Prospective study in a group of patients with COVID-19 pneumonia.
Objective: Assessment of pulmonary and heart dysfunction, fibrosis-related markers and antibodies as well as the search for risk factors for an unfavorable course and possible complications in patients after pneumonia due to SARS-CoV-2 (COVID-19) infection. Patients: A group of approx. 100 patients assessed shortly after pneumonia and followed up, investigated after 3 and 6 months with possible prolongation to 12 months.
Study Type
OBSERVATIONAL
Enrollment
100
National Institute for Tuberculosis and Lung Diseases
Warsaw, Masovian Voivodeship, Poland
Change from baseline in lung transfer factor for carbon monoxide (TL,CO) at 3, 6 and 12 months after COVID-19 pneumonia
Lung transfer factor for carbon monoxide (TL,CO) will be measured using single breath method, results will be reported as absolute values (mmol/min/kPa)
Time frame: 0, 3, 6, 12 months after COVID-19 pneumonia
Change from baseline in lung transfer factor for carbon monoxide (TL,CO) at 3, 6 and 12 months after COVID-19 pneumonia
Lung transfer factor for carbon monoxide (TL,CO) will be measured using single breath method, results will be reported as % of predicted using GLI-2017 references
Time frame: 0, 3, 6, 12 months after COVID-19 pneumonia
Change from baseline in forced vital capacity (FVC) at 3, 6 and 12 months after COVID-19 pneumonia
Forced vital capacity (FVC) will be measured using spirometry according to ATS/ERS 2019 guidelines, results will be reported as absolute values (L)
Time frame: 0, 3, 6, 12 months after COVID-19 pneumonia
Change from baseline in forced vital capacity (FVC) at 3, 6 and 12 months after COVID-19 pneumonia
Forced vital capacity (FVC) will be measured using spirometry according to ATS/ERS 2019 guidelines, results will be reported as % of predicted using GLI-2012 references
Time frame: 0, 3, 6, 12 months after COVID-19 pneumonia
Change from baseline in forced expiratory volume at 1 second (FEV1) at 3, 6 and 12 months after COVID-19 pneumonia
Forced expiratory volume at 1 second (FEV1) will be measured using spirometry according to ATS/ERS 2019 guidelines, results will be reported as absolute values (L)
Time frame: 0, 3, 6, 12 months after COVID-19 pneumonia
Change from baseline in forced expiratory volume at 1 second (FEV1) at 3, 6 and 12 months after COVID-19 pneumonia
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Forced expiratory volume at 1 second (FEV1) will be measured using spirometry according to ATS/ERS 2019 guidelines, results will be reported as % of predicted using GLI-2012 references
Time frame: 0, 3, 6, 12 months after COVID-19 pneumonia
Change from baseline in total lun capacity (TLC) at 3, 6 and 12 months after COVID-19 pneumonia
Total lung capacity will be measured using body plethysmography method according to ATS/ERS 2005 guidelines, results will be reported as absolute values (L)
Time frame: 0, 3, 6, 12 months after COVID-19 pneumonia
Change from baseline in total lun capacity (TLC) at 3, 6 and 12 months after COVID-19 pneumonia
Total lung capacity will be measured using body plethysmography method according to ATS/ERS 2005 guidelines, results will be reported as % of predicted using most recent references
Time frame: 0, 3, 6, 12 months after COVID-19 pneumonia
Change in prevalence of abnormal (low) lung transfer factor for carbon monoxide (TL,CO) results at 3, 6 and 12 months after COVID-19 pneumonia
Abnormal (low) lung transfer factor for carbon monoxide (TL,CO) will be identified with cut-off point at the level of 5th percentile (-1.64 SD) using most recent predicted values (GLI-2017), prevalence will be reported as % of investigated group
Time frame: 0, 3, 6, 12 months after COVID-19 pneumonia
Change in prevalence of obstructive ventilatory impairment at 3, 6 and 12 months after COVID-19 pneumonia
Obstructive ventilatory impairment (airway obstruction) will be identified with FEV1/FVC ratio below lower limit of normal, cut-off point at the level of 5th percentile (-1.64 SD) will be used with most recent predicted values (GLI-2012), prevalence will be reported as % of investigated group
Time frame: 0, 3, 6, 12 months after COVID-19 pneumonia
Change in prevalence of restrictive ventilatory impairment at 3, 6 and 12 months after COVID-19 pneumonia
Restrictive ventilatory impairment will be identified with total lung capacity (TLC) below lower limit of normal, cut-off point at the level of 5th percentile (-1.64 SD) will be used with most recent predicted values, prevalence will be reported as % of investigated group
Time frame: 0, 3, 6, 12 months after COVID-19 pneumonia
Change in lung structure from the baseline
Change in lung structure will be assessed using high resolution computed tomography (HRCT) performed at 3, 6 and 12 months after initial investigation. Quantitive assessment of abnormalities will be performed and compared with initial investigation performed during acute phase of COVID-19 pneumonia.
Time frame: 3, 6, 12 months