Coronavirus InfectionFALCON-C19NCT04408170
Facilitating AcceLerated Clinical Validation Of Novel Diagnostics for COVID-19 (FALCON-C19)
An observational study of Coronavirus Infection and COVID-19, run by Manchester University NHS Foundation Trust at 15 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Coronavirus Infection, COVID-19
- What is being tested?
- Point-of-care test for SARS-CoV-2
- How many people
- 8,380 participants
- Where
- 15 sitesUnited Kingdom
- Study dates
- 19 May 2020to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
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
Who may be able to join
None listed.
Who cannot join
- Patients where it is impossible/unsafe to obtain the required research samples
- Prisoners
- Patients where sampling is not feasible
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United Kingdom15 sites
Sandwell General Hospital Birmingham NHS Trust
Birmingham
University Hospitals of Derby and Burton NHS FT
Derby
Frimley Health NHS FT
Frimley
Airedale NHS FT
Keighley
Leeds Teaching Hospital NHS FT
Leeds
St George's University Hospitals NHS FT
London
Manchester University NHS FT
Manchester, M13 9WU
Newcastle upon Tyne Hospitals NHS FT
Newcastle upon Tyne
Nottingham University Hospitals NHS Trust
Nottingham
Oxford University Hospitals NHS FT
Oxford
Royal Berkshire Hospital NHS FT
Reading
Barking, Havering & Redbridge Hospitals NHS FT
Romford
Salford Royal NHS FT
Salford
University Hospital Southampton NHS FT
Southampton
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent
About this study
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).
- Conditions
- Coronavirus Infection, COVID-19
- Being tested
- Point-of-care test for SARS-CoV-2
- Keywords
- In vitro diagnostics, Point-of-care testing
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care test for SARS-CoV-2Diagnostic test
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 group | Role | What they receive |
|---|---|---|
| Work Stream A | Patients that are recruited in hospital with either query COVID-19 or who have tested positive for COVID-19. Receives: Diagnostic Test: Point-of-care test for SARS-CoV-2 | |
| Work Stream B | Known COVID-positive and/or COVID-negative community testing Receives: Diagnostic Test: Point-of-care test for SARS-CoV-2 | |
| Work Stream C | Undifferentiated community testing Receives: Diagnostic Test: Point-of-care test for SARS-CoV-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start19 May 2020
- Primary completion26 Jan 2021
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Richard Body, Study director, Manchester University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408170
- Sponsor's protocol ID
- B00944
- Acronym
- FALCON-C19
- Status last verified
- Apr 2025
- First submitted
- 26 May 2020
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Byrne RL, Aljayyoussi G, Kontogianni K, Clerkin K, McIntyre M, Wardale J, Williams CT, Body R, Adams ER, de Vos M, Escadafal C, Cubas Atienzar AI. Head-to-head comparison of anterior nares and nasopharyngeal swabs for SARS-CoV-2 antigen detection in a community drive-through test centre in the UK. BMJ Open Respir Res. 2025 Mar 22;12(1):e001747. doi: 10.1136/bmjresp-2023-001747.
PubMed 40122534
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating AcceLerated Clinical Validation Of Novel Diagnostics for COVID-19 (FALCON-C19)
- ClinicalTrials.gov ID
- NCT04408170
- Acronym / sponsor ID
- FALCON-C19 / B00944
- Conditions
- Coronavirus Infection, COVID-19
- Keywords
- In vitro diagnostics, Point-of-care testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,380 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- 19 May 2020 (actual)
- Primary completion
- 26 Jan 2021 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Work Stream A | – | Diagnostic Test: Point-of-care test for SARS-CoV-2Patients that are recruited in hospital with either query COVID-19 or who have tested positive for COVID-19. |
| Work Stream B | – | Diagnostic Test: Point-of-care test for SARS-CoV-2Known COVID-positive and/or COVID-negative community testing |
| Work Stream C | – | Diagnostic Test: Point-of-care test for SARS-CoV-2Undifferentiated community testing |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Patients where it is impossible/unsafe to obtain the required research samples
- Prisoners
- Patients where sampling is not feasible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point-of-care test for SARS-CoV-2Throat 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 | Diagnostic test | Work Stream A, Work Stream B, Work Stream C |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Derived from this study: PubMed 40122534Byrne RL, Aljayyoussi G, Kontogianni K, Clerkin K, McIntyre M, Wardale J, Williams CT, Body R, Adams ER, de Vos M, Escadafal C, Cubas Atienzar AI. Head-to-head comparison of anterior nares and nasopharyngeal swabs for SARS-CoV-2 antigen detection in a community drive-through test centre in the UK. BMJ Open Respir Res. 2025 Mar 22;12(1):e001747. doi: 10.1136/bmjresp-2023-001747.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Body study director
Manchester University NHS Foundation Trust
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Infection and COVID-19, run by Manchester University NHS Foundation Trust at 15 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
If the participant has an active SARS-CoV-2 infection during admission (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04408170, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.