Dynamic Evaluation of COVID-19 Diagnostic Tests (TRODVID-19)

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Diagnostic test: COVID-19 diagnostic test

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Tourcoing, France, 59208
    • Ch Tourcoing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental arm; 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tourcoing Hospital
• Investigators: Principal Investigator: Pierre PATOZ, PharmD, Ch Tourcoing; Principal Investigator: Barthelemy LAFONDESMURS, MD, Ch Tourcoing

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2020
• Primary Completion (Actual): January 13, 2021
• Study Completion (Actual): January 13, 2021

Study Registration Dates

• First Submitted: April 1, 2020
• First Submitted That Met QC Criteria: April 3, 2020
• First Posted (Actual): April 8, 2020

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: RIPH_2020_6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No