A Human Clinical Study to Collect Calibration and Performance Data for the RBA-2 Device
1 other identifier
observational
300
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2020
CompletedFirst Submitted
Initial submission to the registry
April 20, 2020
CompletedFirst Posted
Study publicly available on registry
April 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedApril 22, 2020
April 1, 2020
4 months
April 20, 2020
April 20, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Covid +
Laboratory obtained Covid+ specimen results will be compared to saliva specimen
Interventions
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.
Eligibility Criteria
Participants will be recruited from patients and study staff at the testing site who have been flagged for COVID-19 testing or who are being treated for COVID-19.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kaligia Biosciences, LLClead
- University of South Floridacollaborator
Study Sites (3)
Tampa General Hospital
Tampa, Florida, 33606, United States
University of South Florida
Tampa, Florida, 33612, United States
AdventHealth Tampa
Tampa, Florida, 33613, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2020
First Posted
April 22, 2020
Study Start
April 1, 2020
Primary Completion
August 1, 2020
Study Completion
December 1, 2020
Last Updated
April 22, 2020
Record last verified: 2020-04