The COVID-19 Early Detection in Doctors and Healthcare Workers (CEDiD) Study: study protocol for a prospective observational trial (preprint)

ABSTRACT

Background: The global COVID-19 pandemic has caused worldwide disruption with its exponential spread mandating national and international lockdown measures. Hospital-associated transmission has been identified as a major factor in the perpetuation of COVID-19, with healthcare workers at high-risk of becoming infected with SARS-CoV-2 and representing important vectors for spread, but not routinely having their clinical observations monitored or being tested for COVID-19. Methods: A single-center, prospective observational study of 60 healthcare workers will explore how many healthcare workers in high-risk areas develop COVID-19 infection over a thirty day period. High-risk areas are defined as COVID positive wards, the intensive care unit or the accident and emergency department. Healthcare workers (HCWs) will be recruited and have daily self-administered nasopharyngeal SARS-CoV-2 PCR tests. They will also be provided with a wearable medical device to measure their clinical observations during non-working hours, and be asked to complete a daily self-reported symptom questionnaire over the study period. Statistical analysis will assess the proportion of healthcare workers who develop COVID-19 infection as a primary objective, with secondary objectives exploring what symptoms are developed, time-to-event, and deviations in clinical observations. Discussion: At present clinical observations, symptoms and COVID-19 PCR swabs are not routinely undertaken for healthcare workers. If the CEDiD (COVID-19 Early Detection in Doctors and Healthcare Workers) study is successful, it will provide useful information for workforce decisions in reducing hospital-associated transmission of COVID-19. The data will help in determining whether there are early warning signs for development of COVID-19 infections amongst healthcare workers and may contribute to the evidence base advocating for more regular testing of healthcare workers observations, symptoms and COVID-19 status. Trial registration ClinicalTrials.gov, NCT04363489. Registered on 27th July 2020