Wearable Diagnostic for Detection of COVID-19 Infection
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|ClinicalTrials.gov Identifier: NCT04742569|
Recruitment Status : Recruiting
First Posted : February 8, 2021
Last Update Posted : August 16, 2021
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||2352 participants|
|Official Title:||Wearable Diagnostic for Detection of COVID-19 Infection|
|Actual Study Start Date :||December 21, 2020|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||December 31, 2021|
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
- 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.
- The secondary outcomes of interest include correlation of biometric data indicators to patient reported symptoms. [ Time Frame: 14 days ]Individual-level experiential feedback will be reported through participant symptom- tracking and diagnostic questionnaires for 14 consecutive days.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04742569
|Contact: ELIZABETH ESTERL, DNP, MS, RNfirstname.lastname@example.org|
|Contact: Joseph Ruybal, MSemail@example.com|
|United States, Colorado|
|Greenwood Village, Colorado, United States, 80111|
|Contact: ELIZABETH ESTERL, DNP, MS, RN 720-732-6231 firstname.lastname@example.org|
|Contact: Joseph Ruybal, MS 7209847833 email@example.com|
|Principal Investigator: James Mault, MD|
|Principal Investigator:||James Mault, MD||BioIntelliSense, Inc|