SERODRON: Health Professional Exposure Assessment to Covid-19
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: health workers at hospital 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. |
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.
|
Outcome Measures
Primary Outcome Measures
- Number of contaminated personnel [day 1]
Number of contaminated personnel by occupational category and department on day 1.
Secondary Outcome Measures
- Number of contaminated personnel [month 3]
Number of contaminated personnel by professional category and by service at month 3 a by serological test
- Number of contaminated personnel [month 6]
Number of contaminated personnel by professional category and by service at month 6 a by serological test
- Number of symptomatic staff by occupational category and service [month 3]
Number of symptomatic staff by occupational category and service at Month 3 with positive RT-PCR Cov2 SARS
- Number of symptomatic staff by occupational category and service [month 6]
Number of symptomatic staff by occupational category and service at Month 6 with positive RT-PCR Cov2 SARS
- Number of contaminated personnel with effective protection [evolution at day 1, month 3 and month 6]
Number of contaminated personnel with effective protection: evolution of the antibody index at day 1, month 3 and month 6
- comparison of socio-demographic characteristics and co-morbidities between patients losing their antibodies and those maintaining their antibodies [month 6]
comparison of socio-demographic characteristics and co-morbidities between patients losing their antibodies and those maintaining their antibodies between two stitch dates.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Staff on duty in the health facility
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Eligible to be drawn
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Beneficiary subject affiliated or entitled to a social security scheme
Exclusion Criteria:
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Minor patient
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Refusal to participate
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Patient under guardianship
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Patient under guardianship
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CH Roubaix | Roubaix | France | ||
| 2 | CH Tourcoing | Tourcoing | France | ||
| 3 | CH Wasquehal | Wasquehal | France | ||
| 4 | CH Wattrelos | Wattrelos | France |
Sponsors and Collaborators
- Tourcoing Hospital
Investigators
- Principal Investigator: PATOZ Pierre, PharmD, CH Tourcoing
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RIPH_2020_8