Back to resultsDynamic Evaluation of COVID-19 Diagnostic Tests (TRODVID-19)
Primary Purpose
COVID-19
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
COVID-19 diagnostic test
Sponsored by
About this trial
This is an interventional diagnostic trial for COVID-19
Eligibility Criteria
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
Sites / Locations
- CH Tourcoing
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
experimental arm
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Positive or negative Covid-19 test
Number of diagnoses invalidated by the antigen + CT scan alone without the contribution of PCR.
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
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
Biological parameters
Evolution of biological parameters as a function of time IgM IgA and IgG
Biological parameters
Evolution of biological parameters as a function of time IgM IgA and IgG
medical-economic comparison
medical-economic comparison of the first-line use of the antigenic test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04337996
Brief Title
Dynamic Evaluation of COVID-19 Diagnostic Tests
Acronym
TRODVID-19
Official Title
Dynamic Evaluation of COVID-19 Diagnostic Tests
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 13, 2020 (Actual)
Primary Completion Date
January 13, 2021 (Actual)
Study Completion Date
January 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tourcoing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
COVID-19 diagnostic test
Intervention Description
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)
Primary Outcome Measure Information:
Title
Comparison of the proportion of patients classified as COVID-19 positive according to the 2 strategies
Description
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 Outcome Measure Information:
Title
Positive or negative Covid-19 test
Description
Number of diagnoses invalidated by the antigen + CT scan alone without the contribution of PCR.
Time Frame
day 1
Title
Positive or negative character of the antibodies test
Description
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
Title
Positive or negative character of the antibodies test
Description
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
Title
Biological parameters
Description
Evolution of biological parameters as a function of time IgM IgA and IgG
Time Frame
day 1
Title
Biological parameters
Description
Evolution of biological parameters as a function of time IgM IgA and IgG
Time Frame
Day 21
Title
medical-economic comparison
Description
medical-economic comparison of the first-line use of the antigenic test
Time Frame
day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre PATOZ, PharmD
Organizational Affiliation
CH Tourcoing
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barthelemy LAFONDESMURS, MD
Organizational Affiliation
CH Tourcoing
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Tourcoing
City
Tourcoing
ZIP/Postal Code
59208
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dynamic Evaluation of COVID-19 Diagnostic Tests
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