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COVID-19 Health Professional Impact Study (CHIP)

Primary Purpose

Coronavirus Infection, Severe Acute Respiratory Syndrome

Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Survey
SARS-CoV-2 antibody test
Sponsored by
The Royal Wolverhampton Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Coronavirus Infection

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Royal Wolverhampton NHS Trust

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

All participants

Arm Description

Survey at 6 and 12 months time with optional antibody tests

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 24, 2020
Last Updated
August 15, 2022
Sponsor
The Royal Wolverhampton Hospitals NHS Trust
Collaborators
University of Wolverhampton
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1. Study Identification

Unique Protocol Identification Number
NCT04527432
Brief Title
COVID-19 Health Professional Impact Study
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 16, 2020 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Royal Wolverhampton Hospitals NHS Trust
Collaborators
University of Wolverhampton

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infection, Severe Acute Respiratory Syndrome

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1504 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All participants
Arm Type
Other
Arm Description
Survey at 6 and 12 months time with optional antibody tests
Intervention Type
Other
Intervention Name(s)
Survey
Intervention Description
Survey at baseline, 6 and 12 months
Intervention Type
Diagnostic Test
Intervention Name(s)
SARS-CoV-2 antibody test
Intervention Description
SARS-CoV-2 antibody test results and testing again at 6 and 12 months
Primary Outcome Measure Information:
Title
The number of employees tested who have evidence of SARS-CoV-2 antibodies
Description
evidence of SARS-CoV-2 antibodies
Time Frame
12 months
Title
Factors associated with a positive test
Description
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
Time Frame
12 months
Title
Likelihood of clinically relevant (causing illness) infection with SARS-CoV-2 in subjects with both positive and negative SARS-CoV-2 antibody tests
Description
Infection compared to antibody presence
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Supratik Basu
Organizational Affiliation
The Royal Wolverhampton NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Royal Wolverhampton NHS Trust
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Results will be published in journal
Citations:
PubMed Identifier
35957800
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.
Results Reference
result

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COVID-19 Health Professional Impact Study

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