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

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. Evaluation of the diagnostic accuracy of IVDs for active infection with SARS-CoV-2
2. Evaluation of assays 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).

Study Overview

• Status: Completed
• Conditions: COVID-19; Coronavirus Infection
• Intervention / Treatment: Diagnostic test: Point-of-care test for SARS-CoV-2

• Study Type: Observational
• Enrollment (Actual): 8380

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom
    • Sandwell General Hospital Birmingham NHS Trust
  • Derby, United Kingdom
    • University Hospitals of Derby and Burton NHS FT
  • Frimley, United Kingdom
    • Frimley Health NHS FT
  • Keighley, United Kingdom
    • Airedale NHS FT
  • Leeds, United Kingdom
    • Leeds Teaching Hospital NHS FT
  • London, United Kingdom
    • St George's University Hospitals NHS FT
  • Manchester, United Kingdom, M13 9WU
    • Manchester University NHS FT
  • Newcastle Upon Tyne, United Kingdom
    • Newcastle upon Tyne Hospitals NHS FT
  • Nottingham, United Kingdom
    • Nottingham University Hospitals NHS Trust
  • Oxford, United Kingdom
    • Oxford University Hospitals NHS FT
  • Reading, United Kingdom
    • Royal Berkshire Hospital NHS FT
  • Romford, United Kingdom
    • Barking, Havering & Redbridge Hospitals NHS FT
  • Salford, United Kingdom
    • Salford Royal NHS FT
  • Southampton, United Kingdom
    • University Hospital Southampton NHS FT
  • Stoke-on-Trent, United Kingdom
    • University Hospitals of North Midlands NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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

Description

Work Stream A (in-hospital; Group 1 and Group 2):

Group 1 Inclusion Criteria:

We will include participants (patients or staff):

1. That are 18 years or older
2. That will require testing for COVID-19 in the opinion of the treating clinician
3. 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

Group 2 Inclusion Criteria:

We will include participants:

1. That are 18 years or older
2. 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:

1. That are 18 years or older

   EITHER:

2. They have been identified as positive for SARS-CoV-2 PCR through testing at national laboratory infrastructure OR
3. 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:

1. That are 18 years or older
2. Who are undergoing testing for COVID-19, whether they are symptomatic or symptomatic for COVID-19

Exclusion Criteria for all Work Streams:

1. Patients where it is impossible/unsafe to obtain the required research samples
2. Prisoners
3. Patients where sampling is not feasible

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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 B; Known COVID-positive and/or COVID-negative community testing	Diagnostic test: Point-of-care test for SARS-CoV-2; 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 C; Undifferentiated community testing	Diagnostic test: Point-of-care test for SARS-CoV-2; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Manchester University NHS Foundation Trust
• Investigators: Study Director: Richard Body, Manchester University NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2020
• Primary Completion (Actual): January 26, 2021
• Study Completion (Actual): December 1, 2024

Study Registration Dates

• First Submitted: May 26, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (Actual): May 29, 2020

Study Record Updates

• Last Update Posted (Actual): April 23, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Point-of-care testing; In vitro diagnostics
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronaviridae Infections; Nidovirales Infections; COVID-19; Coronavirus Infections
• Other Study ID Numbers: B00944

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No