A Human Clinical Study to Collect Calibration and Performance Data for the RBA-2 Device

COVID Clinical Trial

Official title:

A Human Clinical Study to Collect Calibration and Performance Data for the RBA-2 Device

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04357977
• Other study ID #: KBS005
• Status: Not yet recruiting
• Start date: April 2020
• Est. completion date: December 2020

Study information

• Verified date: April 2020
• Source: Kaligia Biosciences, LLC
• Contact: Janice Shirley, MPH MBA PA-C
• Phone: 813-919-8857
• Email: advancedclinicalresearch[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The current available diagnostic methods used for the detection of COVID-19 takes up to 4 hours. In some cases, these diagnostics tests make take up to a couple of days. As it is highly contagious, people who are in close contact with the infected person are at high risk of being infected. COVID-19 is transmitted through respiratory droplets produced when an infected person coughs or sneezes. The desire for rapid detection of COVID-19 has become an immediate necessity. The purpose of Kaligia Biosciences' saliva monitoring device (RBA-2) is to detect the presence of the COVID-19 virus in human saliva. The RBA-2 uses Raman Spectros-copy to detect the coronavirus. Once the sample is scanned successfully, the spectra contains the response of the component present in human saliva and provide results in a matter of minutes, rather than hours or days.

Description:

The purpose of this study is to calibrate the performance of RBA-2 using people by comparing the results against a standard diagnostics test. The objective of this study is to collect non-invasive in vivo saliva from confirmed cases of both infected and non-infected COVID-19 patients or site staff at the testing site and compare the test results using the RBA-2 against the standard test results used for diagnosis.

The comparison of the results obtained from the current testing methods will be used to calibrate machine learning algorithms of the RBA-2.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Participants can be patients or staff members at the testing site.

Potential participants may be enrolled if:

1. They are identified as requiring a standard diagnostic test for COVID-19 or are being treated after testing positive for COVID-19;

2. They are age = 18 years old;

3. They are willing and able to provide verbal informed consent.

Exclusion Criteria:

• Patients receiving active treatment with antivirals, chloroquine or immune modulators.

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections
• COVID

Intervention

Diagnostic Test:
• RBA-2
Collection of non-invasive in vivo saliva from confirmed cases of both infected and non-infected COVID-19 patients or site staff at the testing site and compare the test results using the RBA-2 against the standard test results used for diagnosis.

Locations

Country	Name	City	State
United States	AdventHealth Tampa	Tampa	Florida
United States	Tampa General Hospital	Tampa	Florida
United States	University of South Florida	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Kaligia Biosciences, LLC	University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Covid +	The comparison of the results obtained from the current testing methods will be used to calibrate machine learning algorithms of the RBA-2	10 days