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| Name | Class |
|---|---|
| Medical University of Warsaw | OTHER |
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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.
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive patients dicharged after confirmed COVID-19 pneumonia (positive PCR and lung involvement in HRCT, hospitalized)
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| Name | Affiliation | Role |
|---|---|---|
| Piotr W Boros, MD, PhD | National TB & Lung Diseases Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute for Tuberculosis and Lung Diseases | Warsaw | Masovian Voivodeship | 01-138 | Poland |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D045169 | Severe Acute Respiratory Syndrome |
| D011024 | Pneumonia, Viral |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
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blood, serum
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 |
| D018352 |
| Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |