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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Tracking Information | |||||
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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 |
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)
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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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:
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples With DNA Description: Blood, Urine
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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
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Study Groups/Cohorts | SARS-CoV-2 patients
Patients infected by SARS-CoV-2
Intervention: Other: No intervention
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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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 |
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IPD Sharing Statement |
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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 |
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PRS Account | University Hospital, Grenoble | ||||
Verification Date | June 2020 |