COVID-19TRODVID-19NCT04337996
Dynamic Evaluation of COVID-19 Diagnostic Tests
A study testing COVID-19 diagnostic test in people with COVID-19, run by Tourcoing Hospital at 1 site in France.
Trial summary
Rapid antigenic tests are not yet used in real life. Their contribution in the diagnostic strategy based on the gold standard including anamnesis, thoracic CT and PCR has not been evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- COVID-19 diagnostic test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jul 2020to 13 Jan 2021
- 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
- Symptomatic patient with confirmed Gold-Standard SARS-CoV-2 (COVID-19) infection
- Presenting at least one criterion for hospitalization:
- Respiratory failure and oxygenation
- Circulatory failure (systolic BP < 90 mmHg)
- Neurological failure (confusion, drowsiness, altered consciousness)
- Polypathological terrain and co-morbidities (chronic respiratory failure, heart failure or cardiovascular pathology, renal failure, diabetes, immunosuppression, obesity, cirrhosis)
- Eligible for different sampling methods
- Beneficiary of a social insurance scheme or entitled person
Who cannot join
- Gold Standard not in favour of SARS-Cov-2 infection (COVID 19)
- Minor patient
- Refusal to participate
- Patient under guardianship
- Patient under guardianship
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
About this study
Rapid antigenic tests are not yet used in real life. Their contribution in the diagnostic strategy based on the gold standard including anamnesis, thoracic CT and PCR has not been evaluated.
We propose to compare to the Gold-Standard defined above, the combination of an SARS-Cov-2 antigen, anamnesis and thoracic CT for the diagnosis of COVID-19 infection.
Read the detailed description
This is an interventional study comparing gold standard anamnesis, thoracic CT and PCR versus SARS-Cov-2 antigen, anamnesis and thoracic CT for the diagnosis of COVID-19 infection.
Patients will be sampled for the tests at Day 1 and then monitored for symptoms and clinical data and additional test at Day 21.
- Conditions
- COVID-19
- Being tested
- COVID-19 diagnostic 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.
COVID-19 diagnostic testDiagnostic test
COVID-19 diagnostic tests performed at day 1 (antigen in blood serum, SARS-Cov2 PCR, antibodies in blood serum) COVID-19 diagnostic test performed at day 21 (antibodies in blood serum)
| Study group | Role | What they receive |
|---|---|---|
| experimental arm | Experimental | These are patients whose diagnosis of SARS-Cov-2 infection was made on the Gold-Standard: combined history/clinical examination, PCR and CT scan and requiring hospitalization at Tourcoing Hospital. Receives: Diagnostic Test: COVID-19 diagnostic test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the proportion of patients classified as COVID-19 positive according to the 2 strategies
Comparison of the Gold-Standard PCR, anamnesis, thoracic CT scan versus SARS-Cov-2 antigen, anamnesis and thoracic CT scan
Measured: day 1
Secondary outcomes (6)
Positive or negative Covid-19 test
Number of diagnoses invalidated by the antigen + CT scan alone without the contribution of PCR.
Measured: day 1
Positive or negative character of the antibodies test
Comparison of the proportion of patients with positive serology for SARS-Cov2 to the proportion of patients who were classified as COVID-19
Measured: day 1
Positive or negative character of the antibodies test
Comparison of the proportion of patients with positive serology for SARS-Cov2 to the proportion of patients who were classified as COVID-19 at the time of hospitalization
Measured: day 21
Biological parameters
Evolution of biological parameters as a function of time IgM IgA and IgG
Measured: day 1
Biological parameters
Evolution of biological parameters as a function of time IgM IgA and IgG
Measured: Day 21
medical-economic comparison
medical-economic comparison of the first-line use of the antigenic test
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start13 Jul 2020
- Primary completion13 Jan 2021
- Study completion13 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tourcoing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre PATOZ, PharmD, Principal investigator, CH TOURCOINGBarthelemy LAFONDESMURS, MD, Principal investigator, CH TOURCOING
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04337996
- Sponsor's protocol ID
- RIPH_2020_6
- Acronym
- TRODVID-19
- Status last verified
- Jan 2021
- First submitted
- 1 Apr 2020
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Evaluation of COVID-19 Diagnostic Tests
- ClinicalTrials.gov ID
- NCT04337996
- Acronym / sponsor ID
- TRODVID-19 / RIPH_2020_6
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Tourcoing HospitalUniversity, hospital or other
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 13 Jan 2021 (actual)
- Study completion
- 13 Jan 2021 (actual)
- First posted
- 8 Apr 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.
Rapid antigenic tests are not yet used in real life. Their contribution in the diagnostic strategy based on the gold standard including anamnesis, thoracic CT and PCR has not been evaluated.
We propose to compare to the Gold-Standard defined above, the combination of an SARS-Cov-2 antigen, anamnesis and thoracic CT for the diagnosis of COVID-19 infection.
Detailed description
This is an interventional study comparing gold standard anamnesis, thoracic CT and PCR versus SARS-Cov-2 antigen, anamnesis and thoracic CT for the diagnosis of COVID-19 infection.
Patients will be sampled for the tests at Day 1 and then monitored for symptoms and clinical data and additional test at Day 21.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental arm | Experimental | Diagnostic Test: COVID-19 diagnostic testThese are patients whose diagnosis of SARS-Cov-2 infection was made on the Gold-Standard: combined history/clinical examination, PCR and CT scan and requiring hospitalization at Tourcoing Hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Symptomatic patient with confirmed Gold-Standard SARS-CoV-2 (COVID-19) infection
- Presenting at least one criterion for hospitalization:
- Eligible for different sampling methods
- Beneficiary of a social insurance scheme or entitled person
Key exclusion criteria (6 listed)
- Gold Standard not in favour of SARS-Cov-2 infection (COVID 19)
- Minor patient
- Refusal to participate
- Patient under guardianship
- Patient under guardianship
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 diagnostic testCOVID-19 diagnostic tests performed at day 1 (antigen in blood serum, SARS-Cov2 PCR, antibodies in blood serum) COVID-19 diagnostic test performed at day 21 (antibodies in blood serum) | Diagnostic test | experimental arm |
Primary outcome
Comparison of the proportion of patients classified as COVID-19 positive according to the 2 strategies
Time frame: day 1
Comparison of the Gold-Standard PCR, anamnesis, thoracic CT scan versus SARS-Cov-2 antigen, anamnesis and thoracic CT scan
6 secondary outcomes
Positive or negative Covid-19 test
Time frame: day 1
Positive or negative character of the antibodies test
Time frame: day 1
Positive or negative character of the antibodies test
Time frame: day 21
Biological parameters
Time frame: day 1
Biological parameters
Time frame: Day 21
medical-economic comparison
Time frame: day 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 26 Jan 2021.
- 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.
Pierre PATOZ, PharmD principal investigator
CH TOURCOING
Barthelemy LAFONDESMURS, MD principal investigator
CH TOURCOING
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COVID-19 diagnostic test in people with COVID-19, run by Tourcoing Hospital 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 8 inclusion and 6 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 26 Jan 2021. 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?
Comparison of the proportion of patients classified as COVID-19 positive according to the 2 strategies (time frame: day 1). 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 26 Jan 2021; AzTrials last refreshed its copy on 5 Nov 2026.