The current project is a prospective, multicentric cohort study aiming at amultidisciplinary assessment (pulmonary, cardiometabolic, sleep and mental health) of theconsequences of infection by SARS-CoV-2, 3 months after the diagnosis in order to bettercharacterize these complications. 400 patients with a positive diagnosis of SARS-CoV-2will be included in the study 3 months after their diagnosis: They will be followed at 6months, 1 year, 3 years, and 5 years, as function of their after-effects discovered at 3months and their evolution.
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
Other: No intervention
No Intervention. The study consists in a prospective clinical longitudinal follow-up
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
Hôpital Avicenne
Bobigny, France
Centre Hospitalier Henri Mondor, APHP
Créteil, France
CHU Grenoble Alpes
Grenoble, France
CHRU Nancy
Nancy, France
Renaud Tamisier, MD, PhD, MBA, Principal Investigator
University Hospital Grenoble Aples