A Wearable, Battery-free Screening System for SARS-CoV-2, the Virus Causing COVID-19 Infection

NCT04807075 | Terminated

• 1 other identifier: 0027-21-EP
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The corona virus disease (COVID) pandemic has highlighted the importance of rapid, readily available screeners and diagnostics to identify infected individuals. Recent studies have demonstrated that portable electronic nose sensing devices can detect volatile organic compounds (VOCs). These compounds are end products of human metabolism or of enteric bacteria and are excreted through the skin or exhaled breath. Importantly, the sensing devices can be adapted into a wearable device providing continuous monitoring. Our goal is to develop a battery-free, electronic nose sensor to serve as a screener and detect VOC patterns associated to patients with symptomatic and asymptomatic COVID-19 without being invasive. To test the screening ability, devices will be worn by COVID-19 positive and negative patients hospitalized at Nebraska Medicine.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• nose smell-print

  nose smell-print. This is recorded as a set of impedances, one from each sensor filament. This results in an 8-dimensional vector that will be recorded for each subject. The vectors will then be related to diagnostic category (SARS-CoV-2 positive vs. negative). This will be determined separately for each of the sensor devices.

  at enrollment

Secondary Outcomes (1)

• stability of smell print

  three days

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult (age \>18) subjects admitted to the hospital for possible COVID-19.

You may qualify if:

• °Admission for definite or suspected SARS-CoV-2 infection with mild to moderate symptoms and clinical features.
• If insufficient numbers of suspected cases who test negative, individuals admitted with other respiratory problems: COPD exacerbation, viral pneumonia, congestive heart failure who test negative for SARS-CoV-2 will be eligible as controls.
• Able to give informed consent.
• Access to a smartphone capable of downloading the study app and of collecting and transmitting study data.
• Ability to comply with study procedures.
• Ability to self-deploy the study devices and collect study data.

You may not qualify if:

• Inability to give informed consent.
• Allergic history to components of study devices,
• Inability to participate in study procedures.
• Severe disease or admission to a critical care unit.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Chad L Vokoun, MD

  UNMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 19, 2021
• Study Start: April 4, 2021
• Primary Completion: June 7, 2022
• Study Completion: June 7, 2022
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)