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Study of the Incidence of SARS-CoV-2 Infection (COVID-19) (CovImmune 2)

Primary Purpose

Coronavirus Infections

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sampling
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Coronavirus Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Any major subject, voluntary, exposed to the public from 11 May 2020 informed of the study by partner institutions (Departmental Council 06), affiliated to a social security scheme,

Exclusion Criteria:

  • Subject protected by law under tutorship or guardianship, or who cannot participate in a clinical study under the terms of Article L. 1121-16 of the French Public Health Code

Sites / Locations

  • University Nice HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

volonteers

Arm Description

Outcomes

Primary Outcome Measures

positive serologies
number of positive serologies

Secondary Outcome Measures

Full Information

First Posted
June 10, 2020
Last Updated
October 15, 2020
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT04429594
Brief Title
Study of the Incidence of SARS-CoV-2 Infection (COVID-19)
Acronym
CovImmune 2
Official Title
Study of the Incidence of SARS-CoV-2 Infection in the Alpes-Maritimes Department by Analysis of the Specific Humoral and Cellular Response During Deconfinement
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2020 (Actual)
Primary Completion Date
July 15, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective observational cohort study that will define the prevalence and incidence of CA-SARS-Cov2 infection using serological and PCR tests in a group of subjects during deconfinement. The team wishes to include approximately 1000 subjects in this study. The health crisis through containment has also created unprecedented environmental conditions with the very clear decrease in economic activities and a consequent decrease in exposure to the main air pollutants. The aim is therefore to carry out a case-control study in which each subject will be his or her own control in unexposed condition (to PM2.5, PM10, NO...) then exposed (after the recovery of economic activity and the usual levels of air pollutants) and to measure the impact of these pollutants on the immune system and epigenetic markers taking into account seasonality. The occurrence of infectious, cardiovascular, allergic and autoimmune events will then be measured according to the immunological profiles measured at inclusion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infections

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
volonteers
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
blood sampling
Intervention Description
blood sampling at J0, M6, M12, M24, M36, M48, M60
Primary Outcome Measure Information:
Title
positive serologies
Description
number of positive serologies
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Any major subject, voluntary, exposed to the public from 11 May 2020 informed of the study by partner institutions (Departmental Council 06), affiliated to a social security scheme, Exclusion Criteria: Subject protected by law under tutorship or guardianship, or who cannot participate in a clinical study under the terms of Article L. 1121-16 of the French Public Health Code
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara SEITZ, MCUPH
Phone
334 92 03 55 02
Email
seitz-polski.b@chu-nice.fr
Facility Information:
Facility Name
University Nice Hospital
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara SEITZ- POLSKI
Phone
334.92.03.55.02
Email
seitz-polski.b@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
barbara SEITZ POLSKI
First Name & Middle Initial & Last Name & Degree
sonia BOYER SUAVET
First Name & Middle Initial & Last Name & Degree
Christian PRADIER

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of the Incidence of SARS-CoV-2 Infection (COVID-19)

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