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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04916834
• Other study ID #: IGICHP/7.52
• Status: Active, not recruiting
• Start date: August 30, 2020
• Est. completion date: November 30, 2024

Study information

• Verified date: February 2023
• Source: National Institute for Tuberculosis and Lung Diseases, Poland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prospective study in a group of patients with COVID-19 pneumonia.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Confirmed SARS-CoV-2 infection with pneumonia hospitalized

2. 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:

1. Lack of patient consent,

2. Present contraindications for lung function tests

3. Inability to perform correctly lung function measurements

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Pneumonia
• Pneumonia, Viral
• Pulmonary Function
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Locations

Country	Name	City	State
Poland	National Institute for Tuberculosis and Lung Diseases	Warsaw	Mazowieckie

Sponsors (2)

Lead Sponsor	Collaborator
National Institute for Tuberculosis and Lung Diseases, Poland	Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

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