Covid19COVID-VIRONCT04609969
Diagnostic Performance Evaluation of a Novel SARS-CoV-2 (COVID-19) Antigen Detection Test
A study testing RT-qPCR test and COVID-VIRO® test in people with Covid19 and SARS-CoV-2 Infection, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
The current prospective study was designed to assess the diagnostic specificity and sensitivity of a novel antigen-based rapid detection test (COVID-VIRO®) on nasopharyngeal specimens in comparison to the reference test in a real-life setting Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, SARS-CoV-2 Infection
- What is being tested?
- RT-qPCR test and COVID-VIRO® test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 13 Oct 2020to 17 Oct 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (>18 years old) already having a SARS-CoV-2 RT-qPCR positive result within 5 days
- Adult patients (>18 years old) requiring a SARS-CoV-2 RT-qPCR on nasopharyngeal swab specimen for any reason
Who cannot join
- Patients non wishing to participate
- Under guardianship or curatorship or safeguard of justice patients
- Inability to join the hospital other than by public transport
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Performance Evaluation of a Novel SARS-CoV-2 (COVID-19) Antigen Detection Test on Nasopharyngeal Specimens i
The current prospective study was designed to assess the diagnostic specificity and sensitivity of a novel antigen-based rapid detection test (COVID-VIRO®) on nasopharyngeal specimens in comparison to the reference test in a real-life setting
Read the detailed description
Two nasopharyngeal swab specimens will be concurrently collected on:
- adult patients hospitalized in the Infectious Diseases Department of the Centre Hospitalier Régional d'Orléans (CHRO) for confirmed SARS-CoV-2 infection,
- or symptomatic or asymptomatic subjects voluntarily accessing the COVID-19 Screening Department of the CHRO to perform a diagnostic test. COVID VIRO® diagnostic.
Specificity and sensitivity are assessed in comparison to real-time RT-qPCR results.
- Conditions
- Covid19, SARS-CoV-2 Infection
- Being tested
- RT-qPCR test, COVID-VIRO® test
- Keywords
- SARS-CoV-2 infection, COVID19, Antigen detection test
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RT-qPCR testDiagnostic test
Two concurrent nasopharyngeal swab specimens are collected for each participant. Comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR positive patients is used to assess COVID-VIRO® sensitivity. Conversely, comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR negative patients is used to assess COVID-VIRO® specificity.
COVID-VIRO® testDiagnostic test
Two concurrent nasopharyngeal swab specimens are collected for each participant. Comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR positive patients is used to assess COVID-VIRO® sensitivity. Conversely, comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR negative patients is used to assess COVID-VIRO® specificity.
| Study group | Role | What they receive |
|---|---|---|
| Comparison between RT-qPCR and COVID-VIRO® results on nasopharyngeal swab specimens | Experimental | Two concurrent nasopharyngeal swab specimens are collected for each participant. Comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR positive patients is used to assess COVID-VIRO® sensitivity. Conversely, comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR negative patients is used to assess COVID-VIRO® specificity. Receives: Diagnostic Test: RT-qPCR test; Diagnostic Test: COVID-VIRO® test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of COVID VIRO® diagnostic specificity
COVID-VIRO® specificity is calculated using the RT-qPCR results as reference test, according to the following formulas:
Specificity (%) = 100 x [Negative / (Negative + Positive)]
Measured: Month 1
Evaluation of COVID VIRO® diagnostic sensitivity
COVID-VIRO® sensitivity is calculated using the RT-qPCR results as reference test, according to the following formulas:
Sensitivity (%) = 100 x [Positive/ (Positive + Negative)]
Measured: Month 1
Secondary outcomes (1)
Evaluation of COVID VIRO® diagnostic sensitivity for RT-qPCR Cycle threshold value < or > 28
COVID-VIRO® sensitivity is calculated using the RT-qPCR results, restricting for Cycle threshold value
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start13 Oct 2020
- Primary completion17 Oct 2020
- Study completion17 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Two concurrent nasopharyngeal swab specimens are collected for each participant. Comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR positive patients is used to assess COVID-VIRO® sensitivity. Conversely, comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR negative patients is used to assess COVID-VIRO® specificity.
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry PRAZUCK, Dr, Principal investigator, CHR ORLEANS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609969
- Sponsor's protocol ID
- CHRO-2020-18
- Acronym
- COVID-VIRO
- Status last verified
- Dec 2020
- First submitted
- 28 Oct 2020
- Last updated
- 7 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Drame M, Tabue Teguo M, Proye E, Hequet F, Hentzien M, Kanagaratnam L, Godaert L. Should RT-PCR be considered a gold standard in the diagnosis of COVID-19? J Med Virol. 2020 Nov;92(11):2312-2313. doi: 10.1002/jmv.25996. Epub 2020 Jul 14. No abstract available.
PubMed 32383182Zitek T. The Appropriate Use of Testing for COVID-19. West J Emerg Med. 2020 Apr 13;21(3):470-472. doi: 10.5811/westjem.2020.4.47370.
