Study of the Incidence of SARS-CoV-2 Infection (COVID-19) (CovImmune 2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04429594|
Recruitment Status : Recruiting
First Posted : June 12, 2020
Last Update Posted : October 19, 2020
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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|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 :||July 28, 2020|
|Estimated Primary Completion Date :||July 15, 2025|
|Estimated Study Completion Date :||December 31, 2025|
Other: blood sampling
blood sampling at J0, M6, M12, M24, M36, M48, M60
- positive serologies [ Time Frame: 12 months ]number of positive serologies
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04429594
|Contact: Barbara SEITZ, MCUPH||334 92 03 55 firstname.lastname@example.org|
|University Nice Hospital||Recruiting|
|Nice, France, 06000|
|Contact: Barbara SEITZ- POLSKI 334.92.03.55.02 email@example.com|
|Principal Investigator: barbara SEITZ POLSKI|
|Sub-Investigator: sonia BOYER SUAVET|
|Sub-Investigator: Christian PRADIER|