COVID-19
Conditions
Brief 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. 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.
Interventions
DIAGNOSTIC_TESTCOVID-19 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)
Sponsors
Tourcoing Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the proportion of patients classified as COVID-19 positive according to the 2 strategies | day 1 | Comparison of the Gold-Standard PCR, anamnesis, thoracic CT scan versus SARS-Cov-2 antigen, anamnesis and thoracic CT scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive or negative Covid-19 test | day 1 | Number of diagnoses invalidated by the antigen + CT scan alone without the contribution of PCR. |
| Positive or negative character of the antibodies test | day 1 | Comparison of the proportion of patients with positive serology for SARS-Cov2 to the proportion of patients who were classified as COVID-19 |
| Biological parameters | day 1 | Evolution of biological parameters as a function of time IgM IgA and IgG |
| medical-economic comparison | day 1 | medical-economic comparison of the first-line use of the antigenic test |
Countries
France
Outcome results
None listed