Using Biovitals® Sentinel to Monitor Disease Progression in Subjects Quarantined for Suspected COVID-19
Primary Purpose
COVID19
Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
BIOVITALS
Sponsored by
About this trial
This is an interventional diagnostic trial for COVID19 focused on measuring Wearable physiological monitor
Eligibility Criteria
Inclusion Criteria:
- Adult subjects ≥18 years of age
- Quarantined as suspected COVID-19
- Asymptomatic upon enrolment
- All subjects give written informed consent
Exclusion Criteria:
- Failure to provide written informed consent
Sites / Locations
- The University of Hong Kong, Queen Mary HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Biovitals
Control
Arm Description
Continuous physiological monitoring using Biovitals platform including (1) armband with multiple physiological sensor, (2) remote monitoring, and (3) Analytic platform. The arm will be worn 23 hours a day and off for 1 hour during showering for recharging battery during 24 hr quarantine period
Usual standard care
Outcomes
Primary Outcome Measures
Time to diagnosis of COVID-19 by RT-PCR in subjects
Time from quarantine to diagnosis of COVID-19
Secondary Outcome Measures
Compliance to complete the study
Adherence to device
Sensitivity and specificity of Biovitals® Sentinel
To identify COVID19 subjects
Cross infection rate within the family cluster
% of family members infection
Length of hospital stay of positive subjects
Length of hospital stay
Length of ICU stay of positive patients
Length of ICU stay
National Early Warning Score 2 rating of positive patients
Vital signs of positive patients
Viral load of positive patients
Virology laboratory result of nasopharyngeal swab
Worsening of comorbidities
Worsening of comorbidities
Mortality
Mortality
Full Information
NCT ID
NCT04343794
First Posted
February 20, 2020
Last Updated
April 13, 2020
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04343794
Brief Title
Using Biovitals® Sentinel to Monitor Disease Progression in Subjects Quarantined for Suspected COVID-19
Official Title
Using Biovitals® Sentinel to Monitor Disease Progression in Subjects Quarantined for Suspected COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The novel coronavirus (COVID-19) emerged in December 2019, and in mere months has spread to more than 104 countries, resulting in an outbreak of viral pneumonia worldwide.
Current local quarantine policy in Hong Kong for individuals suspected for COVID-19 requires daily self-reported symptomatology and body temperature, given the intermittent nature and the high dependency of self-discipline undermine the practicality of the approach. To date, the advance in sensor technology has made possible to continuously monitor individual physiological parameters using a simple wearable device. Together with the mobile wearable technology that allowing instantaneous, multi-directional, and massive data transfer, remote continuous physiological monitoring is made possible. The Cardiology division, the Univeristy of Hong Kong has been in collaboration with Biofourmis to implement such technology for remote heart failure management. Similar digital therapeutic system can be applied to remotely monitor physiological parameters of large number of quarantined or suspected COVID-19 at home or in quarantine facility. It is purposed to allow the monitoring team to effectively and remotely monitor COVID-19 quarantined and patients, manage and evaluate the disease progression.
Detailed Description
Owing to the massive outbreak of COVID-19, as of March 9, 2020, the virus has reportedly caused 108,618 infections and 3,800 deaths globally. The World Health Organization (WHO) has declared COVID-19 disease a public health emergency of international concern. As there has yet been specific therapeutic or vaccine for the condition, rigorous implementation of traditional public health measures including isolation, quarantine, social distancing, and community containment is the principle strategy to control the COVID-19 epidemic. In addition to the isolation of confirmed COVID-19 infected patients from noninfected population, it is equally if not more important to quarantine asymptomatic individuals with possible exposure to COVID-19 in order to reduce the viral spread. Indeed, quarantine measures have been initiated in many countries and regions, which restrict movements of asymptomatic individuals with COVID-19 exposure often with fever and symptom surveillance at home or designated facilities for the presumed incubation period (14 days). While conceptually attractive, the intermittency and high dependency of selfdiscipline for body temperature and symptom surveillance undermine the practicality and effectiveness of the approach. Furthermore, it has been reported that as many as 50% of COVID-19 infected patients had not had fever until the full-blown disease, thereby body temperature surveillance per se may not be sufficient to detect early disease progression.
