Covid19NCT04807075
A Wearable, Battery-free Screening System for SARS-CoV-2, the Virus Causing COVID-19 Infection
An observational study of Covid19, run by University of Nebraska at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Covid19
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2021to 7 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult (age >18) subjects admitted to the hospital for possible COVID-19.
Who may be able to join
- °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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
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.
Read the detailed description
Purpose. This study will assess the feasibility of using an electronic nose to detect signals indicating infection with severe acute respiratory distress syndrome corona virus-2 (SARS-CoV-2). Five different prototypes of electronic nose will be used that would be deployed differently: 1) a patch, 2) clipped to a garment neckline, 3) clipped to a garment waistline, 4) resting on a bedside table, and 5) integrated into a facemask. Data will be collected over a three day period to determine the quality of the smell-print signals collected by the different deployment regimes. Eligibility. Subjects admitted to University of Nebraska Medical Center (UNMC) with definite or suspected SARS-CoV-2 infection will be eligible. Subjects must have access to a smart phone and be well enough to engage in the active data collection. The goal is to enroll 30 SARS-CoV-2 infected and 30 uninfected individuals. Eligibility of controls will be extended to patients admitted to UNMC with other respiratory problems including chronic obstructive pulmonary disease (COPD) exacerbation, pneumonia and congestive heart failure if needed. Adults (19 years and older) are eligible. Subjects with allergic reactions to components of the devices will be excluded. Interventions and evaluations. Informed consent will be obtained remotely following which an app will be downloaded to their phone. A kit will be delivered to the patients room containing the five devices. The app will support: instruction on use of the devices, reminders to collect data every 2 hours between 08:00 and 20:00, and access to study personnel for support as needed. The app will transmit smell prints from the 5 devices to a secure cloud-based database. The study coordinator will oversee subject education and deployment of the devices by phone/facetime. Subjects will be instructed on use of the devices, which they will self-deploy in positions that do not interfere with any medical equipment. The patch, clip-ons and bedside sensor will be worn continuously from 08:00 to 20:00. The mask will be placed for 5 minutes before each data collection, which will be timed by the phone app. The mask can then be removed until the next data collection. Smell-print data will be collected for three days. Following this, the devices will be replaced into the kit box and collected by the nursing staff. Clinical data will be collected from the electronic health record. Follow up. Following completion of the study, subjects will be asked to complete a brief questionnaire on the experience and asked about their willingness to be contacted for further interviews.
- Conditions
- Covid19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at enrollment
Secondary outcomes (1)
stability of smell print
8-dimensional smell prints will be recorded at approximately 2 hour intervals for waking hours over three days.
Measured: three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start4 Apr 2021
- Primary completion7 Jun 2022
- Study completion7 Jun 2022
Why it stopped: Failure to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chad L Vokoun, MD, Principal investigator, UNMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807075
- Sponsor's protocol ID
- 0027-21-EP
- Status last verified
- Sep 2024
- First submitted
- 17 Mar 2021
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Wearable, Battery-free Screening System for SARS-CoV-2, the Virus Causing COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04807075
- Acronym / sponsor ID
- 0027-21-EP
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Failure to recruit
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 4 Apr 2021 (actual)
- Primary completion
- 7 Jun 2022 (actual)
- Study completion
- 7 Jun 2022 (actual)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose. This study will assess the feasibility of using an electronic nose to detect signals indicating infection with severe acute respiratory distress syndrome corona virus-2 (SARS-CoV-2). Five different prototypes of electronic nose will be used that would be deployed differently: 1) a patch, 2) clipped to a garment neckline, 3) clipped to a garment waistline, 4) resting on a bedside table, and 5) integrated into a facemask. Data will be collected over a three day period to determine the quality of the smell-print signals collected by the different deployment regimes. Eligibility. Subjects admitted to University of Nebraska Medical Center (UNMC) with definite or suspected SARS-CoV-2 infection will be eligible. Subjects must have access to a smart phone and be well enough to engage in the active data collection. The goal is to enroll 30 SARS-CoV-2 infected and 30 uninfected individuals. Eligibility of controls will be extended to patients admitted to UNMC with other respiratory problems including chronic obstructive pulmonary disease (COPD) exacerbation, pneumonia and congestive heart failure if needed. Adults (19 years and older) are eligible. Subjects with allergic reactions to components of the devices will be excluded. Interventions and evaluations. Informed consent will be obtained remotely following which an app will be downloaded to their phone. A kit will be delivered to the patients room containing the five devices. The app will support: instruction on use of the devices, reminders to collect data every 2 hours between 08:00 and 20:00, and access to study personnel for support as needed. The app will transmit smell prints from the 5 devices to a secure cloud-based database. The study coordinator will oversee subject education and deployment of the devices by phone/facetime. Subjects will be instructed on use of the devices, which they will self-deploy in positions that do not interfere with any medical equipment. The patch, clip-ons and bedside sensor will be worn continuously from 08:00 to 20:00. The mask will be placed for 5 minutes before each data collection, which will be timed by the phone app. The mask can then be removed until the next data collection. Smell-print data will be collected for three days. Following this, the devices will be replaced into the kit box and collected by the nursing staff. Clinical data will be collected from the electronic health record. Follow up. Following completion of the study, subjects will be asked to complete a brief questionnaire on the experience and asked about their willingness to be contacted for further interviews.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (age >18) subjects admitted to the hospital for possible COVID-19.
Key inclusion criteria (6 listed)
- °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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
nose smell-print
Time frame: at enrollment
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.
1 secondary outcome
stability of smell print
Time frame: three days
Results and safety
The study was stopped early (reason given: Failure to recruit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chad L Vokoun, MD principal investigator
UNMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Failure to recruit). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nose smell-print (time frame: at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.