Wearable Diagnostic for Detection of COVID-19 Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 790
- 试验地点
- 1
- 主要终点
- The primary outcome of interest is the sensitivity of the BioCloud-based algorithms in detecting early onset of active COVID-19.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
- •Inclusion Criteria:
- •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
- •Exclusion Criteria:
- •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
结局指标
主要结局
The primary outcome of interest is the sensitivity of the BioCloud-based algorithms in detecting early onset of active COVID-19.
时间窗: 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 primary outcome of interest are performance of the BioSticker, a medical grade multi-parameter wearable biosensor.
时间窗: 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.
时间窗: 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.
次要结局
- The secondary outcomes of interest include correlation of biometric data indicators to patient reported symptoms.(14 days)