Development of a Molecular Diagnostic Strategy for SARS-CoV2 Based on Saliva in the Context of th… (NCT04367545) | Clinical Trial Compass
CompletedNot Applicable
Development of a Molecular Diagnostic Strategy for SARS-CoV2 Based on Saliva in the Context of the COVID-19 Pandemic
France130 participantsStarted 2020-04-16
Plain-language summary
The objective of the study is to develop and validate a molecular diagnostic strategy (RT-ddPCR multiplex) of COVID-19 based on a saliva sample and alternative to the RT-qPCR method, in order to :
1. to compensate for the risk of a shortage of diagnostic kits, reagents and materials necessary for molecular diagnosis;
2. to increase the molecular diagnostic capacity of COVID-19 at the Rouen University Hospital;
3. and to have a method compatible with screening extended to populations at risk.
Who can participate
Age range
18 Years
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:
* Person aged over 18 years presenting to the COVID-19 consultation of the Rouen University Hospital for screening
* Person affiliated to a social security scheme
Exclusion Criteria:
* Person objecting to participation in the research after reading information
* Person under the protection of justice,
* Person deprived of their liberty by administrative or judicial decision (guardianship, curatorship, etc.)
* Patient under guardianship or curatorship
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Number of positive patient using saliva method compared to number of positive patient using standard method
Timeframe: One hour
2
Number of negative patient using saliva method compared to number of negative patient using standard method