Condition category
Respiratory
Date applied
11/08/2020
Date assigned
13/08/2020
Last edited
13/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.

In 2020, the virus has spread to many countries around the world and neither a vaccine against the virus or specific treatment for COVID-19 has yet been developed. As of March 2020, it is advised that people minimize travel and social contact, and regularly wash their hands to reduce the spread of the virus.

Groups who are at a higher risk from infection with the virus, and therefore of developing COVID-19, include people aged over 70 years, people who have long-term health conditions (such as asthma or diabetes), people who have a weakened immune system and people who are pregnant. People in these groups, and people who might come into contact with them, can reduce this risk by following the up-to-date advice to reduce the spread of the virus.

Antibodies detected by blood tests indicate that a person has been exposed to SARS-CoV-2 and developed antibodies as part of an immune response to the virus. Antibody tests are important to confirm prior infection, including in individuals with few or no symptoms. There are several different classes (or types) of antibody which may develop in response to any infection. These include immunoglobulin G (known as IgG) and immunoglobulin M (known as IgM).

This study will measure antibodies to COVID-19 in up to 2000 healthcare workers at Barts Health NHS Trust. The percentage of healthcare workers who have been exposed to the SARS-CoV-2 virus and who have developed antibodies will be reported. A proportion of the study participants will be called back for study visits at 3 months and at 6 months after enrolment. The aim of the follow-up visits is to measure how long the antibodies last, and also to determine if having antibodies to COVID-19 protects against getting COVID-19 disease a second time.

In the study, the COVID-19 antibodies will be measured using the Panbio™ COVID-19 IgG/IgM Rapid Test. The Panbio™ COVID-19 IgG/IgM Rapid Test is a test that uses a small drop of blood to detect IgG and IgM antibodies to SARS-CoV-2. Different types of human fluid samples including blood taken from a vein (venous whole blood), blood from a fingerstick (capillary whole blood) and serum or plasma (which are fluids prepared in a lab by processing whole blood samples) can be used on the Panbio™ COVID-19 IgG/IgM Rapid Test The test is interpreted 10-20 minutes after sample application. The result is qualitative, meaning it shows that the antibodies are, or are not, present, rather than giving a value or number to measure the antibodies. In the study, a positive test result will be confirmed by laboratory testing of the same blood sample using the Abbott Architect or Roche Elecsys SARS-CoV-2 antibody tests.

Who can participate?
Healthcare workers at Barts Health NHS Trust can participate in the study. This includes frontline staff such as doctors and nurses as well as administrative staff and other non-clinical staff.

What does the study involve?
During the initial study visit and follow-up visits, the study participants will be asked for a brief medical history, focussed on COVID-19 risk factors, past COVID-19 symptoms and COVID-19 testing. One tube of venous blood will be taken from each participant at each visit. Study participants are also asked to notify the study team of any potential COVID-19 symptoms that occur between visits by sending a message to a secure email address.

What are the possible benefits and risks of participating?
The study participants will receive their COVID-19 antibody result. It is possible that the collection of blood could cause discomfort. However, as this is a routine medical procedure and the samples will be obtained by trained medical personnel, the discomfort is likely to be minimized. COVID-19 transmission is a risk to the participants. However, convalescent patients are not expected to be transmitting the virus. Symptomatic participants, or participants with COVID-19 symptoms during the last 14 days are excluded from the study. All operations will be conducted under strict social distancing to minimize the risk of transmission.

Where is the study run from?
The study is run from Barts Health NHS Trust (UK) and is recruiting participants at 3-4 hospitals

When is the study starting and how long is it expected to run for?
From April 2020 to February 2021

Who is funding the study?
Abbott Rapid Diagnostics (Germany)

Who is the main contact?
Prof. Patrick T. Kennedy
p.kennedy@qmul.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Patrick T. Kennedy

ORCID ID

http://orcid.org/0000-0001-9201-0094

Contact details

Barts Liver Centre
Immunobiology
Blizard Institute
Barts and The London SMD
QMUL
4 Newark Street
London
E1 2AT
United Kingdom
+44 (0)207 882 6187
p.kennedy@qmul.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CLDG-0504, IRAS 284671, CPMS 46155

