Background:The COVID-19 pandemic has challenged the health systems worldwide. Many tools have beendeveloped in response to the pandemic, but there is no current way to quickly screenmultiple people for the disease. Research has shown that people with COVID-19 have higherlevels of some proteins involved in the immune response and inflammation. These proteinscan be detected in sweat using a special camera. Researchers want to see if analysis ofsweat 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 fromfingerprints.Eligibility:Adults ages 18 and older who tested positive or negative for COVID-19 within the last 7days.Design:Participants will visit the NIH Clinical Center for one day within 7 days from COVID-19testing. The visit will last for 3 to 4 hours.Participants who show symptoms for COVID-19 with a positive test will give blood samplesto 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. Thiswill be repeated 3 times. It will take about 15 minutes. Participants will use thedevice. They will get instructions and watch a short video on how to use the device.
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
Identify a pattern classifier to distinguish between SARS-CoV-2 positive and SARS-CoV-2
negative human subjects by analysis of sweat metabolites from hyperspectral images of
fingertips.
Eligibility
Individuals must all be >=18 years old
Must have standard of care molecular testing (either antigen or PCR) for SARS-CoV-2
within 7 days from study enrollment. Those individuals who tested positive will be
enrolled in cohort 1 and those who tested negative will be enrolled in cohort 2
Study Design
This is an exploratory multisite study to evaluate the use of biometric analysis of sweat
metabolites from hyperspectral images of fingertips to detect SARS-CoV-2 infection.
Center for Cancer research (CCR), NCI will be the coordinating center.
All adult subjects that have available testing for SARS-CoV-2 completed within 7 days
from the study enrollment are eligible for this study. The study will have two cohorts,
cohort 1 (SARS-CoV-2 positive), and cohort 2 (SARS-CoV-2 negative). Fifty participants
will be enrolled in each cohort to have hyperspectral imaging of the fingertips.
Every participant will have the right and left index fingers imaged by the camera with a
touchless system. The imaging will be repeated three times. This imaging will take about
10 minutes.
The data obtained by the digital analysis will be compared to the result of the standard
SARS-CoV-2 tests in use at the enrolling sites.
- 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
EXCLUSION CRITERIA:
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 COVID19. Participants who have
received up to 48 hours of treatment will be eligible.
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
INOVA Fairfax Medical Campus
Fairfax, Virginia, United States
Katherine O Lee-Wisdom, R.N.
(240) 858-3525
katherine.lee-wisdom@nih.gov
James L Gulley, M.D.
(301) 480-7164
gulleyj@mail.nih.gov
James L Gulley, M.D., Principal Investigator
National Cancer Institute (NCI)