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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

Tracking Information
First Submitted Date  ICMJE October 7, 2021
First Posted Date  ICMJE October 12, 2021
Last Update Posted Date October 27, 2021
Actual Study Start Date  ICMJE February 18, 2021
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2021)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: October 7, 2021)
Proportion of 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 Hrs ]
Number of SARS-CoV-2 positive patients by sampling type (buccal and nasopharyngeal swab) and analytical method (ELISA POCT vs RT-PC)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2021)
Comparison of Ct values in buccal and nasopharyngeal swabs [ Time Frame: 48 Hours ]
Ct values by PCR in buccal and nasopharyngeal swabs
Original Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2021)
Comparison of Ct values in buccal and nasopharyngeal swabs [ Time Frame: 48 Hrs ]
Ct values by PCR in buccal and nasopharyngeal swabs
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • SARS-CoV-2
  • COVID-19
Intervention  ICMJE Diagnostic Test: ELISA POCT vs RT-PCR
3 swabs taken, buccal for RT-PCR and ELISA POCT, nasopharyngeal for RT-PCR
Study Arms  ICMJE Experimental: Buccal and nasopharyngeal swabs
One patient will have 3 swabs taken, 2 buccal for PCR and ELISA POCT, 1 nasopharyngeal for PCR
Intervention: Diagnostic Test: ELISA POCT vs RT-PCR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 7, 2021)
1500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Eric VOIGLIO, MD, PhD +37798984850 evoiglio@gouv.mc
Listed Location Countries  ICMJE Monaco
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05074745
Other Study ID Numbers  ICMJE PRO_CSM_01_2021
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Scientifique de Monaco
Study Sponsor  ICMJE Centre Scientifique de Monaco
Collaborators  ICMJE Department of Health Affairs, Monaco
Investigators  ICMJE Not Provided
PRS Account Centre Scientifique de Monaco
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP