Facilitating AcceLerated Clinical Validation Of Novel Diagnostics for COVID-19 (FALCON-C19)

NCT04408170 | Completed

• 1 other identifier: B00944
• Study Type: observational
• Target: 8,380
• Locations: 1 country
• Sites: 15

Brief Summary

The United Kingdom and wider world is 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 to our response. 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 our 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 we require efficient but robust clinical evaluation. Therefore, to optimise resource utilisation in this global pandemic, we 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 assays in three priority areas:

1. 1.Evaluation of the diagnostic accuracy of IVDs for active infection with SARS-CoV-2
2. 2.Evaluation of assays monitoring the immune response to SARS-CoV-2 infection
3. 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).

Conditions

Coronavirus Infection; COVID-19

Keywords

In vitro diagnostics; Point-of-care testing

Outcome Measures

Primary Outcomes (2)

• If the participant has an active SARS-CoV-2 infection during admission

  This will be determined using the point-of-care test and the laboratory test results

  Baseline

• The participant has had a past SARS-CoV-2 infection

  This will be determined using the point-of-cacre test for SARS-CoV-2 antibodies and the laboratory test results

  Day 90

Study Arms (3)

Work Stream A

Patients that are recruited in hospital with either query COVID-19 or who have tested positive for COVID-19.

Diagnostic Test: Point-of-care test for SARS-CoV-2

Work Stream B

Known COVID-positive and/or COVID-negative community testing

Diagnostic Test: Point-of-care test for SARS-CoV-2

Work Stream C

Undifferentiated community testing

Diagnostic Test: Point-of-care test for SARS-CoV-2

Interventions

Point-of-care test for SARS-CoV-2 DIAGNOSTIC_TEST

Throat and nose swabs and/or saliva samples and/or whole blood and/or finger stick samples may be taken to be tested on Point-of-care tests for SARS-CoV-2

Work Stream A; Work Stream B; Work Stream C

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Work Stream A: Patients who present or are referred to secondary/tertiary care settings due to possible SARS-CoV-2 infection Work Stream B: Known COVID-positive and/or COVID-negative community testing Work Stream C: Undifferentiated community testing

You may qualify if:

• We will include participants (patients or staff):
• That are 18 years or older
• That will require testing for COVID-19 in the opinion of the treating clinician
• That may have presented with acute symptoms of COVID-19 (e.g. fever, cough, dyspnoea, anosmia) or chest x-ray changes or they may be asymptomatic but require testing for other reasons
• We will include participants:
• That are 18 years or older
• That have been admitted for another reason other than suspected SARS-CoV-2 infection, but when routinely swabbed they have been identified as positive for SARS-CoV-2 PCR
• Work Stream B (Group 3):
• We will include participants:
• That are 18 years or older
• EITHER:
• They have been identified as positive for SARS-CoV-2 PCR through testing at national laboratory infrastructure OR
• They have been identified as negative for SARS-CoV-2 PCR through testing at national laboratory infrastructure
• Work Stream C (Group 4):
• We will include participants:

You may not qualify if:

• Patients where it is impossible/unsafe to obtain the required research samples
• Prisoners
• Patients where sampling is not feasible

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Study Sites (15)

Sandwell General Hospital Birmingham NHS Trust

Birmingham, United Kingdom

Location

University Hospitals of Derby and Burton NHS FT

Derby, United Kingdom

Location

Frimley Health NHS FT

Frimley, United Kingdom

Location

Airedale NHS FT

Keighley, United Kingdom

Location

Leeds Teaching Hospital NHS FT

Leeds, United Kingdom

Location

St George's University Hospitals NHS FT

London, United Kingdom

Location

Manchester University NHS FT

Manchester, M13 9WU, United Kingdom

Location

Newcastle upon Tyne Hospitals NHS FT

Newcastle upon Tyne, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Location

Oxford University Hospitals NHS FT

Oxford, United Kingdom

Location

Royal Berkshire Hospital NHS FT

Reading, United Kingdom

Location

Barking, Havering & Redbridge Hospitals NHS FT

Romford, United Kingdom

Location

Salford Royal NHS FT

Salford, United Kingdom

Location

University Hospital Southampton NHS FT

Southampton, United Kingdom

Location

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, United Kingdom

Location

Related Publications (1)

• Byrne RL, Aljayyoussi G, Kontogianni K, Clerkin K, McIntyre M, Wardale J, Williams CT, Body R, Adams ER, de Vos M, Escadafal C, Cubas Atienzar AI. Head-to-head comparison of anterior nares and nasopharyngeal swabs for SARS-CoV-2 antigen detection in a community drive-through test centre in the UK. BMJ Open Respir Res. 2025 Mar 22;12(1):e001747. doi: 10.1136/bmjresp-2023-001747.

  PMID: 40122534 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Throat and nose swabs and/or saliva samples may be taken at multiple time points and stored for future testing. Whole blood samples may be taken at multiple time points during the study. Samples will be processed and the serum stored. Finger stick samples may also be taken and stored for future testing.

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Richard Body

  Manchester University NHS Foundation Trust

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: May 29, 2020
• Study Start: May 19, 2020
• Primary Completion: January 26, 2021
• Study Completion: December 1, 2024
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (15)