The Nanowear Wearable Covid-19 Observational and Analysis Trend

NCT04717024 | Terminated FDA Device

• 1 other identifier: NWCT20-SS-002
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Trends in COVID 19 exacerbation

  up to 30 days of monitoring leading to discharge or admission to ICU

Interventions

Observational Study - no intervention DEVICE

Observational Study - no intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects of legal age to give informed consent who are currently or recently hospitalized with a primary diagnosis of Covid-19

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nanowear Inc.: lead

Study Sites (2)

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 20, 2021
• Study Start: September 15, 2020
• Primary Completion: April 15, 2021
• Study Completion: April 30, 2021
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)