CoVPN 5002: SARS-CoV-2 Prevalence Study -Supplement Request

摘要 拟议的研究CoVPN 5002将直接有助于SARS-CoV-2的准备工作 疫苗和其他COVID-19预防和治疗研究，通过确定 SARS-CoV-2感染和高风险个体样本中的血清阳性率以及 普通民众。这项研究将确定儿童和成人在多大程度上 研究社区有SARS-CoV-2感染或既往SARS-CoV-2感染的证据（基于 抗体测试、自我报告和医疗记录）。此外，关于参与者的家庭成员 COVID样疾病和死亡，结合参与者的血清学数据，也可能提供 关于家庭内传播动态的信息。调查问卷数据将为估计提供信息 不同年龄组的个人，包括儿童，谁可能有一个 无症状COVID-19感染者。儿童感染的频率以及儿童是否 在社区传播中的重要作用知之甚少。该研究还估计， SARS-CoV-2血清阳性率与医学共病的相关性， 严重的疾病结果，并确定与感染相关的人口和社会风险因素。 最后，这项研究将提供有关SARS-CoV-2传播、COVID-19 疾病、对遏制和缓解措施的态度和采取、种族和民族健康 按主要人口统计的不平等、获得检测和公共卫生资源的机会不同 指标，新的预防和治疗战略的前景，并告知数学模型， 疾病进展和未来COVID-19风险预测。 HPTN SDMC位于西雅图的弗雷德哈钦森癌症研究中心， 该机构的优势，其中还包括HVTN SDMC的优势。HPTN SDMC 拥有在全球临床试验的设计，实施和分析方面经验丰富的生物统计学教师， 监督研究，通过在统计设计、试验实施和 分析，并根据需要制定和实施创新的统计方法， 以科学目标为导向。SDMC提供符合法规的数据管理 其实施的所有试验的功能，包括直接从研究中心采集电子数据， 现场、实验室标本和分析结果的整合以及电子参与者报告 结果。

Abstract The proposed research, CoVPN 5002, will directly contribute to preparedness for SARS-CoV-2 vaccine and other COVID-19 prevention and treatment studies by determining the prevalence of SARS-CoV-2 infection and seroprevalence among samples of individuals at elevated risk as well as the general population. This research will determine the extent to which children and adults in the study communities have SARS-CoV-2 infection or evidence of prior SARS-CoV-2 infection (based on antibody tests, self-report, and medical records). Additionally, about participants’ household members with COVID-like illness and deaths, combined with serologic data from participants, may also provide information about transmission dynamics within households. Questionnaire data will inform estimates of the percent of individuals of different age groups, including children, who may have had an asymptomatic COVID-19 infection. The frequency of infection among children and whether children play an important role in community transmission is poorly understood. The study will also estimate the association of SARS-CoV-2 seroprevalence with medical co-morbidities associated with more severe disease outcomes and identify demographic and social risk factors associated with infection. Finally, this research will provide important information about SARS-CoV-2 transmission, COVID-19 disease, attitudes about and uptake of containment and mitigation measures, racial and ethnic health disparities, varied access to testing and public health resources by key demographic indicators, prospects for new prevention and treatment strategies, and inform mathematical models of disease progression and projection of future COVID-19 risk. The HPTN SDMC, housed at the Fred Hutchinson Cancer Research Center in Seattle, takes advantage of the strengths of the institution, which also includes the HVTN SDMC. The HPTN SDMC has faculty biostatisticians experienced in the design, conduct and analysis of global clinical trials and surveillance studies, who support research through leadership in statistical design, trial conduct and analysis, and development and implementation of innovative statistical methods as needed and motivated by the scientific goals. The SDMC provides regulatory compliant data management functions for all trials it implements, including electronic data capture directly from research sites or the field, integration of laboratory specimens and assay results, and electronic participant reported outcomes.