Impact of COVID-19 on Lung Function in COPD Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Forced Expiratory Volume in the first second (FEV1)
研究概览
简要总结
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.
详细描述
BACKGROUND Million people have suffered COVID-19 in Spain, being the respiratory system the most affected in many patients. Some studies, with short follow-up periods, have reported an impairment of respiratory function after pneumonia due to COVID-19.
COPD patients are considered a risk group for SARS-CoV-2 infection and poor prognosis in case of COVID-19; furthermore, in them respiratory function is usually already impaired.
It is in this context that a study of the evolution of the lung function of COPD patients who have overcome COVID-19 is proposed. It is hypothesized that COVID-19 accelerates the deterioration of lung function in patients with COPD.
AIMS
General:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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,
- •Last valid spirometry after January 1,
- •Availability and acceptance of the follow-up proposed in the study.
排除标准
- •- 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
结局指标
主要结局
Forced Expiratory Volume in the first second (FEV1)
时间窗: Baseline and 12 months
This parameter shall be determined by spirometry after bronchodilator administration, and shall allow measurement of the degree of airway obstruction
次要结局
未报告次要终点