Post-Covid SyndromeSyPoCoNCT05805566
Retrospective and Prospective Cohort of Patients Entering the Multidisciplinary Management of Post-Covid Syndromes
An observational study of Post-Covid Syndrome, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
SARS-CoV2 pneumonia has been a global public health emergency since 2020. The prevalence of the disease is particularly high with more than 500 million cases worldwide (7.5 million in France) since the emergence of the virus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Covid Syndrome
- What is being tested?
- Blood collection
- How many people
- 750 participants
- Where
- 1 siteFrance
- Study dates
- 27 Apr 2023to Apr 2029
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: This study will focus on adult patients with SARS COV2 whose symptoms persist beyond 4 weeks after the acute phase and who will have integrated the Epsilon care system in the pneumology department of Lyon Sud Hospital. It is difficult to define an exact number of subjects because this syndrome is still poorly characterized.
Who may be able to join
- All patients who have joined the Epsilon care pathway since its opening in February 2022, i.e.:
- Patients with post-Covid syndrome referred to the Epsilon sector from the city medicine:
- Patient with documented SARS-Cov2 pneumonia
- With persistent and severe symptoms beyond 4 weeks or complex or disabling symptoms beyond 3 months
- Patient over 18 years old.
- Post-hospital sector:
Show all 11Show fewer
- Patient with documented SARS-Cov2 pneumonia
- Hospitalized for oxygen therapy (at least 48h)
- Not having a referring pulmonologist
- Not institutionalized
- With a life expectancy of more than 6 months.
Who cannot join
- Patient refusing that this data to be used for research purposes (objection form).
- Patient with untreated comorbidities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Department of Acute Pneumology and Thoracic Oncology, Hôpital Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, 69495
Sébastien COURAUD, Pr, Sebastien.couraud@chu-lyon.fr
About this study
Official title: Post-Covid Syndrome Cohort
SARS-CoV2 pneumonia has been a global public health emergency since 2020. The prevalence of the disease is particularly high with more than 500 million cases worldwide (7.5 million in France) since the emergence of the virus.
A substantial proportion of patients with SARS-Cov2 infection present persistent symptoms long after the acute infection. This is independent of the degree of severity of the SARS-Cov2 infection.
Read more
These symptoms can affect the quality of life and impede the return to work. While the majority of symptoms progress favourably with outpatient care, some persist and/or are particularly severe, justifying expert and multidisciplinary care.
This investigation aim to create a clinical database of patients with complex and/or severe post-CoviD and study blood markers what could predict the disease and orientate new ways of treatment.
- Conditions
- Post-Covid Syndrome
- Being tested
- Blood collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionOther
Blood samples will be collected from the patient at baseline. This blood will be collected during the standard of care blood drawing in extra.
| Study group | Role | What they receive |
|---|---|---|
| Post-Covid Syndrome Patients | Not described Receives: Other: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Create a patient cohort
Creation of a retrospective and prospective cohort combining:
- Collection of clinical and paraclinical data, scores, and scales.
- Prospective monitoring of quality of life, other scores as needed. Cross-referencing of clinical data with the results of cellular and molecular analyzes on lymphocytes blood cells, which will be carried out (part carried out by Inserm). by INSERM U1111 as part of the European HERVCOV project.
Measured: Once a year
Secondary outcomes (2)
Identify new research pathway to improve Post-Covid syndrome knowledge
Description of biological data and clinical and paraclinical data to determine the duration of the syndrome, refine the diagnosis and optimize future management.
Measured: 12 month
Biological analyses to find new molecular targets (biomarkers)
Biological analyzes of blood constituents for the detection of molecular and/or cellular modifications, which could be at the origin of the symptoms (Carried out by Inserm).
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start27 Apr 2023
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Covid SyndromeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Enrolment
- 750 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien COURAUD, Pr, Principal investigator, Department of Acute Pneumology and Thoracic Oncology, Hôpital Lyon Sud, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805566
- Sponsor's protocol ID
- 69HCL22_1053
- Acronym
- SyPoCo
- Status last verified
- Feb 2024
- First submitted
- 7 Apr 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Covid Syndrome Cohort
- ClinicalTrials.gov ID
- NCT05805566
- Acronym / sponsor ID
- SyPoCo / 69HCL22_1053
- Conditions
- Post-Covid Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 10 Apr 2023 (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.
SARS-CoV2 pneumonia has been a global public health emergency since 2020. The prevalence of the disease is particularly high with more than 500 million cases worldwide (7.5 million in France) since the emergence of the virus.
A substantial proportion of patients with SARS-Cov2 infection present persistent symptoms long after the acute infection. This is independent of the degree of severity of the SARS-Cov2 infection.
These symptoms can affect the quality of life and impede the return to work. While the majority of symptoms progress favourably with outpatient care, some persist and/or are particularly severe, justifying expert and multidisciplinary care.
This investigation aim to create a clinical database of patients with complex and/or severe post-CoviD and study blood markers what could predict the disease and orientate new ways of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-Covid Syndrome Patients | – | Other: Blood collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will focus on adult patients with SARS COV2 whose symptoms persist beyond 4 weeks after the acute phase and who will have integrated the Epsilon care system in the pneumology department of Lyon Sud Hospital. It is difficult to define an exact number of subjects because this syndrome is still poorly characterized.
Key inclusion criteria (11 listed)
- All patients who have joined the Epsilon care pathway since its opening in February 2022, i.e.:
- Patients with post-Covid syndrome referred to the Epsilon sector from the city medicine:
- Patient with documented SARS-Cov2 pneumonia
- With persistent and severe symptoms beyond 4 weeks or complex or disabling symptoms beyond 3 months
- Patient over 18 years old.
Key exclusion criteria (2 listed)
- Patient refusing that this data to be used for research purposes (objection form).
- Patient with untreated comorbidities
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 |
|---|---|---|
| Blood collectionBlood samples will be collected from the patient at baseline. This blood will be collected during the standard of care blood drawing in extra. | Other | Post-Covid Syndrome Patients |
Primary outcome
Create a patient cohort
Time frame: Once a year
Creation of a retrospective and prospective cohort combining: * Collection of clinical and paraclinical data, scores, and scales. * Prospective monitoring of quality of life, other scores as needed. Cross-referencing of clinical data with the results of cellular and molecular analyzes on lymphocytes blood cells, which will be carried out (part carried out by Inserm). by INSERM U1111 as part of the European HERVCOV project.
2 secondary outcomes
Identify new research pathway to improve Post-Covid syndrome knowledge
Time frame: 12 month
Biological analyses to find new molecular targets (biomarkers)
Time frame: 12 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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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.
Sébastien COURAUD, Pr principal investigator
Department of Acute Pneumology and Thoracic Oncology, Hôpital Lyon Sud, Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Covid Syndrome, run by Hospices Civils de Lyon at 1 site 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 11 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sébastien COURAUD, Pr (+33 (0)4 78 86 44 01, Sebastien.couraud@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Create a patient cohort (time frame: Once a year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.