Impact of COVID-19 on Lung Function in COPD Patients

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Background: In 2019, a novel coronavirus (SARS-COV2) was detected in Wuhan, China as a cause of acute respiratory distress syndrome (COVID-19). Other previous coronaviruses (SARS and MERS) have caused respiratory sequelae (pulmonary fibrosis) demonstrable by tomography and lung function tests. These alterations have begun to be detected in patients who have survived COVID-19. Hypotheses: SARS-COV2 infection accelerates the deterioration of lung function in patients with Chronic Obstructive Pulmonary Disease (COPD).

Objectives: To analyze the evolution of lung function in COPD patients diagnosed with COVID-19, while comparing it with COPD patients without COVID-19 disease. Methodology: Cohort study. The COPD-COVID-19 cohort will consist of the COPD population with and without COVID-19. Previous pulmonary function data will be collected and 2 prospective visits (baseline and follow-up) with clinical assessments and functional tests will be performed. In the event that the participant suffers from COVID-19 during the follow-up, an additional visit will be performed 3 months after the diagnosis, and the final visit will take place 12 months after this additional visit. Determinations: Study factor: diagnosis of COVID-19. Response variable: change in the forced expiratory volume in the first second (FEV1) measured at the start of the study and after 1 year of this first assessment, considering also the basal FEV1 (before March 2020). Other variables: socio-demographic, clinical, functional and treatment. Expected results: Greater decrease in FEV1 in COPD patients with COVID-19, Applicability and Relevance: The proactive detection of functional sequelae will allow early treatment, including pulmonary rehabilitation, with the aim of improving the quality of life of these patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• \- Patients over 18 years of age with a diagnosis of COPD (register code J44.9 according to the 10th edition of the International Classification of Diseases, ICD-10).

• Fulfilling spirometric diagnostic criteria prior to January 1, 2020.

• Last valid spirometry after January 1, 2017.

• Availability and acceptance of the follow-up proposed in the study.

Locations
Other Locations
Spain
Primary HealthCare Center of Falset
RECRUITING
Falset
Contact Information
Primary
Albert Del Pozo-Niubó, MD
adelpozo.tgn.ics@gencat.cat
0034 977831288
Backup
Eva M Satué-Gracia, MD PhD
esatue.tgn.ics@gencat.cat
0034 977778518
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 250
Treatments
Group 1
Patient with COPD and at least 1 SARS-Cov2 Infection
Group 2
Patient with COPD and no SARS-COV2 Infection
Sponsors
Leads: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

This content was sourced from clinicaltrials.gov