Covid19CEDiDNCT04363489
The CEDiD Study (COVID-19 Early Diagnosis in Doctors and Healthcare Workers)
An observational study of Covid19, run by King's College London at 1 site in United Kingdom.
Trial summary
This is a prospective observational cohort study of healthcare workers working in high-risk COVID-19 clinical areas, monitoring heart rate, sleep and temperature, correlating with daily self-reported symptoms, oxygen saturations and PCR Swabs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Wearable Medical Device (Empatica E4), COVID-19 PCR Swab and Pulse Oximeter
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Aug 2020to 30 Jun 2021
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy healthcare workers who work in high-risk COVID-19 areas, and have not themselves had a PCR/Antibody positive diagnosis of COVID-19
Who may be able to join
- Healthy healthcare professionals of any age
Who cannot join
- Previous PCR/Antibody positive test for COVID-19
- Not working in high-risk COVID-19 area (ICU, A\&E, COVID positive wards)
- Involved in COVID-19 Vaccine Trial
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's and St Thomas' NHS Foundation Trust
London
Kariem El-Boghdadly, kariem.elboghdadly@gstt.nhs.uk
About this study
This is a prospective observational cohort study of healthcare workers working in high-risk COVID-19 clinical areas, monitoring heart rate, sleep and temperature, correlating with daily self-reported symptoms, oxygen saturations and PCR Swabs. It will provide information about how many healthcare workers develop COVID-19, what their clinical observations and symptoms are.
Read the detailed description
During the COVID-19 Pandemic, doctors and other healthcare workers who work in COVID+ wards, intensive care unit and the accident and emergency department are at high risk of developing COVID-19 infection.
In April 2020, 14.6% of doctors were off sick with suspected or confirmed COVID-19 infection. Meanwhile, 17.9% of COVID+ patients are thought to be asymptomatic. Therefore, healthcare workers are also high-risk of spreading infection to patients, colleagues and their families.
This is a prospective observational cohort study that leverages wearable medical device technology and data analytics to develop an algorithm for early detection of COVID-19 infection in healthcare workers.
A total of 60 healthy healthcare workers working within high-risk COVID-19 clinical areas will be asked to wear a wearable medical device that measures their heart rate, skin temperature and sleep during non-working hours. They will take daily swabs for COVID-19 from themselves, measure their oxygen levels daily, and answer a survey of self-reported symptoms daily for the 30 day study period.
These will then be analyzed to develop an algorithm for early detection of COVID-19 in healthcare workers, and help to inform future workforce decisions, to promote welfare and prevent the spread of COVID-19.
- Conditions
- Covid19
- Being tested
- Wearable Medical Device (Empatica E4), COVID-19 PCR Swab, Pulse Oximeter
- Keywords
- COVID-19, wearable medical devices, data analytics, doctors
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Medical Device (Empatica E4)Device
A wearable medical device (Empatica E4) which is a smart wristband that detects skin temperature, heart rate and sleep. It is CE and FDA approved.
COVID-19 PCR SwabDiagnostic test
COVID-19 PCR Swab will be self-taken by doctors every day. Fischer nasopharyngeal PCR Swabs
Pulse OximeterDiagnostic test
Participants will measure their oxygen saturations every day, and report them on the survey. Pulmolink A310 pulse oximeters
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 Infection
Number of Healthcare Workers who have a new PCR positive diagnosis of COVID-19
Measured: 30 days
Secondary outcomes (2)
Symptoms
What new symptoms healthcare workers develop when they develop COVID-19 infection
Measured: 30 days
Clinical Observations
What healthcare workers observations are when they develop COVID-19 infection including: Oxygen saturations, Heart Rate, Skin Temperature
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start20 Aug 2020
- Primary completion30 May 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by King's 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Alexander Zargaran, MBBS, Study director, King's College London / Guy's and St Thomas' NHS Foundation TrustAnne Greenough, Study chair, King's College LondonDina Radenkovic, MBBS, Study director, King's College London / Guy's and St Thomas' NHS Foundation TrustRocio Martinez-Nunez, PhD, Study director, King's College LondonKariem El-Boghdadly, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363489
- Sponsor's protocol ID
- CEDiD Study
- Acronym
- CEDiD
- Status last verified
- Apr 2020
- First submitted
- 23 Apr 2020
- Last updated
- 19 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zargaran A, Sousi S, Colville G, Radcliffe G, Malek R, Douiri A, El-Boghdadly K, Nebbia G, Martinez Nunez RT, Greenough A. COVID-19 Early Detection in Doctors and Healthcare Workers (CEDiD) study: a cohort study on the feasibility of wearable devices. BMJ Open. 2025 Apr 5;15(4):e089598. doi: 10.1136/bmjopen-2024-089598.
