CHIP: COVID-19 Health Professional Impact Study

Sponsor
The Royal Wolverhampton Hospitals NHS Trust (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04527432
Collaborator
University of Wolverhampton (Other)
1,504
1
1
22.5
66.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Survey
  • Diagnostic Test: SARS-CoV-2 antibody test
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
1504 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
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
Actual Study Start Date :
Dec 16, 2020
Anticipated Primary Completion Date :
Oct 31, 2022
Anticipated Study Completion Date :
Oct 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: All participants

Survey at 6 and 12 months time with optional antibody tests

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

Outcome Measures

Primary Outcome Measures

  1. The number of employees tested who have evidence of SARS-CoV-2 antibodies [12 months]

    evidence of SARS-CoV-2 antibodies

  2. Factors associated with a positive test [12 months]

    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

  3. Likelihood of clinically relevant (causing illness) infection with SARS-CoV-2 in subjects with both positive and negative SARS-CoV-2 antibody tests [12 months]

    Infection compared to antibody presence

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Royal Wolverhampton NHS Trust Wolverhampton United Kingdom WV10 0QP

Sponsors and Collaborators

  • The Royal Wolverhampton Hospitals NHS Trust
  • University of Wolverhampton

Investigators

  • Principal Investigator: Supratik Basu, The Royal Wolverhampton NHS Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Royal Wolverhampton Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT04527432
Other Study ID Numbers:
  • 2020COV112
First Posted:
Aug 26, 2020
Last Update Posted:
Aug 17, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 17, 2022