前瞻性纵向队列研究 COVID-19 患者及其家庭成员的方案，以研究与疾病严重程度相关的因素：PreCOVID 研究。
Protocol for a prospective, longitudinal cohort of people with COVID-19 and their household members to study factors associated with disease severity: the Predi-COVID study.
机构信息
Department of Population Health, Luxembourg Institute of Health, Strassen, Luxembourg.
IBBL, Luxembourg, Luxembourg.
出版信息
BMJ Open. 2020 Nov 23;10(11):e041834. doi: 10.1136/bmjopen-2020-041834.
INTRODUCTION
A few major clinical factors such as sex, obesity or comorbidities have already been associated with COVID-19 severity, but there is a need to identify new epidemiological, clinical, digital and biological characteristics associated with severity and perform deep phenotyping of patients according to severity. The objectives of the Predi-COVID study are (1) to identify new determinants of COVID-19 severity and (2) to conduct deep phenotyping of patients by stratifying them according to risk of complications, as well as risk factors for infection among household members of Predi-COVID participants (the Predi-COVID-H ancillary study).
METHODS AND ANALYSIS
Predi-COVID is a prospective, hybrid cohort study composed of laboratory-confirmed COVID-19 cases in Luxembourg who will be followed up remotely for 1 year to monitor their health status and symptoms. Predi-COVID-H is an ancillary cohort study on household members of index cases included in Predi-COVID to monitor symptoms and household clusters in this high-risk population. A subcohort of up to 200 Predi-COVID and 300 Predi-COVID-H participants with biological samples will be included. Severity of infection will be evaluated by occurrence and duration of hospitalisation, admission and duration of stay in intensive care units or equivalent structures, provision of and duration of supplemental oxygen and ventilation therapy, transfer to another hospital, as well as the impact of infection on daily activities following hospital discharge.
ETHICS AND DISSEMINATION
The study has been approved by the National Research Ethics Committee of Luxembourg (study number 202003/07) in April 2020. An informed consent is signed by study participants. Scientific articles will be submitted to international peer-reviewed journals, along with press releases for lay audience for major results.
TRIAL REGISTRATION NUMBER
NCT04380987.
简介
一些主要的临床因素，如性别、肥胖或合并症，已经与 COVID-19 的严重程度相关，但仍需要确定与严重程度相关的新的流行病学、临床、数字和生物学特征，并根据严重程度对患者进行深度表型分析。Predi-COVID 研究的目的是（1）确定 COVID-19 严重程度的新决定因素，（2）通过对参与者的家庭成员中的感染危险因素进行分层，根据并发症风险对患者进行深度表型分析（Predi-COVID-H 辅助研究）。
方法和分析
Predi-COVID 是一项前瞻性的混合队列研究，包括卢森堡确诊的 COVID-19 病例，这些病例将通过远程随访 1 年，监测其健康状况和症状。Predi-COVID-H 是对 Predi-COVID 中纳入的指数病例的家庭成员进行的辅助队列研究，以监测这一高危人群的症状和家庭聚集情况。将纳入最多 200 名 Predi-COVID 和 300 名 Predi-COVID-H 有生物样本的参与者。感染严重程度将通过住院、入住和入住重症监护病房或同等结构的时间、补充氧气和通气治疗的提供和持续时间、转院以及感染对出院后日常生活的影响来评估。
伦理和传播
该研究已于 2020 年 4 月获得卢森堡国家研究伦理委员会的批准（研究编号 202003/07）。研究参与者签署了知情同意书。科学文章将提交给国际同行评议期刊，并向广大受众发布主要结果的新闻稿。
试验注册号
NCT04380987。
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