Status:

UNKNOWN

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

Lead Sponsor:

Kaligia Biosciences, LLC

Collaborating Sponsors:

University of South Florida

Conditions:

Coronavirus

COVID

Eligibility:

All Genders

18+ years

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, pe...

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 ...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

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

Key Trial Info

Start Date :

April 1 2020

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2020

Estimated Enrollment :

300 Patients enrolled

Trial Details

Trial ID

NCT04357977

Start Date

April 1 2020

End Date

December 1 2020

Last Update

April 22 2020

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Tampa General Hospital

Tampa, Florida, United States, 33606

2

University of South Florida

Tampa, Florida, United States, 33612

3

AdventHealth Tampa

Tampa, Florida, United States, 33613