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

Study Overview
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Brief Summary
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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: Evaluation of the diagnostic accuracy of IVDs for active infection with SARS-CoV-2 Evaluation of assays monitoring the immune response to SARS-CoV-2 infection 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).

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

Conditions
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Coronavirus Infection, COVID-19

Intervention / Treatment
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* Diagnostic Test: Point-of-care test for SARS-CoV-2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Work Stream A<br>Patients that are recruited in hospital with either query COVID-19 or who have tested positive for COVID-19. | Diagnostic Test: Point-of-care test for SARS-CoV-2<br>* 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<br>|
| Work Stream B<br>Known COVID-positive and/or COVID-negative community testing | Diagnostic Test: Point-of-care test for SARS-CoV-2<br>* 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<br>|
| Work Stream C<br>Undifferentiated community testing | Diagnostic Test: Point-of-care test for SARS-CoV-2<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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In vitro diagnostics, Point-of-care testing