COVID-19: Respiratory and Sleep Follow-up

Study Overview
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Brief Summary
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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
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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

Official Title
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COVID-19: Prospective Follow-up of Pulmonary Function, Sleep Disorders, Quality of Life and Post-traumatic Stress

Conditions
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COVID-19

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SARS-CoV-2 patients<br>Patients infected by SARS-CoV-2 | Other: No intervention<br>* No Intervention. The study consists in a prospective clinical longitudinal follow-up<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diffusion Capacity for Carbon Monoxide (CO) 3 months after COVID diagnosis | Pulmonary function 3 months after COVID diagnosis, as measured by diffusion capacity of carbon monoxide (DLCO) | 3 months after COVID diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Sleep Disordered Breathing (SDB) 3 months after COVID diagnosis | Prevalence of Sleep Disordered Breathing, as measured by polysomnography | 3 months after COVID diagnosis | 
| Prevalence of sleep disorders 3 months after COVID diagnosis | Prevalence of sleep disorders, as measured by polysomnography | 3 months after COVID diagnosis | 
| Prevalence of ventilatory muscle function impairments, 3 months after COVID diagnosis | Prevalence of ventilatory impairments measured by pulmonary function tests | 3 months after COVID diagnosis | 
| Prevalence of cardiac impairments 3 months after COVID diagnosis | Prevalence of cardiac impairments measured by cardiac echography | 3 months after COVID diagnosis | 
| Follow-up of pulmonary diffusion capacity of carbon monoxide | Pulmonary function as measured by diffusion capacity of carbon monoxide (DLCO) | From Baseline (3 months after COVID diagnosis) to 5 years | 
| Follow-up of sleep disorders treatment compliance | Assessment of SDB treatments adherence will be monitored in hours/night | From Baseline (3 months after COVID diagnosis) to 5 years | 
| Follow-up of sleep disorders treatments efficacy | Assessment of SDB treatments efficacy will be based on the residual AHI index (Apnea Hypopnea/hour) under treatment | From Baseline (3 months after COVID diagnosis) to 5 years | 
| HLA alleles aspect of COVID clinical presentation | HLA alleles will be assessed as a component of genetic immune capacity | 3 months after COVID diagnosis | 
| KIR loci aspect of COVID clinical presentation | KIR loci will be assessed as a different component of genetic immune capacity | 3 months after COVID diagnosis | 
| metabolomic aspect of COVID clinical presentation | metabolome expression in sera | 3 months after COVID diagnosis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Pulmonary function, Sleep disorders, Post-traumatic stress, Cardiac function, Sleep Apnea