COVID-19: Respiratory and Sleep Follow-up
关键词
抽象
描述
Europe and in particular Italy, Spain and France are currently affected by the coronavirus 2019-nCoV pandemic, whose immediate prognosis is linked to the development of acute respiratory distress syndrome (ARDS). Beyond the long-term adverse effects on respiratory health and reduced exercise capacity, other complications will occur. These include a more rapid progression of cardiometabolic diseases, a secondary epidemic of disabling post-traumatic stress disorder, and severe sleep disorders. The current project aims at a multidisciplinary assessment of respiratory, cardiac, sleep and mental health sequelae, three months after SARS-CoV-2 diagnosis in order to better characterize these complications.
Three aspects will be targeted in this study : (i) long-term monitoring of deterioration in lung function, (ii) screening for sleep respiratory disorders (sleep apnea syndrome, obesity hypoventilation syndrome) and iii) characterization of sleep disorders and design of specialized intervention to improve sleep quality.
This study is a prospective, multicentric cohort study that aims at constituting a cohort of 400 patients who will be screened for pulmonary, cardiac, sleep, or psychological sequelae 3 months after their diagnosis. They will be then followed for 5 years. The primary outcome will be the diffusion capacity of carbon monoxide (DLCO) 3 months after the diagnosis. Other secondary outcomes will include:
- prevalence of sleep disorders and sleep disordered breathing 3 months after diagnosis and their evolution until 5 years;
- prevalence of cardiac, exercise capacity, respiratory and ventilatory muscles impairments at 3 months and their evolution until 5 years;
- characterization of homogeneous groups of patients who were infected with SARS-CoV-2 and have respiratory, cardiometabolic and/or sleep complications, 3 months after diagnosis (latent class analysis) and evaluate their evolution until 5 years
- determine the prevalence of radiological sequelae at 3 months, and their evolution until 5 years
- determine the psycho-social impact (quality of life, post-traumatic stress, anxiety, productivity at work) at 3 months and its evolution until 5 years
日期
| 最后验证: | 05/31/2020 |
| 首次提交: | 05/12/2020 |
| 提交的预估入学人数: | 05/26/2020 |
| 首次发布: | 05/27/2020 |
| 上次提交的更新: | 06/28/2020 |
| 最近更新发布: | 06/29/2020 |
| 实际学习开始日期: | 05/31/2020 |
| 预计主要完成日期: | 03/04/2021 |
| 预计完成日期: | 03/04/2026 |
状况或疾病
干预/治疗
Other: SARS-CoV-2 patients
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| SARS-CoV-2 patients Patients infected by SARS-CoV-2 | Other: SARS-CoV-2 patients No Intervention. The study consists in a prospective clinical longitudinal follow-up |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 取样方式 | Non-Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Male or Female, aged > 18 years - With a positive diagnosis for SARS-COVID-19, confirmed by RT-PCR or with compatible symptoms - Signed informed consent by patient - Affiliated to a French social and health insurance system or equivalent - For biological collection: patient eligible for sampling (weight >50kg and hemoglobin >7g/dL) and signed inform consent for collection Exclusion Criteria: - Pregnant or breastfeeding women - Prisoners or patients who require protection by the law - Patients not affiliated to a French social and health insurance system or equivalent - Ages <18 years - Diagnosis of infection by other pathogen than SARS-COVID-19 or no indication of infection by COVID-19 |
结果
主要结果指标
1. Diffusion Capacity for Carbon Monoxide (CO) 3 months after COVID diagnosis [3 months after COVID diagnosis]
次要成果指标
1. Prevalence of Sleep Disordered Breathing (SDB) 3 months after COVID diagnosis [3 months after COVID diagnosis]
2. Prevalence of sleep disorders 3 months after COVID diagnosis [3 months after COVID diagnosis]
3. Prevalence of ventilatory muscle function impairments, 3 months after COVID diagnosis [3 months after COVID diagnosis]
4. Prevalence of cardiac impairments 3 months after COVID diagnosis [3 months after COVID diagnosis]
5. Follow-up of pulmonary diffusion capacity of carbon monoxide [From Baseline (3 months after COVID diagnosis) to 5 years]
6. Follow-up of sleep disorders treatment compliance [From Baseline (3 months after COVID diagnosis) to 5 years]
7. Follow-up of sleep disorders treatments efficacy [From Baseline (3 months after COVID diagnosis) to 5 years]
8. HLA alleles aspect of COVID clinical presentation [3 months after COVID diagnosis]
9. KIR loci aspect of COVID clinical presentation [3 months after COVID diagnosis]
10. metabolomic aspect of COVID clinical presentation [3 months after COVID diagnosis]
