CoronavirusNCT04357977
A Human Clinical Study to Collect Calibration and Performance Data for the RBA-2 Device
An observational study of Coronavirus and COVID, run by Kaligia Biosciences, LLC at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronavirus, COVID
- What is being tested?
- RBA-2
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2020to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Patients receiving active treatment with antivirals, chloroquine or immune modulators.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Tampa General Hospital
Tampa, Florida, 33606
University of South Florida
Tampa, Florida, 33612
Rachel Karlnoski, PhD, 813-974-8558, karlnosk@usf.edu
Asa Oxner, MD
AdventHealth Tampa
Tampa, Florida, 33613
Elsie Medina, MS, 813-615-7200 ext. 56514, elsie.medina@adventhealth.com
Jose Tirado
About this study
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.
Read the 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.
- Conditions
- Coronavirus, COVID
- Being tested
- RBA-2
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBA-2Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Covid + | Laboratory obtained Covid+ specimen results will be compared to saliva specimen Receives: Diagnostic Test: RBA-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Covid +
The comparison of the results obtained from the current testing methods will be used to calibrate machine learning algorithms of the RBA-2
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study startApr 2020 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaligia Biosciences, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of South Florida
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357977
- Sponsor's protocol ID
- KBS005
- Status last verified
- Apr 2020
- First submitted
- 20 Apr 2020
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Human Clinical Study to Collect Calibration and Performance Data for the RBA-2 Device
- ClinicalTrials.gov ID
- NCT04357977
- Acronym / sponsor ID
- KBS005
- Conditions
- Coronavirus, COVID
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Kaligia Biosciences, LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of South Florida
- Study start
- Apr 2020 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Covid + | – | Diagnostic Test: RBA-2Laboratory obtained Covid+ specimen results will be compared to saliva specimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- Participants can be patients or staff members at the testing site.
- 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.
Key exclusion criteria (1 listed)
- Patients receiving active treatment with antivirals, chloroquine or immune modulators.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RBA-2Collection 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. | Diagnostic test | Covid + |
Primary outcome
Covid +
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus and COVID, run by Kaligia Biosciences, LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Janice Shirley, MPH MBA PA-C (813-919-8857, advancedclinicalresearch@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Covid + (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2020.