SARS-CoV InfectionCOR-DIAL-SNCT04780334
Rapid Detection of COVID-19 by Portable and Connected Biosensor : Biological Proof of Concept
An observational study of SARS-CoV Infection and Covid19, run by University Hospital, Lille at 1 site in France.
Trial summary
The main objective of this CorDial-S proof-of-concept study is to evaluate the ability to detect COVID-19 infection in nasopharyngeal swabs with CorDial-S and compare it to the PCR technique currently in use. Saliva analysis will be the subject of secondary analysis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- SARS-CoV Infection, Covid19
- What is being tested?
- COVID-19 RT-PCR and Biosensor
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jul 2021to 2 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients admitted to a Reference Health Establishment for suspicion of SARS-CoV-2
Who may be able to join
- Male or female or child without age limit
- Admitted to a Reference Health Establishment (RHS) in an emergency unit, hospitalization or intensive care unit for suspicion of SARS-CoV-2 infection regardless of clinical presentation and degree of severity.
- Patient to be diagnosed by PCR test on nasopharyngeal swab.
- Social insured
Who cannot join
- Refusal of the person to participate (collection of information, second use of his sample, collection of saliva by spitting)
- Pregnant and breastfeeding women
- Protected Majors
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of this CorDial-S proof-of-concept study is to evaluate the ability to detect COVID-19 infection in nasopharyngeal swabs with CorDial-S and compare it to the PCR technique currently in use. Saliva analysis will be the subject of secondary analysis.
The CorDial-S medical device could allow the specimens to be analyzed using a small portable device and the results to be returned in minutes to the medical team and the patient, and communicated in real time with a telemedicine and remote monitoring system to the health authorities to allow the necessary protective, containment and therapeutic management measures to be put in place if necessary.
Read more
The benefits would be
- greater sensitivity
- a great speed because 8tests could be performed at the same time with a result in a few minutes
- a very high specificity at least equivalent to PCR.
This new diagnostic strategy could become extremely valuable in the fight against COVID-19, especially in the case of very long-term persistence and incomplete vaccination of the French and foreign population.
- Conditions
- SARS-CoV Infection, Covid19
- Being tested
- COVID-19 RT-PCR, Biosensor
- Medical subject headings
- Severe Acute Respiratory Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 RT-PCRDiagnostic test
Nasopharyngeal swabs for COVID-19 RT-PCR
BiosensorDiagnostic test
Portable and Connected Biosensor viral
| Study group | Role | What they receive |
|---|---|---|
| Positive diagnosis of SARS-CoV-2 | 100 patients with a positive diagnosis of SARS-CoV-2 Receives: Diagnostic Test: COVID-19 RT-PCR; Diagnostic Test: Biosensor | |
| Negative diagnosis of SARS-CoV-2 | 100 patients with a negative diagnosis of SARS-CoV-2 defined by the gold standard by the medical team Receives: Diagnostic Test: COVID-19 RT-PCR; Diagnostic Test: Biosensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of CorDial-S based on the first nasopharyngeal swab taken on patient admission, compared to the final positive or negative diagnosis of COVID-19 by the medical team
Measured: at patient admission (Baseline)
Secondary outcomes (3)
Cohen's Kappa Coefficient for concordance for the diagnosis of CoV-2-SARS between PCR and CorDial-S based on nasopharyngeal swabs taken at patient admission.
Measured: at patient admission (Baseline)
Sensitivity and specificity of CorDial-S based on the first saliva sample taken at patient admission compared to the final positive or negative diagnosis of COVID-19 by the medical team.
Measured: at patient admission (Baseline)
Cohen's Kappa Coefficient for concordance for the diagnosis of CoV-2-SARS between PCR and CorDial-S based on saliva samples taken at patient admission.
