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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SARS-CoV-2 patients | Patients infected by SARS-CoV-2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No Intervention. The study consists in a prospective clinical longitudinal follow-up |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients infected by SARS-CoV-2
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| Name | Affiliation | Role |
|---|---|---|
| Renaud Tamisier, MD, PhD, MBA | University Hospital Grenoble Aples | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Avicenne | Bobigny | 93000 | France | |||
| Centre Hospitalier Henri Mondor, APHP |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32031570 | Background | Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. | |
| 15860716 | Background |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D012893 | Sleep Wake Disorders |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Blood, Urine
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 |
| Créteil |
| 94000 |
| France |
| CHU Grenoble Alpes | Grenoble | 38043 | France |
| CHRU Nancy | Nancy | 54000 | France |
| Hui DS, Joynt GM, Wong KT, Gomersall CD, Li TS, Antonio G, Ko FW, Chan MC, Chan DP, Tong MW, Rainer TH, Ahuja AT, Cockram CS, Sung JJ. Impact of severe acute respiratory syndrome (SARS) on pulmonary function, functional capacity and quality of life in a cohort of survivors. Thorax. 2005 May;60(5):401-9. doi: 10.1136/thx.2004.030205. |
| 23263616 | Background | Burnham EL, Hyzy RC, Paine R 3rd, Coley C 2nd, Kelly AM, Quint LE, Lynch D, Janssen WJ, Moss M, Standiford TJ. Chest CT features are associated with poorer quality of life in acute lung injury survivors. Crit Care Med. 2013 Feb;41(2):445-56. doi: 10.1097/CCM.0b013e31826a5062. |
| 27025938 | Background | Herridge MS, Moss M, Hough CL, Hopkins RO, Rice TW, Bienvenu OJ, Azoulay E. Recovery and outcomes after the acute respiratory distress syndrome (ARDS) in patients and their family caregivers. Intensive Care Med. 2016 May;42(5):725-738. doi: 10.1007/s00134-016-4321-8. Epub 2016 Mar 30. |
| 22948576 | Background | Luyt CE, Combes A, Becquemin MH, Beigelman-Aubry C, Hatem S, Brun AL, Zraik N, Carrat F, Grenier PA, Richard JM, Mercat A, Brochard L, Brun-Buisson C, Chastre J; REVA Study Group. Long-term outcomes of pandemic 2009 influenza A(H1N1)-associated severe ARDS. Chest. 2012 Sep;142(3):583-592. doi: 10.1378/chest.11-2196. |
| 41872922 | Derived | Cohen JG, Estopier-Castillo V, Olivier C, Destors M, Ferretti GR, Pepin JL, Tamisier R, Bayat S. Imaging biomarkers of post-COVID dyspnea: insights from machine learning CT patterns and parametric response mapping. Respir Res. 2026 Mar 23;27(1):193. doi: 10.1186/s12931-026-03614-5. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |