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Validation of a Rapid, Non-invasive Point-of-care IVD Test for Diagnosis of SARS-COV-2 (COVID-19) Infection (EasyCov)

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ClinicalTrials.gov Identifier: NCT04583319
Recruitment Status : Recruiting
First Posted : October 12, 2020
Last Update Posted : November 9, 2021
Sponsor:
Collaborator:
Istanbul University
Information provided by (Responsible Party):
Firalis SA

Study Description
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Brief Summary:
A prospective non-interventional study to evaluate the performance of EASYCOV IVD as point-of-care (POC) test by comparing SARS-CoV-2 positive patients with SARS-CoV-2 negative controls on paired specimens (nasopharyngeal swabs & saliva samples).

Condition or disease Intervention/treatment
SARS-CoV Diagnostic Test: EasyCov POC

Detailed Description:

A prospective non-interventional study to evaluate the performance of EASYCOV IVD as point-of-care (POC) test by comparing SARS-CoV-2 positive patients with SARS-CoV-2 negative controls on paired specimens (nasopharyngeal swabs & saliva samples).

The operators performing the diagnostic tests will be blinded from the RT-PCR results (i.e. participant's group will be anonymized). Participants who have been tested by an routineTurkish MOH and FDA EUA approved RT-PCR test using nasopharyngeal swabs will be included in the study to perform the EASYCOV IVD tests in a POC setting.

Primary Objective:

• To evaluate the performance of EasyCov IVD as a point-of-care (POC) test performed on saliva samples for the diagnosis of SARS-CoV-2 infection by comparing it to a Turkish MOH and FDA EUA approved RT-PCR test performed on nasopharyngeal samples.

Secondary Objectives:

• Collection and storage of saliva samples, nasopharyngeal swabs at D0 to perform future COVID-19 related research projects and validation of future generations of EASYCOV assays as well as exploratory studies to find candidate biomarkers for Covid-19.

160 participants will be included in 1:1 ratio: 80 SARS-CoV-2 positive and 80 SARS-CoV-2 negative by a Turkish MOH and FDA approved RT-PCR IVD test

Study Design
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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Prospective, Non-interventional Study for Validation of a Rapid, Non-invasive IVD as a Point-of-care Test for Diagnosis of SARS-COV-2 Infection
Actual Study Start Date : December 12, 2020
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
SARS-CoV-2 Positive
patients tested positive for SARS-CoV-2 by routine Turkish MOH and FDA approved RT-PCR IVD test.
 Diagnostic Test: EasyCov POC
Saliva samples will be collected according to the sampling protocol defined each for EASYCOV test. The EasyCoV test will be performed at the beginning of the study before obtaining the routine RT- PCR test results. The operators performing this test will be blinded from the routine RT-PCR results.
SARS-CoV-2 Negative
participants tested negative for SARS-CoV-2 by routine Turkish MOH and FDA approved RT-PCR IVD test.
 Diagnostic Test: EasyCov POC
Saliva samples will be collected according to the sampling protocol defined each for EASYCOV test. The EasyCoV test will be performed at the beginning of the study before obtaining the routine RT- PCR test results. The operators performing this test will be blinded from the routine RT-PCR results.


Outcome Measures
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Primary Outcome Measures :
  1. Positive percent agreement (PPA) [ Time Frame: 1 month ]
    A positive percent agreement (PPA) of EASYCOV PoC assay will be corroborated with the routine Turkish MOH and FDA approved reference method RT-PCR using nasopharyngeal samples.


Secondary Outcome Measures :
  1. Performance [ Time Frame: 1 month ]
    The performance (accuracy, sensitivity, specificity, positive predictive value, negative predictive value) of EASYCOV POC assay will be evaluated compared to the routine Turkish MOH and FDA approved RT-PCR method using nasopharyngeal samples.


Biospecimen Retention:   Samples With DNA
Saliva samples of Subjects will be collected in a FDA approved collection device

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Recruitment will be carried out on patients suspected to have contracted COVID-19 and to be screened by RT-PCR test, according to decision of her/his physician. These patients are routinely screened by a Turkish MOH and FDA approved RT-PCR test for COVID-19 and will be allocated to SARS-COV-2 Positive or Control group based on results obtained from RT-PCR.
Criteria

Inclusion Criteria:

Non-specific inclusion criteria:

  1. Participant aged 18 and above
  2. Participant agreeing to follow the study procedures
  3. Participant able to understand the purpose, nature and methodology of the study
  4. Participant having signed the informed consent

Specific inclusion criteria:

SARS-COV-2 positive patients - Participants tested positive for the SARS-COV-2 by the routine Turkish MOH and FDA approved RT-PCR method.

SARS-COV-2 negative controls

- Participants tested negative for the SARS-COV-2 by the routine Turkish MOH and FDA approved RT-PCR method.

Exclusion Criteria:

  • Minors, persons deprived of their liberty, protected adults or vulnerable persons.
  • Refusal to sign the consent.
Contacts and Locations
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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): NCT04583319


Contacts
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Contact: Rodwell Mkhwananzi, MD +33 38 99 11 328 rodwell.mkhwananzi@firalis.com
Contact: Stéphanie Boutillier, PhD stephanie.boutillier@amoneta-diagnostics.com

Locations
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Turkey
Istanbul University Istanbul Faculty of Medicine (ITF) Recruiting
Istanbul, Turkey
Contact: Selçuk Şen         
Sponsors and Collaborators
Firalis SA
Istanbul University
Investigators
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Principal Investigator: Arif Atahan, Prof.MD Istanbul University Istanbul Faculty of Medicine (ITF), Turkey
More Information
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Responsible Party: Firalis SA
ClinicalTrials.gov Identifier: NCT04583319    
Other Study ID Numbers: ST0194
First Posted: October 12, 2020    Key Record Dates
Last Update Posted: November 9, 2021
Last Verified: August 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 Firalis SA:
SARS Coronavirus
Coronavirus
Covid-19
Additional relevant MeSH terms:
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Infections