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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
Sponsor:
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
Change History
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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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
Responsible Party University Hospital, Grenoble
Study Sponsor University Hospital, Grenoble
Collaborators Not Provided
Investigators
Principal Investigator: Renaud Tamisier, MD, PhD, MBA University Hospital Grenoble Aples
PRS Account University Hospital, Grenoble
Verification Date June 2020