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

• Conditions: Coronavirus; COVID
• Interventions: Diagnostic Test: RBA-2

• Registration Number: NCT04357977
• Lead Sponsor: Kaligia Biosciences, LLC

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2020-04
• Study Start: 2020-04
• Study First Submitted: 2020-04-20
• Study First Submitted QC: 2020-04-20
• Last Update Submitted: 2020-04-20
• Study First Posted: 2020-04-22
• Last Update Posted: 2020-04-22
• Primary Completion: 2020-08
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Covid +	RBA-2	Laboratory obtained Covid+ specimen results will be compared to saliva specimen

Primary Outcome Measures

Name	Time	Method
Covid +	10 days	The comparison of the results obtained from the current testing methods will be used to calibrate machine learning algorithms of the RBA-2

Trial Locations

Locations (3)

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

AdventHealth Tampa; 🇺🇸 Tampa, Florida, United States