Condition category
Infections and Infestations
Date applied
14/07/2020
Date assigned
16/07/2020
Last edited
16/07/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The United Kingdom and wider world are in the midst of the 2019 novel coronavirus (SARS-CoV-2) pandemic. Accurate diagnosis of infection, identification of immunity and monitoring the clinical progression of infection are of paramount importance. Widespread population testing has proven difficult in western countries and has been limited by test availability, human resources and long turnaround times (up to 72 hours). This has limited the ability to control the spread of infection and to develop effective clinical pathways to enable early social isolation of infected patients and early treatment for those most at risk.
The life sciences industry has responded to the pandemic by developing multiple new in vitro diagnostic tests (IVDs). To leverage the potential clinical benefit of those tests efficient but robust clinical evaluation is required. Therefore, to optimise resource utilisation in this global pandemic, researchers will conduct a platform adaptive diagnostic study on a national level, utilising a national network of expertise in the evaluation of diagnostic technology. This study will enable the evaluation of multiple tests in three priority areas:
1. Evaluation of the diagnostic accuracy of IVDs for active infection with SARS-CoV-2
2. Evaluation of tests monitoring the immune response to SARS-CoV-2 infection
3. Evaluation of the prognostic value of commercially available tests for predicting prognosis in patients with suspected or confirmed SARS-CoV-2 infection (this arm will not be active immediately but may be activated after initiation).

Who can participate?
Patients aged 18 or over with suspected or confirmed diagnosis of COVID-19

What does the study involve?
Swabs from the participant's nose and throat are taken, along with a saliva and blood sample. Additional samples may also be taken on five occasions over the next 90 days, depending on the test being evaluated at the participating site. This samples would either be tested locally at the participating site, or they may be sent to a central laboratory for testing. Basic data will also be collected from the participant, which includes demographics, presenting symptoms, past medical history, physical examination findings, vital signs and the results of any routine tests that the participant undergoes as part of their routine care. Follow-up data will also be collected at 30 and 90 days. This will include details of the participant's condition, such as mortality status, requirement for intensive care, organ support and oxygen treatment.

What are the possible benefits and risks of participating?
Whilst there are no individual benefits to being involved in this study, society and the national response to the pandemic will benefit from the confidence that new tests used by the NHS to detect COVID-19 will be accurate, reliable and give the results quickly. Apart from the inconvenience of having further samples taken, there are no additional risks to the participant.

Where is the study run from?
Manchester University NHS Foundation Trust (UK)

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

Who is funding the study?
National Institute for Health Research (NIHR), through the UK Research & Innovation (UKRI) fund (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

Not applicable

Contact information

Type

Public

Primary contact

Dr Eloise Cook

ORCID ID

Contact details

Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom

Type

Scientific

Additional contact

Prof Richard Body

ORCID ID

http://orcid.org/0000-0001-9089-8130

Contact details

Emergency Department
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

NCT04408170

Protocol/serial number

CPMS 45932, IRAS 284229

Study information

Scientific title

Facilitating Accelerated CLinical evaluation Of Novel diagnostic tests for COVID-19 (FALCON C-19)

Acronym

FALCON C-19

Study hypothesis

In response to the COVID-19 pandemic, multiple in vitro diagnostics tests (IVDs) have been rapidly developed to detect SARS-CoV-2 infection or immunity. To meet the urgent demand for increased testing capacity, many IVDs have received emergency use authorization. However, clinical evaluations to date have mainly been single-centre, employing differing reference standards with variable protocols. There remains an urgent need for a multi-site, rapid, and methodologically robust approach to in-context clinical validation.

Ethics approval

Approved 04/06/2020, Wales Research Ethics Committee 5 Bangor (Health and Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, UK; +44 (0)7970 422139; Wales.REC5@wales.nhs.uk), ref: 20/WA/0169

Study design

Observational; Design type: Validation of investigation /therapeutic procedures

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

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

Condition

COVID-19 (SARS-CoV-2 infection)

Intervention

The following samples will be taken:
1. Combined nasal/throat swab and/or saliva and approximately 15 ml venous blood taken at the time of first contact (baseline/day 0)
2. Combined nasal/throat swab and/or saliva will also be collected on day 1
3. Approximately 2 ml whole blood and/or finger stick blood samples drawn serially on days 1, 3, 5, 9, 30 and 90
Please note, not all of the diagnostic evaluations will require a full sample set. The samples collected will depend on the diagnostic test that is being evaluated at the study site

Data collection
Basic data will be collected from participants about their demographics, presenting symptoms, past medical history, relevant vaccinations, physical examination findings, vital signs and the results of any routine tests that they undergo as part of their clinical care. On follow-up visits, details of the participant’s condition will be collected (e.g. mortality status, requirement for intensive care, organ support and oxygen treatment).

Intervention type

Other

Phase

Drug names

Primary outcome measure

“Standard” diagnostic accuracy of point-of-care tests for active and past COVID-19 infection with reference to the Public Health England reference standard; Timepoint(s): Baseline, Day 1, Day 3, Day 5 Day 9, Day 30 and Day 90

Secondary outcome measures

1. Detection of antibodies to SARS-CoV-2 by a reference method
2. Length of hospital stay measured using clinical notes
3. Development of multi-organ failure measured using clinical notes
4. Critical care admission measured using clinical notes
5. Mechanical ventilation measured using clinical notes
6. Organ support measured using clinical notes
7. Vasopressor use measured using clinical notes
8. SARS-CoV-2 related death measured using clinical notes
Timepoint(s): Day 30 and Day 90

Overall trial start date

30/03/2020

Overall trial end date

30/06/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Patients presenting to secondary/tertiary care with possible SARS-CoV-2 infection who require testing, in the opinion of the treating clinician. Those patients may have presented with acute symptoms of COVID-19 (e.g. fever, cough, dyspnoea) or they may be asymptomatic, but require testing for other reasons

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 1000; UK Sample Size: 1000

Participant exclusion criteria

1. Impossible or unsafe to obtain the required research samples
2. Prisoners
3. Patients with confirmed previous infection to SARS-CoV-2
4. Patients where sampling is not feasible

Recruitment start date

01/06/2020

Recruitment end date

28/02/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Manchester Royal Infirmary
Manchester University NHS Foundation Trust Oxford Road
Manchester
M13 9WL
United Kingdom

Sponsor information

Organisation

Manchester University NHS Foundation Trust

Sponsor details

Research Office
1st Floor
The Nowgen Centre
29 Grafton Street
Manchester
M13 9WU
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.manchester.ac.uk/

Funders

Funder type

Government

Funder name

UK Research and Innovation

Alternative name(s)

UKRI

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations

Location

United Kingdom

Funder name

National Institute for Health Research (NIHR) (UK)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The researchers will endeavour to publish the findings of this research openly, whether their findings are positive or negative. This is likely to be in medical journals, and the findings may also be published on relevant websites. The researchers will endeavour to ensure that all findings are published with open access. They also plan to disseminate the findings to the Department of Health and Social Care.

IPD sharing statement
The data-sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/06/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

14/07/2020: Trial's existence confirmed by the NIHR.