Clinical trial NCT04453891: Hexoskin Feasibility Study With COVID-19 Patients
Official title: Evaluating the Feasibility of Monitoring Symptomatic COVID-19 Patients, and Predicting Disease Progression Using a Validated Digital Health Program
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: COVID-19
Lead sponsor: Carré Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-01
Enrollment: 0
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 positive patients aged 55 and above, and resident of any state in the United States.

Brief summary: This pilot study aims to investigate the feasibility of using Hexoskin cardiorespiratory and activity data, as well as patient symptomatology, to provide an AI model for disease progression that will be at the service of the clinical team to recommend the best customized and evolving care trajectory for each patient.

Detailed description: The following protocol proposes a mixed methods pilot study, whereby the immediate purpose is to generate quantifiable information regarding the feasibility of a virtual trial with the Hexoskin Platform, collection of data quality in COVID-19 patients, and values for algorithm construction. In essence, sixteen participants with a confirmed COVID-19 diagnosis will be invited to wear the Hexoskin biometric garment during the course of several hours per week, over a period of 28 days. In addition to the biometric data collection, participants will be invited to complete four questionnaires. The biometric data will be combined to the sociodemographic information and patient symptomatology to construct an algorithm which can accurately predict patient outcomes.

Eligibility criteria: Inclusion Criteria:

* Minimum waist size of 24 inches, and maximum waist size of 45 inches
* Confirmed COVID-19 diagnosis from a licensed healthcare practitioner
* Permanent resident or citizen of the United States
* Access to a smartphone
* Access to a functional email
* Access to a thermometer
* Access to a measuring tape
* Experiencing at least three of the following COVID-19 symptoms (fever, cough, difficulty breathing, intense fatigue, sudden loss of smell and/or taste without nasal congestion, sore throat, headache, aching muscles, loss of appetite, diarrhea).

Exclusion Criteria:

* Hexoskin should not be used by people with allergies to the following materials: polyester, synthetic fibers. Usage must be stopped if the product causes skin irritation or rashes.
* Hexoskin should not be used by people with Pacemakers or Implantable Cardioverter-Defibrillator (ICD) devices.
* Hexoskin must not be used simultaneously with a Holter Monitor, as the equipment would interfere with the placement of the Hexoskin sensors.
* Hexoskin must not be used in an MRI machine as it contains metallic parts.
* Individuals who do not fit any of the Hexoskin Shirts sizes (Men: between 2XS - 6XL, Women: between 2XS - 4XL).
* Individuals who have a documented medical condition or illness requiring intensive medical treatment.
* Women of Childbearing Potential whom are not using effective contraceptive measures

Primary outcomes:
measure: Qualitative assessment of the feasibility of the Hexoskin Platform and Virtual Recruitment Process via three subjective feedback questionnaires provided to all patients enrolled in the study.
timeFrame: Up to six months
measure: Ensure the collection of high-quality data during wake and sleep activities, registered as overall > 90% good quality cardiac data and overall > 90% good quality respiratory data per recording.
timeFrame: Up to six months
measure: Ensure adequate patient compliance, qualified as > 75% of total recording hours completed, and > 75% of daily questionnaires completed.
timeFrame: Up to six months
measure: Investigate the predictive power of Hexoskin physiological data, patient information and symptoms information to correctly classify patient disease progression quantified as the area under the receiver operator characteristics curve (AUC ROC > 0.70).
timeFrame: Up to six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: 1-888-887-2044
name: Nguyen Thu Ngan Trinh
role: PRINCIPAL_INVESTIGATOR
References: