Wearable Diagnostic for Detection of COVID-19 Infection

NCT04742569 | Completed

• 1 other identifier: 1294415
• Study Type: observational
• Target: 790
• Locations: 1 country
• Sites: 1

Brief 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 and interpreted by non-laboratory personnel.

Conditions

COVID-19

Keywords

Recent known exposure to COVID-19; Asymptomatic; Early COVID-19 Symptoms

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  14 days

Secondary Outcomes (1)

• The secondary outcomes of interest include correlation of biometric data indicators to patient reported symptoms.

  14 days

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Cohort 1- Vaccine Group
• 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.
• 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

Sponsors & Collaborators

• ClinOne, Inc.: lead
• BioIntelliSense, Inc: collaborator
• Phillips North America, LLC: collaborator
• University of Colorado, Denver: collaborator
• United States Department of Defense: collaborator

Study Sites (1)

ClinOne, Inc

Greenwood Village, Colorado, 80111, United States

Location

Related Publications (5)

• 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.

  PMID: 32960881 RESULT

• 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.

  PMID: 32422057 RESULT

• 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.

  PMID: 33299095 RESULT

• Ra SH, Lim JS, Kim G, et al. Thorax Epub ahead of print: 2020 September 22; doi:10.1136/ thoraxjnl-2020-215042

  RESULT

• 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.

  PMID: 32674815 RESULT

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

• James Mault, MD

  BioIntelliSense, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: February 8, 2021
• Study Start: December 21, 2020
• Primary Completion: January 15, 2022
• Study Completion: January 15, 2022
• Last Updated: January 20, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)