Impact of COVID-19 on lung function in COPD patients
This study is testing how COVID-19 affects lung function in people with COPD by comparing those who had the virus to those who didn't.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina Academic / other |
| Locations | 1 site (Falset, Tarragona) |
| Trial ID | NCT05770440 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to analyze how COVID-19 affects lung function in patients with Chronic Obstructive Pulmonary Disease (COPD). It will compare the lung function evolution of COPD patients who have had COVID-19 with those who have not. Participants will undergo clinical assessments and functional tests at baseline and follow-up visits, with previous pulmonary function data also being collected. The study seeks to understand the potential acceleration of lung function deterioration due to COVID-19 in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with a confirmed diagnosis of COPD who have had spirometry tests conducted prior to January 1, 2020.
Not a fit: Patients who have experienced severe or critical COVID-19 or those without a valid spirometry record will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the long-term respiratory impacts of COVID-19 on COPD patients, potentially guiding future treatment and management strategies.
How similar studies have performed: While some studies have explored respiratory sequelae from COVID-19, this specific approach focusing on COPD patients is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * - 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. Exclusion Criteria: * - Lack of basal spirometry recorded in the Computerized Primary Care Clinical History (eCAP). * Spirometry results not compatible with COPD. * Having suffered severe and/or critical COVID: It will be considered in accordance with the NICE classification: * (1) Serious illness: Patients with clinical signs of pneumonia (fever, cough, dyspnea, rapid breathing) plus one of the following seriousness: a) respiratory frequency greater than 30 breaths per minute; b) severe respiratory distress or; c) SatO2 lower than 90% in ambient air. * (2) Critical illness: Includes patients with Acute Respiratory Distress Syndrome (ARDS) and/or patients with septic shock and/or multi-organ disease. * Any chronic or terminal condition that may make it difficult to carry out the necessary tests during the study period
Where this trial is running
Falset, Tarragona
- Primary HealthCare Center of Falset — Falset, Tarragona, Spain (Recruiting)
Study contacts
- Principal investigator: Albert Del Pozo-Niubó, MD — Institut Català de la Salut
- Study coordinator: Albert Del Pozo-Niubó, MD
- Email: adelpozo.tgn.ics@gencat.cat
- Phone: 0034 977831288
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.