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新冠病毒感染后至少 6 个月的长期健康后遗症和生活质量:COVIDOM 研究的设计和原理,该研究作为 NAPKON 基于人群队列平台(POP)的一部分。

Long-term health sequelae and quality of life at least 6 months after infection with SARS-CoV-2: design and rationale of the COVIDOM-study as part of the NAPKON population-based cohort platform (POP).

机构信息

Institute of Clinical Epidemiology and Biometry, University of Würzburg, Julius Maximilian University of Würzburg, Wurzburg, Germany.

Institute of Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Berlin, Germany.

出版信息

Infection. 2021 Dec;49(6):1277-1287. doi: 10.1007/s15010-021-01707-5. Epub 2021 Oct 12.

DOI:10.1007/s15010-021-01707-5
PMID:34642875
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8508400/
Abstract

PURPOSE

Over the course of COVID-19 pandemic, evidence has accumulated that SARS-CoV-2 infections may affect multiple organs and have serious clinical sequelae, but on-site clinical examinations with non-hospitalized samples are rare. We, therefore, aimed to systematically assess the long-term health status of samples of hospitalized and non-hospitalized SARS-CoV-2 infected individuals from three regions in Germany.

METHODS

The present paper describes the COVIDOM-study within the population-based cohort platform (POP) which has been established under the auspices of the NAPKON infrastructure (German National Pandemic Cohort Network) of the national Network University Medicine (NUM). Comprehensive health assessments among SARS-CoV-2 infected individuals are conducted at least 6 months after the acute infection at the study sites Kiel, Würzburg and Berlin. Potential participants were identified and contacted via the local public health authorities, irrespective of the severity of the initial infection. A harmonized examination protocol has been implemented, consisting of detailed assessments of medical history, physical examinations, and the collection of multiple biosamples (e.g., serum, plasma, saliva, urine) for future analyses. In addition, patient-reported perception of the impact of local pandemic-related measures and infection on quality-of-life are obtained.

RESULTS

As of July 2021, in total 6813 individuals infected in 2020 have been invited into the COVIDOM-study. Of these, about 36% wished to participate and 1295 have already been examined at least once.

CONCLUSION

NAPKON-POP COVIDOM-study complements other Long COVID studies assessing the long-term consequences of an infection with SARS-CoV-2 by providing detailed health data of population-based samples, including individuals with various degrees of disease severity.

TRIAL REGISTRATION

Registered at the German registry for clinical studies (DRKS00023742).

摘要

目的

在 COVID-19 大流行期间,有证据表明 SARS-CoV-2 感染可能影响多个器官并产生严重的临床后遗症,但很少有针对非住院样本的现场临床检查。因此,我们旨在系统评估来自德国三个地区住院和非住院 SARS-CoV-2 感染个体的样本的长期健康状况。

方法

本研究描述了 COVIDOM 研究,该研究是在 NAPKON 基础设施(德国国家大流行队列网络)的支持下,在国家网络大学医学(NUM)的人群队列平台(POP)内进行的。在急性感染后至少 6 个月,在研究地点基尔、维尔茨堡和柏林对 SARS-CoV-2 感染个体进行全面健康评估。通过当地公共卫生当局确定并联系有潜在感染可能的个体,无论初始感染的严重程度如何。实施了一个协调一致的检查方案,包括详细的病史评估、身体检查以及收集多个生物样本(如血清、血浆、唾液、尿液)进行未来分析。此外,还获得了患者对当地大流行相关措施和感染对生活质量的影响的感知。

结果

截至 2021 年 7 月,共有 6813 名 2020 年感染的个体被邀请参加 COVIDOM 研究。其中,约 36%的人希望参与,已有 1295 人至少接受过一次检查。

结论

NAPKON-POP COVIDOM 研究通过提供基于人群的样本的详细健康数据,包括不同严重程度疾病的个体,补充了其他评估 SARS-CoV-2 感染长期后果的长 COVID 研究。

试验注册

在德国临床试验注册处(DRKS00023742)注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/344c/8613148/3acf9c40049b/15010_2021_1707_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/344c/8613148/927b6015413c/15010_2021_1707_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/344c/8613148/3acf9c40049b/15010_2021_1707_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/344c/8613148/927b6015413c/15010_2021_1707_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/344c/8613148/3acf9c40049b/15010_2021_1707_Fig2_HTML.jpg

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