NCT04384705

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
361

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

June 17, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

August 30, 2022

Status Verified

August 1, 2022

Enrollment Period

3.2 years

First QC Date

May 6, 2020

Last Update Submit

August 29, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change of lipid profile during exposure to SARS-Cov-2

    lipid profile

    at the end of the study, maximum 1 year

Secondary Outcomes (3)

  • HDL-cholesterol size

    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

    at the end of the study, maximum 1 year

Study Arms (1)

caregivers

caregivers

Other: research specific blood sample

Interventions

* one blood sample before the epidemic phase * one blood sample during epidemic phase * one blood sample after epidemic phase

caregivers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Caregiver in Reunion island University Hospital Center who practice in a care service possibly exposed to the coronavirus

You may qualify if:

  • Caregiver in Reunion island University Hospital Center
  • Practicing in a care service possibly exposed to the coronavirus
  • Signed Consent

You may not qualify if:

  • Refusal to participate
  • Already infected by Covid19

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Universitaire Réunion

Saint-Denis, 97400, France

Location

Centre Hospitalier Universitaire de la Réunion

Saint-Pierre, 97448, France

Location

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Design

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

Study Record Dates

First Submitted

May 6, 2020

First Posted

May 12, 2020

Study Start

June 17, 2020

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

August 30, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations