Wearable Diagnostic for Detection of COVID-19 Infection

An observational study of COVID-19, run by ClinOne, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The goals of this study are 1) to validate the use of a wearable diagnostic capability and software as a medical device (SaMD) algorithm for the pre or early-symptomatic detection of COVID-19 infection, 2) assess the wearable device on the subjects, and 3) ensure data are collected, securely stored, and easily read… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: COVID-19
Type of treatment: Vaccines
How many people: 790 participants
Where: 1 siteUnited States
Study dates: 21 Dec 2020to 15 Jan 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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Cohort 1- Exposed/Early Symptomatic Group All adult subjects seeking a COVID-19 test and meeting enrollment criteria will be offered enrollment into this study. The Inclusion Criteria are: 1. Adults - 18 years of age and older 2. Both genders, all races and ethnic groups 3. English speaking adult subjects only Cohort 2- Vaccine Group: Potential subjects seeking the mRNA-based Pfizer/BioNTech and Moderna vaccine 1. Subjects who are scheduled to receive the COVID vaccination series through local and national clinics, health systems and pharmacies. 2. Subjects who become aware of the study through public notices, postings, and advertisements, and other marketing efforts.

Who may be able to join

age 18 or older;
able to follow the study device wear instructions per the Instructions for Use;
no positive viral test within 60 days prior to enrollment; and
willing and able to provide written, informed consent.
Subjects seeking the mRNA-based Pfizer/BioNTech and Moderna vaccine series are eligible for the study if they are:
Age 18 or older; 12 years of age -17 years of age are approved to participate in the vaccine Cohort portion of the study.

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scheduled to receive their first and second dose of the Pfizer/BioNTech or Moderna COVID-19 vaccine
able to follow the study device wear instructions per the Instructions for Use;
no positive viral test within 60 days prior to enrollment; and
willing and able to provide written, informed consent.
Willing and able to take an oral temperature

Who cannot join

pregnant or breastfeeding;
wearing a defibrillator or pacemaker;
known or suspected cardiac dysrhythmias
known or suspected allergy to adhesives;
chronic daily use of non-steroidal anti-inflammatory medications (NSAIDs) and antipyretic medications
open wounds or infected, irritated, scarred, or inflamed areas of skin on the upper chest preventing placement of the biosensor; and

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current or planned use of either an investigation pharmaceutical or an investigational device during the study.
Cohort 1- Vaccine Group
Potential subjects seeking the mRNA-based Pfizer/BioNTech and Moderna vaccine series will be excluded from the study if they are or have any of the following:
pregnant or breastfeeding;
wearing a defibrillator or pacemaker;
known or suspected cardiac dysrhythmias
known or suspected allergy to adhesives;
chronic daily use of non-steroidal anti-inflammatory medications (NSAIDs) and antipyretic medications
open wounds or infected, irritated, scarred, or inflamed areas of skin on the upper chest preventing placement of the biosensor; and
current or planned use of either an investigation pharmaceutical or an investigational device during the study.
previously fully vaccinated subjects

Trial locations and contacts

1 site in 1 country.

United States1 site

ClinOne, Inc
Greenwood Village, Colorado, 80111

Other trials in United States

About this study

Read the detailed description

This is an open label iterative study designed to calibrate the algorithm to maximize its test characteristics. The sample size is derived from the minimum number of COVID-19 subjects required to evaluate algorithm sensitivity and specificity. A sample size of 200 true positive COVID-19 infections is anticipated to assess device predictive analytics. Assuming a six-month enrollment period, a 15 percent patient lost to follow-up rate, and a positive COVID-19 infection rate of 10 percent within the study population, a sample size of 2,352 subjects will be enrolled in this prospective study.

Primary Outcomes: The primary outcomes of interest are performance of the BioSticker multiparameter vital signs wearable and the sensitivity of the BioCloud-based algorithms in detecting early onset of active COVID-19 related signs and symptom in subjects prior to or coincident with a positive COVID-19 diagnostic test and the specificity of the BioSticker algorithms in distinguishing positive diagnosis of infection from negative diagnosis of infection among subjects. COVID-19 infection will be confirmed by both participant affirmation and diagnostic laboratory testing. Additional primary outcome is the intuitive presentation of affirmative diagnostic results from the BioSticker early detection algorithm(s).

Secondary Outcomes: The secondary outcomes of interest include correlation of biometric data indicators to individual-level experiential feedback reported through participant symptom-tracking and diagnostic questionnaires.

Conditions: COVID-19
Keywords: Recent known exposure to COVID-19, Asymptomatic, Early COVID-19 Symptoms
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04742569
Study group	Role	What they receive
Cohort 1- Exposed/Early Symptomatic		The population identified for this study includes subjects who request COVID-19 testing in response to a concern for recent COVID-19 exposure and/or concern of COVID-19-like related symptoms. We will recruit and enroll patients through public facing websites, clinic and pharmacy vaccination schedules and on-site vaccination marketing. For the population with recent COVID-19 exposure and/or concern of COVID-19-like related symptoms, population identification includes subjects who visit eTrueNorth's https://www.doineedacovid19test.com/ website where subjects have access to over 7,500 testing site locations across the nation. Otherwise, individuals seeking COVID-19 testing will be directed to the ClinOne, Inc. website for information regarding the Wearable Diagnostic for Detection of COVID-19 Infection study contact information for study participation, enrollment into the study using eConsent, and will receive a BioSticker wearable kit by express mail the next day.
CoHort 2- Pfizer or Moderna Vaccine		Secondly, the other population identified for this study includes subjects who are scheduled for the first and second dose of the mRNA-based Pfizer/BioNTech and Moderna vaccine series. For the population seeking the mRNA-based Pfizer/BioNTech and Moderna vaccine series, we will recruit and enroll patients through public-facing websites, clinic, and pharmacy vaccination schedules, and on-site vaccination marketing

What is being measured

The primary outcome is the main question the study is designed to answer.

The primary outcome of interest are performance of the BioSticker, a medical grade multi-parameter wearable biosensor.
Biometric data will be measured for 14 days using the application of the BioSticker on the upper left side of the chest.
Measured: 14 days
The primary outcome of interest are performance of the BioSticker, a medical grade multi-parameter wearable biosensor.
Vital Signs measurements will be collected for 14 days using the application of the BioSticker on the upper left side of the chest.
Measured: 14 days
The primary outcome of interest are performance of the BioSticker wearable for detecting early onset of active COVID-19 related symptoms.
Symptom tracking data will be collected through daily questionnaires for 14 consecutive days, administered through ClinOne. Health data known to be associated with COVID-19 risk and severity, including comorbid conditions, risk factors, and demographic data will be collected from subjects during screening and enrollment via the ClinOne study website.
Measured: 14 days
The primary outcome of interest is the sensitivity of the BioCloud-based algorithms in detecting early onset of active COVID-19.
BioSticker sensor data will be time-stamped and annotated against clinical events (e.g., fever, cough), symptom progression data, and other indicators of infection as they are identified. Weighting coefficients for predictive algorithms will be tuned and algorithms will be iteratively refined using machine learning methods and small batches of data anticipated to include between 20 and 50 positive cases per set, and validated against sensor data obtained from COVID-19-negative subjects.
Measured: 14 days

Secondary outcomes (1)

The secondary outcomes of interest include correlation of biometric data indicators to patient reported symptoms.
Individual-level experiential feedback will be reported through participant symptom- tracking and diagnostic questionnaires for 14 consecutive days.
Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Dec 202015 Jan 2022

