The Nanowear Wearable Covid-19 Observational and Analysis Trend (NanoCOAT)

November 7, 2023 updated by: Nanowear Inc.
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Not yet recruiting
        • Hackensack University Medical Center
        • Contact:
        • Principal Investigator:
          • Sameer Jamal, MD
    • New York
      • Brooklyn, New York, United States, 11219
        • Recruiting
        • Maimonides Medical Center
        • Contact:
        • Sub-Investigator:
          • Sergey Motov, MD
        • Principal Investigator:
          • John D Marshall, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 30 days of monitoring leading to discharge or admission to ICU

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 30 days of monitoring leading to discharge or admission to ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanowear Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2020

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

January 19, 2021

First Submitted That Met QC Criteria

January 19, 2021

First Posted (Actual)

January 20, 2021

Study Record Updates

Last Update Posted (Actual)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NWCT20-SS-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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