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Terminated OBSERVATIONAL NCT05044780

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

Sponsor: National Cancer Institute (NCI)

Conditions COVID-19
Updated 33 times since 2021 Last updated: Apr 25, 2026 Started: Aug 30, 2022 Primary completion: Jan 31, 2025 Completion: Jan 31, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Slow/insufficient accrual

A observational or N/A phase clinical study on COVID-19, this trial is terminated or withdrawn. The trial is conducted by National Cancer Institute (NCI) and has accumulated 33 data snapshots since 2022. Infectious disease trials contribute critical data for public health response and treatment development.

Study Description(click to expand)

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...

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.

Status Flow

~Oct 2021 – ~Nov 2021 · 31 days · monthly snapshot~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshot~Dec 2021 – ~Jan 2022 · 31 days · monthly snapshot~Jan 2022 – ~Feb 2022 · 31 days · monthly snapshot~Feb 2022 – ~Mar 2022 · 28 days · monthly snapshot~Mar 2022 – ~Apr 2022 · 31 days · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Jan 2023 · 2 months · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~May 2023 · 3 months · monthly snapshot~May 2023 – ~Jun 2023 · 31 days · monthly snapshot~Jun 2023 – ~Jul 2023 · 30 days · monthly snapshot~Jul 2023 – ~Aug 2023 · 31 days · monthly snapshot~Aug 2023 – ~Sep 2023 · 31 days · monthly snapshot~Sep 2023 – ~Oct 2023 · 30 days · monthly snapshot~Oct 2023 – ~Jun 2024 · 8 months · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Nov 2024 · 31 days · monthly snapshot~Nov 2024 – ~Dec 2024 · 30 days · monthly snapshot~Dec 2024 – ~Jan 2025 · 31 days · monthly snapshot~Jan 2025 – ~Feb 2025 · 31 days · monthly snapshot~Feb 2025 – ~Apr 2025 · 59 days · monthly snapshot~Apr 2025 – ~May 2025 · 30 days · monthly snapshot~May 2025 – ~Sep 2025 · 4 months · monthly snapshot~Sep 2025 – ~Feb 2026 · 5 months · monthly snapshot~Feb 2026 – ~May 2026 · 3 months · monthly snapshotMay 4, 2026 – present · 12 days · daily API

Change History

33 versions recorded
  1. May 4, 2026 — Present [daily]

    Terminated

    Status: CompletedTerminated

  2. Feb 2026 — May 2026 [monthly]

    Completed

  3. Sep 2025 — Feb 2026 [monthly]

    Completed

    Status: RecruitingCompleted

  4. May 2025 — Sep 2025 [monthly]

    Recruiting

  5. Apr 2025 — May 2025 [monthly]

    Recruiting

Show 28 earlier versions
  1. Feb 2025 — Apr 2025 [monthly]

    Recruiting

  2. Jan 2025 — Feb 2025 [monthly]

    Recruiting

  3. Dec 2024 — Jan 2025 [monthly]

    Recruiting

  4. Nov 2024 — Dec 2024 [monthly]

    Recruiting

  5. Oct 2024 — Nov 2024 [monthly]

    Recruiting

  6. Sep 2024 — Oct 2024 [monthly]

    Recruiting

  7. Jul 2024 — Sep 2024 [monthly]

    Recruiting

  8. Jun 2024 — Jul 2024 [monthly]

    Recruiting

  9. Oct 2023 — Jun 2024 [monthly]

    Recruiting

  10. Sep 2023 — Oct 2023 [monthly]

    Recruiting

  11. Aug 2023 — Sep 2023 [monthly]

    Recruiting

  12. Jul 2023 — Aug 2023 [monthly]

    Recruiting

  13. Jun 2023 — Jul 2023 [monthly]

    Recruiting

  14. May 2023 — Jun 2023 [monthly]

    Recruiting

  15. Feb 2023 — May 2023 [monthly]

    Recruiting

  16. Jan 2023 — Feb 2023 [monthly]

    Recruiting

  17. Nov 2022 — Jan 2023 [monthly]

    Recruiting

  18. Sep 2022 — Nov 2022 [monthly]

    Recruiting

    Status: Not Yet RecruitingRecruiting

  19. Jul 2022 — Sep 2022 [monthly]

    Not Yet Recruiting

  20. Jun 2022 — Jul 2022 [monthly]

    Not Yet Recruiting

  21. May 2022 — Jun 2022 [monthly]

    Not Yet Recruiting

  22. Apr 2022 — May 2022 [monthly]

    Not Yet Recruiting

  23. Mar 2022 — Apr 2022 [monthly]

    Not Yet Recruiting

  24. Feb 2022 — Mar 2022 [monthly]

    Not Yet Recruiting

  25. Jan 2022 — Feb 2022 [monthly]

    Not Yet Recruiting

  26. Dec 2021 — Jan 2022 [monthly]

    Not Yet Recruiting

  27. Nov 2021 — Dec 2021 [monthly]

    Not Yet Recruiting

  28. Oct 2021 — Nov 2021 [monthly]

    Not Yet Recruiting

    First recorded

Eligibility 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.

Contact Information

Sponsor contact:
  • National Cancer Institute (NCI)
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .