COVID-19: Respiratory and Sleep Follow-up

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

395 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-06

Study Completion Date

2026-06-01

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.

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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

Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SARS-CoV-2 patients

Patients infected by SARS-CoV-2

No intervention

Intervention Type OTHER

No Intervention. The study consists in a prospective clinical longitudinal follow-up

Interventions

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No intervention

No Intervention. The study consists in a prospective clinical longitudinal follow-up

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No