Clinical Trials Logo
  1. Home
  2. Covid19
  3. NCT04363489
  4. Details
NCT04363489 Clinical Trial

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

Covid19 Clinical Trial

— CEDiD  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04363489
Other study ID # CEDiD Study
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 20, 2020
Est. completion date June 30, 2021

Study information
Verified date April 2020
Source King's College London
Contact Kariem El-Boghdadly, FRCA
Phone 020 7188 7188
Email kariem.elboghdadly@gstt.nhs.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date June 30, 2021
Est. primary completion date May 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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
• Pulse Oximeter
Participants will measure their oxygen saturations every day, and report them on the survey. Pulmolink A310 pulse oximeters

Locations
Country Name City State
United Kingdom Guy's and St Thomas' NHS Foundation Trust London

Sponsors (2)
Lead Sponsor Collaborator
King's College London Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary COVID-19 Infection Number of Healthcare Workers who have a new PCR positive diagnosis of COVID-19 30 days
Secondary Symptoms What new symptoms healthcare workers develop when they develop COVID-19 infection 30 days
Secondary Clinical Observations What healthcare workers observations are when they develop COVID-19 infection including: Oxygen saturations, Heart Rate, Skin Temperature 30 days
See also
  Status Clinical Trial Phase
Completed NCT05047692 - Safety and Immunogenicity Study of AdCLD-CoV19-1: A COVID-19 Preventive Vaccine in Healthy Volunteers Phase 1
Recruiting NCT04395768 - International ALLIANCE Study of Therapies to Prevent Progression of COVID-19 Phase 2
Terminated NCT04555096 - A Trial of GC4419 in Patients With Critical Illness Due to COVID-19 Phase 2
Completed NCT04508777 - COVID SAFE: COVID-19 Screening Assessment for Exposure
Completed NCT04506268 - COVID-19 SAFE Enrollment N/A
Completed NCT04961541 - Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine Phase 1/Phase 2
Active, not recruiting NCT04546737 - Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients N/A
Terminated NCT04542993 - Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy Phase 2
Not yet recruiting NCT04543006 - Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19 N/A
Terminated NCT04581915 - PHRU CoV01 A Trial of Triazavirin (TZV) for the Treatment of Mild-moderate COVID-19 Phase 2/Phase 3
Completed NCT04532294 - Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants Phase 1
Completed NCT04494646 - BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19) Phase 2
Not yet recruiting NCT04527211 - Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel Phase 3
Completed NCT04387292 - Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic N/A
Completed NCT04537663 - Prevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults Phase 4
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT04979858 - Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask N/A
Not yet recruiting NCT05038449 - Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19 N/A
Completed NCT04610502 - Efficacy and Safety of Two Hyperimmune Equine Anti Sars-CoV-2 Serum in COVID-19 Patients Phase 2
Active, not recruiting NCT06042855 - ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin) Phase 3