PubMed 40187781
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CEDiD Study (COVID-19 Early Diagnosis in Doctors and Healthcare Workers)
- ClinicalTrials.gov ID
- NCT04363489
- Acronym / sponsor ID
- CEDiD / CEDiD Study
- Conditions
- Covid19
- Keywords
- COVID-19, wearable medical devices, data analytics, doctors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 30 May 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 27 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.
This is a prospective observational cohort study of healthcare workers working in high-risk COVID-19 clinical areas, monitoring heart rate, sleep and temperature, correlating with daily self-reported symptoms, oxygen saturations and PCR Swabs. It will provide information about how many healthcare workers develop COVID-19, what their clinical observations and symptoms are.
Detailed description
During the COVID-19 Pandemic, doctors and other healthcare workers who work in COVID+ wards, intensive care unit and the accident and emergency department are at high risk of developing COVID-19 infection.
In April 2020, 14.6% of doctors were off sick with suspected or confirmed COVID-19 infection. Meanwhile, 17.9% of COVID+ patients are thought to be asymptomatic. Therefore, healthcare workers are also high-risk of spreading infection to patients, colleagues and their families.
This is a prospective observational cohort study that leverages wearable medical device technology and data analytics to develop an algorithm for early detection of COVID-19 infection in healthcare workers.
A total of 60 healthy healthcare workers working within high-risk COVID-19 clinical areas will be asked to wear a wearable medical device that measures their heart rate, skin temperature and sleep during non-working hours. They will take daily swabs for COVID-19 from themselves, measure their oxygen levels daily, and answer a survey of self-reported symptoms daily for the 30 day study period.
These will then be analyzed to develop an algorithm for early detection of COVID-19 in healthcare workers, and help to inform future workforce decisions, to promote welfare and prevent the spread of COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy healthcare workers who work in high-risk COVID-19 areas, and have not themselves had a PCR/Antibody positive diagnosis of COVID-19
Key inclusion criteria (1 listed)
- Healthy healthcare professionals of any age
Key exclusion criteria (3 listed)
- Previous PCR/Antibody positive test for COVID-19
- Not working in high-risk COVID-19 area (ICU, A\&E, COVID positive wards)
- Involved in COVID-19 Vaccine Trial
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 |
|---|---|---|
| Wearable Medical Device (Empatica E4)A wearable medical device (Empatica E4) which is a smart wristband that detects skin temperature, heart rate and sleep. It is CE and FDA approved. | Device | – |
| COVID-19 PCR SwabCOVID-19 PCR Swab will be self-taken by doctors every day. Fischer nasopharyngeal PCR Swabs | Diagnostic test | – |
| Pulse OximeterParticipants will measure their oxygen saturations every day, and report them on the survey. Pulmolink A310 pulse oximeters | Diagnostic test | – |
Primary outcome
COVID-19 Infection
Time frame: 30 days
Number of Healthcare Workers who have a new PCR positive diagnosis of COVID-19
2 secondary outcomes
Symptoms
Time frame: 30 days
Clinical Observations
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Derived from this study: PubMed 40187781Zargaran A, Sousi S, Colville G, Radcliffe G, Malek R, Douiri A, El-Boghdadly K, Nebbia G, Martinez Nunez RT, Greenough A. COVID-19 Early Detection in Doctors and Healthcare Workers (CEDiD) study: a cohort study on the feasibility of wearable devices. BMJ Open. 2025 Apr 5;15(4):e089598. doi: 10.1136/bmjopen-2024-089598.
- 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.
Alexander Zargaran, MBBS study director
King's College London / Guy's and St Thomas' NHS Foundation Trust
Anne Greenough study chair
King's College London
Dina Radenkovic, MBBS study director
King's College London / Guy's and St Thomas' NHS Foundation Trust
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 Covid19, run by King's 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 1 inclusion and 3 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 19 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kariem El-Boghdadly, FRCA (020 7188 7188, kariem.elboghdadly@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 Infection (time frame: 30 days). 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 NCT04363489, which also lists 1 linked publication.
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 19 Mar 2021.