Hyperspectral Analysis of Sweat Metabolite Biometrics for Real-Time Detection of COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Hyperspectal Analysis
研究概览
简要总结
Background:
The COVID-19 pandemic has challenged the health systems worldwide. Many tools have been developed in response to the pandemic, but there is no current way to quickly screen multiple people for the disease. Research has shown that people with COVID-19 have higher levels of some proteins involved in the immune response and inflammation. These proteins can be detected in sweat using a special camera. Researchers want to see if analysis of sweat from fingerprints could be used to detect COVID-19 infection in people.
Objective:
To test a new technology to detect COVID-19 infection based on an analysis of sweat from fingerprints.
Eligibility:
Adults ages 18 and older who tested positive or negative for COVID-19 within the last 7 days.
Design:
Participants will visit the NIH Clinical Center for one day within 7 days from COVID-19 testing. The visit will last for 3 to 4 hours.
Participants who show symptoms for COVID-19 with a positive test will give blood samples to correlate with the sweat markers. About 1/2 tablespoon of blood will be drawn.
For sweat markers, 10 fingers will be imaged by a camera using a touchless system. This will be repeated 3 times. It will take about 15 minutes. Participants will use the device. They will get instructions and watch a short video on how to use the device.
详细描述
Background
The Coronavirus Disease 19 (COVID19) pandemic has challenged healthcare systems worldwide. Massive testing, contact tracing and social distancing proved to be the most effective tools to fight the pandemic prior to the development of vaccines.
Despite the effort to develop rapid diagnostic testing, we still don t have an available large population screening modality. Analysis of sweat metabolites from hyperspectral images of fingertips has the potential to be a valid clinic strategy to detect Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)infected individuals.
COVID19 has shown higher levels of inflammatory proteins like IL6, LDH, CRP, and d-dimer which have been implicated with severe COVID-19 induced pneumonitis and coagulopathy. These molecules can be detected as sweat metabolites and used as a biomarker for viral infection detection.
Objective
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •Eligible subjects must meet the following inclusion criteria:
- •Age >=18 years.
- •Eligible for one of the following cohorts:
- •Cohort 1: Participants who tested positive for SARS-CoV-2 via standard of care molecular testing within 7 days of enrollment. Either antigen or PCR testing is acceptable. Results from home tests are not accepted.
- •Cohort 2: Participants must have a standard of care molecular testing negative for SARS-CoV-2 done within 7 days of enrollment. Either antigen or PCR testing is acceptable for enrollment. Results from home tests are not accepted.
- •Ability of subject or Legally Authorized Representative (LAR) or Durable Power of Attorney (DPA) to understand and the willingness to sign a written informed consent document
排除标准
- •Subjects with the following characteristics will be excluded from the study:
- •Participants who have received remdesivir and/or dexamethasone for longer than 48 hours prior to hyperspectral imaging for the treatment of COVID
- •Participants who have received up to 48 hours of treatment will be eligible.
研究组 & 干预措施
Cohort 2/SARS-CoV-2 negative
Participants with molecular testing negative for SARS-CoV-2
Cohort 1/SARS-CoV-2 positive
Participants with molecular testing positive for SARS-CoV-2
结局指标
主要结局
Hyperspectal Analysis
时间窗: One day
Identify a pattern classifier to distinguish between SARS-CoV-2 positive (cohort 1) and SARS-CoV-2 negative (cohort 2) human subjects by hyperspectral analysis of sweat metabolites.
次要结局
未报告次要终点