Evolution of Protective Immunization Against SARS-CoV-2 Among Hospital Workers in Health Care Facilities
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- To establish the level of immunization (seroprevalence) to COVID-19 as determined by the seroneutralization test in a population of exposed hospital workers
研究概览
简要总结
To measure the immunization rate (seroneutralization) in a population of exposed hospital workers (nursing staff assigned to dedicated COVID-19 care units, laboratory staff handling COVID-19 samples).
详细描述
Current studies on seroconversion and the time course of immunity following exposure to SARS-CoV-2 do not document: i) Seroconversion in populations in repeated and frequent contact with patients; ii) The temporal dynamics of seroconversion at medium term. These two elements are however fundamental in the comprehension and management of this epidemic or of its potential resurgence in the following months and years.
Objective: To measure the immunization rate (seroneutralization) in a population of exposed hospital workers (nursing staff assigned to dedicated COVID-19 care units, laboratory staff handling COVID-19 samples).
Secondary objectives:
- Determine the kinetics of the protective response over 12 months (4 times).
- Compare immunization profiles according to: gender, age, lockdown, blood type, occupational class, exposure, asymptomatic/symptomatic.
- Compare immunization kinetics between exposed and low-exposure hospital workers.
- To determine the characteristics of the ELISA test in comparison with the reference test (seroneutralization).
Perspectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cohort of exposed hospital workers
- •Hospital caregiver or non-clinician agreeing to participate in the study defined as: Healthcare personnel (physician, nurse, orderly, physical therapist, midwives) who have worked for a minimum of 2 weeks since March 1, 2020 in a care unit dedicated to the management of patients confirmed or suspected of COVID-19 infection, in the participating centers: intensive care units, emergency rooms, COVID-19 units;
- •Staff (physician, technician) who have worked for a minimum of 2 weeks since March 1, 2020 in the AP-HM laboratories handling samples from patients confirmed or suspected of having COVID-19 infection
- •Person affiliated to a social security system
- •Cohort of 'unexposed' hospital workers
- •Hospital care worker (physician, nurse, orderly) willing to participate in the study who has not worked since March 1, 2020 in an intensive care unit or emergency department or other department dedicated to the management of patients confirmed or suspected of having COVID-19 infection.
- •Person affiliated with a social security system
排除标准
- •Hospital worker declining to participate If the hospital worker changes assignment after the first collection, he/she remains in the exposed cohort.
- •Protected adult
- •Person under legal guardianship or curatorship
研究组 & 干预措施
Exposed hospital staff
Hospital health care or non-health care staff willing to participate in the study:
- Healthcare personnel (physician, nurse, caregiver) who have worked for a minimum of 2 weeks since March 1, 2020 in a care unit dedicated to the management of patients confirmed or suspected of COVID-19 infection, in the participating centers: intensive care units, emergency rooms, radiology, COVID-19 units;
- Staff (physician, technician) who have worked for a minimum of 2 weeks since March 1, 2020 in the AP-HM laboratories handling samples from patients confirmed or suspected of having COVID-19 infection.
干预措施: Blood sample (Other)
'Non-exposed' hospital workers
Hospital health care worker (physician, nurse, caregiver) willing to participate in the study who has not worked since March 1, 2020 in an intensive care unit or emergency department or other department dedicated to the management of patients confirmed or suspected of having COVID-19 infection.
干预措施: Blood sample (Other)
结局指标
主要结局
To establish the level of immunization (seroprevalence) to COVID-19 as determined by the seroneutralization test in a population of exposed hospital workers
时间窗: 4, 8 and 12 months follow-up visits after the initial visit
Positive seroneutralization test result: the threshold of positivity is set at 40, i.e. any serum with a seroneutralizing value greater than or equal to 40 will be considered positive.
次要结局
- Compare immunization profiles(12 months after the initial visit)
- Kinetics of the protective antibody immune response (protective immunization against SARS-CoV-2 COVID-19) in a population of exposed hospital workers over a 12-month period.(4, 8 and 12 months follow-up visits after the initial visit)
- Identify the technical (sensitivity and specificity) and predictive (positive and negative predictive values) characteristics of the ELISA test evaluated in comparison with the reference test (serum neutralization) in the population of interest.(12 months)
- Record COVID-19 seroprevalences established by ELISA at different time points: inclusion, 4 months, 8 months, and 12 months after inclusion.(4, 8 and 12 months follow-up visits after the initial visit)
- Compare the seroprevalence of SARS-CoV-2 and the kinetics of immunization between two groups (exposed hospital workers and a less exposed hospital workers).(4, 8 and 12 months follow-up visits after the initial visit)