Clinical trial NCT04429724: Health Professional Exposure Assessment to Covid-19
Official title: Health Professional Exposure Assessment to Covid-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Lead sponsor: Tourcoing Hospital
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 2129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Understanding the SARS-Cov2 epidemic is a major public health issue, both in the community and in the hospital sector. Because of their central position in the management of patients infected with COVID-19, hospital staff may be considered at high risk of infection. The development of serological tests makes it possible to reliably document a contamination, symptomatic or not, that is more than 3 weeks old. These tests, combined with clinical questioning of the symptoms, make it possible to determine the proportion of asymptomatic infections whose impact in the transmission of this disease appears to be major. The duration of the presence of the antibodies that are hoped to neutralize after infection with CoV2-SARS remains uncertain. Documenting the evolution of antibody levels and their monitoring in a population at high risk of re-exposure to CoV2-SARS is a major issue in understanding this disease and in assessing the risk of infection among healthcare workers.

Detailed description: This is a multi-center, prospective, interventional, low-risk, low-constraint, biological collection study to assess the exposure of health care workers to COVID-19.

Three blood samples will be taken at day 1, month 3 and month 6. The blood samples will be stored in a serum biological collection. A prospective data collection will be set up at the level of symptoms and co-morbidities at each collection at D1, M3 and M6.

In the event of the appearance of symptoms between samples, a self-questionnaire will be completed by the participating personnel as well as an invitation to screening by RT-PCR SARS Cov2 according to standard practices in force at the national level as well as an additional serological test.

Eligibility criteria: Inclusion Criteria:

* Staff on duty in the health facility
* Eligible to be drawn
* Beneficiary subject affiliated or entitled to a social security scheme

Exclusion Criteria:

* Minor patient
* Refusal to participate
* Patient under guardianship
* Patient under guardianship

Primary outcomes:
measure: Number of contaminated personnel
timeFrame: day 1
Secondary outcomes:
measure: Number of contaminated personnel
timeFrame: month 3
measure: Number of contaminated personnel
timeFrame: month 6
measure: Number of symptomatic staff by occupational category and service
timeFrame: month 3
measure: Number of symptomatic staff by occupational category and service
timeFrame: month 6
measure: Number of contaminated personnel with effective protection
timeFrame: evolution at day 1, month 3 and month 6
measure: comparison of socio-demographic characteristics and co-morbidities between patients losing their antibodies and those maintaining their antibodies
timeFrame: month 6
Other outcomes:
Locations:
city: Roubaix
country: France
facility: CH Roubaix
city: Tourcoing
country: France
facility: CH Tourcoing
city: Wasquehal
country: France
facility: CH Wasquehal
city: Wattrelos
country: France
facility: CH Wattrelos
Study officials:
affiliation: CH TOURCOING
name: PATOZ Pierre, PharmD
role: PRINCIPAL_INVESTIGATOR
References: