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

April 25, 2026 updated by: National Cancer Institute (NCI)

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.

Study Overview

Status

Terminated

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Inova Fairfax Medical Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hyperspectal Analysis
Time Frame: 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.
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: James L Gulley, M.D., National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2022

Primary Completion (Actual)

January 31, 2025

Study Completion (Actual)

January 31, 2025

Study Registration Dates

First Submitted

September 14, 2021

First Submitted That Met QC Criteria

September 14, 2021

First Posted (Actual)

September 16, 2021

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 25, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10000178
  • 000178-C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD recorded in the medical record will be shared with intramural investigators upon request.

IPD Sharing Time Frame

Clinical data available during the study and indefinitely.

IPD Sharing Access Criteria

Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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