Serological Response to SARS-Cov-2 Virus in Personnel of the Institut Bergonié in the Context of the COVID-19 Pandemic - PRO-SERO-COV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 526
- 试验地点
- 1
- 主要终点
- Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at Inclusion
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
PRO-SERO-COV
Blood sample and self-administered questionnaire
干预措施: PRO-SERO-COV (Other)
结局指标
主要结局
Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at Inclusion
时间窗: 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
次要结局
- 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)