跳至主要内容
临床试验/NCT04566965
NCT04566965终止不适用

Serology to Covid for Recording Exposures and Evaluating Needs (SCREEN)

Children's Hospital Medical Center, Cincinnati1 个研究点 分布在 1 个国家目标入组 232 人开始时间: 2020年8月18日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
232
试验地点
1
主要终点
The 12-month cumulative incidence of acquired COVID infection in the study cohort.

研究概览

简要总结

As the global and pandemic spread of the novel coronavirus (SARS-CoV-2, COVID-19) continues, many knowledge gaps remain with regard to the epidemiology and transmission of infection, as well as the normal immunological responses after viral exposure. Cincinnati had its first confirmed case of COVID-19 on March 14, 2020, and despite extensive shelter-in-place and social distancing efforts, community spread continues at over 150-200 new cases per week. As new residents and fellows arrive in July 2020 to Cincinnati Children's Hospital Medical Center (CCHMC), many of whom come from metropolitan areas across the country, it is imperative that investigators determine the current prevalence of infection, measure the cumulative incidence of infection over the next 12-24 months, investigate the normal antibody patterns after infection, and help elucidate what constitutes a protective immunological response. The investigators have a unique but time-limited opportunity to optimally track the epidemiology and natural history of SARS-CoV-2 infection among trainees at CCHMC, including risk factors for transmission and immunological recovery. SCREEN will investigate epidemiological and immunological features of SARS-CoV-2 virus infection within the cohort of CCHMC residents and fellows who have patient contact. By collecting and analyzing weekly serial samples for SARS-CoV-2 (nasal swab for virus by PCR) and monthly serological exposure (serum antibodies by ELISA), the investigators will determine the prevalence and cumulative incidence of infection by SARS-CoV-2; the investigators will also document the antibody responses over time and identify cases of apparent viral recrudescence or re-infection.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Current full-time residents and fellows at CCHMC
  • Cell phone that can be used for text messaging or web-based viewing of surveys
  • Willing and able to provide informed consent
  • Ability to comply with all study related evaluations and follow-up

排除标准

  • Any condition or illness that makes study participation ill-advised

结局指标

主要结局

The 12-month cumulative incidence of acquired COVID infection in the study cohort.

时间窗: Weekly for 12 months

Acquired COVID is defined as testing negative for COVID at baseline and having 1 or more weekly nasal swab samples testing positive for the virus by PCR.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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