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.
Study Type
OBSERVATIONAL
Enrollment
28
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.
Koç University Hospital
Istanbul, Turkey (Türkiye)
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
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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