Recruiting

Sky Medical™

Sponsor:

Sky Medical Supplies & Equipments, LLC

Code:

NCT05491993

Conditions

COVID-19

Sars-CoV-2 Infection

Eligibility Criteria

Sex: All

Age: 7+

Healthy Volunteers: Not accepted

Interventions

Sky Medical™ Rapid Antigen Test

Study Details

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

Study ID

NCT05491993

Start date

Feb 22, 2022

Status verified date

Aug, 2022

Completion date

Jan 11, 2023

Anticipated

Primary completion date

Jan 11, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: SARS-CoV-2 Antigen Rapid Test

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.

Interventions

Sky Medical™ Rapid Antigen Test

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

Primary outcome measure

  • Percent Positive Agreement and Negative Percent Agreement [ Time Frame: 90 Days ]

Central Contacts and Locations

Central contacts

Mariana-Kathryn LaParl

(954)804-3760MarianaLaParl@skymedical.us

Locations

American Research Labs

Recruiting

Lake Worth, Florida, United States, 33462

Contacts

Sri Madireddy, PhD

561-801-5835sri@celestamedical.com

Principal Investigator:

Sri Madireddy, PhD

More Information

Sponsor

Sky Medical Supplies & Equipments, LLC

Last update posted

Aug 8, 2022

Last verified

Aug, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sky Medical Supplies & Equipments, LLC on 2022-08-08.