NCT04609969

Brief Summary

The current prospective study was designed to assess the diagnostic specificity and sensitivity of a novel antigen-based rapid detection test (COVID-VIRO®) on nasopharyngeal specimens in comparison to the reference test in a real-life setting

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 13, 2020

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2020

Completed
Last Updated

December 7, 2020

Status Verified

December 1, 2020

Enrollment Period

4 days

First QC Date

October 28, 2020

Last Update Submit

December 4, 2020

Conditions

Covid19SARS-CoV-2 Infection

Keywords

SARS-CoV-2 infectionCOVID19Antigen detection test

Outcome Measures

Primary Outcomes (2)

  • Evaluation of COVID VIRO® diagnostic specificity

    COVID-VIRO® specificity is calculated using the RT-qPCR results as reference test, according to the following formulas: Specificity (%) = 100 x \[Negative / (Negative + Positive)\]

    Month 1

  • Evaluation of COVID VIRO® diagnostic sensitivity

    COVID-VIRO® sensitivity is calculated using the RT-qPCR results as reference test, according to the following formulas: Sensitivity (%) = 100 x \[Positive/ (Positive + Negative)\]

    Month 1

Secondary Outcomes (1)

  • Evaluation of COVID VIRO® diagnostic sensitivity for RT-qPCR Cycle threshold value < or > 28

    Month 1

Study Arms (1)

Comparison between RT-qPCR and COVID-VIRO® results on nasopharyngeal swab specimens

EXPERIMENTAL

Two concurrent nasopharyngeal swab specimens are collected for each participant. Comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR positive patients is used to assess COVID-VIRO® sensitivity. Conversely, comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR negative patients is used to assess COVID-VIRO® specificity.

Diagnostic Test: RT-qPCR testDiagnostic Test: COVID-VIRO® test

Interventions

RT-qPCR testDIAGNOSTIC_TEST

Two concurrent nasopharyngeal swab specimens are collected for each participant. Comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR positive patients is used to assess COVID-VIRO® sensitivity. Conversely, comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR negative patients is used to assess COVID-VIRO® specificity.

Comparison between RT-qPCR and COVID-VIRO® results on nasopharyngeal swab specimens
COVID-VIRO® testDIAGNOSTIC_TEST

Two concurrent nasopharyngeal swab specimens are collected for each participant. Comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR positive patients is used to assess COVID-VIRO® sensitivity. Conversely, comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR negative patients is used to assess COVID-VIRO® specificity.

Comparison between RT-qPCR and COVID-VIRO® results on nasopharyngeal swab specimens

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (\>18 years old) already having a SARS-CoV-2 RT-qPCR positive result within 5 days
  • Adult patients (\>18 years old) requiring a SARS-CoV-2 RT-qPCR on nasopharyngeal swab specimen for any reason

You may not qualify if:

  • Patients non wishing to participate
  • Under guardianship or curatorship or safeguard of justice patients
  • Inability to join the hospital other than by public transport

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Régional d'Orléans, France

Orléans, 45000, France

Location

Related Publications (2)

  • Drame M, Tabue Teguo M, Proye E, Hequet F, Hentzien M, Kanagaratnam L, Godaert L. Should RT-PCR be considered a gold standard in the diagnosis of COVID-19? J Med Virol. 2020 Nov;92(11):2312-2313. doi: 10.1002/jmv.25996. Epub 2020 Jul 14. No abstract available.

    PMID: 32383182BACKGROUND

  • Zitek T. The Appropriate Use of Testing for COVID-19. West J Emerg Med. 2020 Apr 13;21(3):470-472. doi: 10.5811/westjem.2020.4.47370.

    PMID: 32302278BACKGROUND

Related Links

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Thierry PRAZUCK, Dr

    CHR ORLEANS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Two concurrent nasopharyngeal swab specimens are collected for each participant. Comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR positive patients is used to assess COVID-VIRO® sensitivity. Conversely, comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR negative patients is used to assess COVID-VIRO® specificity.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2020

First Posted

October 30, 2020

Study Start

October 13, 2020

Primary Completion

October 17, 2020

Study Completion

October 17, 2020

Last Updated

December 7, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)