NCT04916834

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2020

Completed
7 months until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

3.3 years

First QC Date

November 9, 2020

Last Update Submit

February 21, 2023

Conditions

Covid19SARS-CoV InfectionPulmonary FunctionPneumonia, Viral

Outcome Measures

Primary Outcomes (12)

  • 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

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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).

You may not qualify if:

  • Lack of patient consent,
  • Present contraindications for lung function tests
  • Inability to perform correctly lung function measurements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute for Tuberculosis and Lung Diseases

Warsaw, Masovian Voivodeship, 01-138, Poland

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood, serum

MeSH Terms

Conditions

COVID-19Severe Acute Respiratory SyndromePneumonia, Viral

Condition Hierarchy (Ancestors)

PneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Piotr W Boros, MD, PhD

    National TB & Lung Diseases Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2020

First Posted

June 8, 2021

Study Start

August 30, 2020

Primary Completion

November 30, 2023

Study Completion

November 30, 2024

Last Updated

February 23, 2023

Record last verified: 2023-02

Locations

PL(1)