跳至主要内容
临床试验/NCT05052580
NCT05052580已完成不适用

Test to Stay in School: COVID-19 Testing Following Exposure in School Communities

Duke University2 个研究点 分布在 1 个国家目标入组 4,733 人开始时间: 2021年10月1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
4,733
试验地点
2
主要终点
Number of Students With Positive COVID-19 Test Following Known Within-school Exposure.

研究概览

简要总结

Participants in school communities who have been exposed to SARS-CoV-2 will be tested for COVID-19 on the day of exposure (day 1) and at days 3, 5, and 7 following initial known exposure. Mitigation practices including masking, the context of exposure (classroom, school bus, after school sporting event, lunch, etc.), and results of COVID-19 test will be documented.

详细描述

This is a prospective, interventional study with a primary objective of evaluating severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission following exposure in Kindergarten through 12th grade schools. Participants will be tested with a COVID-19 testing kit that is Food and Drug Administration (FDA)-authorized under an emergency use authorization (EUA) for non-prescription use for both symptomatic and asymptomatic evaluation in children and adults. Participants who consent to participate in this study will be tested at days 1, 3, 5, and 7 following a known COVID-19 exposure on day 0. If a participant does not know of the exposure until more than one day following they exposure, they will be tested on the day they become aware of the exposure and then resume the aforementioned testing schedule (e.g. participant identifies exposure 3 days after the exposure, test on day 3, day 5, and day 7).

If the COVID-19 tests are negative, the participant will remain in the school environment. A positive COVID-19 test or the development of symptoms on any day after exposure would require isolation according to school, local and state guidelines. Demographic information, daily presence or absence of symptoms, whether the infected person or close contact was masked, setting of the exposure, test results, and school absences will be collected following consent. Data regarding school level mitigation practices will also be collected. Data collected from this study may be combined with school-provided data and publically available community data.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Consent completed
  • Child or adult that is part of a school community
  • Known exposure to SARS-CoV-2 in the school setting (e.g. school bus, classroom, school sporting event, etc.)

排除标准

  • 未提供

结局指标

主要结局

Number of Students With Positive COVID-19 Test Following Known Within-school Exposure.

时间窗: up to day 7 following a known COVID-19 exposure on day 0

Number of Staff With Positive COVID-19 Tests Following Known Within-school Exposure.

时间窗: up to day 7 following a known COVID-19 exposure on day 0

Number of Exposed Participants (as Measured by Nurse Report) Undergoing the Test-to-stay Protocol That Result in Additional Transmission.

时间窗: up to day 7 following a known COVID-19 exposure on day 0

Exposures That Result in Additional Transmission (TAR = # of positives in TTS close contacts, out of all TTS close contacts)

Time (in Days) to Test Positivity (Reported as a Mean) Among Those Exposed to SARS-CoV-2 and Undergoing the Test-to-stay Protocol.

时间窗: up to day 7 following a known COVID-19 exposure on day 0

次要结局

  • Number of Unmasked Staff Who Were Exposed From Masked Compared to Unmasked Individuals.(up to day 7 following a known COVID-19 exposure on day 0)
  • Number of Students With Positive COVID-19 Test After Athletic vs. Classroom Exposure.(up to day 7 following a known COVID-19 exposure on day 0)
  • Total Number of School Days Missed Due to Quarantine After SARS-CoV-2 Exposure, Reported as a Mean.(up to day 7 following a known COVID-19 exposure on day 0)
  • Number of Students With Positive COVID-19 Test After Indoor vs. Outdoor Exposure.(up to day 7 following a known COVID-19 exposure on day 0)
  • Number of Masked Staff Who Were Exposed From Masked Compared to Unmasked Individuals.(up to day 7 following a known COVID-19 exposure on day 0)
  • Number of Students With Positive COVID-19 Test After Bus vs. Classroom Exposure.(up to day 7 following a known COVID-19 exposure on day 0)
  • Total Number of School Days Missed Due to Isolation After Positive COVID-19 Test, Reported as a Mean.(up to day 7 following a known COVID-19 exposure on day 0)
  • Number of Masked Students Who Were Exposed From Masked Versus Unmasked Individuals.(up to day 7 following a known COVID-19 exposure on day 0)
  • Number of Unmasked Students Who Were Exposed From Masked Compared to Unmasked Individuals.(up to day 7 following a known COVID-19 exposure on day 0)
  • Total Number of School Days Missed Due to Symptoms After Exposure, Reported as a Mean.(up to day 7 following a known COVID-19 exposure on day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Test to Stay in School: COVID-19 Testing Following... | 临床试验