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

NCT04583319 | Completed DMC

• 1 other identifier: ST0194
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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).

Conditions

SARS-CoV

Keywords

SARS Coronavirus; Coronavirus; Covid-19

Outcome Measures

Primary Outcomes (1)

• Positive percent agreement (PPA)

  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.

  1 month

Secondary Outcomes (1)

• Performance

  1 month

Study Arms (2)

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

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

Interventions

EasyCov POC DIAGNOSTIC_TEST

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; SARS-CoV-2 Positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Minors, persons deprived of their liberty, protected adults or vulnerable persons.
• Refusal to sign the consent.

Sponsors & Collaborators

• Firalis SA: lead
• Istanbul University: collaborator

Study Sites (1)

Istanbul University Istanbul Faculty of Medicine (ITF)

Istanbul, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples of Subjects will be collected in a FDA approved collection device

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases

Study Officials

• Arif Atahan, Prof.MD

  Istanbul University Istanbul Faculty of Medicine (ITF), Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 12, 2020
• Study Start: December 12, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)