Dynamic Evaluation of COVID-19 Diagnostic Tests
TRODVID-19
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable covid19
Started Jul 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2020
CompletedFirst Posted
Study publicly available on registry
April 8, 2020
CompletedStudy Start
First participant enrolled
July 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 13, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2021
CompletedJanuary 26, 2021
January 1, 2021
6 months
April 1, 2020
January 25, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Positive or negative Covid-19 test
day 1
Positive or negative character of the antibodies test
day 1
Positive or negative character of the antibodies test
day 21
Biological parameters
day 1
Biological parameters
Day 21
- +1 more secondary outcomes
Study Arms (1)
experimental arm
EXPERIMENTALThese 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.
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CH Tourcoing
Tourcoing, 59208, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre PATOZ, PharmD
CH TOURCOING
- PRINCIPAL INVESTIGATOR
Barthelemy LAFONDESMURS, MD
CH TOURCOING
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2020
First Posted
April 8, 2020
Study Start
July 13, 2020
Primary Completion
January 13, 2021
Study Completion
January 13, 2021
Last Updated
January 26, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share