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Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Buccal Screening Evaluation Using an RT-PCR Assay and a Rapid ELISA Test Among Symptomatic and Asymptomatic Patients (CORDAGES)

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ClinicalTrials.gov Identifier: NCT05074745
Recruitment Status : Recruiting
First Posted : October 12, 2021
Last Update Posted : October 27, 2021
Sponsor:
Collaborator:
Department of Health Affairs, Monaco
Information provided by (Responsible Party):
Centre Scientifique de Monaco

Brief Summary:

The main objective is to expand screening for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by evaluating the diagnostic accuracy of the RT-PCR test (Cobas® Roche, Switzerland) and the ELISA Point of Contact Testing (PORTABLE COVID-19 ANTIGEN LAB® Stark, Italy) on buccal swab compared to the reference test, the RT-PCR test (Cobas® Roche, Switzerland) on nasopharyngeal swab.

Secondary objectives

  • To evaluate the diagnostic accuracy of oral swab RT-PCR and POCT relative to the quantitative amplification (Ct) values of the NP Swab RT-PCR assay.
  • Analyze RT-PCR amplification cycle thresholds (Ct) and POCT diagnostic accuracy as a function of the presence and timing of symptoms.
  • Among symptomatic participants, compare clinical presentations between positive and negative participants on the NP swab RT-PCR test.
  • The RT-PCR test may be imperfectly sensitive, ranging from 71 to 98%3. Using a Bayesian latent class model, the investigators will assess the true accuracy of POCT as it does not require the assumption that any one test or combination of tests is perfect14,15.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 COVID-19 Diagnostic Test: ELISA POCT vs RT-PCR Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Monocentric, Prospective, 3 components Nasopharyngeal swab by PCR Buccal swab by PCR Buccal by ELISA POCT
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Buccal Screening Evaluation Using an RT-PCR Assay and a Rapid ELISA Test Among Symptomatic and Asymptomatic Patients: the CORDAGES Study
Actual Study Start Date : February 18, 2021
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Buccal and nasopharyngeal swabs
One patient will have 3 swabs taken, 2 buccal for PCR and ELISA POCT, 1 nasopharyngeal for PCR
Diagnostic Test: ELISA POCT vs RT-PCR
3 swabs taken, buccal for RT-PCR and ELISA POCT, nasopharyngeal for RT-PCR




Primary Outcome Measures :
  1. Proportion of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive patients for the two different sampling types (buccal vs nasopharyngeal) and two methods (ELISA POCT vs RT-PCR) [ Time Frame: 48 Hours ]
    Number of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive patients by sampling type (buccal and nasopharyngeal swab) and analytical method (ELISA POCT vs RT-PC)


Secondary Outcome Measures :
  1. Comparison of Ct values in buccal and nasopharyngeal swabs [ Time Frame: 48 Hours ]
    Ct values by PCR in buccal and nasopharyngeal swabs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18+ patient eligible for COVID-19 testing in Monaco
  • symptoms suggestive of COVID-19
  • contact with a confirmed case of COVID-19

Exclusion Criteria:

  • refusal to participate in the study
  • preventive screening of professional groups
  • inability to return to the screening center within 48-72 hours of the first visit.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05074745


Contacts
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Contact: Eric VOIGLIO, MD, PhD +37798984850 evoiglio@gouv.mc

Locations
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Monaco
Centre National de Depistage - Espace Leo Ferre Recruiting
Monaco, Monaco, 98000
Contact: Eric VOIGLIO, MD, PhD    +37798984850    evoiglio@gouv.mc   
Contact: Thomas ALTHAUS, MD, PhD       talthaus@gouv.mc   
Principal Investigator: Eric VOIGLIO, MD, PhD         
Sub-Investigator: Thomas ALTHAUS, MD, PhD         
Sub-Investigator: Herve RAPS, MD         
Sub-Investigator: Olivier DEJOUX, MD         
Sub-Investigator: Patrick RAMPAL, MD         
Sponsors and Collaborators
Centre Scientifique de Monaco
Department of Health Affairs, Monaco
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Responsible Party: Centre Scientifique de Monaco
ClinicalTrials.gov Identifier: NCT05074745    
Other Study ID Numbers: PRO_CSM_01_2021
First Posted: October 12, 2021    Key Record Dates
Last Update Posted: October 27, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Scientifique de Monaco:
SARS-CoV-2
POCT
RT-PCR
Contact case
ELISA
Buccal
Additional relevant MeSH terms:
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COVID-19
Severe Acute Respiratory Syndrome
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases