SARS-CoV2 InfectionCOVI-LIPI-DNCT05476224
Qualitative and Functional Investigation of Lipids in Patients With SARS-CoV2 Infection - In Search of Atherogenic Sequelae
An observational study of SARS-CoV2 Infection, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Currently, the world is facing a SARS-CoV2 coronavirus epidemic, which is responsible for COVID-19. In France, this virus has already infected several million people and is responsible for the death of more than 127,000. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV2 Infection
- What is being tested?
- Blood sample of 30 ml
- How many people
- 228 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jun 2022to 12 Apr 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: SARS-CoV2 infection
Who may be able to join
- Participants with a history of asymptomatic/mildly symptomatic SARS-CoV2 infection:
- Age ≥18 years
- Participant who has provided consent
- Participant affiliated to National health insurance
- Participant with asymptomatic or minimally symptomatic SARS CoV2 infection who did not require hospitalization at least 6 months prior to study inclusion.
- SARS CoV2 infection proven by positive PCR or antigenic test at the time of signs of infection or positive SARS-CoV2 infection-specific serology at the time of infection (IgG+).
Show all 24Show fewer
- Participants with a history of symptomatic SARS-CoV2 infection hospitalized at the Dijon University Hospital excluding the intensive care unit:
- Age ≥18 years
- Participant having provided consent
- Participant affiliated to National health insurance
- Participant having presented a symptomatic SARS CoV2 infection requiring admission to a regular hospital unit at least 6 months prior to inclusion in the study.
- SARS CoV2 infection proven by a positive PCR or antigenic test at the time of signs of infection or a positive SARS-CoV2 specific serology at the time of infection (IgG+).
- Participants with a history of symptomatic SARS-CoV2 infection hospitalized at Dijon University Hospital in the ICU:
- Age ≥18 years
- Participant who has provided consent
- Participant affiliated to National health insurance
- Participant with symptomatic SARS CoV2 infection requiring admission to an intensive care unit at least 6 months prior to study inclusion.
- SARS CoV2 infection proven by a positive PCR or antigenic test at the time of signs of infection or a positive SARS-CoV2 specific serology at the time of infection (IgG+).
- Participants with no history of SARS-CoV2 infection:
- Age≥18 years
- Participant who has provided consent
- Participant affiliated to National health insurance
- Participant with no evidence of SARS CoV2 infection and negative SARS-CoV2 serology.
- For vaccinated participants: negative specific serology for SARS-CoV2 infection
Who cannot join
- For all participants:
- SARS Cov2 vaccination within one month prior to inclusion.
- Previous SARS Cov1 infection documented
- Previous study participant
- Participant under legal protection (guardianship)
- Participant subject to a legal protection measure
Show all 28Show fewer
- A protected adult
- Pregnant, parturient or breastfeeding women
- Treatment with corticosteroids in the last year
- Treatment with lipid-lowering drugs
- Known genetic mutation modifying HDL cholesterol
- Progressive neoplasia
- Chronic alcoholism
- Primary biliary cirrhosis
- Hyperthyroidism
- Unstable hypothyroidism
- History of cardiac or cardiovascular side effects following SARS-CoV2 vaccination (thrombosis, myocarditis etc)
- For participants with a history of asymptomatic/mildly symptomatic SARS-CoV2 infection:
- Hospitalization with a prior SARS-CoV2 infection in a conventional or intensive care unit
- For participants with a history of symptomatic SARS-CoV2 infection hospitalized outside the ICU:
- Previous ICU hospitalization for SARS-CoV2 infection
- For participants with no history of SARS-CoV2 infection:
- Previous positive SARS-CoV2 PCR
- Negative SARS-CoV2 PCR and presence of clinical symptoms suggestive of SARS-CoV2 infection
- Previous positive serology for SARS-CoV2 infection
- Secondary exclusion criteria :
- For healthy volunteers with no history of SARS-CoV2 infection:
- Positive specific serology for SARS-CoV2 infection at the screening visit.
Trial locations and contacts
1 site in 1 country.
About this study
Currently, the world is facing a SARS-CoV2 coronavirus epidemic, which is responsible for COVID-19. In France, this virus has already infected several million people and is responsible for the death of more than 127,000.
Infection is associated with a higher number of cardiovascular events (myocardial infarction, stroke, cardiac arrhythmia, thrombosis ...) in the short and medium term after infection. The long-term complications of this infection are not yet known and are the subject of research in France and in the world.
Read more
In order to investigate the possible long term sequelae of this virus infection, this research aims to evaluate the potential cholesterol abnormalities caused by COVID-19, which could play a significant role in the increase of cardiovascular risk in affected patients.
A total of 180 analysable participants will be recruited in this study. They will be divided into four groups of participants that will be compared to one another:
- 30 participants who were infected with SARS-CoV2 with no or few signs and did not require hospitalization.
- 30 participants who were infected with SARS-CoV2 and whose severity of illness required hospitalization in a COVID unit
- 30 participants who were infected with SARS-CoV2 and required intensive care hospitalization due to severity of illness.
- 90 participants who were not infected with SARS-CoV2.
For each participant, the study will last approximately 1 hour, the time to fill out the consent forms, to answer a few questions about their current medical history and finally to take a blood sample for lipid measurements.
