Vital Sensor Monitors for CV19 Detection
ICU-Grade Wearable Sensors With Novel Respiratory Biomarkers to Diagnose and Detect Pre- and Very Early Symptomatic COVID-19 Infection Using Predictive Machine Learning Algorithms
1 other identifier
observational
324
1 country
1
Brief Summary
This study will monitor physical bio-markers such as heart rate, respiratory rate, and temperature to detect potential COVID-19 infections.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 5, 2020
CompletedFirst Submitted
Initial submission to the registry
November 13, 2020
CompletedFirst Posted
Study publicly available on registry
November 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedMay 6, 2023
May 1, 2023
5 months
November 13, 2020
May 4, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
1.Efficacy of wearable device to detect respiratory infection parameters: cough count
Device data measuring cough count. Captured by analysis of peak acclerometer graphing and duration in meters per second squared (m/s2).
1 year
Secondary Outcomes (1)
2.Monitoring of respiratory infection symptoms, WURSS-11 Survey
Time Frame: 1 year
Study Arms (2)
Healthy Adults
Adults 18 years or older
COVID19
Adults 18 years or older diagnosed with COVID 19
Interventions
Eligibility Criteria
Healthy adults and adults exposed to or diagnosed with COVID19
You may qualify if:
- Adults aged 18 years old or over
- Recent (within 1 week) occupational or home exposure to a newly diagnosed COVID-19 infected individual
- Able and willing to give written consent and comply with study procedures
You may not qualify if:
- Inability to understand instructions and follow a three step command
- The subject is pregnant, nursing or planning a pregnancy
- Inability to provide written consent
- Past confirmed COVID-19 infection with resolution of symptoms
- Past confirmed COVID-19 active infection moderate or severe symptoms
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwestern Universitylead
- United States Department of Defensecollaborator
Study Sites (1)
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 13, 2020
First Posted
November 19, 2020
Study Start
November 5, 2020
Primary Completion
March 31, 2021
Study Completion
August 31, 2021
Last Updated
May 6, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share