Impact of Severe Acute Respiratory Syndrome (SARS-CoV-2/COVID-19) Related Pneumonia on Lung Function and Structure.

Study Overview
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Brief Summary
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Prospective study in a group of patients with COVID-19 pneumonia.

Detailed Description
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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.

Official Title
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Impact of SARS-CoV-2/COVID-19 Related Pneumonia on Lung Function and Structure - Prospective Case Control Study

Conditions
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Covid19, SARS-CoV Infection, Pulmonary Function, Pneumonia, Viral

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed SARS-CoV-2 infection with pneumonia hospitalized Two negative PCR results of a swab from the respiratory tract in succession, including the last one taken no later than 3 days before the planned lung function tests (1st visit). Exclusion Criteria: Lack of patient consent, Present contraindications for lung function tests Inability to perform correctly lung function measurements

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |