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

Sponsor

Centre Hospitalier Universitaire de Nice (Other)

Overall Status

Recruiting

CT.gov ID

NCT04429594

Collaborator

(none)

1,000

Enrollment

Location

Arm

65.1

Anticipated Duration (Months)

15.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronavirus Infections	Other: blood sampling	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

Jul 28, 2020

Anticipated Primary Completion Date :

Jul 15, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: volonteers	Other: blood sampling blood sampling at J0, M6, M12, M24, M36, M48, M60

Arm

Intervention/Treatment

Other: volonteers

Other: blood sampling

blood sampling at J0, M6, M12, M24, M36, M48, M60

Outcome Measures

Primary Outcome Measures

positive serologies [12 months]
number of positive serologies

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Nice Hospital	Nice		France	06000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Nice

ClinicalTrials.gov Identifier:

NCT04429594

Other Study ID Numbers:

20-PP-14

First Posted:

Jun 12, 2020

Last Update Posted:

Oct 19, 2020

Last Verified:

Jun 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infections

Communicable Diseases

Coronavirus Infections

COVID-19

Study Results

No Results Posted as of Oct 19, 2020