CoronavirusREMOTE-COVIDNCT04337489
Remote Monitoring Use In Cases Of Suspected COVID-19 (Coronavirus)
An observational study of Coronavirus, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The study aims to see if participant deterioration due to suspected coronavirus in a designated location (e.g. hotel) can be identified sooner by wearing the sensor. If sick patients can be identified early, participants are more likely to have better outcomes; the study believes that the sensor can help us do this. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Coronavirus
- What is being tested?
- SensiumVitals wearable sensor
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Jul 2020to 26 Mar 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Returning traveller from a high-risk area into a London airport. * Have mild symptoms indicative of Covid-19 * Unable to self-isolate
Who may be able to join
- Aged 18 years or over.
- Able to provide written consent.
Who cannot join
- Any participants that withdraw their consent.
- A skin condition/reaction preventing wearing the wearable sensor.
- The presence of a permanent pacemaker or cardiac defibrillator.
- Any form of psychiatric disorder or a condition that, in the opinion of the investigator, may hinder communication with the research team.
- Inability to cooperate or communicate with the research team.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: REmote MOniToring usE in Suspected Cases of COVID-19 (Coronavirus): REMOTE-COVID Trial
The study aims to see if participant deterioration due to suspected coronavirus in a designated location (e.g. hotel) can be identified sooner by wearing the sensor. If sick patients can be identified early, participants are more likely to have better outcomes; the study believes that the sensor can help us do this. The sensor measures heart rate, respiratory rate and temperature every 2 minutes and this can be reviewed by the clinical team looking after the participants.
- Conditions
- Coronavirus
- Being tested
- SensiumVitals wearable sensor
- Keywords
- coronavirus, remote monitoring, deterioration, escalation
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SensiumVitals wearable sensorDevice
A waterproof, light, wearable sensor measuring vital signs (heart rate, respiratory rate, temperature) continuously.
What is being measured
The primary outcome is the main question the study is designed to answer.
Deterioration Resulting in Healthcare Review
Detection of clinical deterioration using wearable sensors resulting in healthcare review (e.g. GP telephone consultation)
Measured: 1 year
Secondary outcomes (1)
Hospitalisation
Deterioration resulting in hospitalisation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start28 Jul 2020
- Primary completion26 Mar 2021
- Study completion26 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- CW+ Charity
- Responsible party
- Sponsor
- Investigators
- Ara Darzi, Prof, Principal investigator, Institute of Global Health Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04337489
- Sponsor's protocol ID
- REMOTE-COVID
- Acronym
- REMOTE-COVID
- Status last verified
- Sep 2024
- First submitted
- 1 Apr 2020
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Iqbal FM, Joshi M, Davies G, Khan S, Ashrafian H, Darzi A. The pilot, proof of concept REMOTE-COVID trial: remote monitoring use in suspected cases of COVID-19 (SARS-CoV 2). BMC Public Health. 2021 Apr 1;21(1):638. doi: 10.1186/s12889-021-10660-9.
PubMed 33794832Iqbal FM, Joshi M, Davies G, Khan S, Ashrafian H, Darzi A. Design of the pilot, proof of concept REMOTE-COVID trial: remote monitoring use in suspected cases of COVID-19 (SARS-CoV-2). Pilot Feasibility Stud. 2021 Mar 5;7(1):62. doi: 10.1186/s40814-021-00804-4.
PubMed 33673868
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REmote MOniToring usE in Suspected Cases of COVID-19 (Coronavirus): REMOTE-COVID Trial
- ClinicalTrials.gov ID
- NCT04337489
- Acronym / sponsor ID
- REMOTE-COVID / REMOTE-COVID
- Conditions
- Coronavirus
- Keywords
- coronavirus, remote monitoring, deterioration, escalation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- CW+ Charity
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 26 Mar 2021 (actual)
- Study completion
- 26 Mar 2021 (actual)
- First posted
- 7 Apr 2020 (actual)
- Results
- Posted 8 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to see if participant deterioration due to suspected coronavirus in a designated location (e.g. hotel) can be identified sooner by wearing the sensor. If sick patients can be identified early, participants are more likely to have better outcomes; the study believes that the sensor can help us do this. The sensor measures heart rate, respiratory rate and temperature every 2 minutes and this can be reviewed by the clinical team looking after the participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Returning traveller from a high-risk area into a London airport. * Have mild symptoms indicative of Covid-19 * Unable to self-isolate
Key inclusion criteria (2 listed)
- Aged 18 years or over.
- Able to provide written consent.
Key exclusion criteria (5 listed)
- Any participants that withdraw their consent.
- A skin condition/reaction preventing wearing the wearable sensor.
- The presence of a permanent pacemaker or cardiac defibrillator.
- Any form of psychiatric disorder or a condition that, in the opinion of the investigator, may hinder communication with the research team.
- Inability to cooperate or communicate with the research team.
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 |
|---|---|---|
| SensiumVitals wearable sensorA waterproof, light, wearable sensor measuring vital signs (heart rate, respiratory rate, temperature) continuously. | Device | – |
Primary outcome
Deterioration Resulting in Healthcare Review
Time frame: 1 year
Detection of clinical deterioration using wearable sensors resulting in healthcare review (e.g. GP telephone consultation)
1 secondary outcome
Hospitalisation
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33794832Iqbal FM, Joshi M, Davies G, Khan S, Ashrafian H, Darzi A. The pilot, proof of concept REMOTE-COVID trial: remote monitoring use in suspected cases of COVID-19 (SARS-CoV 2). BMC Public Health. 2021 Apr 1;21(1):638. doi: 10.1186/s12889-021-10660-9.
- Derived from this study: PubMed 33673868Iqbal FM, Joshi M, Davies G, Khan S, Ashrafian H, Darzi A. Design of the pilot, proof of concept REMOTE-COVID trial: remote monitoring use in suspected cases of COVID-19 (SARS-CoV-2). Pilot Feasibility Stud. 2021 Mar 5;7(1):62. doi: 10.1186/s40814-021-00804-4.
- Trial ProtocolLink provided by the sponsor.
- Published articleLink provided by the sponsor.
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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.
Ara Darzi, Prof principal investigator
Institute of Global Health Innovation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus, run by Imperial College London at 1 site in United Kingdom.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 8 Oct 2024. 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deterioration Resulting in Healthcare Review (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04337489, which also lists 2 linked publications.
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 8 Oct 2024.