COVID-19Co-SURVIVORSNCT04406324
COVID-19: Respiratory and Sleep Follow-up
An observational study of COVID-19, run by University Hospital, Grenoble at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 395 participants
- Where
- 4 sitesFrance
- Study dates
- 6 Jun 2020to 1 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients infected by SARS-CoV-2
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hôpital Avicenne
Bobigny, 93000
Centre Hospitalier Henri Mondor, APHP
Créteil, 94000
CHU Grenoble Alpes
Grenoble, 38043
CHRU Nancy
Nancy, 54000
About this study
Official title: 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.
Read the 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
- Conditions
- COVID-19
- Being tested
- No intervention
- Keywords
- COVID-19, Pulmonary function, Sleep disorders, Post-traumatic stress, Cardiac function, Sleep Apnea
- Medical subject headings
- COVID-19, Sleep Wake Disorders, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No Intervention. The study consists in a prospective clinical longitudinal follow-up
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV-2 patients | Patients infected by SARS-CoV-2 Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months after COVID diagnosis
Secondary outcomes (10)
Prevalence of Sleep Disordered Breathing (SDB) 3 months after COVID diagnosis
Prevalence of Sleep Disordered Breathing, as measured by polysomnography
Measured: 3 months after COVID diagnosis
Prevalence of sleep disorders 3 months after COVID diagnosis
Prevalence of sleep disorders, as measured by polysomnography
Measured: 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
Measured: 3 months after COVID diagnosis
Prevalence of cardiac impairments 3 months after COVID diagnosis
Prevalence of cardiac impairments measured by cardiac echography
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 months after COVID diagnosis
metabolomic aspect of COVID clinical presentation
metabolome expression in sera
Measured: 3 months after COVID diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start6 Jun 2020
- Primary completion7 Mar 2022
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 395 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renaud Tamisier, MD, PhD, MBA, Principal investigator, University Hospital Grenoble Aples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406324
- Sponsor's protocol ID
- 38RC20.157
- Acronym
- Co-SURVIVORS
- Status last verified
- Jul 2024
- First submitted
- 13 May 2020
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 32031570Hui 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.
PubMed 15860716Burnham 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.
PubMed 23263616Herridge 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.
PubMed 27025938Luyt 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.
PubMed 22948576Cohen JG, Estopier-Castillo V, Olivier C, Destors M, Ferretti GR, Pepin JL, Tamisier R, Bayat S. Imaging biomarkers of post-COVID dyspnea: insights from machine learning CT patterns and parametric response mapping. Respir Res. 2026 Mar 23;27(1):193. doi: 10.1186/s12931-026-03614-5.
PubMed 41872922
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19: Prospective Follow-up of Pulmonary Function, Sleep Disorders, Quality of Life and Post-traumatic Stress
- ClinicalTrials.gov ID
- NCT04406324
- Acronym / sponsor ID
- Co-SURVIVORS / 38RC20.157
- Conditions
- COVID-19
- Keywords
- COVID-19, Pulmonary function, Sleep disorders, Post-traumatic stress, Cardiac function, Sleep Apnea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 395 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 6 Jun 2020 (actual)
- Primary completion
- 7 Mar 2022 (actual)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 patients | – | Other: No interventionPatients infected by SARS-CoV-2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients infected by SARS-CoV-2
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo Intervention. The study consists in a prospective clinical longitudinal follow-up | Other | SARS-CoV-2 patients |
Primary outcome
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)
10 secondary outcomes
Prevalence of Sleep Disordered Breathing (SDB) 3 months after COVID diagnosis
Time frame: 3 months after COVID diagnosis
Prevalence of sleep disorders 3 months after COVID diagnosis
Time frame: 3 months after COVID diagnosis
Prevalence of ventilatory muscle function impairments, 3 months after COVID diagnosis
Time frame: 3 months after COVID diagnosis
Prevalence of cardiac impairments 3 months after COVID diagnosis
Time frame: 3 months after COVID diagnosis
Follow-up of pulmonary diffusion capacity of carbon monoxide
Time frame: From Baseline (3 months after COVID diagnosis) to 5 years
Follow-up of sleep disorders treatment compliance
Time frame: From Baseline (3 months after COVID diagnosis) to 5 years
Follow-up of sleep disorders treatments efficacy
Time frame: From Baseline (3 months after COVID diagnosis) to 5 years
HLA alleles aspect of COVID clinical presentation
Time frame: 3 months after COVID diagnosis
KIR loci aspect of COVID clinical presentation
Time frame: 3 months after COVID diagnosis
metabolomic aspect of COVID clinical presentation
Time frame: 3 months after COVID diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Background: PubMed 32031570Wang 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.
- Background: PubMed 15860716Hui 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.
- Background: PubMed 23263616Burnham 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.
- Background: PubMed 27025938Herridge 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.
- Background: PubMed 22948576Luyt 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.
- Derived from this study: PubMed 41872922Cohen JG, Estopier-Castillo V, Olivier C, Destors M, Ferretti GR, Pepin JL, Tamisier R, Bayat S. Imaging biomarkers of post-COVID dyspnea: insights from machine learning CT patterns and parametric response mapping. Respir Res. 2026 Mar 23;27(1):193. doi: 10.1186/s12931-026-03614-5.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renaud Tamisier, MD, PhD, MBA principal investigator
University Hospital Grenoble Aples
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by University Hospital, Grenoble at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diffusion Capacity for Carbon Monoxide (CO) 3 months after COVID diagnosis (time frame: 3 months after COVID diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04406324, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.