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临床试验/NCT04831866
NCT04831866已完成不适用

Coronavirus Disease 2019 (COVID-19) Surveillance and Exposure Testing in School Communities

Duke University2 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2021年4月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4,000
试验地点
2
主要终点
Describe return to school outcomes in Kindergarten through 12th grade schools in Exposure Cohort.

研究概览

简要总结

This is a prospective, observational study of COVID-19 surveillance and exposure testing in school communities. Participating school communities are providing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) tests to students and staff at their schools per school, local, and national guidelines. This study will combine data received from the schools with data collected directly from participants to guide analysis of the co-primary objectives. Participants will be grouped into two different cohorts, depending on each school's SARS-CoV-2 test administration practices.

Surveillance Cohort: Schools participating in this cohort will be performing surveillance testing weekly on approximately 10-20% of students and 100% of staff.

Exposure Cohort: Schools participating in this cohort will be performing exposure testing on students and staff who have been identified as having close contact with school members diagnosed with SARS-CoV-2 infection.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Data from all participating school communities will be included in this study (no inclusion/exclusion criteria will be assessed).

排除标准

  • 未提供

结局指标

主要结局

Describe return to school outcomes in Kindergarten through 12th grade schools in Exposure Cohort.

时间窗: 2 years

Mean time to return-to-school after SARS-CoV-2 exposure in the month after initiation of the school-provided testing program compared to the month prior to initiation of the school-provided testing program.

Evaluate secondary transmission/prevalence of SARS-CoV-2 in Kindergarten through 12th grade schools in the Exposure Cohort.

时间窗: 2 years

Proportion of students/staff with positive SARS-CoV-2 test following within-school exposure.

Describe return to school outcomes in Kindergarten through 12th grade schools in Surveillance Cohort.

时间窗: 2 years

Proportion of students who return to in-person education in Fall 2021, Spring 2022, and Fall 2022 from participating schools conducting surveillance testing compared to districts without testing.

Evaluate secondary transmission/prevalence of SARS-CoV-2 in Kindergarten through 12th grade schools in the Surveillance Cohort.

时间窗: 2 years

Proportion of students/staff with positive SARS-CoV-2 test identified by surveillance testing.

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 (2)

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