An observational study in Covid19, SARS-CoV Infection and Pulmonary Function, sponsored by National Institute for Tuberculosis and Lung Diseases, Poland. Status unknown at 1 site in Poland. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-02-23.
Sponsored by National Institute for Tuberculosis and Lung Diseases, Poland · Observational
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.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's planned enrollment of 100 is below the median of 268 across 3,208 observational studies indexed under COVID-19.
Browse COVID-19 studies →National Institute for Tuberculosis and Lung Diseases, Poland is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive patients dicharged after confirmed COVID-19 pneumonia (positive PCR and lung involvement in HRCT, hospitalized)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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National Institute for Tuberculosis and Lung Diseases, Poland