Condition category
Infections and Infestations
Date applied
10/07/2020
Date assigned
21/08/2020
Last edited
25/08/2020
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.

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?
Pfizer (USA)

Who is the main contact?
Angela Hyder-Wright, angela.hyder-wright@lstmed.ac.uk or 2volresearch@lstmed.ac.uk

Trial website

https://www.lstmed.ac.uk/projects/the-faster-trial-diagnostics-development-for-covid-19

Contact information

Type

Public

Primary contact

Mrs Angela Hyder-Wright

ORCID ID

http://orcid.org/0000-0002-5989-2811

Contact details

Accelerator Research Clinic
Liverpool Life Sciences Accelerator Building
1 Daulby Street
Liverpool
L7 8XZ
United Kingdom
+44 (0)7540976888
angela.hyder-wright@lstmed.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

20-036, IRAS 282147

Study information

Scientific title

Facilitating A SARS CoV-2 TEst for Rapid triage (FASTER)

Acronym

FASTER

Study hypothesis

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.

Ethics approval

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; oxfordc.rec@hra.nhs.uk), ref: 20/SC/0169

Study design

Observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

See additional files

Condition

COVID-19 (SARS-CoV-2 infection)

Intervention

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.

Intervention type

Other

Phase

Drug names

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

18/03/2020

Overall trial end date

14/04/2021

Reason abandoned (if study stopped)

Eligibility

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. Lack of capacity or unable to perform verbal consent

Recruitment start date

14/04/2020

Recruitment end date

14/04/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Liverpool and Broadgreen University Hospital
Prescott Street
Liverpool
L7 8XP
United Kingdom

Trial participating centre

Aintree University Hospital
Lower Lane
Liverpool
L9 7AL
United Kingdom

Sponsor information

Organisation

Liverpool School of Tropical Medicine

Sponsor details

Pembroke Place
Liverpool
L3 5QA
United Kingdom
+44 (0)1517053794
lstmgov@lstmed.ac.uk

Sponsor type

University/education

Website

http://www.lstmed.ac.uk/

Funders

Funder type

Industry

Funder name

Pfizer

Alternative name(s)

Pfizer Inc., Pfizer Consumer Healthcare

Funding Body Type

private sector organisation

Funding Body Subtype

For-profit companies (industry)

Location

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

14/04/2022

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Editorial Notes

25/08/2020: The following changes were made to the trial record: 1. Uploaded protocol (not peer reviewed) Version 3.0 06 May 2020. 2. The participant information sheets were uploaded as additional files. 24/07/2020: Trial’s existence confirmed by South Central - Oxford C REC.