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

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

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Renaud Tamisier, MD, PhD, MBA; Phone Number: +33 476 768 469; Email: rtamisier@chu-grenoble.fr

Study Locations

• France
  • Bobigny, France, 93000
    • Recruiting
    • Hôpital Avicenne
    • Contact: Carole Planes, MD, Pr
  • Créteil, France, 94000
    • Recruiting
    • Centre Hospitalier Henri Mondor, APHP
    • Contact: Genevieve Derumeaux, MD, Pr
  • Grenoble, France, 38043
    • Recruiting
    • CHU Grenoble Alpes
    • Sub-Investigator: Marie DESTORS, MD
    • Contact: Renaud Tamisier, MD, Pr, PhD; Phone Number: (0033)476768469; Email: 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
  • Nancy, France, 54000
    • Not yet recruiting
    • CHRU Nancy
    • Contact: Bruno Chenuel, MD, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients infected by SARS-CoV-2

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

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

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Anticipated): March 5, 2021
• Study Completion (Anticipated): March 5, 2026

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 27, 2020
• First Posted (Actual): May 28, 2020

Study Record Updates

• Last Update Posted (Actual): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 29, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Sleep Apnea; COVID-19; Sleep disorders; Cardiac function; Pulmonary function; Post-traumatic stress
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 38RC20.157

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No