AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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.

David Siu, MD FRCP contact

22554694

cwdsiu@hku.hk

Ivan Hung, MD FRCPath contact

22554049

ivanhung@hku.hk

Hong Kong1 site, 1 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

    Recruiting

Other trials in Hong Kong

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 groups in NCT04343794
Study groupRoleWhat they receive
BiovitalsExperimentalContinuous 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
ControlNo interventionUsual standard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. Compliance to complete the study

    Adherence to device

    Measured: within 14 days

  2. Sensitivity and specificity of Biovitals® Sentinel

    To identify COVID19 subjects

    Measured: within 14 days

  3. Cross infection rate within the family cluster

    % of family members infection

    Measured: within 14 days

  4. Length of hospital stay of positive subjects

    Length of hospital stay

    Measured: 1 year at study completion

  5. Length of ICU stay of positive patients

    Length of ICU stay

    Measured: 1 year at study completion

  6. National Early Warning Score 2 rating of positive patients

    Vital signs of positive patients

    Measured: 4 weeks from diagnosis

  7. Viral load of positive patients

    Virology laboratory result of nasopharyngeal swab

    Measured: 4 weeks from diagnosis

  8. Worsening of comorbidities

    Worsening of comorbidities

    Measured: 1 year at study completion

  9. 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.

  1. First posted13 Apr 2020
  2. Study start1 Apr 2020
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion31 Jan 2022 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in