Protocol Details
Hyperspectral Analysis of Sweat Metabolite Biometrics for Real-Time Detection of COVID-19
This study is NOT currently recruiting participants.
Summary
Number | 000178-C |
Sponsoring Institute | National Cancer Institute (NCI) |
Recruitment Detail | Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: 120 Years |
Referral Letter Required | No |
Population Exclusion(s) | Children |
Keywords | camera;
IL6;
D-dimer;
Coronavirus;
SAR-COV-2;
Natural History |
Recruitment Keyword(s) | None |
Condition(s) | COVID-19 |
Investigational Drug(s) | None |
Investigational Device(s) | None |
Intervention(s) | None |
Supporting Site | National Cancer Institute |
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.
Eligibility
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.
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT05044780