Impact of SARS-CoV-2/COVID-19 Related Pneumonia on Lung Function and Structure.
Study Details
Study Description
Brief Summary
Prospective study in a group of patients with COVID-19 pneumonia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed Description
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 Design
Outcome Measures
Primary Outcome Measures
- Change from baseline in lung transfer factor for carbon monoxide (TL,CO) at 3, 6 and 12 months after COVID-19 pneumonia [0, 3, 6, 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)
- Change from baseline in lung transfer factor for carbon monoxide (TL,CO) at 3, 6 and 12 months after COVID-19 pneumonia [0, 3, 6, 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
- Change from baseline in forced vital capacity (FVC) at 3, 6 and 12 months after COVID-19 pneumonia [0, 3, 6, 12 months after COVID-19 pneumonia]
Forced vital capacity (FVC) will be measured using spirometry according to ATS/ERS 2019 gudelines, results will be reported as absolute values (L)
- Change from baseline in forced vital capacity (FVC) at 3, 6 and 12 months after COVID-19 pneumonia [0, 3, 6, 12 months after COVID-19 pneumonia]
Forced vital capacity (FVC) will be measured using spirometry according to ATS/ERS 2019 gudelines, results will be reported as % of predicted using GLI-2012 references
- Change from baseline in forced expiratory volume at 1 second (FEV1) at 3, 6 and 12 months after COVID-19 pneumonia [0, 3, 6, 12 months after COVID-19 pneumonia]
Forced expiratory volume at 1 second (FEV1) will be measured using spirometry according to ATS/ERS 2019 gudelines, results will be reported as absolute values (L)
- Change from baseline in forced expiratory volume at 1 second (FEV1) at 3, 6 and 12 months after COVID-19 pneumonia [0, 3, 6, 12 months after COVID-19 pneumonia]
Forced expiratory volume at 1 second (FEV1) will be measured using spirometry according to ATS/ERS 2019 gudelines, results will be reported as % of predicted using GLI-2012 references
- Change from baseline in total lun capacity (TLC) at 3, 6 and 12 months after COVID-19 pneumonia [0, 3, 6, 12 months after COVID-19 pneumonia]
Total lung capacity will be measured using body plethysmography method according to ATS/ERS 2005 gudelines, results will be reported as absolute values (L)
- Change from baseline in total lun capacity (TLC) at 3, 6 and 12 months after COVID-19 pneumonia [0, 3, 6, 12 months after COVID-19 pneumonia]
Total lung capacity will be measured using body plethysmography method according to ATS/ERS 2005 gudelines, results will be reported as % of predicted using most recent references
- 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 [0, 3, 6, 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
- Change in prevalence of obstructive ventilatory impairment at 3, 6 and 12 months after COVID-19 pneumonia [0, 3, 6, 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
- Change in prevalence of restrictive ventilatory impairment at 3, 6 and 12 months after COVID-19 pneumonia [0, 3, 6, 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
- Change in lung structure from the baseline [3, 6, 12 months]
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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Institute for Tuberculosis and Lung Diseases | Warsaw | Mazowieckie | Poland | 01-138 |
Sponsors and Collaborators
- National Institute for Tuberculosis and Lung Diseases, Poland
- Medical University of Warsaw
Investigators
- Principal Investigator: Piotr W Boros, MD, PhD, National TB & Lung Diseases Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IGICHP/7.52