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基于人群的前瞻性 COVID-19 队列研究方案:德国慕尼黑(KoCo19)。

Protocol of a population-based prospective COVID-19 cohort study Munich, Germany (KoCo19).

机构信息

Institute and Outpatient Clinic for Occupational, Social and Environmental Medicine, Ludwig-Maximilians-Universität (LMU) University Hospital Munich, Ziemssenstr. 1, 80336, Munich, Germany.

Center for International Health, LMU University Hospital, Munich, Germany.

出版信息

BMC Public Health. 2020 Jun 30;20(1):1036. doi: 10.1186/s12889-020-09164-9.

Abstract

BACKGROUND

Due to the SARS-CoV-2 pandemic, public health interventions have been introduced globally in order to prevent the spread of the virus and avoid the overload of health care systems, especially for the most severely affected patients. Scientific studies to date have focused primarily on describing the clinical course of patients, identifying treatment options and developing vaccines. In Germany, as in many other regions, current tests for SARS-CoV2 are not conducted on a representative basis and in a longitudinal design. Furthermore, knowledge about the immune status of the population is lacking. Nonetheless, these data are needed to understand the dynamics of the pandemic and hence to appropriately design and evaluate interventions. For this purpose, we recently started a prospective population-based cohort in Munich, Germany, with the aim to develop a better understanding of the state and dynamics of the pandemic.

METHODS

In 100 out of 755 randomly selected constituencies, 3000 Munich households are identified via random route and offered enrollment into the study. All household members are asked to complete a baseline questionnaire and subjects ≥14 years of age are asked to provide a venous blood sample of ≤3 ml for the determination of SARS-CoV-2 IgG/IgA status. The residual plasma and the blood pellet are preserved for later genetic and molecular biological investigations. For twelve months, each household member is asked to keep a diary of daily symptoms, whereabouts and contacts via WebApp. If symptoms suggestive for COVID-19 are reported, family members, including children < 14 years, are offered a pharyngeal swab taken at the Division of Infectious Diseases and Tropical Medicine, LMU University Hospital Munich, for molecular testing for SARS-CoV-2. In case of severe symptoms, participants will be transferred to a Munich hospital. For one year, the study teams re-visits the households for blood sampling every six weeks.

DISCUSSION

With the planned study we will establish a reliable epidemiological tool to improve the understanding of the spread of SARS-CoV-2 and to better assess the effectiveness of public health measures as well as their socio-economic effects. This will support policy makers in managing the epidemic based on scientific evidence.

摘要

背景

由于 SARS-CoV-2 大流行,全球范围内已采取公共卫生干预措施,以防止病毒传播并避免医疗保健系统超负荷运转,尤其是针对受影响最严重的患者。迄今为止,科学研究主要集中在描述患者的临床病程、确定治疗方案和开发疫苗上。在德国,与许多其他地区一样,目前对 SARS-CoV2 的检测并非基于代表性和纵向设计进行。此外,人们对人群的免疫状况缺乏了解。尽管如此,这些数据对于了解大流行的动态以及因此适当设计和评估干预措施是必要的。为此,我们最近在德国慕尼黑启动了一项基于人群的前瞻性队列研究,旨在更好地了解大流行的现状和动态。

方法

在随机选择的 755 个选区中的 100 个选区中,通过随机路线确定 3000 个慕尼黑家庭,并邀请其参加研究。要求所有家庭成员填写基线问卷,年龄≥14 岁的人需提供≤3ml 的静脉血样,以确定 SARS-CoV-2 IgG/IgA 状态。剩余的血浆和血球沉淀用于以后的遗传和分子生物学研究。在 12 个月内,要求每个家庭成员通过 WebApp 记录每日症状、行踪和接触情况。如果报告有疑似 COVID-19 的症状,将为家庭成员(包括<14 岁的儿童)提供在慕尼黑 LMU 大学医院传染病和热带医学科进行的咽拭子检测,以进行 SARS-CoV-2 的分子检测。如果出现严重症状,将将患者转至慕尼黑的一家医院。在一年的时间里,研究团队每六周会重新访问家庭进行采血。

讨论

通过计划中的研究,我们将建立一种可靠的流行病学工具,以提高对 SARS-CoV-2 传播的理解,并更好地评估公共卫生措施的有效性及其社会经济影响。这将为决策者提供基于科学证据的管理大流行的支持。

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