COVID19NCT04343794
Using Biovitals® Sentinel to Monitor Disease Progression in Subjects Quarantined for Suspected COVID-19
A study testing BIOVITALS in people with COVID19, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID19
- What is being tested?
- BIOVITALS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Apr 2020to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects ≥18 years of age
- Quarantined as suspected COVID-19
- Asymptomatic upon enrolment
- All subjects give written informed consent
Who cannot join
- Failure to provide written informed consent
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The University of Hong Kong, Queen Mary Hospital
Hong Kong
David Siu, MD, 22554649, cwdsiu@hku.hk
Ivan Hung, MD, 22554049, ivanhung@hku.hk
About this study
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.
Read the 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.
- Conditions
- COVID19
- Being tested
- BIOVITALS
- Keywords
- Wearable physiological monitor
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIOVITALSDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Biovitals | Experimental | 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 Receives: Device: BIOVITALS |
| Control | No intervention | Usual standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to diagnosis of COVID-19 by RT-PCR in subjects
Time from quarantine to diagnosis of COVID-19
Measured: within 14 days
Secondary outcomes (9)
Compliance to complete the study
Adherence to device
Measured: within 14 days
Sensitivity and specificity of Biovitals® Sentinel
To identify COVID19 subjects
Measured: within 14 days
Cross infection rate within the family cluster
% of family members infection
Measured: within 14 days
Length of hospital stay of positive subjects
Length of hospital stay
Measured: 1 year at study completion
Length of ICU stay of positive patients
Length of ICU stay
Measured: 1 year at study completion
National Early Warning Score 2 rating of positive patients
Vital signs of positive patients
Measured: 4 weeks from diagnosis
Viral load of positive patients
Virology laboratory result of nasopharyngeal swab
Measured: 4 weeks from diagnosis
Worsening of comorbidities
Worsening of comorbidities
Measured: 1 year at study completion
Mortality
Mortality
Measured: 1 year at study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start1 Apr 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19Studies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan FN Hung MD, The University of Hong Kong
- Investigators
- David Siu, MD FRCP, Principal investigator, HKU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343794
- Sponsor's protocol ID
- COVID19_Biovitals_Protocol_1
- Status last verified
- Apr 2020
- First submitted
- 20 Feb 2020
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Biovitals® Sentinel to Monitor Disease Progression in Subjects Quarantined for Suspected COVID-19
- ClinicalTrials.gov ID
- NCT04343794
- Acronym / sponsor ID
- COVID19_Biovitals_Protocol_1
- Conditions
- COVID19
- Keywords
- Wearable physiological monitor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 13 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biovitals | Experimental | Device: BIOVITALSContinuous 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 intervention | –Usual standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult subjects ≥18 years of age
- Quarantined as suspected COVID-19
- Asymptomatic upon enrolment
- All subjects give written informed consent
Key exclusion criteria (1 listed)
- Failure to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIOVITALSBiovitals 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 | Device | Biovitals |
Primary outcome
Time to diagnosis of COVID-19 by RT-PCR in subjects
Time frame: within 14 days
Time from quarantine to diagnosis of COVID-19
9 secondary outcomes
Compliance to complete the study
Time frame: within 14 days
Sensitivity and specificity of Biovitals® Sentinel
Time frame: within 14 days
Cross infection rate within the family cluster
Time frame: within 14 days
Length of hospital stay of positive subjects
Time frame: 1 year at study completion
Length of ICU stay of positive patients
Time frame: 1 year at study completion
National Early Warning Score 2 rating of positive patients
Time frame: 4 weeks from diagnosis
Viral load of positive patients
Time frame: 4 weeks from diagnosis
Worsening of comorbidities
Time frame: 1 year at study completion
Mortality
Time frame: 1 year at study completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Siu, MD FRCP principal investigator
HKU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIOVITALS in people with COVID19, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Siu, MD FRCP (22554694, cwdsiu@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to diagnosis of COVID-19 by RT-PCR in subjects (time frame: within 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2020.