First posted8 Feb 2021
Study start21 Dec 2020
Primary completion15 Jan 2022
Study completion15 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies 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: Cohort
Time perspective: Prospective
Enrolment: 790 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04742569
Sponsor's protocol ID: 1294415
Status last verified: Jan 2022
First submitted: 14 Jan 2021
Last updated: 20 Jan 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Buitrago-Garcia D, Egli-Gany D, Counotte MJ, Hossmann S, Imeri H, Ipekci AM, Salanti G, Low N. Occurrence and transmission potential of asymptomatic and presymptomatic SARS-CoV-2 infections: A living systematic review and meta-analysis. PLoS Med. 2020 Sep 22;17(9):e1003346. doi: 10.1371/journal.pmed.1003346. eCollection 2020 Sep.
PubMed 32960881
Kucirka LM, Lauer SA, Laeyendecker O, Boon D, Lessler J. Variation in False-Negative Rate of Reverse Transcriptase Polymerase Chain Reaction-Based SARS-CoV-2 Tests by Time Since Exposure. Ann Intern Med. 2020 Aug 18;173(4):262-267. doi: 10.7326/M20-1495. Epub 2020 May 13.
PubMed 32422057
Natarajan A, Su HW, Heneghan C. Assessment of physiological signs associated with COVID-19 measured using wearable devices. NPJ Digit Med. 2020 Nov 30;3(1):156. doi: 10.1038/s41746-020-00363-7.
PubMed 33299095
Ra SH, Lim JS, Kim G, et al. Thorax Epub ahead of print: 2020 September 22; doi:10.1136/ thoraxjnl-2020-215042
Rudolph JL, Halladay CW, Barber M, McConeghy KW, Mor V, Nanda A, Gravenstein S. Temperature in Nursing Home Residents Systematically Tested for SARS-CoV-2. J Am Med Dir Assoc. 2020 Jul;21(7):895-899.e1. doi: 10.1016/j.jamda.2020.06.009. Epub 2020 Jun 9.
PubMed 32674815

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Wearable Diagnostic for Detection of COVID-19 Infection
ClinicalTrials.gov ID: NCT04742569
Acronym / sponsor ID: 1294415
Conditions: COVID-19
Keywords: Recent known exposure to COVID-19, Asymptomatic, Early COVID-19 Symptoms
Study type: Observational
Recruitment status: Completed
Enrolment: 790 participants (actual)
Lead sponsor: ClinOne, Inc.Industry (pharma, biotech, devices)
Collaborators: BioIntelliSense, Inc, Phillips North America, LLC, University of Colorado, Denver, United States Department of Defense
Study start: 21 Dec 2020 (actual)
Primary completion: 15 Jan 2022 (actual)
Study completion: 15 Jan 2022 (actual)
First posted: 8 Feb 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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Cohort 1- Exposed/Early Symptomatic	–	–The population identified for this study includes subjects who request COVID-19 testing in response to a concern for recent COVID-19 exposure and/or concern of COVID-19-like related symptoms. We will recruit and enroll patients through public facing websites, clinic and pharmacy vaccination schedules and on-site vaccination marketing. For the population with recent COVID-19 exposure and/or concern of COVID-19-like related symptoms, population identification includes subjects who visit eTrueNorth's https://www.doineedacovid19test.com/ website where subjects have access to over 7,500 testing site locations across the nation. Otherwise, individuals seeking COVID-19 testing will be directed to the ClinOne, Inc. website for information regarding the Wearable Diagnostic for Detection of COVID-19 Infection study contact information for study participation, enrollment into the study using eConsent, and will receive a BioSticker wearable kit by express mail the next day.
CoHort 2- Pfizer or Moderna Vaccine	–	–Secondly, the other population identified for this study includes subjects who are scheduled for the first and second dose of the mRNA-based Pfizer/BioNTech and Moderna vaccine series. For the population seeking the mRNA-based Pfizer/BioNTech and Moderna vaccine series, we will recruit and enroll patients through public-facing websites, clinic, and pharmacy vaccination schedules, and on-site vaccination marketing

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Cohort 1- Exposed/Early Symptomatic Group All adult subjects seeking a COVID-19 test and meeting enrollment criteria will be offered enrollment into this study. The Inclusion Criteria are: 1. Adults - 18 years of age and older 2. Both genders, all races and ethnic groups 3. English speaking adult subjects only Cohort 2- Vaccine Group: Potential subjects seeking the mRNA-based Pfizer/BioNTech and Moderna vaccine 1. Subjects who are scheduled to receive the COVID vaccination series through local and national clinics, health systems and pharmacies. 2. Subjects who become aware of the study through public notices, postings, and advertisements, and other marketing efforts.

