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

NHS Foundation Trust

Status: Completed

Conditions: COVID-19; Coronavirus Infection

Treatments: Diagnostic Test: Point-of-care test for SARS-CoV-2

Study type: Observational

Funder types: Other

Identifiers

NCT04408170

B00944

Details and patient eligibility

About

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).

Enrollment: 8,380 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

8,380 participants in 3 patient groups

Work Stream A

Description:

Patients that are recruited in hospital with either query COVID-19 or who have tested positive for COVID-19.

Treatment:

Diagnostic Test: Point-of-care test for SARS-CoV-2

Work Stream B

Description:

Known COVID-positive and/or COVID-negative community testing

Treatment:

Diagnostic Test: Point-of-care test for SARS-CoV-2

Work Stream C

Description:

Undifferentiated community testing

Treatment:

Diagnostic Test: Point-of-care test for SARS-CoV-2