PubMed 32302278
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance Evaluation of a Novel SARS-CoV-2 (COVID-19) Antigen Detection Test on Nasopharyngeal Specimens i
- ClinicalTrials.gov ID
- NCT04609969
- Acronym / sponsor ID
- COVID-VIRO / CHRO-2020-18
- Conditions
- Covid19, SARS-CoV-2 Infection
- Keywords
- SARS-CoV-2 infection, COVID19, Antigen detection test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 17 Oct 2020 (actual)
- Study completion
- 17 Oct 2020 (actual)
- First posted
- 30 Oct 2020 (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 current prospective study was designed to assess the diagnostic specificity and sensitivity of a novel antigen-based rapid detection test (COVID-VIRO®) on nasopharyngeal specimens in comparison to the reference test in a real-life setting
Detailed description
Two nasopharyngeal swab specimens will be concurrently collected on:
- adult patients hospitalized in the Infectious Diseases Department of the Centre Hospitalier Régional d'Orléans (CHRO) for confirmed SARS-CoV-2 infection,
- or symptomatic or asymptomatic subjects voluntarily accessing the COVID-19 Screening Department of the CHRO to perform a diagnostic test. COVID VIRO® diagnostic.
Specificity and sensitivity are assessed in comparison to real-time RT-qPCR results.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Two concurrent nasopharyngeal swab specimens are collected for each participant. Comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR positive patients is used to assess COVID-VIRO® sensitivity. Conversely, comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR negative patients is used to assess COVID-VIRO® specificity.
| Arm | Type | Receives |
|---|---|---|
| Comparison between RT-qPCR and COVID-VIRO® results on nasopharyngeal swab specimens | Experimental | Diagnostic Test: RT-qPCR test, Diagnostic Test: COVID-VIRO® testTwo concurrent nasopharyngeal swab specimens are collected for each participant. Comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR positive patients is used to assess COVID-VIRO® sensitivity. Conversely, comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR negative patients is used to assess COVID-VIRO® specificity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (>18 years old) already having a SARS-CoV-2 RT-qPCR positive result within 5 days
- Adult patients (>18 years old) requiring a SARS-CoV-2 RT-qPCR on nasopharyngeal swab specimen for any reason
Key exclusion criteria (3 listed)
- Patients non wishing to participate
- Under guardianship or curatorship or safeguard of justice patients
- Inability to join the hospital other than by public transport
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 |
|---|---|---|
| RT-qPCR testTwo concurrent nasopharyngeal swab specimens are collected for each participant. Comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR positive patients is used to assess COVID-VIRO® sensitivity. Conversely, comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR negative patients is used to assess COVID-VIRO® specificity. | Diagnostic test | Comparison between RT-qPCR and COVID-VIRO® results on nasopharyngeal swab specimens |
| COVID-VIRO® testTwo concurrent nasopharyngeal swab specimens are collected for each participant. Comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR positive patients is used to assess COVID-VIRO® sensitivity. Conversely, comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR negative patients is used to assess COVID-VIRO® specificity. | Diagnostic test | Comparison between RT-qPCR and COVID-VIRO® results on nasopharyngeal swab specimens |
Primary outcome
Evaluation of COVID VIRO® diagnostic specificity
Time frame: Month 1
COVID-VIRO® specificity is calculated using the RT-qPCR results as reference test, according to the following formulas: Specificity (%) = 100 x [Negative / (Negative + Positive)]
Evaluation of COVID VIRO® diagnostic sensitivity
Time frame: Month 1
COVID-VIRO® sensitivity is calculated using the RT-qPCR results as reference test, according to the following formulas: Sensitivity (%) = 100 x [Positive/ (Positive + Negative)]
1 secondary outcome
Evaluation of COVID VIRO® diagnostic sensitivity for RT-qPCR Cycle threshold value < or > 28
Time frame: Month 1
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 7 Dec 2020.
- Background: PubMed 32383182Drame M, Tabue Teguo M, Proye E, Hequet F, Hentzien M, Kanagaratnam L, Godaert L. Should RT-PCR be considered a gold standard in the diagnosis of COVID-19? J Med Virol. 2020 Nov;92(11):2312-2313. doi: 10.1002/jmv.25996. Epub 2020 Jul 14. No abstract available.
- Background: PubMed 32302278Zitek T. The Appropriate Use of Testing for COVID-19. West J Emerg Med. 2020 Apr 13;21(3):470-472. doi: 10.5811/westjem.2020.4.47370.
- WHO coronavirus Dashboard on Sept 15th,2020Link provided by the sponsor.
- France Epidemiologic situation on 2020 september 20thLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Thierry PRAZUCK, Dr principal investigator
CHR ORLEANS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RT-qPCR test and COVID-VIRO® test in people with Covid19 and SARS-CoV-2 Infection, run by Centre Hospitalier Régional d'Orléans 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 2 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 7 Dec 2020. 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?
Evaluation of COVID VIRO® diagnostic specificity (time frame: Month 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04609969, which also lists 2 linked publications.
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 7 Dec 2020.