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.
A fast and reliable diagnostic assay that could be used at the point-of-need (PON) is yet to be developed. We have been working closely with our commercial partners in 2020 on the development of highly sensitive PON tests to facilitate diagnosis at the point of need and to reduce the consequences of diagnostic delay.
This study aims to investigate the relationship between COVID-19 and presence or lower respiratory tract infection (LRTI) with bacteria called Streptococcus pneumoniae (which are commonly found in the throat without necessarily causing symptoms) as well as S. pneumoniae colonisation/LRTI and COVID-19 related disease severity among those that are COVID-19 positive.
Who can participate?
Healthy adults over 18 years old that are attending the hospital with signs and symptoms of coronavirus can participate in the study.
What does the study involve?
The study involves samples being taken at day 0 (consent), day 2, day 7 and day 28. The samples include saliva, throat and nose swabs, nasosorption (blotting paper inserted into the nose to collect some concentrated nasal secretions), urine and blood. Data is collected from hospital case notes, all samples and data collected are annonymous.
What are the possible benefits and risks of participating?
Some sampling including nose swabs and blood samples may cause temporary discomfort or bruising however the sampling is minimally invasive. There are no direct benefits of taking part in the study, participation is helping to develop knowledge and improve diagnostic tests. The nose and throat swab is used to detect the coronavirus and may pick up a positive result where the NHS sample has not been taken or taken at a different time-point that has not detected the virus.
Where is the study run from?
Liverpool School of Tropical Medicine (LSTM)
When is the study starting and how long is it expected to run for?
March 2020 to April 2021
Who is funding the study?
Who is the main contact?
Angela Hyder-Wright, firstname.lastname@example.org or email@example.com
20-036, IRAS 282147
Facilitating A SARS CoV-2 TEst for Rapid triage (FASTER)
This project will evaluate point-of-need (PON) tests for the detection of the novel strain of coronavirus SARS-CoV-2 causing the rapidly growing deadly outbreak of COVID-19 and will study the association between COVID-19 and S. pneumoniae colonisation and clinical outcome.
We are working with industrial partners who have developed a low-cost, lateral flow assay (LFA) to detect viral circulating antigens and IgM/G against COVID-19 in less than 15 minutes. These PON tests are intended for the rapid triage of patients with fever and/or cough. Furthermore, the PON tests will be formatted as self-tests, offering the additional benefit of deploying widely in the home and community settings. In addition, we will evaluate ELISA assays to detect IgG, IgA and IgM against COVID-19.
Approved 08/06/2020, National Health Research Ethics Committee South Central Oxford C (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)207 104 8041; firstname.lastname@example.org), ref: 20/SC/0169
Observational cohort study
Primary study design
Secondary study design
Patient information sheet
See additional files
COVID-19 (SARS-CoV-2 infection)
Healthy adults over 18 years old that are attending the hospital with signs and symptoms of coronavirus infection can participate in the study. The study involves samples being taken at day 0 (consent), day 2, day 7 and day 28. The samples include saliva, throat and nose swabs, nasosorption (blotting paper inserted into the nose to collect some concentrated nasal secretions), urine and blood. Data is collected from hospital case notes, all samples and data collected are anonymous.
Primary outcome measure
1. Pneumococcal colonisation measured in SARS-CoV-2-positive participants and SARS-CoV-2-negative controls by PCR at baseline, day 2, day 7 and day 28
2. SARS-CoV-2 is detected and quantified by RT-qPCR in NP swabs at baseline, day 2, day 7 and day 28 (for the SARS-CoV-2-positive participants)
Secondary outcome measures
1. Levels of inflammation are assessed by levels of 30 cytokines in nasal fluid and serum at baseline, day 2, day 7 and day 28
2. T-cell and B-cell antigen-specific responses are measured by flow cytometry based assays using PBMCS at baseline, day 2, day 7 and day 28
3. Antibody responses against SARS-CoV-2 are measured by ELISA at baseline, day 2, day 7 and day 28
4. Cellular immune responses to SARS-CoV-2 are measured by flow cytometry and functional assays in BAL samples collected at 3 - 6 months and 9 - 12 months (in both SARS-CoV-2-positive participants and SARS-CoV-2-negative controls)
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Adults 18 years old
2. Presenting with any of the following COVID-19 symptoms
2.1 Fever ≥37.8°C +/-
2.2. Shortness of breath +/-
2.3. New/ persistent cough
2.4 Clinical or radiological evidence of pneumonia
3. Fluent spoken English - to ensure a comprehensive understanding of the research project and their proposed involvement
4. Capacity to give informed verbal consent
Target number of participants
Participant exclusion criteria
1. Lack of capacity or unable to perform verbal consent
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Royal Liverpool and Broadgreen University Hospital
Trial participating centre
Aintree University Hospital
Pfizer Inc., Pfizer Consumer Healthcare
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
United States of America
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.
Intention to publish date
Participant level data
Basic results (scientific)