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

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Not yet recruiting
CT.gov ID
NCT05044780
Collaborator
(none)
100
Enrollment
2
Locations
10.4
Anticipated Duration (Months)
50
Patients Per Site
4.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase

    Detailed Description

    Background

    The new COVID19 pandemic has challenged the health system worldwide. Massive testing contact tracing and social distancing proved to be the most effective tools to fight the pandemic in absence of an effective vaccine.

    Despite the effort to develop rapid diagnostic testing, we still don t have an available large population screening modality. Hyperspectral analysis of sweat metabolites from fingerprint has the potential to be a valid clinic strategy to detect COVID19 infected individuals.

    COVID19 infection 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 COVID19 positive and COVID19 negative human subjects by hyperspectral analysis of sweat metabolites.

    Eligibility

    Individuals must all be >=18 years old

    Must have standard of care molecular testing for COVID19 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 to detect COVID19 infection. Center for Cancer research (CCR), NCI will be the coordinating center.

    All adult subjects that have available testing for COVID-19 completed within 7 days from the study enrollment are eligible for this study. The study will have two cohorts, cohort 1 (COVID19 positive), and cohort 2 (COVID19 negative). Fifty participants will be enrolled in each cohort to receive additional COVID19 testing based on the hyperspectral analysis of fingerprint sweat metabolites.

    Every participant will have all ten fingers imaged by the camera with a touchless system. The ten fingers imaging will be repeated three times. This imaging will take about 15 minutes.

    The hyperspectral instruments will be used directly by the participants without any additional human resources to carry out this data collection.

    The data obtained by the digital analysis will be compared to the result of the standard COVID19 test in use at the National Institute of Health and Inova Fairfax Medical Campus.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Hyperspectral Analysis of Sweat Metabolite Biometrics for Real-Time Detection of COVID-19
    Anticipated Study Start Date :
    Oct 20, 2021
    Anticipated Primary Completion Date :
    Sep 1, 2022
    Anticipated Study Completion Date :
    Sep 1, 2022

    Arms and Interventions

    ArmIntervention/Treatment
    Cohort 1/COVID19 positive

    Participants with molecular testing positive for COVID19

    Cohort 2/COVID19 negative

    Participants with molecular testing negative for COVID19

    Outcome Measures

    Primary Outcome Measures

    1. Hyperspectal Analysis [One day]

      Identify a pattern classifier to distinguish between COVID19 positive (cohort 1) and COVID 19 negative (cohort 2) human subjects by hyperspectral analysis of sweat metabolites.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • INCLUSION CRITERIA:
    Eligible subjects must meet the following inclusion criteria:
    • Age >=18 years.

    • Must have a standard of care molecular testing positive for COVID19 to be enrolled in cohort 1 or a standard of care molecular testing negative for COVID19 to be enrolled in cohort 2 done within 7 days

    • Ability of subject or Legally Authorized Representative (LAR) 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 started on treatment with remdesivir and/or dexamethasone for the treatment of COVID19

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1National Institutes of Health Clinical CenterBethesdaMarylandUnited States20892
    2INOVA Fairfax HospitalFalls ChurchVirginiaUnited States22042

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT05044780
    Other Study ID Numbers:
    • 10000178
    • 000178-C
    First Posted:
    Sep 16, 2021
    Last Update Posted:
    Oct 15, 2021
    Last Verified:
    Sep 13, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Cancer Institute (NCI)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 15, 2021