Ignite Creation Date:
2024-05-06 @ 3:44 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04742569
Status:
COMPLETED
Last Update Posted:
2022-01-20
First Post:
2021-01-14
Brief Title:
Wearable Diagnostic for Detection of COVID-19 Infection
Sponsor:
ClinOne Inc
Organization:
ClinOne Inc
Study Overview
Official Title:
Wearable Diagnostic for Detection of COVID-19 Infection
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 2352 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 algorithms
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
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 algorithms
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None