A Multicentric Prospective Study: Assessment of Pulmonary Long-term Sequelae of Coronavirus Disease 2019 (COVID-19) Pneumonia With Chest Computed Tomography and Pulmonary Function Tests
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Prevalence of structural lung sequelae after COVID-19 pneumonia
研究概览
简要总结
The goal of this prospective multicentric study is to evaluate the presence of long-term pulmonary sequelae in patients who had required hospitalization for treating COVID-19 pneumonia, trough chest CT and pulmonary function tests (PFT).
Secondly we would like to evaluate the possible correlation between the chest CT findings and pulmonary function tests pre-existing co-morbidities and type of therapy used during hospitalization.
详细描述
The investigators will invite to participate in this study patients who had been hospitalized with positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) , namely with positive reverse transcription polymerase chain reaction or positive rapid antigen test, and with respiratory insufficiency (at admission or developed during hospital stay), or with viral pneumonia documented with thorax x-ray or Chest CT, during the period between march 2020 and march 2022.
Patients who agree to participate and sign the informed consent will be enrolled in the study.
Participants will be evaluate in two different periods: approximately 4 to 6 months after hospital discharge and approximately 12 to 14 months after hospital discharge.
The first evaluation includes a physical examination at medical post-COVID-19 consultation, pulmonary function tests and reduced dose chest CT.
The second evaluation includes a physical examination at medical post-COVID-19 consultation, and will include reduced dose chest CT and pulmonary function tests only if there were significative findings on those exams on the first evaluation, or if there are any clinical significative findings at the present moment.
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
- •at least 18 years old of age;
- •positive SARS-CoV-2 reverse transcription-polymerase chain reaction on a nasopharyngeal and/or oropharyngeal swab or positive SARS-CoV-2 rapid antigen test
- •hospitalization in one of two hospitals of our institution (university center) in consequence of SARS-CoV-2 related disease between march of 2020 and march of 2022 and having :
- •respiratory insufficiency when admitted or developing after admission or image documented viral pneumonia ;
- •at least one thorax x-ray or lung CT acquired during the hospitalization period
排除标准
- •previous lung cancer
- •previous intersticial lung disease
结局指标
主要结局
Prevalence of structural lung sequelae after COVID-19 pneumonia
时间窗: 12 -14 months
evaluate the presence of lung structural sequelae with chest CT
Prevalence of functional lung impairment after COVID-19 pneumonia
时间窗: 12 -14 months
evaluate the presence of impaired PFT after COVID-19 pneumonia
Association between chest CT findings and PFT impairment after COVID-19 pneumonia
时间窗: 12-14 months
evaluate the possible correlation between the presence of pulmonary structural alterations on chest CT and the presence of impaired PFT
次要结局
- Association between chest CT findings after COVID-19 pneumonia and pre-existing co-morbidities(12 -14 months)
- Association between chest CT findings and PFT impairment after COVID-19 pneumonia(4-6 months)
- Prevalence of structural lung sequelae after COVID-19 pneumonia(4-6 months)
- Prevalence of functional lung impairment after COVID-19 pneumonia(4-6 months)
- Association between chest CT findings after COVID-19 pneumonia and therapy used during hospitalization(12-14 months)
研究者
Mónica Diniz, MD
Principal Investigator
Centro Hospitalar Universitario do Algarve