Ignite Creation Date:
2024-05-06 @ 3:06 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04527432
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-28
First Post:
2020-08-24
Brief Title:
COVID-19 Health Professional Impact Study
Sponsor:
The Royal Wolverhampton Hospitals NHS Trust
Organization:
The Royal Wolverhampton Hospitals NHS Trust
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHIP
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None