COVID-19: Respiratory and Sleep Follow-up (Co-SURVIVORS)

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ClinicalTrials.gov Identifier: NCT04406324

Recruitment Status : Recruiting

First Posted : May 28, 2020

Last Update Posted : June 30, 2020

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Sponsor:

Information provided by (Responsible Party):

University Hospital, Grenoble

Study Description

Brief 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.

Condition or disease	Intervention/treatment
COVID-19	Other: No intervention

Detailed 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

Study Design

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Study Type :	Observational
Estimated Enrollment :	400 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	COVID-19: Prospective Follow-up of Pulmonary Function, Sleep Disorders, Quality of Life and Post-traumatic Stress
Actual Study Start Date :	June 1, 2020
Estimated Primary Completion Date :	March 5, 2021
Estimated Study Completion Date :	March 5, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COVID-19 (Coronavirus Disease 2019)

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
SARS-CoV-2 patients Patients infected by SARS-CoV-2	Other: No intervention No Intervention. The study consists in a prospective clinical longitudinal follow-up

Outcome Measures

Primary Outcome Measures :

Diffusion Capacity for Carbon Monoxide (CO) 3 months after COVID diagnosis [ Time Frame: 3 months after COVID diagnosis ]
Pulmonary function 3 months after COVID diagnosis, as measured by diffusion capacity of carbon monoxide (DLCO)

Secondary Outcome Measures :

Prevalence of Sleep Disordered Breathing (SDB) 3 months after COVID diagnosis [ Time Frame: 3 months after COVID diagnosis ]
Prevalence of Sleep Disordered Breathing, as measured by polysomnography
Prevalence of sleep disorders 3 months after COVID diagnosis [ Time Frame: 3 months after COVID diagnosis ]
Prevalence of sleep disorders, as measured by polysomnography
Prevalence of ventilatory muscle function impairments, 3 months after COVID diagnosis [ Time Frame: 3 months after COVID diagnosis ]
Prevalence of ventilatory impairments measured by pulmonary function tests
Prevalence of cardiac impairments 3 months after COVID diagnosis [ Time Frame: 3 months after COVID diagnosis ]
Prevalence of cardiac impairments measured by cardiac echography
Follow-up of pulmonary diffusion capacity of carbon monoxide [ Time Frame: From Baseline (3 months after COVID diagnosis) to 5 years ]
Pulmonary function as measured by diffusion capacity of carbon monoxide (DLCO)
Follow-up of sleep disorders treatment compliance [ Time Frame: From Baseline (3 months after COVID diagnosis) to 5 years ]
Assessment of SDB treatments adherence will be monitored in hours/night
Follow-up of sleep disorders treatments efficacy [ Time Frame: From Baseline (3 months after COVID diagnosis) to 5 years ]
Assessment of SDB treatments efficacy will be based on the residual AHI index (Apnea Hypopnea/hour) under treatment
HLA alleles aspect of COVID clinical presentation [ Time Frame: 3 months after COVID diagnosis ]
HLA alleles will be assessed as a component of genetic immune capacity
KIR loci aspect of COVID clinical presentation [ Time Frame: 3 months after COVID diagnosis ]
KIR loci will be assessed as a different component of genetic immune capacity
metabolomic aspect of COVID clinical presentation [ Time Frame: 3 months after COVID diagnosis ]
metabolome expression in sera

Biospecimen Retention: Samples With DNA

Blood, Urine

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients infected by SARS-CoV-2

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04406324

Contacts

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Contact: Renaud Tamisier, MD, PhD, MBA	+33 476 768 469	rtamisier@chu-grenoble.fr

Locations

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France
Hôpital Avicenne	Recruiting
Bobigny, France, 93000
Contact: Carole Planes, MD, Pr
Centre Hospitalier Henri Mondor, APHP	Recruiting
Créteil, France, 94000
Contact: Genevieve Derumeaux, MD, Pr
CHU Grenoble Alpes	Recruiting
Grenoble, France, 38043
Contact: Renaud Tamisier, MD, Pr, PhD (0033)476768469 rtamisier@chu-grenoble.fr
Sub-Investigator: Jean-Louis Pepin, MD, Pr, PhD
Sub-Investigator: Sam Bayat, MD, Pr, PhD
Sub-Investigator: Anne-Laure Mounayar, MD
Sub-Investigator: Nicolas Terzi, MD, Pr
Sub-Investigator: Marie Destors, MD
CHRU Nancy	Not yet recruiting
Nancy, France, 54000
Contact: Bruno Chenuel, MD, Pr

Sponsors and Collaborators

University Hospital, Grenoble

Investigators

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Principal Investigator:	Renaud Tamisier, MD, PhD, MBA	University Hospital Grenoble Aples

More Information

Publications:

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. Erratum In: JAMA. 2021 Mar 16;325(11):1113.

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.

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.

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.

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.

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Responsible Party:	University Hospital, Grenoble
ClinicalTrials.gov Identifier:	NCT04406324
Other Study ID Numbers:	38RC20.157
First Posted:	May 28, 2020 Key Record Dates
Last Update Posted:	June 30, 2020
Last Verified:	June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by University Hospital, Grenoble:


COVID-19 Pulmonary function Sleep disorders	Post-traumatic stress Cardiac function Sleep Apnea

Additional relevant MeSH terms:

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COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases	Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases

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