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COVID-19 iCura SARS-CoV-2 Ag OTC: Clinical Evaluation

NCT05555030 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-02-15

No results posted yet for this study

Summary

SARS-CoV-2 rapid antigen over the counter clinical performance evaluation.

Conditions

Interventions

DEVICE

iCura COVID-19 Antigen Rapid Home Test

Candidate Ag self-test kit anterior nasal specimen collection and testing will be done under the supervision of qualified site personnel in person. Comparator NP samples shall be collected at least 15 minutes prior to Ag samples with at least 15 minutes between nasal collections including collections that may occur prior to study enrollment. Comparator samples will be collected first by qualified personnel at a study site or physician's office using an FDA authorized nasopharyngeal swab collection kit and SARS-CoV-2 molecular assay.

DIAGNOSTIC_TEST

RT-PCR Test

High sensitivity RT-PCR COVID-19 Test

Sponsors & Collaborators

  • Paragon Rx Clinical, Inc.

    collaborator UNKNOWN

  • iCura Diagnostics, LLC

    collaborator UNKNOWN

  • New Day Diagnostics

    lead NETWORK

Principal Investigators

  • Jason Liggett, PhD · New Day Diagnostics

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-04
Primary Completion
2022-12-20
Completion
2022-12-20
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05555030 on ClinicalTrials.gov