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临床试验/NCT05198869
NCT05198869Unknown不适用

SpotLight-19 Research and Development Study

Ottawa Hospital Research Institute4 个研究点 分布在 1 个国家目标入组 12,500 人开始时间: 2021年12月29日最近更新:
适应症

试验速览

阶段
不适用
入组人数
12,500
试验地点
4
主要终点
spectra indicative of COVID-19 infection

研究概览

简要总结

In this study, we will use the SpotLight-19 device in patients presenting to a coronavirus disease (COVID-19) Assessment Centre for polymerase chain reaction (PCR) testing. Consenting patients will undergo a Spotlight-19 scan. We will link the scan to PCR results, age, vaccination status, and COVID-19 symptoms in order to calibrate the SpotLight-19 prediction algorithm of a state of COVID-19 infection.

详细描述

Implementation of rapid, accessible, and accurate COVID-19 testing is a cornerstone of public health efforts to contain and respond to the spreading virus. To respond to this need, ISBRG Corp is applying its SpotLight-19 device to the challenge of developing a non-invasive screening test for COVID-19. The SpotLight-19 device is designed to use non-invasive visible and near-infrared (NIR) spectroscopic measurements of an individual's fingertip and an artificial intelligence technology platform calibrated using viral diagnostic measurements to identify and recognize a spectral fingerprint specific to COVID-19.

All individuals (3yrs or older) presenting to designated hospital COVID-19 Assessment Centres in Ottawa will be recruited to participate. Only people with extreme fingertip scarring will be excluded. Consenting participants will undergo a scan using the SpotLight-19 device - this includes a Fitzpatrick Skin Assessment and 10-20 second scans of the fingertip with the SpotLight-19 device. Following the scan participants will undergo a PCR test as per usual care. The PCR result, participant age, COVID-19 vaccination status, and presence of COVID-19 symptoms will be collected from the medical record and shared with ISBRG Corp. A minimum of 250 COVID-19 positive and a minimum of 250 COVID-19 negative as determined by PCR will be sought. The number of enrolled participants to achieve the sample size will depend on the COVID-19 positivity rate.

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

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

入选标准

  • Qualifies for COVID-19 testing as per Assessment Site protocol; or
  • Is capable of cooperating with testing
  • Is clinically stable such that the testing protocol may be completed safely

排除标准

  • Extreme fingertip scarring or other physical condition that prevents use of the device

结局指标

主要结局

spectra indicative of COVID-19 infection

时间窗: immediate upon scan

specific wavelengths of light that correlate with COVID-19 infection

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alan Forster

Principal Investigator

Ottawa Hospital Research Institute

研究点 (4)

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