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

Completed

• Conditions: SARS-CoV
• Interventions: Diagnostic Test: EasyCov POC

• Registration Number: NCT04583319
• Lead Sponsor: Firalis SA

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).

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 Timeline

• Study First Submitted: 2020-09-30
• Study First Submitted QC: 2020-10-09
• Study First Posted: 2020-10-12
• Study Start: 2020-12-12
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SARS-CoV-2 Negative	EasyCov POC	participants tested negative for SARS-CoV-2 by routine Turkish MOH and FDA approved RT-PCR IVD test.
SARS-CoV-2 Positive	EasyCov POC	patients tested positive for SARS-CoV-2 by routine Turkish MOH and FDA approved RT-PCR IVD test.

Primary Outcome Measures

Name	Time	Method
Positive percent agreement (PPA)	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

Name	Time	Method
Performance	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.

Trial Locations

Locations (1)

Istanbul University Istanbul Faculty of Medicine (ITF); 🇹🇷 Istanbul, Turkey