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

NCT ID: NCT04363489

Last Updated: 2021-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-20

Study Completion Date

2021-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Covid19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

COVID-19 PCR Swab

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

Intervention Type DIAGNOSTIC_TEST

Pulse Oximeter

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alexander Zargaran, MBBS

Role: STUDY_DIRECTOR

King's College London / Guy's and St Thomas' NHS Foundation Trust

Anne Greenough

Role: STUDY_CHAIR

King's College London

Dina Radenkovic, MBBS

Role: STUDY_DIRECTOR

King's College London / Guy's and St Thomas' NHS Foundation Trust

Rocio Martinez-Nunez, PhD

Role: STUDY_DIRECTOR

King's College London

Kariem El-Boghdadly

Role: PRINCIPAL_INVESTIGATOR

Guy's and St Thomas' NHS Foundation Trust

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Guy's and St Thomas' NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Kariem El-Boghdadly, FRCA

Role: CONTACT

020 7188 7188

Alexander Zargaran, MBBS, BSc

Role: CONTACT

020 7188 7188

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Kariem El-Boghdadly

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 40187781 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CEDiD Study

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Prevention of Long Covid Syndrome
NCT05793736 COMPLETED NA