Dynamic Evaluation of COVID-19 Diagnostic Tests

NCT ID: NCT04337996

Last Updated: 2021-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-13

Study Completion Date

2021-01-13

Brief Summary

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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

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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.

Conditions

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COVID-19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

COVID-19 diagnostic test

Intervention Type 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)

Interventions

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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)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tourcoing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre PATOZ, PharmD

Role: PRINCIPAL_INVESTIGATOR

CH TOURCOING

Barthelemy LAFONDESMURS, MD

Role: PRINCIPAL_INVESTIGATOR

CH TOURCOING

Locations

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CH Tourcoing

Tourcoing, , France

Site Status

Countries

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France

Other Identifiers

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RIPH_2020_6

Identifier Type: -

Identifier Source: org_study_id

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