NCT04363489

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 27, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

August 20, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

March 19, 2021

Status Verified

April 1, 2020

Enrollment Period

9 months

First QC Date

April 23, 2020

Last Update Submit

March 18, 2021

Conditions

Keywords

COVID-19wearable medical devicesdata analyticsdoctors

Outcome Measures

Primary Outcomes (1)

  • COVID-19 Infection

    Number of Healthcare Workers who have a new PCR positive diagnosis of COVID-19

    30 days

Secondary Outcomes (2)

  • Symptoms

    30 days

  • Clinical Observations

    30 days

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • Healthy healthcare professionals of any age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

COVID-19 PCR Swabs

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Alexander Zargaran, MBBS

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

    STUDY DIRECTOR
  • Anne Greenough

    King's College London

    STUDY CHAIR
  • Dina Radenkovic, MBBS

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

    STUDY DIRECTOR
  • Rocio Martinez-Nunez, PhD

    King's College London

    STUDY DIRECTOR
  • Kariem El-Boghdadly

    Guy's and St Thomas' NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kariem El-Boghdadly, FRCA

CONTACT

Alexander Zargaran, MBBS, BSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2020

First Posted

April 27, 2020

Study Start

August 20, 2020

Primary Completion

May 30, 2021

Study Completion

June 30, 2021

Last Updated

March 19, 2021

Record last verified: 2020-04

Locations