Study information

Scientific title

COVID-19 antibody response in healthcare staff: Prevalence, duration and protection against recurring infection

Acronym

COVID-19 Healthcare Worker Study

Study hypothesis

1. To assess the prevalence of past immune response to the SARS-CoV-2 virus among Healthcare Workers using measurements of SARS-CoV-2 antibodies
2. To evaluate the duration of SARS-CoV-2 antibodies at 3- and 6-months follow-up
3. To determine the incidence reduction of SARS-CoV-2 infection during the follow-up time period in the population with a positive SARS-CoV-2 antibody result at enrolment, compared to the population with a negative SARS-CoV-2 antibody result at enrolment

Ethics approval

Approved 29/05/2020, London - Camden & Kings Cross Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ; +44 (0)207 104 8086; CamdenandKingsCross.REC@hra.nhs.uk), ref 20/HRA/2675

Study design

Single-centre observational longitudinal cohort study

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

COVID-19 (SARS-CoV-2 infection) antibody response in healthcare workers

Intervention

This is an observational study. Participants will receive standard of care treatment for any conditions that arise during the study period. During the initial study visit and follow-up visits, the study participants will be asked for a brief medical history, focused on COVID-19 risk factors, past COVID-19 symptoms and COVID-19 testing. One tube of venous blood will be taken from each participant at each visit for antibody testing. Study participants are also asked to notify the study team of any potential COVID-19 symptoms that occur between visits by sending a message to a secure email address. Each study visit will last 15-30 minutes. Selected participants will be followed-up 3 months and 6 months after the enrollment study visit. The maximum duration of observation and follow up is 7 months from the date of enrollment.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Prevalence of past immune response to the SARS-CoV-2 virus among healthcare workers, as determined using measurements of SARS-CoV-2 antibodies from blood samples using the Panbio™ COVID-19 IgG/IgM Rapid Test, with confirmation of positive results using the Abbott Architect® SARS-CoV-2 IgG test, at baseline

Secondary outcome measures

1. Duration of SARS-CoV-2 antibodies at follow-up visits in those with a positive antibody test result at enrolment using measurements of SARS-CoV-2 antibodies from blood samples using the Panbio™ COVID-19 IgG/IgM Rapid Test, with confirmation of positive results using the Abbott Architect® SARS-CoV-2 IgG test, at baseline, 3 and 6 months
2. Incidence reduction of SARS-CoV-2 infection during the follow-up time period in the population with a positive SARS-CoV-2 antibody result at enrolment in comparison with a population with a negative SARS-CoV-2 antibody result at enrolment using measurements of SARS-CoV-2 antibodies from blood samples using the Panbio™ COVID-19 IgG/IgM Rapid Test, with confirmation of positive results using the Abbott Architect® SARS-CoV-2 IgG test, at baseline, 3 and 6 months

Overall trial start date

22/04/2020

Overall trial end date

31/03/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged ≥18 years
2. Agrees to complete all aspects of the study

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

Up to 2000 healthcare workers

Participant exclusion criteria

1. Previously participated in this study on a previous occasion
2. Unable or unwilling to provide informed consent
3. Is a vulnerable person as deemed unfit for the study by the Principal Investigator
4. Current symptoms of COVID-19 or has had COVID-19 symptoms within the last 14 days

Recruitment start date

02/06/2020

Recruitment end date

21/08/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Barts Health NHS Trust
Whitechapel Rd London E1 1BB
London
E1 1BB
United Kingdom

Sponsor information

Organisation

Abbott (Germany)

Sponsor details

Abbott Rapid Diagnostics Jena GmbH
Orlaweg 1
Jena
07743
Germany
+44 7792902244
camilla.forssten@abbott.com

Sponsor type

Industry

Website

http://www.abbott.com/

Funders

Funder type

Industry

Funder name

Abbott Rapid Diagnostics Jena GmbH

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available. This is due to the study being observational only, and consent has not been obtained for making de-identified participant data available under GDPR. The data will be clearly explained in a peer-reviewed publication.

Intention to publish date

30/06/2021

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

13/08/2020: Trial’s existence confirmed by the HRA and Health and Care Research Wales (HCRW).