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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04408170
Recruitment Status : Recruiting
First Posted : May 29, 2020
Last Update Posted : August 11, 2021
Sponsor:
Information provided by (Responsible Party):
Manchester University NHS Foundation Trust

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).

Condition or disease Intervention/treatment
Coronavirus Infection COVID-19 Diagnostic Test: Point-of-care test for SARS-CoV-2

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Facilitating AcceLerated Clinical Validation Of Novel Diagnostics for COVID-19 (FALCON-C19)
Actual Study Start Date : May 19, 2020
Estimated Primary Completion Date : March 30, 2022
Estimated Study Completion Date : March 30, 2022

Group/Cohort Intervention/treatment
Work Stream A
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
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

Work Stream B
Known COVID-positive and/or COVID-negative community testing
Diagnostic Test: Point-of-care test for SARS-CoV-2
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

Work Stream C
Undifferentiated community testing
Diagnostic Test: Point-of-care test for SARS-CoV-2
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




Primary Outcome Measures :
  1. If the participant has an active SARS-CoV-2 infection during admission [ Time Frame: Baseline ]
    This will be determined using the point-of-care test and the laboratory test results

  2. The participant has had a past SARS-CoV-2 infection [ Time Frame: Day 90 ]
    This will be determined using the point-of-cacre test for SARS-CoV-2 antibodies and the laboratory test results


Biospecimen Retention:   Samples With DNA

Throat and nose swabs and/or saliva samples may be taken at multiple time points and stored for future testing.

Whole blood samples may be taken at multiple time points during the study. Samples will be processed and the serum stored.

Finger stick samples may also be taken and stored for future testing.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04408170


Contacts
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Contact: Eloïse Cook 0161 701 7540 FALCONstudy@mft.nhs.uk

Locations
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United Kingdom
Sandwell General Hospital Birmingham NHS Trust Recruiting
Birmingham, United Kingdom
Contact: Central study team       FALCONstudy@mft.nhs.uk   
University Hospitals of Derby and Burton NHS FT Recruiting
Derby, United Kingdom
Contact: Central study team       FALCONstudy@mft.nhs.uk   
Frimley Health NHS FT Recruiting
Frimley, United Kingdom
Contact: Central study team       FALCONstudy@mft.nhs.uk   
Airedale NHS FT Recruiting
Keighley, United Kingdom
Contact: Central study team       FALCONstudy@mft.nhs.uk   
Leeds Teaching Hospital NHS FT Recruiting
Leeds, United Kingdom
Contact: Central study team       FALCONstudy@mft.nhs.uk   
St George's University Hospitals NHS FT Recruiting
London, United Kingdom
Contact: Central study team       FALCONstudy@mft.nhs.uk   
Manchester University NHS FT Recruiting
Manchester, United Kingdom, M13 9WU
Contact: Eloise Cook    0161 276 3638    FALCONstudy@mft.nhs.uk   
Newcastle upon Tyne Hospitals NHS FT Recruiting
Newcastle Upon Tyne, United Kingdom
Contact: Central study team       FALCONstudy@mft.nhs.uk   
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom
Contact: Central study team       FALCONstudy@mft.nhs.uk   
Oxford University Hospitals NHS FT Recruiting
Oxford, United Kingdom
Contact: Central study team       FALCONstudy@mft.nhs.uk   
Royal Berkshire Hospital NHS FT Recruiting
Reading, United Kingdom
Contact: Central study team       FALCONstudy@mft.nhs.uk   
Barking, Havering & Redbridge Hospitals NHS FT Recruiting
Romford, United Kingdom
Contact: Central study team       FALCONstudy@mft.nhs.uk   
Salford Royal NHS FT Recruiting
Salford, United Kingdom
Contact: Central study team       FALCONstudy@mft.nhs.uk   
University Hospital Southampton NHS FT Recruiting
Southampton, United Kingdom
Contact: Central study team       FALCONstudy@mft.nhs.uk   
University Hospitals of North Midlands NHS Trust Recruiting
Stoke-on-Trent, United Kingdom
Contact: Central study team       FALCONstudy@mft.nhs.uk   
Sponsors and Collaborators
Manchester University NHS Foundation Trust
Investigators
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Study Director: Richard Body Manchester University NHS Foundation Trust
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Responsible Party: Manchester University NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04408170    
Other Study ID Numbers: B00944
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: August 11, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Manchester University NHS Foundation Trust:
In vitro diagnostics
Point-of-care testing
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases