NCT04408170

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 8,380 (actual)
• Sponsor: Manchester University NHS Foundation Trust · Other Government
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: —

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).

Conditions

• Coronavirus Infection
• COVID-19

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-05-19
• Primary completion: 2021-01-26
• Completion: 2024-12-01
• First posted: 2020-05-29
• Last updated: 2025-04-23

Locations

15 sites across 1 country: United Kingdom