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

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Key information

Conditions

Coronavirus Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sandwell General Hospital Birmingham NHS Trust, Birmingham, United Kingdom

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Group 1 Inclusion Criteria:

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

Group 2 Inclusion Criteria:

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:

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

Exclusion criteria

for all Work Streams:

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

Treatment and study plan

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

Primary outcomes

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

Time frame: Baseline

This will be determined using the point-of-care test and the laboratory test results
The participant has had a past SARS-CoV-2 infection

Time frame: Day 90

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

Sponsors and collaborators

Lead sponsor

Manchester University NHS Foundation Trust

Other Gov

Registry information

Acronym: FALCON-C19

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2024
First posted: May 29, 2020
Registry last updated: Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed