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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Covid19

Intervention / Treatment
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* Device: Wearable Medical Device (Empatica E4)
* Diagnostic Test: COVID-19 PCR Swab
* Diagnostic Test: Pulse Oximeter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 Infection | Number of Healthcare Workers who have a new PCR positive diagnosis of COVID-19 | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms | What new symptoms healthcare workers develop when they develop COVID-19 infection | 30 days | 
| Clinical Observations | What healthcare workers observations are when they develop COVID-19 infection including: Oxygen saturations, Heart Rate, Skin Temperature | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, wearable medical devices, data analytics, doctors