Clinical trial NCT04408170: Facilitating AcceLerated Clinical Validation Of Novel Diagnostics for COVID-19 (FALCON-C19)
Official title: Facilitating AcceLerated Clinical Validation Of Novel Diagnostics for COVID-19 (FALCON-C19)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Infection
COVID-19
Keywords: In vitro diagnostics
Point-of-care testing
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2020-05-29
Enrollment: 8380
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Work Stream A: Patients who present or are referred to secondary/tertiary care settings due to possible SARS-CoV-2 infection

Work Stream B: Known COVID-positive and/or COVID-negative community testing

Work Stream C: Undifferentiated community testing

Brief 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).


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

Group 1 Inclusion Criteria:

We will include participants (patients or staff):

1. That are 18 years or older
2. That will require testing for COVID-19 in the opinion of the treating clinician
3. 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:

1. That are 18 years or older
2. 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:

1. That are 18 years or older

   EITHER:
2. They have been identified as positive for SARS-CoV-2 PCR through testing at national laboratory infrastructure OR
3. 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:

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

Exclusion Criteria for all Work Streams:

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

Primary outcomes:
measure: If the participant has an active SARS-CoV-2 infection during admission
timeFrame: Baseline
measure: The participant has had a past SARS-CoV-2 infection
timeFrame: Day 90
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Sandwell General Hospital Birmingham NHS Trust
city: Derby
country: United Kingdom
facility: University Hospitals of Derby and Burton NHS FT
city: Frimley
country: United Kingdom
facility: Frimley Health NHS FT
city: Keighley
country: United Kingdom
facility: Airedale NHS FT
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospital NHS FT
city: London
country: United Kingdom
facility: St George's University Hospitals NHS FT
city: Manchester
country: United Kingdom
facility: Manchester University NHS FT
city: Newcastle Upon Tyne
country: United Kingdom
facility: Newcastle upon Tyne Hospitals NHS FT
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS FT
city: Reading
country: United Kingdom
facility: Royal Berkshire Hospital NHS FT
city: Romford
country: United Kingdom
facility: Barking, Havering & Redbridge Hospitals NHS FT
city: Salford
country: United Kingdom
facility: Salford Royal NHS FT
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS FT
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospitals of North Midlands NHS Trust
Study officials:
affiliation: Manchester University NHS Foundation Trust
name: Richard Body
role: STUDY_DIRECTOR
References: