Hyperspectral Analysis of Sweat Metabolite Biometrics for Real-Time Detection of COVID-19

NCT05044780 | Terminated

• 2 other identifiers: 10000178000178-C
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

COVID-19

Keywords

camera; IL6; D-dimer; Coronavirus; SAR-COV-2; Natural History

Outcome Measures

Primary Outcomes (1)

• Hyperspectal Analysis

  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.

  One day

Study Arms (2)

Cohort 1/SARS-CoV-2 positive

Participants with molecular testing positive for SARS-CoV-2

Cohort 2/SARS-CoV-2 negative

Participants with molecular testing negative for SARS-CoV-2

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will consist of two cohorts and each cohort will enroll 50 participants. Cohort 1 will enroll symptomatic participants who sought medical attention and tested positive for SARS-CoV-2, and Cohort 2 will enroll asymptomatic participants with a negative SARS-CoV-2 test.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

INOVA Fairfax Medical Campus

Fairfax, Virginia, 22031, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• James L Gulley, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: September 16, 2021
• Study Start: August 30, 2022
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.

Locations

US (2)