Dynamic Evaluation of COVID-19 Diagnostic Tests

Not Applicable

Completed

• Conditions: COVID-19
• Interventions: Diagnostic Test: COVID-19 diagnostic test

• Registration Number: NCT04337996
• Lead Sponsor: Tourcoing Hospital

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.

Study Timeline

• Study First Submitted: 2020-04-01
• Study First Submitted QC: 2020-04-03
• Study First Posted: 2020-04-08
• Study Start: 2020-07-13
• Status Verified: 2021-01
• Primary Completion: 2021-01-13
• Study Completion: 2021-01-13
• Last Update Submitted: 2021-01-25
• Last Update Posted: 2021-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental arm	COVID-19 diagnostic test	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Positive or negative character of the antibodies test	day 21	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
Biological parameters	Day 21	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
Positive or negative Covid-19 test	day 1	Number of diagnoses invalidated by the antigen + CT scan alone without the contribution of PCR.

Trial Locations

Locations (1)

CH Tourcoing; 🇫🇷 Tourcoing, France