COVID-19
Conditions
Keywords
COVID-19, Pulmonary function, Sleep disorders, Post-traumatic stress, Cardiac function, Sleep Apnea
Brief summary
The current project is a prospective, multicentric cohort study aiming at a multidisciplinary assessment (pulmonary, cardiometabolic, sleep and mental health) of the consequences of infection by SARS-CoV-2, 3 months after the diagnosis in order to better characterize these complications. 400 patients with a positive diagnosis of SARS-CoV-2 will be included in the study 3 months after their diagnosis: They will be followed at 6 months, 1 year, 3 years, and 5 years, as function of their after-effects discovered at 3 months and their evolution.
Detailed description
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
Interventions
OTHERNo intervention
No Intervention. The study consists in a prospective clinical longitudinal follow-up
Sponsors
University Hospital, Grenoble
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diffusion Capacity for Carbon Monoxide (CO) 3 months after COVID diagnosis | 3 months after COVID diagnosis | Pulmonary function 3 months after COVID diagnosis, as measured by diffusion capacity of carbon monoxide (DLCO) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of sleep disorders 3 months after COVID diagnosis | 3 months after COVID diagnosis | Prevalence of sleep disorders, as measured by polysomnography |
| Prevalence of ventilatory muscle function impairments, 3 months after COVID diagnosis | 3 months after COVID diagnosis | Prevalence of ventilatory impairments measured by pulmonary function tests |
| Prevalence of cardiac impairments 3 months after COVID diagnosis | 3 months after COVID diagnosis | Prevalence of cardiac impairments measured by cardiac echography |
| Follow-up of pulmonary diffusion capacity of carbon monoxide | From Baseline (3 months after COVID diagnosis) to 5 years | Pulmonary function as measured by diffusion capacity of carbon monoxide (DLCO) |
| Prevalence of Sleep Disordered Breathing (SDB) 3 months after COVID diagnosis | 3 months after COVID diagnosis | Prevalence of Sleep Disordered Breathing, as measured by polysomnography |
| Follow-up of sleep disorders treatments efficacy | From Baseline (3 months after COVID diagnosis) to 5 years | Assessment of SDB treatments efficacy will be based on the residual AHI index (Apnea Hypopnea/hour) under treatment |
| HLA alleles aspect of COVID clinical presentation | 3 months after COVID diagnosis | HLA alleles will be assessed as a component of genetic immune capacity |
| KIR loci aspect of COVID clinical presentation | 3 months after COVID diagnosis | KIR loci will be assessed as a different component of genetic immune capacity |
| metabolomic aspect of COVID clinical presentation | 3 months after COVID diagnosis | metabolome expression in sera |
| Follow-up of sleep disorders treatment compliance | From Baseline (3 months after COVID diagnosis) to 5 years | Assessment of SDB treatments adherence will be monitored in hours/night |
Countries
France
Outcome results
None listed