Key inclusion criteria (11 listed)

age 18 or older;
able to follow the study device wear instructions per the Instructions for Use;
no positive viral test within 60 days prior to enrollment; and
willing and able to provide written, informed consent.
Subjects seeking the mRNA-based Pfizer/BioNTech and Moderna vaccine series are eligible for the study if they are:

Key exclusion criteria (17 listed)

pregnant or breastfeeding;
wearing a defibrillator or pacemaker;
known or suspected cardiac dysrhythmias
known or suspected allergy to adhesives;
chronic daily use of non-steroidal anti-inflammatory medications (NSAIDs) and antipyretic medications

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

The primary outcome of interest are performance of the BioSticker, a medical grade multi-parameter wearable biosensor.
Time frame: 14 days
Biometric data will be measured for 14 days using the application of the BioSticker on the upper left side of the chest.
The primary outcome of interest are performance of the BioSticker, a medical grade multi-parameter wearable biosensor.
Time frame: 14 days
Vital Signs measurements will be collected for 14 days using the application of the BioSticker on the upper left side of the chest.
The primary outcome of interest are performance of the BioSticker wearable for detecting early onset of active COVID-19 related symptoms.
Time frame: 14 days
Symptom tracking data will be collected through daily questionnaires for 14 consecutive days, administered through ClinOne. Health data known to be associated with COVID-19 risk and severity, including comorbid conditions, risk factors, and demographic data will be collected from subjects during screening and enrollment via the ClinOne study website.
The primary outcome of interest is the sensitivity of the BioCloud-based algorithms in detecting early onset of active COVID-19.
Time frame: 14 days
BioSticker sensor data will be time-stamped and annotated against clinical events (e.g., fever, cough), symptom progression data, and other indicators of infection as they are identified. Weighting coefficients for predictive algorithms will be tuned and algorithms will be iteratively refined using machine learning methods and small batches of data anticipated to include between 20 and 50 positive cases per set, and validated against sensor data obtained from COVID-19-negative subjects.

1 secondary outcome

The secondary outcomes of interest include correlation of biometric data indicators to patient reported symptoms.
Time frame: 14 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
Results publication: PubMed 32960881Buitrago-Garcia D, Egli-Gany D, Counotte MJ, Hossmann S, Imeri H, Ipekci AM, Salanti G, Low N. Occurrence and transmission potential of asymptomatic and presymptomatic SARS-CoV-2 infections: A living systematic review and meta-analysis. PLoS Med. 2020 Sep 22;17(9):e1003346. doi: 10.1371/journal.pmed.1003346. eCollection 2020 Sep.
Results publication: PubMed 32422057Kucirka LM, Lauer SA, Laeyendecker O, Boon D, Lessler J. Variation in False-Negative Rate of Reverse Transcriptase Polymerase Chain Reaction-Based SARS-CoV-2 Tests by Time Since Exposure. Ann Intern Med. 2020 Aug 18;173(4):262-267. doi: 10.7326/M20-1495. Epub 2020 May 13.
Results publication: PubMed 33299095Natarajan A, Su HW, Heneghan C. Assessment of physiological signs associated with COVID-19 measured using wearable devices. NPJ Digit Med. 2020 Nov 30;3(1):156. doi: 10.1038/s41746-020-00363-7.
Results publicationRa SH, Lim JS, Kim G, et al. Thorax Epub ahead of print: 2020 September 22; doi:10.1136/ thoraxjnl-2020-215042
Results publication: PubMed 32674815Rudolph JL, Halladay CW, Barber M, McConeghy KW, Mor V, Nanda A, Gravenstein S. Temperature in Nursing Home Residents Systematically Tested for SARS-CoV-2. J Am Med Dir Assoc. 2020 Jul;21(7):895-899.e1. doi: 10.1016/j.jamda.2020.06.009. Epub 2020 Jun 9.
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.

James Mault, MD principal investigator

BioIntelliSense, Inc

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 COVID-19, run by ClinOne, Inc. 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 11 inclusion and 17 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: finished, as of the sponsor's last update on 20 Jan 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The primary outcome of interest are performance of the BioSticker, a medical grade multi-parameter wearable biosensor. (time frame: 14 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04742569, which also lists 5 linked publications.

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 20 Jan 2022.