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.
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
+33 476 768 469
rtamisier@chu-grenoble.fr
Renaud Tamisier, MD, PhD, MBA, Principal Investigator
University Hospital Grenoble Aples