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The CEDiD Study (COVID-19 Early Diagnosis in Doctors and Healthcare Workers)

The CEDiD Study (COVID-19 Early Diagnosis in Doctors and Healthcare Workers)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04363489
Acronym
CEDiD
Enrollment
60
Registered
2020-04-27
Start date
2020-08-20
Completion date
2021-06-30
Last updated
2021-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

COVID-19, wearable medical devices, data analytics, doctors

Brief 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. 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.

Interventions

DEVICEWearable 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.

DIAGNOSTIC_TESTCOVID-19 PCR Swab

COVID-19 PCR Swab will be self-taken by doctors every day. Fischer nasopharyngeal PCR Swabs

DIAGNOSTIC_TESTPulse Oximeter

Participants will measure their oxygen saturations every day, and report them on the survey. Pulmolink A310 pulse oximeters

Sponsors

Guy's and St Thomas' NHS Foundation Trust
CollaboratorOTHER
King's College London
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Healthy healthcare professionals of any age

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
COVID-19 Infection30 daysNumber of Healthcare Workers who have a new PCR positive diagnosis of COVID-19

Secondary

MeasureTime frameDescription
Symptoms30 daysWhat new symptoms healthcare workers develop when they develop COVID-19 infection
Clinical Observations30 daysWhat healthcare workers observations are when they develop COVID-19 infection including: Oxygen saturations, Heart Rate, Skin Temperature

Countries

United Kingdom

Contacts

Primary ContactKariem El-Boghdadly, FRCA
kariem.elboghdadly@gstt.nhs.uk020 7188 7188
Backup ContactAlexander Zargaran, MBBS, BSc
alexander.zargaran@kcl.ac.uk020 7188 7188

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026