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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04717024
Recruitment Status : Recruiting
First Posted : January 20, 2021
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
Nanowear Inc.

Study Description
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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.

Condition or disease Intervention/treatment
Covid19 Device: Observational Study - no intervention

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Nanowear Wearable Covid-19 Observational and Analysis Trend
Actual Study Start Date : September 15, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Device: Observational Study - no intervention
    Observational Study - no intervention

Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04717024


Locations
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United States, New Jersey
Hackensack University Medical Center Not yet recruiting
Hackensack, New Jersey, United States, 07601
Contact: Patricia Arakelian, RN, BSN, CCRP    551-996-5722    Patricia.Arakelian@hackensackmeridian.org   
Principal Investigator: Sameer Jamal, MD         
United States, New York
Maimonides Medical Center Recruiting
Brooklyn, New York, United States, 11219
Contact: Rukshana Hossain, MPH    718-283-8693    RHossain@maimonidesmed.org   
Sub-Investigator: Sergey Motov, MD         
Principal Investigator: John D Marshall, MD         
Sponsors and Collaborators
Nanowear Inc.
More Information
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Responsible Party: Nanowear Inc.
ClinicalTrials.gov Identifier: NCT04717024    
Other Study ID Numbers: NWCT20-SS-002
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases