Clinical trial NCT04527432: COVID-19 Health Professional Impact Study
Official title: A Pilot Assessment of the COVID-19 Antibody Status and Associated Factors, in Individuals Employed by a Large Acute NHS Trust During the Coronavirus Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronavirus Infection
Severe Acute Respiratory Syndrome
Lead sponsor: The Royal Wolverhampton Hospitals NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of Wolverhampton
First posted: 2020-08-26
Enrollment: 1504
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The COVID-19 (coronavirus) pandemic has had a huge impact on healthcare resources and staff in the UK. Understanding the key risk factors associated with infection amongst healthcare workers is essential for future pandemic response plans.

Currently there are scarce data relating to the infection rates and associated factors amongst healthcare workers in the United Kingdom (UK). Studies of infection rates in healthcare workers have largely relied on the real-time reverse transcriptase-polymerase chain reaction (RT-PCR) test to date and it appears that Healthcare workers are twice as likely to succumb to Coronavirus infection, when compared to the general population and those from Black and minority ethnic (BAME) backgrounds appear to be particularly at risk.

Currently there is no evidence that the presence of SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) antibodies provides seasonal or long term immunity to future infection.

Therefore, this study aims to understand the current level of SARS-CoV-2 antibody positivity and try to determine the likely risk to healthcare workers in the UK to COVID-19 infection. This study hopes to find out whether certain individual characteristics will have an impact on likelihood of infection susceptibility and antibody response and determine the impact of the presence of antibodies on the likelihood of future clinical infection over a 12 month period.

The study involves an initial online survey and linkage to the recent antibody test, then a further online survey in 6 and 12 months' time. The data obtained will be linked to data that the Human Resources Department (HR) holds.

Participants also have the option to partake in another antibody test at 6 and 12 months' time and linked to the data collected.

Detailed description: Participants will have access to the study via the link given in an SMS (Short Message Service - text message) which will direct then to the first online survey.

They will then be contacted again in 6 and 12 months' time to complete the online survey again.

The survey answers will be linked to the results of the antibody tests by their mobile and Employment Number and also to data held about them by the HR Department.

The survey will take approximately 15 minutes to complete and will include questions on the following: profession; work-line type; demographics and behavioural factors; ethnicity; and symptoms (if COVID 19 was manifested).

Participants can also attend for another blood test (SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) antibody test) to detect any presence of antibodies at 6 and 12 months (optional) which will again be linked to the survey and HR data.

Eligibility criteria: Inclusion Criteria:

* All Staff employed by Royal Wolverhampton Trust, having undergone the SARS-CoV-2antibody test at the Trust's testing facility

Exclusion Criteria:

* Royal Wolverhampton NHS Trust staff who have not participated in antibody testing • Staff who have opted out to receiving the text message invite and be part of the study

Primary outcomes:
measure: The number of employees tested who have evidence of SARS-CoV-2 antibodies
timeFrame: 12 months
measure: Factors associated with a positive test
timeFrame: 12 months
measure: Likelihood of clinically relevant (causing illness) infection with SARS-CoV-2 in subjects with both positive and negative SARS-CoV-2 antibody tests
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhampton NHS Trust
Study officials:
affiliation: The Royal Wolverhampton NHS Trust
name: Supratik Basu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sethi S, Manuelpillai N, Mandal A, Simpson O, Morrissey H, Ball P, Sharrod-Cole H, Ford C, Whittaker AC, Drayson M, Race A, Bateman J, Basu S, Cotton J. COVID-19 seroprevalence after the first UK wave of the pandemic and its association with the physical and mental wellbeing of secondary care healthcare workers. Brain Behav Immun Health. 2022 Oct;24:100492. doi: 10.1016/j.bbih.2022.100492. Epub 2022 Aug 6.