absent
Time frame: in hospital and at 6-12 months after discharge
Plan to share: No
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Koc University Hospital