COVID-19: Respiratory and Sleep Follow-up

COVID-19 Clinical Trial

— Co-SURVIVORS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04406324
• Other study ID #: 38RC20.157
• Status: Recruiting
• Start date: June 1, 2020
• Est. completion date: March 5, 2026

Study information

• Verified date: June 2020
• Source: University Hospital, Grenoble
• Contact: Renaud Tamisier, MD, PhD, MBA
• Phone: +33 476 768 469
• Email: rtamisier[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: March 5, 2026
• Est. primary completion date: March 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Sleep Wake Disorders

Intervention

Other:
• No intervention
No Intervention. The study consists in a prospective clinical longitudinal follow-up

Locations

Country	Name	City	State
France	Hôpital Avicenne	Bobigny
France	Centre Hospitalier Henri Mondor, APHP	Créteil
France	CHU Grenoble Alpes	Grenoble
France	CHRU Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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 Feb 7. doi: 10.1001/jama.2020.1585. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Prevalence of sleep disorders 3 months after COVID diagnosis	Prevalence of sleep disorders, as measured by polysomnography	3 months after COVID diagnosis
Secondary	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
Secondary	Prevalence of cardiac impairments 3 months after COVID diagnosis	Prevalence of cardiac impairments measured by cardiac echography	3 months after COVID diagnosis
Secondary	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
Secondary	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
Secondary	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
Secondary	HLA alleles aspect of COVID clinical presentation	HLA alleles will be assessed as a component of genetic immune capacity	3 months after COVID diagnosis
Secondary	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
Secondary	metabolomic aspect of COVID clinical presentation	metabolome expression in sera	3 months after COVID diagnosis