The Nanowear Wearable Covid-19 Observational and Analysis Trend

Covid19 Clinical Trial

— NanoCOAT  

Official title:

The Nanowear Wearable Covid-19 Observational and Analysis Trend

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04717024
• Other study ID #: NWCT20-SS-002
• Status: Recruiting
• Start date: September 15, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2023
• Source: Nanowear Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Device:
• Observational Study - no intervention
Observational Study - no intervention

Locations

Country	Name	City	State
United States	Maimonides Medical Center	Brooklyn	New York
United States	Hackensack University Medical Center	Hackensack	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Nanowear Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hosptialized patient data	The primary study endpoint is adequate collection of hospitalized COVID 19 patient health metric data through the Nanowear WMDRS	up to 30 days of monitoring leading to discharge or admission to ICU
Secondary	Trends in COVID 19 exacerbation	Exploratory information will be used to compare the signals obtained from the device to the severity of Covid-19 as measured by clinical evaluation	up to 30 days of monitoring leading to discharge or admission to ICU