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

Completed

• Conditions: COVID-19; Coronavirus Infection
• Interventions: Diagnostic Test: Point-of-care test for SARS-CoV-2

• Registration Number: NCT04408170
• Lead Sponsor: Manchester University NHS Foundation Trust

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. 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-19
• Study First Submitted: 2020-05-26
• Study First Submitted QC: 2020-05-28
• Study First Posted: 2020-05-29
• Primary Completion: 2021-01-26
• Study Completion: 2024-12-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8380

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Work Stream B	Point-of-care test for SARS-CoV-2	Known COVID-positive and/or COVID-negative community testing
Work Stream C	Point-of-care test for SARS-CoV-2	Undifferentiated community testing
Work Stream A	Point-of-care test for SARS-CoV-2	Patients that are recruited in hospital with either query COVID-19 or who have tested positive for COVID-19.

Primary Outcome Measures

Name	Time	Method
The participant has had a past SARS-CoV-2 infection	Day 90	This will be determined using the point-of-cacre test for SARS-CoV-2 antibodies and the laboratory test results
If the participant has an active SARS-CoV-2 infection during admission	Baseline	This will be determined using the point-of-care test and the laboratory test results

Trial Locations

Locations (15)

Sandwell General Hospital Birmingham NHS Trust; 🇬🇧 Birmingham, United Kingdom

Leeds Teaching Hospital NHS FT; 🇬🇧 Leeds, United Kingdom

Newcastle upon Tyne Hospitals NHS FT; 🇬🇧 Newcastle Upon Tyne, United Kingdom

Salford Royal NHS FT; 🇬🇧 Salford, United Kingdom

St George's University Hospitals NHS FT; 🇬🇧 London, United Kingdom

Oxford University Hospitals NHS FT; 🇬🇧 Oxford, United Kingdom

Royal Berkshire Hospital NHS FT; 🇬🇧 Reading, United Kingdom

Airedale NHS FT; 🇬🇧 Keighley, United Kingdom

Nottingham University Hospitals NHS Trust; 🇬🇧 Nottingham, United Kingdom

University Hospitals of Derby and Burton NHS FT; 🇬🇧 Derby, United Kingdom

Barking, Havering & Redbridge Hospitals NHS FT; 🇬🇧 Romford, United Kingdom

Frimley Health NHS FT; 🇬🇧 Frimley, United Kingdom

Manchester University NHS FT; 🇬🇧 Manchester, United Kingdom

University Hospital Southampton NHS FT; 🇬🇧 Southampton, United Kingdom

University Hospitals of North Midlands NHS Trust; 🇬🇧 Stoke-on-Trent, United Kingdom