Official Title
Using Biovitals® Sentinel to Monitor Disease Progression in Subjects Quarantined for Suspected COVID-19
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.

Unknown status


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

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

Eligibility Gender
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Hong Kong

The University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong

Investigator: David Siu, MD
Contact: 22554649


David Siu, MD FRCP

Ivan Hung, MD FRCPath

David Siu, MD FRCP, Principal Investigator

The University of Hong Kong
NCT Number
Wearable physiological monitor
MeSH Terms
Disease Progression