Burden of SARS-CoV-2 Infection in Populations With High or Low Risk of Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,000
- 试验地点
- 2
- 主要终点
- SARS-CoV-2 infection
研究概览
简要总结
Introduction. Some issues remain to be elucidated about SARS-CoV-2 infection to plan prevention interventions based on scientific evidence, such as the actual prevalence of infection including subclinical and seroconverted cases, the reasons for the different spread and severity of the infection in different subjects and geographical areas as well as the impact of the COVID-19 crisis on the health of healthcare professionals and in the general population.
The aims of this project are: (i) to estimate and compare the real prevalence of the SARS-CoV-2 infection and seroconversion in two populations at high or low risk of infection,in Lombardia region and Molise region, respectively; focusing on subgroups at higher risk such as healthcare workers (HCWs); (ii) to estimate the incidence of burnout and post-traumatic stress disorder in HCWs; (iii) to identify factors associated with SARS-CoV-2 infection positivity and to follow up its mid-term effects on health.
Methods. Participants will be randomly selected from the general population of both territories and from the HCWs list of the two healthcare facilities involved. SARS-CoV-2 IgG and IgM blood levels will be measured and anamnestic data will be collected through computerized tools. Prevalence of currently or previously infected subjects and their disease status and severity will be estimated and the association with potential risk factors will be analyzed through multivariable regression analyses.
Expected results. The study will identify the burden of the infection in the general and HCWs populations. It will also identify the determinants of differences in the spread and severity of the infection, to hypothesize new preventive or therapeutic interventions. This study will provide a basis for monitoring the progress of the infection and its medium-term health consequences, Finally it will allow planning future studies, through analyses in biological samples which will be collected in dedicated biobanks.
详细描述
SARS-CoV-2 infection currently affects more than two million people worldwide and has caused the death of more than 150,000 people. In Lombardia there were 64.000 confirmed positive subjects (64:10,000) and 12,000 dead, with a large number of healthcare workers (HCWs) involved. However, the number of recovered is starting to rise and, thanks to the containment measures introduced, the number of new cases per day is falling. However, the situation is quite different in other part of Italy; f.i. in Molise, a southern Italy region, there is a much lower incidence of positivity and mortality: 269 confirmed positive (9:10,000) and 16 deaths.
To plan the second phase of outbreak management, waiting for the development of a vaccine and valid therapeutic tools, preventive interventions should be revisited based on evidence from the literature and from local epidemiological data. However, although the infection is now worldwide spread, some issues are still not known.
The actual number of subjects with an active or past SARS-CoV-2 infection is not known, since the approach used was based on tests performed in severe cases and in their contacts, while few investigations have been carried out on the general population. The impact of the emergency on the health of both HCWs or general population is not yet known. Furthermore, the reasons for the different spread of the infection in the North and South of the country, as well as the different characteristics of the subjects who have or have had the infection with respect to those who have not had it are not yet fully known; moreover, among the positive ones, the characteristics associated with the development of the more serious forms or the absence of symptoms, remain to be elucidated. In fact, the studies conducted so far were large studies that collected few data or were more detailed studies focused only on few hospitalized subjects.
It is therefore necessary to conduct new studies on the general population, based on large samples randomly selected from populations at high and low spread of the infection as well as in subgroups at higher risk such as HCWs, and based on a large set of collected data. The aims of this project are: (i) to estimate the real prevalence of the SARS-CoV-2 infection and seroconversion in two populations at high and low risk of infection, in a comparative way, from the territories of ASST Sette Laghi of Varese, Lombardia region (confirmed cases 18:10,000) and a region at lower prevalence of confirmed cases such as the Molise region (confirmed cases 9:10,000 subjects), also focusing on subgroups at higher risk such as healthcare workers (HCWs); (ii) to estimate the rate of burnout and post-traumatic stress disorder in HCWs during the study period; (iii) to identify factors associated with SARS-CoV-2 infection positivity and follow up at mead-term its effect on health.
Finally, the investigators will biobank biological samples for future studies, in already available specialized facilities.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Signing a written consent
排除标准
- 未提供
结局指标
主要结局
SARS-CoV-2 infection
时间窗: From December 15 2020 to June 15 2021
To estimate and compare the real prevalence of the SARS-CoV-2 infection and seroconversion in two populations at high or low risk of infection. The knowledge of the real prevalence of currently or previously infected subjects, then the actual immunization in the general population and in HCWs, will allow to estimate the real impact of the condition and to better predict the time-course of potential new outbreaks, considering the estimated impact of the herd immunity in slowing it down
Burnout and post-traumatic stress disorder in HCWs
时间窗: From December 15 2020 to June 15 2021
To estimate the incidence of burnout and post-traumatic stress disorder in HCWs. To understand the impact of COVID-19 crisis on their health, also by quantifying their stress levels, and to set the priorities for intervention in this population subgroup (HCWs)
SARS-CoV-2 infection positivity factors/determinants
时间窗: From December 15 2020 to December 15 2021
To identify different characteristics of the subjects who have / have had the infection or the positives who have developed more serious forms will allow better understanding of the transmission pathways or the mechanism underlying the pathogenesis of the viral infection and of its manifestations, facilitating the development of new preventive or therapeutic interventions
次要结局
- Population cohort of immunized subjects(From December 15 2020 to June 15 2022)
- Biobank biospecimen collection(From December 15 2020 to June 15 2022)
研究者
Licia Iacoviello
Professor
Neuromed IRCCS
