An interventional study of COVID-19 diagnostic test in COVID-19, sponsored by Tourcoing Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-26.
Sponsored by Tourcoing Hospital · Not applicable, Interventional, and Diagnostic
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 8 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Tourcoing Hospital is the lead sponsor of 21 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Presenting at least one criterion for hospitalization:
Exclusion Criteria:
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
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)
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
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tourcoing Hospital