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.
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.
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DOI：
10.1136/bmjopen-2020-041834
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发表时间：
2020-11-23
期刊：
影响因子：
2.9
通讯作者：
Huiart L
中科院分区：
文献类型：
--
作者：
Fagherazzi G;Fischer A;Betsou F;Vaillant M;Ernens I;Masi S;Mossong J;Staub T;Brault D;Bahlawane C;Rashid MA;Ollert M;Gantenbein M;Huiart L
性别、肥胖或合并症等少数主要临床因素已经与COVID-19严重程度相关，但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;及（2）根据并发症风险以及Predi-COVID参与者家庭成员中的感染风险因素对患者进行分层，从而对患者进行深入的表型分析（Predi-COVID-H辅助研究）。Predi-COVID是一项前瞻性混合队列研究，由卢森堡实验室确诊的COVID-19病例组成，将对这些病例进行1年的远程随访，以监测其健康状况和症状。Predi-COVID-H是一项针对Predi-COVID指数病例家庭成员的辅助队列研究，旨在监测这一高风险人群的症状和家庭聚集性。将纳入最多200名Predi-COVID和300名Predi-COVID-H参与者的子队列，并提供生物样本。将通过住院的发生率和持续时间、重症监护室或同等机构的入院和住院时间、辅助供氧和通气治疗的提供和持续时间、转移到另一家医院以及出院后感染对日常活动的影响来评价感染的严重程度。该研究已于2020年4月获得卢森堡国家研究伦理委员会批准（研究编号202003/07）。研究参与者签署知情同意书。科学文章将提交给国际同行评审期刊，沿着向非专业读者发布主要结果的新闻稿。 NCT 04380987。
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). 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. 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. NCT04380987.
DOI：
10.31478/202003b
发表时间：
2020-01-01
期刊：
NAM perspectives
影响因子：
--
作者：
Hick, John L;Hanfling, Dan;Pavia, Andrew T
通讯作者：
Pavia, Andrew T
影响因子：
158.5
作者：
Beigel, John H.;Tomashek, Kay M.;Lane, H. Clifford
通讯作者：
Lane, H. Clifford