- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04337489
Remote Monitoring Use In Cases Of Suspected COVID-19 (Coronavirus) (REMOTE-COVID)
September 30, 2024 updated by: Imperial College London
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
London, United Kingdom
- Imperial College London
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 95 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
- Returning traveller from a high-risk area into a London airport.
- Have mild symptoms indicative of Covid-19
- Unable to self-isolate
Description
Inclusion Criteria:
- Aged 18 years or over.
- Able to provide written consent.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospitalisation
Time Frame: 1 year
|
Deterioration resulting in hospitalisation
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ara Darzi, Prof, Institute of Global Health Innovation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Iqbal 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 28, 2020
Primary Completion (Actual)
March 26, 2021
Study Completion (Actual)
March 26, 2021
Study Registration Dates
First Submitted
April 1, 2020
First Submitted That Met QC Criteria
April 6, 2020
First Posted (Actual)
April 7, 2020
Study Record Updates
Last Update Posted (Actual)
October 8, 2024
Last Update Submitted That Met QC Criteria
September 30, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REMOTE-COVID
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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