Using Biovitals® Sentinel to Monitor Disease Progression in Subjects Quarantined for Suspected COVID-19
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable covid19
Started Apr 2020
Longer than P75 for not_applicable covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2020
CompletedStudy Start
First participant enrolled
April 1, 2020
CompletedFirst Posted
Study publicly available on registry
April 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedApril 15, 2020
April 1, 2020
1.8 years
February 20, 2020
April 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to diagnosis of COVID-19 by RT-PCR in subjects
Time from quarantine to diagnosis of COVID-19
within 14 days
Secondary Outcomes (9)
Compliance to complete the study
within 14 days
Sensitivity and specificity of Biovitals® Sentinel
within 14 days
Cross infection rate within the family cluster
within 14 days
Length of hospital stay of positive subjects
1 year at study completion
Length of ICU stay of positive patients
1 year at study completion
- +4 more secondary outcomes
Study Arms (2)
Biovitals
EXPERIMENTALContinuous 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
Control
NO INTERVENTIONUsual standard care
Interventions
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
Eligibility Criteria
You may qualify if:
- Adult subjects ≥18 years of age
- Quarantined as suspected COVID-19
- Asymptomatic upon enrolment
- All subjects give written informed consent
You may not qualify if:
- \- Failure to provide written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Siu, MD FRCP
HKU
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 20, 2020
First Posted
April 13, 2020
Study Start
April 1, 2020
Primary Completion
December 31, 2021
Study Completion
January 31, 2022
Last Updated
April 15, 2020
Record last verified: 2020-04