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

COVID-19 Clinical Trial

— FALCON-C19  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04408170
• Other study ID #: B00944
• Status: Completed
• Start date: May 19, 2020
• Est. completion date: October 1, 2023

Study information

• Verified date: October 2023
• Source: Manchester University NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8380
• Est. completion date: October 1, 2023
• Est. primary completion date: January 26, 2021
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• COVID-19

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Manchester University NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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