Clinical trial NCT04916834: Impact of Severe Acute Respiratory Syndrome (SARS-CoV-2/COVID-19) Related Pneumonia on Lung Function and Structure.
Official title: Impact of SARS-CoV-2/COVID-19 Related Pneumonia on Lung Function and Structure - Prospective Case Control Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
SARS-CoV Infection
Pulmonary Function
Pneumonia, Viral
Lead sponsor: National Institute for Tuberculosis and Lung Diseases, Poland
Sponsor class: OTHER
Collaborators: name: Medical University of Warsaw
First posted: 2021-06-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients dicharged after confirmed COVID-19 pneumonia (positive PCR and lung involvement in HRCT, hospitalized)

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in lung transfer factor for carbon monoxide (TL,CO) at 3, 6 and 12 months after COVID-19 pneumonia
timeFrame: 0, 3, 6, 12 months after COVID-19 pneumonia
measure: Change from baseline in lung transfer factor for carbon monoxide (TL,CO) at 3, 6 and 12 months after COVID-19 pneumonia
timeFrame: 0, 3, 6, 12 months after COVID-19 pneumonia
measure: Change from baseline in forced vital capacity (FVC) at 3, 6 and 12 months after COVID-19 pneumonia
timeFrame: 0, 3, 6, 12 months after COVID-19 pneumonia
measure: Change from baseline in forced vital capacity (FVC) at 3, 6 and 12 months after COVID-19 pneumonia
timeFrame: 0, 3, 6, 12 months after COVID-19 pneumonia
measure: Change from baseline in forced expiratory volume at 1 second (FEV1) at 3, 6 and 12 months after COVID-19 pneumonia
timeFrame: 0, 3, 6, 12 months after COVID-19 pneumonia
measure: Change from baseline in forced expiratory volume at 1 second (FEV1) at 3, 6 and 12 months after COVID-19 pneumonia
timeFrame: 0, 3, 6, 12 months after COVID-19 pneumonia
measure: Change from baseline in total lun capacity (TLC) at 3, 6 and 12 months after COVID-19 pneumonia
timeFrame: 0, 3, 6, 12 months after COVID-19 pneumonia
measure: Change from baseline in total lun capacity (TLC) at 3, 6 and 12 months after COVID-19 pneumonia
timeFrame: 0, 3, 6, 12 months after COVID-19 pneumonia
measure: 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
timeFrame: 0, 3, 6, 12 months after COVID-19 pneumonia
measure: Change in prevalence of obstructive ventilatory impairment at 3, 6 and 12 months after COVID-19 pneumonia
timeFrame: 0, 3, 6, 12 months after COVID-19 pneumonia
measure: Change in prevalence of restrictive ventilatory impairment at 3, 6 and 12 months after COVID-19 pneumonia
timeFrame: 0, 3, 6, 12 months after COVID-19 pneumonia
measure: Change in lung structure from the baseline
timeFrame: 3, 6, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: National Institute for Tuberculosis and Lung Diseases
state: Mazowieckie
Study officials:
affiliation: National TB & Lung Diseases Research Institute
name: Piotr W Boros, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: