- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04384705
HDL Target of CoViD19 ? Analysis on the Caregivers of the Reunion University Hospital (H-Cov-Run)
August 29, 2022 updated by: Centre Hospitalier Universitaire de la Réunion
Since December 2019, the Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) pandemic has spread around the world.
The people most exposed to this virus remain the healthcare personnel who are on the front line in the fight against this pandemic.
Due to the delayed nature of the pandemic in Reunion island and its insular geographical situation, the study of the voluntary medical personnel will allow the investigators to establish a longitudinal follow-up of the anomalies of the lipidic balance in relation to the exposure to the SARS-Cov virus.
2. During bacterial infections, the lipid profiles are profoundly modified with very significant reductions in plasma cholesterol levels, LDL-C but especially HDL-C whose concentrations are particularly low.
Lipid profiles are altered during viral infections, for example, the severity of dengue is inversely correlated with total cholesterol and LDL-C but not with HDL-C levels, according to a recent meta-analysis.
The hepatitis C virus circulates in serum linked to lipoproteins rich in triglycerides and HDL can facilitate its entry into cells via Scavenger receptor class B type 1 (SRB1).
Likewise, it has been shown that apoA1 can bind to the dengue virus and increase its infectivity by promoting its entry into cells, also via SRB1.
At the moment, nothing is known about the lipid profiles in subjects with SARS-CoV-2.
The investigator hypothesize that a drop in plasma HDL-C levels and a change in their size during infection could justify future therapeutic approaches aimed at supplementing the subjects most at risk of pulmonary complications.
In a model of Pseudomonas aeruginosa pneumonia in mice, investigators have shown that the injection of reconstituted HDL allowed to limit the pulmonary inflammation and the deleterious consequences of the infection.
The investigator propose to study not only the lipid profiles in subjects who are infected with SARS-CoV-2 but also the polymorphisms of genes involved in the regulation of lipoprotein levels like that of Cholesterol Ester-Transfer Protein (CETP) depending on the developed forms, symptomatic or not.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
361
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Saint-Denis, France, 97400
- Centre Hospitalier Universitaire Réunion
-
Saint-Pierre, France, 97448
- Centre hospitalier universitaire de la Réunion
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Caregiver in Reunion island University Hospital Center who practice in a care service possibly exposed to the coronavirus
Description
Inclusion Criteria:
- Caregiver in Reunion island University Hospital Center
- Practicing in a care service possibly exposed to the coronavirus
- Signed Consent
Exclusion Criteria:
- Refusal to participate
- Already infected by Covid19
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
caregivers
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of lipid profile during exposure to SARS-Cov-2
Time Frame: at the end of the study, maximum 1 year
|
lipid profile
|
at the end of the study, maximum 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HDL-cholesterol size
Time Frame: at the end of the study, maximum 1 year
|
HDL-cholesterol size
|
at the end of the study, maximum 1 year
|
circulating plasma cytokine levels
Time Frame: at the end of the study, maximum 1 year
|
circulating plasma cytokine levels
|
at the end of the study, maximum 1 year
|
ACE2 gene polymorphisms
Time Frame: at the end of the study, maximum 1 year
|
ACE2 gene polymorphisms
|
at the end of the study, maximum 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 17, 2020
Primary Completion (Anticipated)
September 1, 2023
Study Completion (Anticipated)
September 1, 2023
Study Registration Dates
First Submitted
May 6, 2020
First Submitted That Met QC Criteria
May 11, 2020
First Posted (Actual)
May 12, 2020
Study Record Updates
Last Update Posted (Actual)
August 30, 2022
Last Update Submitted That Met QC Criteria
August 29, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/CHU/08
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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