The CEDiD Study (COVID-19 Early Diagnosis in Doctors and Healthcare Workers) (CEDiD)
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|ClinicalTrials.gov Identifier: NCT04363489|
Recruitment Status : Not yet recruiting
First Posted : April 27, 2020
Last Update Posted : August 4, 2020
|Condition or disease||Intervention/treatment|
|Covid19||Device: Wearable Medical Device (Empatica E4) Diagnostic Test: COVID-19 PCR Swab Diagnostic Test: Pulse Oximeter|
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 Type :||Observational|
|Estimated Enrollment :||60 participants|
|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|
- 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
- COVID-19 Infection [ Time Frame: 30 days ]Number of Healthcare Workers who have a new PCR positive diagnosis of COVID-19
- Symptoms [ Time Frame: 30 days ]What new symptoms healthcare workers develop when they develop COVID-19 infection
- 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
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
|Contact: Kariem El-Boghdadly, FRCA||020 7188 email@example.com|
|Contact: Alexander Zargaran, MBBS, BSc||020 7188 firstname.lastname@example.org|
|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|