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

Status unconfirmed

Conditions studied: Coronavirus, COVID

In brief

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.

Key facts

Study ID

NCT04357977

Run by

Kaligia Biosciences, LLC

People needed

300

Starts

2020-04-01

Expected to finish

2020-12-01

Last updated by the study team

2020-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participants can be patients or staff members at the testing site.
• Potential participants may be enrolled if:
• They are identified as requiring a standard diagnostic test for COVID-19 or are being treated after testing positive for COVID-19;
• They are age ≥ 18 years old;
• They are willing and able to provide verbal informed consent.

You may not qualify if…

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

Where it is running

• Tampa General Hospital — Tampa, Florida, United States
• University of South Florida — Tampa, Florida, United States
• AdventHealth Tampa — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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