Sample Collection Study to Aid Evaluation of an Influenza A/B, Respiratory Syncytial Virus & COVI… (NCT04782336) | Clinical Trial Compass
CompletedNot Applicable
Sample Collection Study to Aid Evaluation of an Influenza A/B, Respiratory Syncytial Virus & COVID-19 Virus POC Test
United Kingdom79 participantsStarted 2021-06-30
Plain-language 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 (RSV), SARS-CoV-2 or those who have been in recent contact with SARS-CoV-2 positive patients. Collected samples will aid the development, calibration and performance evaluation of the LumiraDx POC Test.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 tre…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study was about collecting nasal swabs, throat swabs, and saliva samples rather than testing a treatment, what would my role have actually been as a participant — and does contributing samples like this still offer any direct benefit to me?
2This trial covered COVID-19, RSV, and both Influenza A and B together — if I have one of these infections right now, is participating in a sample collection study like this, or a similar one, something worth considering alongside my regular care?
3Because this study is already completed, are there any follow-up studies or point-of-care diagnostic tests that came out of this research that might be relevant to how my current illness is being diagnosed?
4The study aimed to collect samples across a range of demographics — can you help me understand whether the diagnostic tools being developed from studies like this are likely to be accurate and reliable for someone with my specific background or health profile?
5Since this was a sample collection study with no Phase designation, meaning it wasn't testing a drug or device on participants directly, how does joining a study like this compare to simply pursuing standard testing and treatment for my respiratory illness?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Collection of Nasal Swabs, Throat Swabs and Saliva Samples across a range of demographics.