COVID-19 Health Professional Impact Study

Coronavirus Infection Clinical Trial

— CHIP  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04527432
• Other study ID #: 2020COV112
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 24, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2023
• Source: The Royal Wolverhampton Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1504
• Est. completion date: June 30, 2024
• Est. primary completion date: October 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• Severe Acute Respiratory Syndrome

Intervention

Other:
• Survey
Survey at baseline, 6 and 12 months

Diagnostic Test:
• SARS-CoV-2 antibody test
SARS-CoV-2 antibody test results and testing again at 6 and 12 months

Locations

Country	Name	City	State
United Kingdom	The Royal Wolverhampton NHS Trust	Wolverhampton

Sponsors (2)

Lead Sponsor	Collaborator
The Royal Wolverhampton Hospitals NHS Trust	University of Wolverhampton

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of employees tested who have evidence of SARS-CoV-2 antibodies	evidence of SARS-CoV-2 antibodies	12 months
Primary	Factors associated with a positive test	Survey to establish; Type of healthcare role; Ethnicity; Age; Index of multiple deprivation; Previous RT-PCR test status; Previous clinical COVID infection; Previous period of self isolation; Level of COVID-19 related anxiety; Presence of one or more high risk factors for COVID 19; Presence or absence of self-reported COVID 19 symptoms	12 months
Primary	Likelihood of clinically relevant (causing illness) infection with SARS-CoV-2 in subjects with both positive and negative SARS-CoV-2 antibody tests	Infection compared to antibody presence	12 months