- Conditions
- SARS-CoV2 Infection
- Being tested
- Blood sample of 30 ml
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample of 30 mlBiological
The parameters analyzed on this blood sample: Fasting blood glucose, HbA1C, creatinine, creatinine clearance (MDRD), fasting lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides.
| Study group | Role | What they receive |
|---|---|---|
| A history of asymptomatic/mildly symptomatic SARS-CoV2 infection | Participant with asymptomatic or mild symptomatic SARS CoV2 infection that did not require hospitalization at least 6 months prior to study inclusion Receives: Biological: Blood sample of 30 ml | |
| A history of symptomatic SARS-CoV2 infection hospitalized at the CHU of Dijon outside the ICU | participant with symptomatic SARS CoV2 infection requiring conventional hospitalization at least 6 months prior to study inclusion Receives: Biological: Blood sample of 30 ml | |
| A history of symptomatic SARS-CoV2 infection hospitalized in the ICU | participant with a symptomatic SARS CoV2 infection requiring an ICU hospitalization at least 6 months prior to study inclusion Receives: Biological: Blood sample of 30 ml | |
| No history of SARS-CoV2 infection matched on sex and age | participant with no evidence of SARS CoV2 infection and negative SARS-CoV2 serology Receives: Biological: Blood sample of 30 ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration expressed as a percentage of sphingomyelin to total HDL mass
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start14 Jun 2022
- Primary completion12 Apr 2023
- Study completion12 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV2 InfectionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476224
- Sponsor's protocol ID
- ROULAND ANRS 2022
- Acronym
- COVI-LIPI-D
- Status last verified
- Sep 2023
- First submitted
- 25 Jul 2022
- Last updated
- 2 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative and Functional Investigation of Lipids in Patients With SARS-CoV2 Infection - In Search of Atherogenic Sequelae
- ClinicalTrials.gov ID
- NCT05476224
- Acronym / sponsor ID
- COVI-LIPI-D / ROULAND ANRS 2022
- Conditions
- SARS-CoV2 Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 12 Apr 2023 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 27 Jul 2022 (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.
Currently, the world is facing a SARS-CoV2 coronavirus epidemic, which is responsible for COVID-19. In France, this virus has already infected several million people and is responsible for the death of more than 127,000.
Infection is associated with a higher number of cardiovascular events (myocardial infarction, stroke, cardiac arrhythmia, thrombosis ...) in the short and medium term after infection. The long-term complications of this infection are not yet known and are the subject of research in France and in the world.
In order to investigate the possible long term sequelae of this virus infection, this research aims to evaluate the potential cholesterol abnormalities caused by COVID-19, which could play a significant role in the increase of cardiovascular risk in affected patients.
A total of 180 analysable participants will be recruited in this study. They will be divided into four groups of participants that will be compared to one another:
- 30 participants who were infected with SARS-CoV2 with no or few signs and did not require hospitalization.
- 30 participants who were infected with SARS-CoV2 and whose severity of illness required hospitalization in a COVID unit
- 30 participants who were infected with SARS-CoV2 and required intensive care hospitalization due to severity of illness.
- 90 participants who were not infected with SARS-CoV2.
For each participant, the study will last approximately 1 hour, the time to fill out the consent forms, to answer a few questions about their current medical history and finally to take a blood sample for lipid measurements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A history of asymptomatic/mildly symptomatic SARS-CoV2 infection | – | Biological: Blood sample of 30 mlParticipant with asymptomatic or mild symptomatic SARS CoV2 infection that did not require hospitalization at least 6 months prior to study inclusion |
| A history of symptomatic SARS-CoV2 infection hospitalized at the CHU of Dijon outside the ICU | – | Biological: Blood sample of 30 mlparticipant with symptomatic SARS CoV2 infection requiring conventional hospitalization at least 6 months prior to study inclusion |
| A history of symptomatic SARS-CoV2 infection hospitalized in the ICU | – | Biological: Blood sample of 30 mlparticipant with a symptomatic SARS CoV2 infection requiring an ICU hospitalization at least 6 months prior to study inclusion |
| No history of SARS-CoV2 infection matched on sex and age | – | Biological: Blood sample of 30 mlparticipant with no evidence of SARS CoV2 infection and negative SARS-CoV2 serology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- SARS-CoV2 infection
Key inclusion criteria (24 listed)
- Age ≥18 years
- Participant who has provided consent
- Participant affiliated to National health insurance
- Participant with asymptomatic or minimally symptomatic SARS CoV2 infection who did not require hospitalization at least 6 months prior to study inclusion.
- SARS CoV2 infection proven by positive PCR or antigenic test at the time of signs of infection or positive SARS-CoV2 infection-specific serology at the time of infection (IgG+).
Key exclusion criteria (28 listed)
- SARS Cov2 vaccination within one month prior to inclusion.
- Previous SARS Cov1 infection documented
- Previous study participant
- Participant under legal protection (guardianship)
- Participant subject to a legal protection measure
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 sample of 30 mlThe parameters analyzed on this blood sample: Fasting blood glucose, HbA1C, creatinine, creatinine clearance (MDRD), fasting lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides. | Biological | A history of asymptomatic/mildly symptomatic SARS-CoV2 infection, A history of symptomatic SARS-CoV2 infection hospitalized at the CHU of Dijon outside the ICU, A history of symptomatic SARS-CoV2 infection hospitalized in the ICU, No history of SARS-CoV2 infection matched on sex and age |
Primary outcome
Plasma concentration expressed as a percentage of sphingomyelin to total HDL mass
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
Related trials for SARS-CoV2 Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
The record lists no contact. Use the official record to reach the sponsor.
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 SARS-CoV2 Infection, run by Centre Hospitalier Universitaire Dijon 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 24 inclusion and 28 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: finished, as of the sponsor's last update on 2 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Plasma concentration expressed as a percentage of sphingomyelin to total HDL mass (time frame: At baseline). 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 2 Oct 2023.