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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

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

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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

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




Primary Outcome Measures :
  1. 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 :
  1. 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

  2. Prevalence of sleep disorders 3 months after COVID diagnosis [ Time Frame: 3 months after COVID diagnosis ]
    Prevalence of sleep disorders, as measured by polysomnography

  3. 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

  4. Prevalence of cardiac impairments 3 months after COVID diagnosis [ Time Frame: 3 months after COVID diagnosis ]
    Prevalence of cardiac impairments measured by cardiac echography

  5. 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)

  6. 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

  7. 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

  8. 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

  9. 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

  10. metabolomic aspect of COVID clinical presentation [ Time Frame: 3 months after COVID diagnosis ]
    metabolome expression in sera


Biospecimen Retention:   Samples With DNA
Blood, Urine


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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

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
Publications:
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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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Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Mental Disorders