Dynamic Evaluation of COVID-19 Diagnostic Tests

Tourcoing Hospital8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

COVID-19

Interventions

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)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CH Tourcoing

Tourcoing, France

Outcomes

Primary Outcomes

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

Time frame: day 1

Secondary Outcomes

Positive or negative Covid-19 test

Number of diagnoses invalidated by the antigen + CT scan alone without the contribution of PCR.

Time frame: 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

Time frame: 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

Time frame: day 21

Biological parameters

Evolution of biological parameters as a function of time IgM IgA and IgG

Time frame: day 1

Biological parameters

Evolution of biological parameters as a function of time IgM IgA and IgG

Time frame: Day 21

medical-economic comparison

medical-economic comparison of the first-line use of the antigenic test

Time frame: day 1

Data from ClinicalTrials.gov

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