COVID-19NCT05044780
Hyperspectral Analysis of Sweat Metabolite Biometrics for Real-Time Detection of COVID-19
An observational study of COVID-19, run by National Cancer Institute (NCI) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- COVID-19
- How many people
- 66 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Aug 2022to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
INOVA Fairfax Medical Campus
Fairfax, Virginia, 22031
About this study
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.
Read more
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.
Read the 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.
- Conditions
- COVID-19
- Keywords
- camera, IL6, D-dimer, Coronavirus, SAR-COV-2, Natural History
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start30 Aug 2022
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Why it stopped: Slow/insufficient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- James L Gulley, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044780
- Sponsor's protocol ID
- 10000178
- Other IDs
- 000178-C
- Status last verified
- Apr 2026
- First submitted
- 14 Sep 2021
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperspectral Analysis of Sweat Metabolite Biometrics for Real-Time Detection of COVID-19
- ClinicalTrials.gov ID
- NCT05044780
- Acronym / sponsor ID
- 10000178
- Conditions
- COVID-19
- Keywords
- camera, IL6, D-dimer, Coronavirus, SAR-COV-2, Natural History
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow/insufficient accrual
- Enrolment
- 66 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Age >=18 years.
- Eligible for one of the following cohorts:
- 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
Key exclusion criteria (2 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Slow/insufficient accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James L Gulley, M.D. principal investigator
National Cancer Institute (NCI)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by National Cancer Institute (NCI) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow/insufficient accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hyperspectal Analysis (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.