Using sweat analysis to detect COVID-19 infection
Hyperspectral Analysis of Sweat Metabolite Biometrics for Real-Time Detection of COVID-19
This study is testing a new way to detect COVID-19 by looking at sweat from fingerprints to see if it can tell if someone is infected or not.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 177 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 2 sites (Bethesda, Maryland and 1 other locations) |
| Trial ID | NCT05044780 on ClinicalTrials.gov |
What this trial studies
This study aims to explore a novel method for detecting COVID-19 by analyzing sweat metabolites from fingerprints using hyperspectral imaging technology. Participants aged 18 and older, who have tested positive or negative for COVID-19 within the last week, will be enrolled in two cohorts. The study will involve a single visit to the NIH Clinical Center, where blood samples will be collected from symptomatic participants with positive tests to correlate with sweat analysis results. The goal is to identify a pattern classifier that can distinguish between SARS-CoV-2 positive and negative individuals based on their sweat biometrics.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone standard molecular testing for COVID-19 within the last 7 days.
Not a fit: Patients who have received remdesivir or dexamethasone for more than 48 hours prior to imaging may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a rapid and non-invasive method for screening large populations for COVID-19.
How similar studies have performed: While the use of sweat analysis for disease detection is a novel approach, similar studies have shown promise in other contexts, but this specific method for COVID-19 detection is largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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.
Where this trial is running
Bethesda, Maryland and 1 other locations
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
- INOVA Fairfax Medical Campus — Fairfax, Virginia, United States (Completed)
Study contacts
- Principal investigator: James L Gulley, M.D. — National Cancer Institute (NCI)
- Study coordinator: Katherine O Lee-Wisdom, R.N.
- Email: katherine.lee-wisdom@nih.gov
- Phone: (240) 858-3525
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.