Condition category
Infections and Infestations
Date applied
16/04/2020
Date assigned
18/05/2020
Last edited
19/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
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.

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.

Trial website

Contact information

Type

Scientific

Primary contact

Prof Adam Finn

ORCID ID

http://orcid.org/0000-0003-1756-5668

Contact details

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
+44 (0)117 342 0172
adam.finn@bristol.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 282718

Study information

Scientific title

Longitudinal study of COVID-19: symptoms, virology & immunity

Acronym

LOGIC

Study hypothesis

What are the dynamic relationships between symptoms, mucosal viral load and immunological responses, which are potential correlates of protection, in SARS-CoV-2 infection?

Ethics approval

Approved 20/04/2020, Yorkshire & The Humber - Leeds West Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 (0)207 1048 088), ref: 20/YH/0148

Study design

Longitudinal observational 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)

Intervention

1. Online consent, baseline data collection
2. Online daily symptom diary - for 3 months
3. Self-sampling upper respiratory tract (nose, throat & saliva) - twice weekly for 3 months
4. Blood sampling - weeks 0, 6, 12, 18 and 52

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

COVID-19 symptoms measured using online daily symptom diary every day for 3 months

Secondary outcome measures

1. COVID-19 infection measured using self-sampling of upper respiratory tract (nose, throat & saliva) - twice weekly for 3 months
2. Serum antibody levels and peripheral antigen-specific memory T cells measured using blood sampling at weeks 0, 6, 12, 18, and 52

Overall trial start date

23/03/2020

Overall trial end date

31/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

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

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

135

Participant exclusion criteria

1. Staff who, on average, work less than two shifts per week
2. Staff who anticipate that they will not able to complete at least 6 weeks of the study, excluding annual leave e.g. about to go on maternity leave

Recruitment start date

30/04/2020

Recruitment end date

20/04/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bristol Royal Hosptial for Children
University Hospitals Bristol and Weston NHS Foundation Trust Upper Mauldin Street
Bristol
BS2 8BJ
United Kingdom

Sponsor information

Organisation

University of Bristol

Sponsor details

Research Governance Team
Research & Enterprise Division
University of Bristol
Trinity Street
College Green
One Cathedral Square
Bristol
BS1 5DD
United Kingdom
+44 (0)117 394 0177
research-governance@bristol.ac.uk

Sponsor type

University/education

Website

http://bristol.ac.uk/

Funders

Funder type

Charity

Funder name

The Grand Appeal

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 available from the corresponding author on reasonable request.

Intention to publish date

30/04/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

19/05/2020: Uploaded protocol (not peer reviewed) as an additional file. 18/05/2020: Trial’s existence confirmed by NHS HRA.