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

Summary:

The aim of this study is to evaluate the accuracy of a number of commercially available tests for diagnosing COVID-19 infection within hospitals. Accurate diagnosis of infection, identification of immunity and monitoring the progress of the infection are of great importance to our response to COVID-19. Widespread population testing has proved difficult in western countries and has been limited by availability of tests, staff availability and long turnaround times (up to 72 hours). This has limited our ability to control the spread of infection and to develop effective ways to ensure early self- isolation of infected patients and early treatment for those most at risk. Industry has developed a number of new in vitro (outside the human body) diagnostic tests. To take advantage of the potential benefit of those tests we need effective assessment of the tests. This study will evaluate tests in three priority areas: - Evaluation of the accuracy of in vitro tests for the diagnosis of active infection with COVID-19; - Evaluation of tests to show the immune response to COVID-19; - Evaluation of tests for predicting the likely course of the disease in patients with suspected or confirmed COVID-19 infection. (This will not be done immediately but may start later). The study will take place in both primary healthcare (in the community) and secondary healthcare (generally hospitals) settings. The study described in this application (referred to as FALCON) focuses only on hospitals. A separate study (RAPTOR) will look at primary healthcare settings.

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.

Study URL:

https://www.condor-platform.org/condor_workstreams/falcon

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FALCON C-19 (Workstream B)

Facilitating Accelerated CLinical evaluation of Novel diagnostic tests for COVID-19 (FALCON C19 - Workstream B)

Status: Open

Type: Observational

Funder: NIHR / UKRI

Sponsor: Manchester University NHS Foundation Trust

CI: Dr Richard Body

IRAS-Number: 284229

CPMS-ID: 47296

Approval Date: 04 May 2020

Summary:

The aim of this study is to evaluate the accuracy of a number of commercially available tests for diagnosing COVID-19 infection within hospitals. Accurate diagnosis of infection, identification of immunity and monitoring the progress of the infection are of great importance to our response to COVID-19. Widespread population testing has proved difficult in western countries and has been limited by availability of tests, staff availability and long turnaround times (up to 72 hours). This has limited our ability to control the spread of infection and to develop effective ways to ensure early self- isolation of infected patients and early treatment for those most at risk. Industry has developed a number of new in vitro (outside the human body) diagnostic tests. To take advantage of the potential benefit of those tests we need effective assessment of the tests. This study will evaluate tests in three priority areas: Evaluation of the accuracy of in vitro tests for the diagnosis of active infection with COVID-19; Evaluation of tests to show the immune response to COVID-19; Evaluation of tests for predicting the likely course of the disease in patients with suspected or confirmed COVID-19 infection. (This will not be done immediately but may start later). The study will take place in both primary healthcare (in the community) and secondary healthcare (generally hospitals) settings. The study described in this application (referred to as FALCON) focuses only on hospitals. A separate study (RAPTOR) will look at primary healthcare settings.

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. 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. At the request of the Government, the scope of FALCON has recently been urgently broadened, to support the national COVID-19 testing programme. Timelines have also been shortened, with a desired turnaround time now of 2 to 3 weeks per test evaluation. A study amendment has been approved in line with this, and the study now broadly falls into three parts: (1) Novel test device and instrument evaluation: at the existing sites identified, and new sites are being sought; (2) Sample collection (nose and throat swabs, and saliva samples): to support the work of the Test Validation Group at the DHSC, and sites are being sought to support this; (3) Moonshot amendment, evaluation of specific devices at 15 testing centres (which are in the process of being identified), with analysis undertaken through Lighthouse Labs.

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