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Hyperspectral Analysis of Sweat Metabolite Biometrics for Real-Time Detection of COVID-19
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.
Conditions:
🦠 COVID-19
🗓️ Study Start (Actual) 30 August 2022
🗓️ Primary Completion (Estimated) 1 February 2025
✅ Study Completion (Estimated) 1 February 2025
👥 Enrollment (Estimated) 120
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Bethesda, Maryland, United States
📍 Fairfax, Virginia, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

      Inclusion Criteria:

      • * Age \>=18 years.
      • * Eligible for one of the following cohorts:
      • * Cohort 1: Participants who sought medical attention for symptoms and tested positive for SARS-CoV-2 via standard of care molecular testing within 7 days of enrollment. Either antigen or PCR testing is acceptable.
      • * 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.
      • * 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.
Ages Eligible for Study: 18 Years to 120 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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 Registration Dates

  • First Submitted 14 September 2021
  • First Submitted that Met QC Criteria 14 September 2021
  • First Posted 16 September 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 25 June 2024
  • Last Update Posted 26 June 2024
  • Last Verified 24 June 2024
I'm interested ...!!