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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04363489
Recruitment Status : Not yet recruiting
First Posted : April 27, 2020
Last Update Posted : August 4, 2020
Sponsor:
Collaborator:
Guy's and St Thomas' NHS Foundation Trust
Information provided by (Responsible Party):
King's College London

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.

Condition or disease Intervention/treatment
Covid19 Device: Wearable Medical Device (Empatica E4) Diagnostic Test: COVID-19 PCR Swab Diagnostic Test: Pulse Oximeter

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The CEDiD Study (COVID-19 Early Diagnosis in Doctors and Healthcare Workers)
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: 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.
  • Diagnostic Test: COVID-19 PCR Swab
    COVID-19 PCR Swab will be self-taken by doctors every day. Fischer nasopharyngeal PCR Swabs
  • Diagnostic Test: Pulse Oximeter
    Participants will measure their oxygen saturations every day, and report them on the survey. Pulmolink A310 pulse oximeters


Primary Outcome Measures :
  1. COVID-19 Infection [ Time Frame: 30 days ]
    Number of Healthcare Workers who have a new PCR positive diagnosis of COVID-19


Secondary Outcome Measures :
  1. Symptoms [ Time Frame: 30 days ]
    What new symptoms healthcare workers develop when they develop COVID-19 infection

  2. Clinical Observations [ Time Frame: 30 days ]
    What healthcare workers observations are when they develop COVID-19 infection including: Oxygen saturations, Heart Rate, Skin Temperature


Biospecimen Retention:   Samples Without DNA
COVID-19 PCR Swabs


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04363489


Contacts
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Contact: Kariem El-Boghdadly, FRCA 020 7188 7188 kariem.elboghdadly@gstt.nhs.uk
Contact: Alexander Zargaran, MBBS, BSc 020 7188 7188 alexander.zargaran@kcl.ac.uk

Sponsors and Collaborators
King's College London
Guy's and St Thomas' NHS Foundation Trust
Investigators
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Study Director: Alexander Zargaran, MBBS King's College London / Guy's and St Thomas' NHS Foundation Trust
Study Chair: Anne Greenough King's College London
Study Director: 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
Principal Investigator: Kariem El-Boghdadly Guy's and St Thomas' NHS Foundation Trust
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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT04363489    
Other Study ID Numbers: CEDiD Study
First Posted: April 27, 2020    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by King's College London:
COVID-19
wearable medical devices
data analytics
doctors