Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
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) |
0, 3, 6, 12 months after COVID-19 pneumonia |
|
Primary |
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 |
0, 3, 6, 12 months after COVID-19 pneumonia |
|
Primary |
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) |
0, 3, 6, 12 months after COVID-19 pneumonia |
|
Primary |
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 |
0, 3, 6, 12 months after COVID-19 pneumonia |
|
Primary |
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) |
0, 3, 6, 12 months after COVID-19 pneumonia |
|
Primary |
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 % of predicted using GLI-2012 references |
0, 3, 6, 12 months after COVID-19 pneumonia |
|
Primary |
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) |
0, 3, 6, 12 months after COVID-19 pneumonia |
|
Primary |
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 |
0, 3, 6, 12 months after COVID-19 pneumonia |
|
Primary |
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 |
0, 3, 6, 12 months after COVID-19 pneumonia |
|
Primary |
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 |
0, 3, 6, 12 months after COVID-19 pneumonia |
|
Primary |
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 |
0, 3, 6, 12 months after COVID-19 pneumonia |
|
Primary |
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. |
3, 6, 12 months |
|