Measured: at patient admission (Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start7 Jul 2021
- Primary completion2 May 2022
- Study completion2 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enagnon Kazali ALIDJINOU, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780334
- Sponsor's protocol ID
- 2021_0063
- Other IDs
- 2021-A00387-34
- Acronym
- COR-DIAL-S
- Status last verified
- May 2023
- First submitted
- 2 Mar 2021
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Detection of COVID-19 by Portable and Connected Biosensor : Biological Proof of Concept
- ClinicalTrials.gov ID
- NCT04780334
- Acronym / sponsor ID
- COR-DIAL-S / 2021_0063
- Conditions
- SARS-CoV Infection, Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 2 May 2022 (actual)
- Study completion
- 2 May 2022 (actual)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this CorDial-S proof-of-concept study is to evaluate the ability to detect COVID-19 infection in nasopharyngeal swabs with CorDial-S and compare it to the PCR technique currently in use. Saliva analysis will be the subject of secondary analysis.
The CorDial-S medical device could allow the specimens to be analyzed using a small portable device and the results to be returned in minutes to the medical team and the patient, and communicated in real time with a telemedicine and remote monitoring system to the health authorities to allow the necessary protective, containment and therapeutic management measures to be put in place if necessary.
The benefits would be
- greater sensitivity
- a great speed because 8tests could be performed at the same time with a result in a few minutes
- a very high specificity at least equivalent to PCR.
This new diagnostic strategy could become extremely valuable in the fight against COVID-19, especially in the case of very long-term persistence and incomplete vaccination of the French and foreign population.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive diagnosis of SARS-CoV-2 | – | Diagnostic Test: COVID-19 RT-PCR, Diagnostic Test: Biosensor100 patients with a positive diagnosis of SARS-CoV-2 |
| Negative diagnosis of SARS-CoV-2 | – | Diagnostic Test: COVID-19 RT-PCR, Diagnostic Test: Biosensor100 patients with a negative diagnosis of SARS-CoV-2 defined by the gold standard by the medical team |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients admitted to a Reference Health Establishment for suspicion of SARS-CoV-2
Key inclusion criteria (4 listed)
- Male or female or child without age limit
- Admitted to a Reference Health Establishment (RHS) in an emergency unit, hospitalization or intensive care unit for suspicion of SARS-CoV-2 infection regardless of clinical presentation and degree of severity.
- Patient to be diagnosed by PCR test on nasopharyngeal swab.
- Social insured
Key exclusion criteria (3 listed)
- Refusal of the person to participate (collection of information, second use of his sample, collection of saliva by spitting)
- Pregnant and breastfeeding women
- Protected Majors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 RT-PCRNasopharyngeal swabs for COVID-19 RT-PCR | Diagnostic test | Negative diagnosis of SARS-CoV-2, Positive diagnosis of SARS-CoV-2 |
| BiosensorPortable and Connected Biosensor viral | Diagnostic test | Negative diagnosis of SARS-CoV-2, Positive diagnosis of SARS-CoV-2 |
Primary outcome
Sensitivity and specificity of CorDial-S based on the first nasopharyngeal swab taken on patient admission, compared to the final positive or negative diagnosis of COVID-19 by the medical team
Time frame: at patient admission (Baseline)
3 secondary outcomes
Cohen's Kappa Coefficient for concordance for the diagnosis of CoV-2-SARS between PCR and CorDial-S based on nasopharyngeal swabs taken at patient admission.
Time frame: at patient admission (Baseline)
Sensitivity and specificity of CorDial-S based on the first saliva sample taken at patient admission compared to the final positive or negative diagnosis of COVID-19 by the medical team.
Time frame: at patient admission (Baseline)
Cohen's Kappa Coefficient for concordance for the diagnosis of CoV-2-SARS between PCR and CorDial-S based on saliva samples taken at patient admission.
Time frame: at patient admission (Baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enagnon Kazali ALIDJINOU, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV Infection and Covid19, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of CorDial-S based on the first nasopharyngeal swab taken on patient admission, compared to the final positive or negative diagnosis of COVID-19 by the medical team (time frame: at patient admission (Baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.