Qualitative and Functional Investigation of Lipids in Patients With SARS-CoV2 Infection - In Search of Atherogenic Sequelae

NCT05476224 | Completed

• 1 other identifier: ROULAND ANRS 2022
• Study Type: observational
• Target: 228
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

SARS-CoV2 Infection

Outcome Measures

Primary Outcomes (1)

• Plasma concentration expressed as a percentage of sphingomyelin to total HDL mass

  At baseline

Study Arms (4)

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

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

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

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

Biological: Blood sample of 30 ml

Interventions

Blood sample of 30 ml BIOLOGICAL

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

SARS-CoV2 infection

You may qualify if:

• 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
• 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+).
• 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
• 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
• 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+).

You may not qualify if:

• For all participants:
• Previous SARS Cov1 infection documented
• Previous study participant
• Participant under legal protection (guardianship)
• Participant subject to a legal protection measure
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 27, 2022
• Study Start: June 14, 2022
• Primary Completion: April 12, 2023
• Study Completion: April 12, 2023
• Last Updated: October 2, 2023

Record last verified: 2023-09

Locations

FR (1)