Rapid Detection of COVID-19 by Portable and Connected Biosensor
COR-DIAL-1
2 other identifiers
observational
200
1 country
1
Brief Summary
The objective of study is to estimate the sensitivity and specificity of the COR-DIAL based on nasopharyngeal samples taken at the patient's admission in relation to the final diagnosis of COVID-19 made by the medical team.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2020
Typical duration for all trials
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 27, 2020
CompletedFirst Posted
Study publicly available on registry
April 29, 2020
CompletedStudy Start
First participant enrolled
August 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2023
CompletedDecember 17, 2024
May 1, 2023
2.7 years
April 27, 2020
December 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity and specificity of the COR-DIAL based on nasopharyngeal swabs taken on admission of the patient compared to the final diagnosis of COVID-19 made by the medical team
Baseline (at admission)
Secondary Outcomes (1)
Cohen's Kappa Coefficient for concordance for the diagnosis of CoV-2-SARS between PCR and COR-DIAL based on nasopharyngeal swabs taken on patient admission
Baseline (at admission)
Study Arms (2)
positive SARS-Cov2
100 patients with a positive diagnosis of SARS-CoV-2
negative SARS-Cov2
100 patients with a negative diagnosis of SARS-CoV-2 defined by the gold standard by the medical team
Interventions
Nasopharyngeal swabs for COVID-19 RT-PCR
Eligibility Criteria
patients admitted to a Reference Health Establishment for suspicion of SARS-CoV-2
You may qualify if:
- Male or female or child without age limit
- Admitted to a Reference Health Establishment in an emergency unit, hospitalisation or intensive care unit for suspicion of SARS-CoV-2 infection, regardless of the clinical presentation and degree of severity.
- Patient to be diagnosed using a PCR test on nasopharyngeal swab.
- Social insured
You may not qualify if:
- Atypical or suspicious cases without a final diagnosis of COVID-19 positive or negative
- Patient refusal to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU lille
Lille, 59037, France
Biospecimen
nasopharyngeal swab and saliva
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Enagnon Kazali ALIDJINOU, MD
University Hospital, Lille
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2020
First Posted
April 29, 2020
Study Start
August 24, 2020
Primary Completion
May 2, 2023
Study Completion
May 2, 2023
Last Updated
December 17, 2024
Record last verified: 2023-05