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

• ClinicalTrials.gov Identifier: NCT04406324
• Recruitment Status: Recruiting
• First Posted: May 28, 2020
• Last Update Posted: June 30, 2020
• Sponsor: University Hospital, Grenoble
• Information provided by (Responsible Party): University Hospital, Grenoble

Tracking Information

• First Submitted Date: May 13, 2020
• First Posted Date: May 28, 2020
• Last Update Posted Date: June 30, 2020
• Actual Study Start Date: June 1, 2020
• Estimated Primary Completion Date: March 5, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 27, 2020)

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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 27, 2020)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: COVID-19: Respiratory and Sleep Follow-up
• Official Title: COVID-19: Prospective Follow-up of Pulmonary Function, Sleep Disorders, Quality of Life and Post-traumatic Stress
• 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.

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
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Blood, Urine

• Sampling Method: Non-Probability Sample
• Study Population: Patients infected by SARS-CoV-2
• Condition: COVID-19

Intervention

Other: No intervention

No Intervention. The study consists in a prospective clinical longitudinal follow-up

Study Groups/Cohorts

SARS-CoV-2 patients

Patients infected by SARS-CoV-2

Intervention: Other: No intervention

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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 27, 2020): 400
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 5, 2026
• Estimated Primary Completion Date: March 5, 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: France

Administrative Information

• NCT Number: NCT04406324
• Other Study ID Numbers: 38RC20.157
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: University Hospital, Grenoble
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital, Grenoble
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: University Hospital, Grenoble
• Verification Date: June 2020