Evaluation of Quickly Diagnostic Saliva Tests for SARS-CoV-2 (NCT04337424) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Quickly Diagnostic Saliva Tests for SARS-CoV-2
France627 participantsStarted 2020-04-13
Plain-language summary
Coronavirus disease 2019 or COVID-19 is a highly contagious infectious disease. Symptoms of the disease are non-specific (fever, cough, dyspnea and fatigue), common with many seasonal viruses, which complicates the diagnosis. For mild forms, which represent the vast majority of cases, hospitalization is not necessary and treatment is symptomatic. However in more severe cases, hospitalization is required and sometimes even admission to an intensive care unit.
Several diagnostic tests are already available, but they require, in all cases, the intervention of qualified health personnel to carry out the sample, which includes a risk of contagion and an expensive and time-consuming laboratory analysis and reagents. These tests are therefore not very suitable for massive screenings.
We want to evaluate the performance of a detection test performed on a salivary sample in the diagnosis of SARS-CoV-2. This test will be non-invasive, performed without any analytical device and will restore its qualitative result "infected versus non-infected" in less than 1 hour (30min objective).
Who can participate
Age range
18 Years – 90 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:
\- Control subjects (COV2- group): Participants ( Healthcare staff, patients and DRIVE participants) negative for SARS-CoV-2
\- Infected subjects (COV2 + group): Patients diagnosed positive for SARS-CoV-2 hospital staff known to be positive and coming to do a control PCR DRIVE participants.
Exclusion Criteria:
* Eligibility Criteria:
Inclusion Criteria:
\- Control subjects (COV2- group): Healthcare staff presumed and diagnosed negative for SARS-CoV-2
\- Infected subjects (COV2 + group): Patients diagnosed positive for SARS-CoV-2 hospital staff known to be positive and coming to do a control PCR
Exclusion Criteria:
* Not affiliated with a French Social Security Systemscheme or equivalent system
* Persons deprived of their liberty, adult protected under guardianship or vulnerable persons
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.
1This trial was testing saliva-based diagnostic tests for SARS-CoV-2 rather than a treatment — does that mean participating would only involve giving a saliva sample, and would there be any direct benefit to me as a participant?
2Since this trial has already completed, would my doctor be able to help me find out what the results showed about how accurate these saliva tests were compared to standard nasal swab testing?
3Because this study was focused on detecting SARS-CoV-2 RNA specifically, does my doctor think saliva-based testing is now a reliable option for me, or is a nasal swab still considered more accurate in my situation?
4Since the trial is listed as 'Phase NA,' meaning it wasn't testing a drug or treatment, what would my doctor say are the practical implications of this kind of diagnostic research for how I get tested going forward?
5Are there other completed or ongoing studies on COVID-19 diagnostics that my doctor thinks are more relevant to my current situation, given that this particular trial has already wrapped up?
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.