Evaluating new point-of-care diagnostic tests for COVID-19
| ISRCTN | ISRCTN86124626 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86124626 |
| ClinicalTrials.gov (NCT) | NCT04408170 |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 284229 |
| Protocol serial number | CPMS 45932, IRAS 284229 |
| Sponsor | Manchester University NHS Foundation Trust |
| Funders | UK Research and Innovation, National Institute for Health Research (NIHR) (UK) |
- Submission date
- 14/07/2020
- Registration date
- 16/07/2020
- Last edited
- 14/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
The United Kingdom and wider world are 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. 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 the 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 efficient but robust clinical evaluation is required. Therefore, to optimise resource utilisation in this global pandemic, researchers 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 tests in three priority areas:
1. Evaluation of the diagnostic accuracy of IVDs for active infection with SARS-CoV-2
2. Evaluation of tests 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).
Who can participate?
Patients aged 18 or over with suspected or confirmed diagnosis of COVID-19
What does the study involve?
Swabs from the participant's nose and throat are taken, along with a saliva and blood sample. Additional samples may also be taken on five occasions over the next 90 days, depending on the test being evaluated at the participating site. This samples would either be tested locally at the participating site, or they may be sent to a central laboratory for testing. Basic data will also be collected from the participant, which includes demographics, presenting symptoms, past medical history, physical examination findings, vital signs and the results of any routine tests that the participant undergoes as part of their routine care. Follow-up data will also be collected at 30 and 90 days. This will include details of the participant's condition, such as mortality status, requirement for intensive care, organ support and oxygen treatment.
What are the possible benefits and risks of participating?
Whilst there are no individual benefits to being involved in this study, society and the national response to the pandemic will benefit from the confidence that new tests used by the NHS to detect COVID-19 will be accurate, reliable and give the results quickly. Apart from the inconvenience of having further samples taken, there are no additional risks to the participant.
Where is the study run from?
Manchester University NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
March 2020 to October 2022
Who is funding the study?
National Institute for Health Research (NIHR), through the UK Research & Innovation (UKRI) fund (UK)
Who is the main contact?
Unfortunately, this study is not recruiting public volunteers at this time. This is because the research isn’t ready for volunteers yet or the researchers are directly identifying volunteers in certain areas or hospitals. Please do not contact the research team as they will not be able to respond. For more information about COVID-19 research, visit the Be Part of Research homepage.
Contact information
Public, Scientific
Emergency Department
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
 ORCID ID |
0000-0001-9089-8130 |
|---|
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational; Design type: Validation of investigation /therapeutic procedures |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Facilitating Accelerated CLinical evaluation Of Novel diagnostic tests for COVID-19 (FALCON C-19) |
| Study acronym | FALCON C-19 |
| Study objectives | In response to the COVID-19 pandemic, multiple in vitro diagnostics tests (IVDs) have been rapidly developed to detect SARS-CoV-2 infection or immunity. To meet the urgent demand for increased testing capacity, many IVDs have received emergency use authorization. However, clinical evaluations to date have mainly been single-centre, employing differing reference standards with variable protocols. There remains an urgent need for a multi-site, rapid, and methodologically robust approach to in-context clinical validation. |
| Ethics approval(s) | Approved 04/06/2020, Wales Research Ethics Committee 5 Bangor (Health and Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, UK; +44 (0)7970 422139; Wales.REC5@wales.nhs.uk), ref: 20/WA/0169 |
| Health condition(s) or problem(s) studied | COVID-19 (SARS-CoV-2 infection) |
| Intervention | The following samples will be taken: 1. Combined nasal/throat swab and/or saliva and approximately 15 ml venous blood taken at the time of first contact (baseline/day 0) 2. Combined nasal/throat swab and/or saliva will also be collected on day 1 3. Approximately 2 ml whole blood and/or finger stick blood samples drawn serially on days 1, 3, 5, 9, 30 and 90 Please note, not all of the diagnostic evaluations will require a full sample set. The samples collected will depend on the diagnostic test that is being evaluated at the study site Data collection Basic data will be collected from participants about their demographics, presenting symptoms, past medical history, relevant vaccinations, physical examination findings, vital signs and the results of any routine tests that they undergo as part of their clinical care. On follow-up visits, details of the participant’s condition will be collected (e.g. mortality status, requirement for intensive care, organ support and oxygen treatment). |
| Intervention type | Other |
| Primary outcome measure(s) |
“Standard” diagnostic accuracy of point-of-care tests for active and past COVID-19 infection with reference to the Public Health England reference standard; Timepoint(s): Baseline, Day 1, Day 3, Day 5 Day 9, Day 30 and Day 90 |
| Key secondary outcome measure(s) |
1. Detection of antibodies to SARS-CoV-2 by a reference method |
| Completion date | 01/10/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 1000 |
| Key inclusion criteria | Patients presenting to secondary/tertiary care with possible SARS-CoV-2 infection who require testing, in the opinion of the treating clinician. Those patients may have presented with acute symptoms of COVID-19 (e.g. fever, cough, dyspnoea) or they may be asymptomatic, but require testing for other reasons |
| Key exclusion criteria | 1. Impossible or unsafe to obtain the required research samples 2. Prisoners 3. Patients with confirmed previous infection to SARS-CoV-2 4. Patients where sampling is not feasible |
| Date of first enrolment | 01/06/2020 |
| Date of final enrolment | 29/04/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Oxford Road
Manchester
M13 9WL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the fact that much of the data is commercially sensitive. For enquiries please contact the chief investigator Prof. Richard Body (richard.body@mft.nhs.uk). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
14/06/2024: A study contact was changed.
12/12/2023: The intention to publish date was changed from 31/12/2023 to 30/06/2024.
02/11/2022: IPD sharing statement added.
25/10/2022: The following changes were made to the trial record:
1. The recruitment end date has been changed from 01/10/2022 to 29/04/2023.
2. The overall trial end date has been changed from 01/10/2022 to 01/10/2023.
3. The intention to publish date was changed from 31/12/2022 to 31/12/2023.
23/03/2022: The following changes have been made:
1. The recruitment end date has been changed from 28/02/2021 to 01/10/2022.
2. The overall trial end date has been changed from 31/03/2022 to 01/10/2022 and the plain English summary has been updated to reflect this change.
07/12/2021: The following changes were made to the trial record:
1. The primary contact was changed.
2. The overall end date was changed from 31/12/2021 to 31/03/2022.
3. The intention to publish date was changed from 31/12/2021 to 31/12/2022.
4. The plain English summary was updated to reflect these changes.
02/06/2021: The following changes were made to the trial record:
1. The overall end date was changed from 30/06/2021 to 31/12/2021.
2. The intention to publish date was changed from 30/06/2022 to 31/12/2021.
3. The plain English summary was updated to reflect these changes.
14/07/2020: Trial's existence confirmed by the NIHR.
