Clinical trial NCT04363489: The CEDiD Study (COVID-19 Early Diagnosis in Doctors and Healthcare Workers)
Official title: The CEDiD Study (COVID-19 Early Diagnosis in Doctors and Healthcare Workers)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Keywords: COVID-19
wearable medical devices
data analytics
doctors
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Guy's and St Thomas' NHS Foundation Trust
First posted: 2020-04-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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

Primary outcomes:
measure: COVID-19 Infection
timeFrame: 30 days
Secondary outcomes:
measure: Symptoms
timeFrame: 30 days
measure: Clinical Observations
timeFrame: 30 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
Study officials:
affiliation: King's College London / Guy's and St Thomas' NHS Foundation Trust
name: Alexander Zargaran, MBBS
role: STUDY_DIRECTOR
affiliation: King's College London
name: Anne Greenough
role: STUDY_CHAIR
affiliation: King's College London / Guy's and St Thomas' NHS Foundation Trust
name: Dina Radenkovic, MBBS
role: STUDY_DIRECTOR
affiliation: King's College London
name: Rocio Martinez-Nunez, PhD
role: STUDY_DIRECTOR
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Kariem El-Boghdadly
role: PRINCIPAL_INVESTIGATOR
References: