The symptoms, virology and immunity of COVID in healthcare workers

Plain English summary of protocol

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.

Strategies to prevent spread of infection include social distancing and the development of a vaccine. These require detailed understanding of the disease. There are some basic questions about COVID-19 to which we urgently need answers, including:
1. How often are COVID-19 tests negative during the infection or positive without showing any signs of illness?
2. Can we reliably test for immunity to COVID-19 after infection or vaccination with a blood test?
3. How long after infection does immunity last?
To answer these questions, we need to understand the links between the symptoms of COVID-19, swab tests for infection and blood tests for immunity. The researchers will study all these things in doctors and nurses working in the Emergency Department of Bristol Royal Hospital for Children over a three month period starting in April 2020.

Who can participate?
Any patient-facing clinical staff member working regularly in the Children’s Emergency Department (CED) of Bristol Royal Hospital for Children, including doctors, nurses and healthcare assistants.

What does the study involve?
Staff who agree to participate will fill out an online symptom dairy every day. Twice a week, participants will swab their own nose and throat and provide a saliva sample, which we can test for COVID-19 in the laboratory. Blood samples will be taken from participants at the beginning of the study, at 6-week intervals for 18 weeks, and again after a year. The main advantage of studying doctors and nurses is that they can easily and safely obtain samples from their own nose/throat/mouth. After the study has been completed, we will analyse the results and publish them in a scientific journal. This study will help us provide answers to the fundamental questions about COVID-19 infection that are needed to inform public health measures such as social distancing and vaccination.

What are the possible benefits and risks of participating?
Benefits - By taking part you will be contributing directly to understanding the relationship between symptoms, virology and immune responses to COVID-19. This will help improve public health measures to minimise transmission, and develop tests so that vaccines can be evaluated.
Risks - Taking a throat and nasal swab might be a bit uncomfortable for a few seconds. Blood tests can also be uncomfortable and cause mild bruising. All staff taking your blood are trained and experienced. Throughout the study you can contact the study team by phone or email if you have any questions or concerns.

Where is the study run from?
Bristol Royal Hospital for Children (UK)

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

Who is funding the study?
The Grand Appeal (UK)

Who is the main contact?
Unfortunately, this study is not recruiting public volunteers at this time. This is because the research isn’t ready for volunteers yet or the researchers are directly identifying volunteers in certain areas or hospitals. Please do not contact the research team as they will not be able to respond. For more information about COVID-19 research, visit the Be Part of Research homepage.

Contact information

Prof Adam Finn
Scientific

Bristol Children's Vaccine Centre
Level 6 Education Centre
University Hospitals Bristol and Weston NHS Foundation Trust
Upper Mauldin Street
Bristol
BS2 8AE
United Kingdom

ORCID ID	0000-0003-1756-5668
Phone	+44 (0)117 342 0172
Email	adam.finn@bristol.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centre

Sponsor information

University of Bristol
University/education

Research Governance Team
Research & Enterprise Division
University of Bristol
Trinity Street, College Green
One Cathedral Square
Bristol
BS1 5DD
England
United Kingdom

Phone	+44 (0)117 394 0177
Email	research-governance@bristol.ac.uk
Website	http://bristol.ac.uk/
"ROR"	https://ror.org/0524sp257

Funders

Funder type

Charity

Results and Publications

Study outputs

Additional files

ISRCTN44324934_PROTOCOL_v1.1_19Apr2020.pdf

uploaded 19/05/2020

Editorial Notes

28/06/2024: The following changes were made to the trial record:
1. Publication reference added.
2. Link to dataset added.
3. The total final enrolment was added.
4. The participant level data sharing statement was added.
16/03/2021: Internal review.
19/05/2020: Uploaded protocol (not peer reviewed) as an additional file.
18/05/2020: Trial’s existence confirmed by NHS HRA.