COVID-19 Health Professional Impact Study

NCT04527432 | Completed

• 1 other identifier: 2020COV112
• Study Type: interventional
• Target: 1,504
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Infection; Severe Acute Respiratory Syndrome

Outcome Measures

Primary Outcomes (3)

• The number of employees tested who have evidence of SARS-CoV-2 antibodies

  evidence of SARS-CoV-2 antibodies

  12 months

• 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

• 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

Study Arms (1)

All participants

OTHER

Survey at 6 and 12 months time with optional antibody tests

Other: Survey; Diagnostic Test: SARS-CoV-2 antibody test

Interventions

Survey OTHER

Survey at baseline, 6 and 12 months

All participants

SARS-CoV-2 antibody test DIAGNOSTIC_TEST

SARS-CoV-2 antibody test results and testing again at 6 and 12 months

All participants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Royal Wolverhampton Hospitals NHS Trust: lead
• University of Wolverhampton: collaborator

Study Sites (1)

The Royal Wolverhampton NHS Trust

Wolverhampton, WV10 0QP, United Kingdom

Location

Related 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 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.

  PMID: 35957800 RESULT

MeSH Terms

Conditions

Coronavirus Infections; Severe Acute Respiratory Syndrome

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Supratik Basu

  The Royal Wolverhampton NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 26, 2020
• Study Start: November 24, 2020
• Primary Completion: October 27, 2023
• Study Completion: October 27, 2023
• Last Updated: April 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)