Dynamic Evaluation of COVID-19 Diagnostic Tests

COVID-19 Clinical Trial

— TRODVID-19  

Official title:

Dynamic Evaluation of COVID-19 Diagnostic Tests

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04337996
• Other study ID #: RIPH_2020_6
• Status: Completed
• Phase: N/A
• Start date: July 13, 2020
• Est. completion date: January 13, 2021

Study information

• Verified date: January 2021
• Source: Tourcoing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 13, 2021
• Est. primary completion date: January 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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)

Locations

Country	Name	City	State
France	CH Tourcoing	Tourcoing

Sponsors (1)

Lead Sponsor	Collaborator
Tourcoing Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Positive or negative Covid-19 test	Number of diagnoses invalidated by the antigen + CT scan alone without the contribution of PCR.	day 1
Secondary	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
Secondary	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
Secondary	Biological parameters	Evolution of biological parameters as a function of time IgM IgA and IgG	day 1
Secondary	Biological parameters	Evolution of biological parameters as a function of time IgM IgA and IgG	Day 21
Secondary	medical-economic comparison	medical-economic comparison of the first-line use of the antigenic test	day 1