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

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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

Tracking Information
First Submitted Date May 26, 2020
First Posted Date May 29, 2020
Last Update Posted Date August 11, 2021
Actual Study Start Date May 19, 2020
Estimated Primary Completion Date March 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 28, 2020)
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

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.

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

Condition
  • Coronavirus Infection
  • COVID-19
Intervention 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
Study Groups/Cohorts
  • Work Stream A
    Patients that are recruited in hospital with either query COVID-19 or who have tested positive for COVID-19.
    Intervention: Diagnostic Test: Point-of-care test for SARS-CoV-2
  • Work Stream B
    Known COVID-positive and/or COVID-negative community testing
    Intervention: Diagnostic Test: Point-of-care test for SARS-CoV-2
  • Work Stream C
    Undifferentiated community testing
    Intervention: Diagnostic Test: Point-of-care test for SARS-CoV-2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 28, 2020)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 30, 2022
Estimated Primary Completion Date March 30, 2022   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Eloïse Cook 0161 701 7540 FALCONstudy@mft.nhs.uk
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT04408170
Other Study ID Numbers B00944
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Manchester University NHS Foundation Trust
Study Sponsor Manchester University NHS Foundation Trust
Collaborators Not Provided
Investigators
Study Director: Richard Body Manchester University NHS Foundation Trust
PRS Account Manchester University NHS Foundation Trust
Verification Date August 2021