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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 diagnostic test | Diagnostic 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Positive or negative Covid-19 test | Number of diagnoses invalidated by the antigen + CT scan alone without the contribution of PCR. | day 1 |
| Positive or negative character of the antibodies test |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre PATOZ, PharmD | CH TOURCOING | Principal Investigator |
| Barthelemy LAFONDESMURS, MD | CH TOURCOING | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Tourcoing | Tourcoing | 59208 | France |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Comparison of the proportion of patients with positive serology for SARS-Cov2 to the proportion of patients who were classified as COVID-19
| 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 | day 21 |
| Biological parameters | Evolution of biological parameters as a function of time IgM IgA and IgG | day 1 |
| Biological parameters | Evolution of biological parameters as a function of time IgM IgA and IgG | Day 21 |
| medical-economic comparison | medical-economic comparison of the first-line use of the antigenic test | day 1 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |