Status:
COMPLETED
Facilitating AcceLerated Clinical Validation Of Novel Diagnostics for COVID-19 (FALCON-C19)
Lead Sponsor:
Manchester University NHS Foundation Trust
Conditions:
Coronavirus Infection
COVID-19
Eligibility:
All Genders
18-100 years
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 progress...
Eligibility Criteria
Inclusion
- Work Stream A (in-hospital; Group 1 and Group 2):
- Group 1 Inclusion Criteria:
- We will include participants (patients or staff):
- That are 18 years or older
- That will require testing for COVID-19 in the opinion of the treating clinician
- 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:
- That are 18 years or older
- 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:
- That are 18 years or older
- EITHER:
- They have been identified as positive for SARS-CoV-2 PCR through testing at national laboratory infrastructure OR
- 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:
- That are 18 years or older
- Who are undergoing testing for COVID-19, whether they are symptomatic or symptomatic for COVID-19
- Exclusion Criteria for all Work Streams:
- Patients where it is impossible/unsafe to obtain the required research samples
- Prisoners
- Patients where sampling is not feasible
Exclusion
Key Trial Info
Start Date :
May 19 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
8380 Patients enrolled
Trial Details
Trial ID
NCT04408170
Start Date
May 19 2020
End Date
December 1 2024
Last Update
April 23 2025
Active Locations (15)
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1
Sandwell General Hospital Birmingham NHS Trust
Birmingham, United Kingdom
2
University Hospitals of Derby and Burton NHS FT
Derby, United Kingdom
3
Frimley Health NHS FT
Frimley, United Kingdom
4
Airedale NHS FT
Keighley, United Kingdom