Status:
SUSPENDED
Sample Collection Study to Aid Evaluation of an Influenza A/B, Respiratory Syncytial Virus & COVID-19 Virus POC Test
Lead Sponsor:
LumiraDx UK Limited
Conditions:
Covid19
RSV Infection
Eligibility:
All Genders
Phase:
NA
Brief Summary
Collection of Nasal Swabs, Throat Swabs and Saliva Samples from patients presenting at their designated care or testing facility displaying symptoms of either Influenza, Respiratory Syncytial Virus (R...
Detailed Description
INFORM is a sample collection study targeting a population of patients attending their designated care or testing facility, suspected of having a respiratory illness typical of Influenza, RSV or COVID...
Eligibility Criteria
Inclusion
- Preliminary assessment of the patient by the Investigator/Designee should be suggestive of Influenza and/or COVID-19 and/or RSV at the time of the study visit. This may include referral to a testing facility.
- The patient will be completing or has completed a Standard of Care (SOC) Influenza A/B, COVID-19 and/or an RSV test on the day of study. This SOC sampling can be conducted prior or post the patient consenting to this study.
- Written Informed Consent must be obtained prior to study enrolment:
- A participant who is 16 years or older must be willing to give written informed consent and must agree to comply with study procedures.
- The Legal Guardian or Legal Authorised Representative of a participant who is under the age of 16 must give written informed consent and agree to comply with study procedures. Active written assent should be obtained from children of appropriate intellectual age (as determined by the consent taker in accordance with GCP).
Exclusion
- The patient underwent a nasal wash/aspirate as part of standard of care testing during their current visit.
- The patient is undergoing treatment currently and/or within the past 14 days of the study visit with an inhaled influenza vaccine (FluMist®) or anti-viral medication, which may include but is not limited to Amantadine (Symmetrel®), Rimantadine (Flumadine®), Zanamivir (Relenza®), Oseltamivir (Tamiflu®), or Baloxavir Marboxil (Xofluza™).
- The patient is undergoing treatment currently or had undergone within the past 14 days of the study visit with RSV-related medication which may include but is not limited to Ribavirin (Virazole), RSV-IGIV (RespiGam) or palivizumab (Synagis).
- The patient is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic, drug, or device including either treatment or therapy.
- The patient does not have the capacity to consent as determined by the Research Team.
- The patient is deemed to be unsuitable for research at the Research Team's discretion.
Key Trial Info
Start Date :
December 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
2500 Patients enrolled
Trial Details
Trial ID
NCT04782336
Start Date
December 12 2020
End Date
June 30 2024
Last Update
January 26 2024
Active Locations (6)
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1
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
2
NHS Lothian - Royal Hospital for Children & Young People
Edinburgh, United Kingdom
3
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
4
Barts Health NHS Trust
London, United Kingdom, E1 1BB