Health Professional Exposure Assessment to Covid-19

COVID-19 Clinical Trial

— SERODRON  

Official title:

Health Professional Exposure Assessment to Covid-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04429724
• Other study ID #: RIPH_2020_8
• Status: Completed
• Phase: N/A
• Start date: July 6, 2020
• Est. completion date: March 16, 2021

Study information

• Verified date: May 2022
• Source: Tourcoing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2129
• Est. completion date: March 16, 2021
• Est. primary completion date: March 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Diagnostic Test:
• Diagnostic test Covid-19
Three blood samples will be taken at day 1, month 3 and month 6 A prospective data collection will be set up at the level of symptoms and co-morbidities at each collection at D1, M3 and M6.

Locations

Country	Name	City	State
France	CH Roubaix	Roubaix
France	CH Tourcoing	Tourcoing
France	CH Wasquehal	Wasquehal
France	CH Wattrelos	Wattrelos

Sponsors (1)

Lead Sponsor	Collaborator
Tourcoing Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of contaminated personnel	Number of contaminated personnel by occupational category and department on day 1.	day 1
Secondary	Number of contaminated personnel	Number of contaminated personnel by professional category and by service at month 3 a by serological test	month 3
Secondary	Number of contaminated personnel	Number of contaminated personnel by professional category and by service at month 6 a by serological test	month 6
Secondary	Number of symptomatic staff by occupational category and service	Number of symptomatic staff by occupational category and service at Month 3 with positive RT-PCR Cov2 SARS	month 3
Secondary	Number of symptomatic staff by occupational category and service	Number of symptomatic staff by occupational category and service at Month 6 with positive RT-PCR Cov2 SARS	month 6
Secondary	Number of contaminated personnel with effective protection	Number of contaminated personnel with effective protection: evolution of the antibody index at day 1, month 3 and month 6	evolution at day 1, month 3 and month 6
Secondary	comparison of socio-demographic characteristics and co-morbidities between patients losing their antibodies and those maintaining their antibodies	comparison of socio-demographic characteristics and co-morbidities between patients losing their antibodies and those maintaining their antibodies between two stitch dates.	month 6