Covid19NCT04916834
Impact of Severe Acute Respiratory Syndrome (SARS-CoV-2/COVID-19) Related Pneumonia on Lung Function and Structure.
An observational study of Covid19 and SARS-CoV Infection, run by National Institute for Tuberculosis and Lung Diseases, Poland at 1 site in Poland.
Trial summary
Prospective study in a group of patients with COVID-19 pneumonia. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Covid19, SARS-CoV Infection, Pulmonary Function
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 30 Aug 2020to 30 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients dicharged after confirmed COVID-19 pneumonia (positive PCR and lung involvement in HRCT, hospitalized)
Who may be able to join
- 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).
Who cannot join
- Lack of patient consent,
- Present contraindications for lung function tests
- Inability to perform correctly lung function measurements
Trial locations and contacts
1 site in 1 country.
Poland1 site
National Institute for Tuberculosis and Lung Diseases
Warsaw, Masovian Voivodeship, 01-138
About this study
Official title: 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.
Read the 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.
- Conditions
- Covid19, SARS-CoV Infection, Pulmonary Function, Pneumonia, Viral
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome, Pneumonia, Viral
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start30 Aug 2020
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute for Tuberculosis and Lung Diseases, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Warsaw
- Responsible party
- Sponsor
- Investigators
- Piotr W Boros, MD, PhD, Principal investigator, National TB & Lung Diseases Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916834
- Sponsor's protocol ID
- IGICHP/7.52
- Status last verified
- Feb 2023
- First submitted
- 9 Nov 2020
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of SARS-CoV-2/COVID-19 Related Pneumonia on Lung Function and Structure - Prospective Case Control Study
- ClinicalTrials.gov ID
- NCT04916834
- Acronym / sponsor ID
- IGICHP/7.52
- Conditions
- Covid19, SARS-CoV Infection, Pulmonary Function, Pneumonia, Viral
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Institute for Tuberculosis and Lung Diseases, PolandUniversity, hospital or other
- Collaborators
- Medical University of Warsaw
- Study start
- 30 Aug 2020 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective study in a group of patients with COVID-19 pneumonia.
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
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients dicharged after confirmed COVID-19 pneumonia (positive PCR and lung involvement in HRCT, hospitalized)
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (3 listed)
- Lack of patient consent,
- Present contraindications for lung function tests
- Inability to perform correctly lung function measurements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline in lung transfer factor for carbon monoxide (TL,CO) at 3, 6 and 12 months after COVID-19 pneumonia
Time frame: 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
Time frame: 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
Time frame: 0, 3, 6, 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)
Change from baseline in forced vital capacity (FVC) at 3, 6 and 12 months after COVID-19 pneumonia
Time frame: 0, 3, 6, 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
Change from baseline in forced expiratory volume at 1 second (FEV1) at 3, 6 and 12 months after COVID-19 pneumonia
Time frame: 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 guidelines, 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
Time frame: 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 guidelines, 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
Time frame: 0, 3, 6, 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)
Change from baseline in total lun capacity (TLC) at 3, 6 and 12 months after COVID-19 pneumonia
Time frame: 0, 3, 6, 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
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piotr W Boros, MD, PhD principal investigator
National TB & Lung Diseases Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and SARS-CoV Infection, run by National Institute for Tuberculosis and Lung Diseases, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in lung transfer factor for carbon monoxide (TL,CO) at 3, 6 and 12 months after COVID-19 pneumonia (time frame: 0, 3, 6, 12 months after COVID-19 pneumonia). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.