In the past few decades, advances in sensor technology miniaturize electronic physiological sensors that could be incorporated into wearable devices allowing continuous monitoring of physiological parameters such as skin temperature, heart rate, respiratory rate, oxygen saturation, perspiration and activity of ambulatory subjects in a 24/7 basis. Together with current telecommunication platform capable of instantaneous and multi-directional massive data transfer, it is possible to remotely monitor a large number of individual subjects' physiological parameters in a real-time manner, and relay to managing physicians for timely intervention. Nonetheless, such potentials have not been fully explored in the real-world disease management. The current study will assess the impact of remote continuous real-time physiological monitoring using wearable armband device Everion® (Biofourmis, Singapore) and artificial intelligence-powered analytical platform Biovitals® Sentinel (Biofourmis, Singapore) on detection of disease progression in asymptomatic subjects with COVID-19 exposure under mandatory quarantine at designated facilities in Hong Kong. The research hypothesis is that by processing continuous physiological data collected using wearable device Everion® and patient reported outcomes with a cloud-based analytics platform Biovitals® Sentinel, it will possible to detect physiological changes and other clinically meaningful alerts that indicate early clinical progression in quarantined subjects with COVID-19 exposure.
The wearable vital sign monitor Everion® is capable to track multiple vitals sings including heart rate, heart rate variability, blood pulse variation, respiration rate under rest, activity, steps, skin temperature and etc. It is Bluetooth connected to a dedicated study-smartphone that allows remote transfer of all the physiological data captured by the wearable device in real time. A specially-designed application (APP) on the study-smartphone enables the patient to participate in health monitoring by reporting symptoms regularly and make aware of his/her physical and physiological patterns via the monitoring displays on the smart-phone. The patient's passive physiological data from the device and the active data on the symptoms and outcomes from Biovitals® analytics platform are automatically transferred to the monitoring console on the cloud. Thus, the Biofourmis platform solution is proposed to allow the monitoring team to effectively and remotely monitor COVID-19 patients and evaluate the disease progression. Leveraging Everion, the smartphone APP, Biovitals® analytics platform and the caregiver dashboard, biofourmis has built an end to end solution, Biovitals® Sentinel to remote monitor and manage the suspected subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID19
Keywords
Wearable physiological monitor
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Biovitals
Arm Type
Experimental
Arm Description
Continuous physiological monitoring using Biovitals platform including (1) armband with multiple physiological sensor, (2) remote monitoring, and (3) Analytic platform. The arm will be worn 23 hours a day and off for 1 hour during showering for recharging battery during 24 hr quarantine period
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual standard care
Intervention Type
Device
Intervention Name(s)
BIOVITALS
Intervention Description
Biovitals platform including (1) armband with multiple physiological sensor, (2) remote monitoring, and (3) Analytic platform. The arm will be worn 23 hours a day and off for 1 hour during showering for recharging battery during 24 hr quarantine period
Primary Outcome Measure Information:
Title
Time to diagnosis of COVID-19 by RT-PCR in subjects
Description
Time from quarantine to diagnosis of COVID-19
Time Frame
within 14 days
Secondary Outcome Measure Information:
Title
Compliance to complete the study
Description
Adherence to device
Time Frame
within 14 days
Title
Sensitivity and specificity of Biovitals® Sentinel
Description
To identify COVID19 subjects
Time Frame
within 14 days
Title
Cross infection rate within the family cluster
Description
% of family members infection
Time Frame
within 14 days
Title
Length of hospital stay of positive subjects
Description
Length of hospital stay
Time Frame
1 year at study completion
Title
Length of ICU stay of positive patients
Description
Length of ICU stay
Time Frame
1 year at study completion
Title
National Early Warning Score 2 rating of positive patients
Description
Vital signs of positive patients
Time Frame
4 weeks from diagnosis
Title
Viral load of positive patients
Description
Virology laboratory result of nasopharyngeal swab
Time Frame
4 weeks from diagnosis
Title
Worsening of comorbidities
Description
Worsening of comorbidities
Time Frame
1 year at study completion
Title
Mortality
Description
Mortality
Time Frame
1 year at study completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult subjects ≥18 years of age
Quarantined as suspected COVID-19
Asymptomatic upon enrolment
All subjects give written informed consent
Exclusion Criteria:
- Failure to provide written informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Siu, MD FRCP
Phone
22554694
Email
cwdsiu@hku.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Ivan Hung, MD FRCPath
Phone
22554049
Email
ivanhung@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Siu, MD FRCP
Organizational Affiliation
HKU
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Hong Kong, Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Siu, MD
Phone
22554649
Email
cwdsiu@hku.hk
First Name & Middle Initial & Last Name & Degree
Ivan Hung, MD
Phone
22554049
Email
ivanhung@hku.hk
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Using Biovitals® Sentinel to Monitor Disease Progression in Subjects Quarantined for Suspected COVID-19
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