Study Detail

FALCON C-19

Facilitating Accelerated CLinical evaluation Of Novel diagnostic tests for COVID-19 (FALCON C-19)

Status: Open

Type: Observational

Funder: NIHR/UKRI

Sponsor: Manchester University NHS Foundation Trust

CI: Dr Richard Body

IRAS-Number: 284229

CPMS-ID: 45932

Approval Date: 04 May 2020

Description:

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. CONDOR is the overarching platform which will be providing coordination, and as such, it has been deemed not to require submission to the HRA. Two research studies (FALCON and RAPTOR) which feed into this platform. 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). Recognising the need for a holistic, specialty-agnostic approach, our overall programme of work will take place in both primary and secondary healthcare settings, spanning the breadth of a patient's journey. The study described in this application (referred to as FALCON) focuses only on secondary care settings. A separate study (RAPTOR) is being initiated to evaluate IVDs for COVID-19 diagnosis in community settings.

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