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

Coronavirus Infections Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04429594
• Other study ID #: 20-PP-14
• Status: Recruiting
• Phase: N/A
• Start date: July 28, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2020
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Barbara SEITZ, MCUPH
• Phone: 334 92 03 55 02
• Email: seitz-polski.b[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2025
• Est. primary completion date: July 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Coronavirus Infections
• Infection
• Severe Acute Respiratory Syndrome

Intervention

Other:
• blood sampling
blood sampling at J0, M6, M12, M24, M36, M48, M60

Locations

Country	Name	City	State
France	University Nice Hospital	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	positive serologies	number of positive serologies	12 months