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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Pneumonia, Viral; Covid19; SARS-CoV Infection; Pulmonary Function

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Poland
  • Mazowieckie
    • Warsaw, Mazowieckie, Poland, 01-138
      • National Institute for Tuberculosis and Lung Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients dicharged after confirmed COVID-19 pneumonia (positive PCR and lung involvement in HRCT, hospitalized)

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Institute for Tuberculosis and Lung Diseases, Poland
• Collaborators: Medical University of Warsaw
• Investigators: Principal Investigator: Piotr W Boros, MD, PhD, National TB & Lung Diseases Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2020
• Primary Completion (Anticipated): November 30, 2023
• Study Completion (Anticipated): November 30, 2024

Study Registration Dates

• First Submitted: November 9, 2020
• First Submitted That Met QC Criteria: June 7, 2021
• First Posted (Actual): June 8, 2021

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Severe Acute Respiratory Syndrome; COVID-19; Pneumonia; Pneumonia, Viral
• Other Study ID Numbers: IGICHP/7.52

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No