The Nanowear Wearable Covid-19 Observational and Analysis Trend
Overview
The NanoCOAT study is a multi-center, prospective, non-randomized, feasibility, observational, non-significant risk study. The NanoCOAT study will enroll a minimum of 10 and a maximum of 100 subjects in a potential for a multi-site in order to collect data and analyze physiological and biometric trends due to Covid-19.
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: December 31, 2023
Interventions
- Device: Observational Study – no intervention
- Observational Study – no intervention
Clinical Trial Outcome Measures
Primary Measures
- Hosptialized patient data
- Time Frame: up to 30 days of monitoring leading to discharge or admission to ICU
- The primary study endpoint is adequate collection of hospitalized COVID 19 patient health metric data through the Nanowear WMDRS
Secondary Measures
- Trends in COVID 19 exacerbation
- Time Frame: up to 30 days of monitoring leading to discharge or admission to ICU
- Exploratory information will be used to compare the signals obtained from the device to the severity of Covid-19 as measured by clinical evaluation
Participating in This Clinical Trial
Inclusion Criteria
- Subject has provided informed consent – Male or female over the age of 18 years – The patient is currently hospitalized with a primary diagnosis of Covid-19 Exclusion Criteria:
- Subject is unwilling or unable to wear the vest during hospitalization. – Subjects who are pregnant. – Subject is intubated or admitted to ICU – Subject has an implantable cardiac device (i.e pacemaker or internal cardioverter defibrillator)
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Nanowear Inc.
- Provider of Information About this Clinical Study
- Sponsor
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.