Dynamic Evaluation of COVID-19 Diagnostic Tests

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Dynamic Evaluation of COVID-19 Diagnostic Tests

Conditions
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COVID-19

Intervention / Treatment
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* Diagnostic Test: COVID-19 diagnostic test


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental arm<br>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. | Diagnostic Test: COVID-19 diagnostic test<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |