This Trial is a Clinical Performance Validation Study That Will Evaluate the Clinical Agreement of the Sky Medical™ Rapid Antigen Test Comparing the Antigen Rapid Test to RT-PCR

NCT05491993 | Unknown DMC FDA Device

• 1 other identifier: SKYCOV001-2
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective study that will evaluate the clinical agreement of the Sky Medical™ Rapid Antigen Test compared to SARS-CoV-2 RT-PCR.

Conditions

COVID-19; Sars-CoV-2 Infection

Outcome Measures

Primary Outcomes (1)

• Percent Positive Agreement and Negative Percent Agreement

  Calculate the performance of the Rapid Antigen Test compared to PCR using swab samples.

  90 Days

Study Arms (1)

SARS-CoV-2 Antigen Rapid Test

EXPERIMENTAL

The same group of patients participated in two arms of the study. One arm was for obtaining data on the Rapid Antigen Test for Covid-19. The comparator arm was to obtain data from the RT-PCR.

Diagnostic Test: Sky Medical™ Rapid Antigen Test

Interventions

Sky Medical™ Rapid Antigen Test DIAGNOSTIC_TEST

Rapid Antigen Diagnostic Test device performance comparative to RT-PCR.

SARS-CoV-2 Antigen Rapid Test

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent.
• Subject is suspected case of COVID-19 by clinical criteria: a patient with acute respiratory tract infection (sudden onset of at least one of the following: cough, fever, shortness of breath, fatigue, decreased appetite, myalgia) AND with no other etiology that fully explains the clinical presentation, with or without a history of close contact with a confirmed or probable COVID-19 case in the last 14 days prior to onset of symptoms.
• Subject is an appropriate candidate for Nasopharyngeal sample collection.
• Subject is willing to provide Nasopharyngeal samples.

You may not qualify if:

• Individuals who present with 10 or greater days of Covid-19 Related Symptoms, (Fever, Cough, Fatigue, Decreased Appetite, Shortness of Breath, Myalgia) or post- defervescence and/or convalescence.

Sponsors & Collaborators

• Sky Medical Supplies & Equipments, LLC: lead

Study Sites (1)

American Research Labs

Lake Worth, Florida, 33462, United States

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

• Sri Madireddy, PhD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariana-Kathryn LaParl

CONTACT

(954)804-3760; MarianaLaParl@skymedical.us

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The purpose of this study is to validate the performance of the SARS-CoV-2 Antigen Test bioassay for rapid detection of infection when using a nasopharyngeal swab. A prospective randomized and blinded study to evaluate a rapid point of care bioassay for the detection of virus particles compared with the currently validated RT-PCR detection standard. Nasopharyngeal samples will be collected along with the current standard of care collection.

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 8, 2022
• Study Start: February 22, 2022
• Primary Completion: January 11, 2023
• Study Completion: January 11, 2023
• Last Updated: August 8, 2022

Record last verified: 2022-08

Locations

US (1)