Covid19
Conditions
Brief summary
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.
Interventions
Observational Study - no intervention
Sponsors
Nanowear Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hosptialized patient data | 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
| Measure | Time frame | Description |
|---|---|---|
| Trends in COVID 19 exacerbation | 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 |
Countries
United States
Outcome results
None listed