Serological Response to SARS-Cov-2 Virus in Personnel of the Institut Bergonié in the Context of the COVID-19 Pandemic - PRO-SERO-COV
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Institut Bergonié
- Enrollment
- 526
- Locations
- 2
- Primary Endpoint
- Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at Inclusion
Study Overview
Brief Summary
The question of the immune response of the population, particularly of professional populations in contact with vulnerable populations (such as those with chronic conditions such as cancer), is an important issue. Knowing the evolution of this response over time in this population can help answer outstanding questions. The PRO-SERO-COV study is a seroprevalence study of caregivers working in the hospital sector with a follow-up at 3 months and 12 months. The objective is to evaluate and monitor at 3 and 12 months the serological immune status to an infection by the SARS-CoV-2 virus in active volunteer professionals working at the Institut Bergonié with different types of exposure: healthcare professionals and professionals in other services.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adult 18 years-old and older.
- •Person in employment (on fixed-term or permanent contracts) since (at least) March 17th, 2020, the date of national implementation of containment measures in response to the COVID-19 pandemic.
- •Signed informed consent.
- •Person affiliated to a French social security regimen in accordance with Article 1121-11 of the French Public Health Code).
Exclusion Criteria
- •Report of known active SARS-CoV-2 infection within 10 days prior to the date of signing the consent. Known active SARS-CoV-2 infection is defined as a positive result on a diagnostic RT-PCR test.
- •Presence of known symptoms suggestive of COVID-19 within 10 days prior to the date of signing consent: fever, fatigue, dry cough, shortness of breath, loss of taste and/or smell, headache, body aches, aches and pains, conjunctivitis or colds, digestive disorders (vomiting, diarrhea).
- •A person who is unable to follow and comply with research procedures due to geographical, social or psychological reasons.
- •Pregnant or breastfeeding woman.
- •Person deprived of their liberty, incapable or incapable of giving their consent.
Outcomes
Primary Outcomes
Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at Inclusion
Time Frame: Time 0 (Inclusion)
Total antibodies (IgG and IgM) directed against the N (nucleocapsid) protein of the virus were determined by ECLIA on a Cobas® 8000 (Roche Diagnostic, France) with the Elecsys Anti-SARS-CoV-2 kit. Serum was also tested by ELISA with the SARS-CoV-2 (IgG) ELISA Kit (EuroIm-mun, France). These ELISA and ECLIA tests were carried out in the medical biology laboratory of the Institut Bergonié. Serological immune status to a previous infection by the SARS-CoV-2 virus was evaluated for each patient and defined as : * Positive in case of positive ELISA test AND/OR positive ECLIA test * Negative otherwise
Secondary Outcomes
- Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at 3 Months(3 months)
- Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at 12 Months(12 months)
- Number of Health Care Workers With Active COVID-19 Infection(Time 0 (inclusion), 3 months, 12 months)
- Number of Health Care Workers With Symptoms of Anxiety at 3 Months(3 months)
- Number of Health Care Workers With Symptoms of Anxiety at 0 Months (Inclusion)(Time 0 (inclusion))
- Number of Health Care Workers With Symptoms of Anxiety at 12 Months(12 months)