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SpotLight-19 Research & Development Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05198869
Recruitment Status : Recruiting
First Posted : January 20, 2022
Last Update Posted : January 20, 2022
Sponsor:
Collaborator:
ISBRG Corp
Information provided by (Responsible Party):
Alan Forster, Ottawa Hospital Research Institute

Brief Summary:
In this study, we will use the SpotLight-19 device in patients presenting to a coronavirus disease (COVID-19) Assessment Centre for polymerase chain reaction (PCR) testing. Consenting patients will undergo a Spotlight-19 scan. We will link the scan to PCR results, age, vaccination status, and COVID-19 symptoms in order to calibrate the SpotLight-19 prediction algorithm of a state of COVID-19 infection.

Condition or disease Intervention/treatment Phase
Screening Device: Spectral scan Not Applicable

Detailed Description:

Implementation of rapid, accessible, and accurate COVID-19 testing is a cornerstone of public health efforts to contain and respond to the spreading virus. To respond to this need, ISBRG Corp is applying its SpotLight-19 device to the challenge of developing a non-invasive screening test for COVID-19. The SpotLight-19 device is designed to use non-invasive visible and near-infrared (NIR) spectroscopic measurements of an individual's fingertip and an artificial intelligence technology platform calibrated using viral diagnostic measurements to identify and recognize a spectral fingerprint specific to COVID-19.

All individuals (3yrs or older) presenting to designated hospital COVID-19 Assessment Centres in Ottawa will be recruited to participate. Only people with extreme fingertip scarring will be excluded. Consenting participants will undergo a scan using the SpotLight-19 device - this includes a Fitzpatrick Skin Assessment and 10-20 second scans of the fingertip with the SpotLight-19 device. Following the scan participants will undergo a PCR test as per usual care. The PCR result, participant age, COVID-19 vaccination status, and presence of COVID-19 symptoms will be collected from the medical record and shared with ISBRG Corp. A minimum of 250 COVID-19 positive and a minimum of 250 COVID-19 negative as determined by PCR will be sought. The number of enrolled participants to achieve the sample size will depend on the COVID-19 positivity rate.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: SpotLight-19 Research and Development Study
Actual Study Start Date : December 29, 2021
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Spectral scan (All participants)
  1. Fitzpatrick skin assessment.
  2. Fingertip scanned using the SpotLight-19 device. The scan is approximately 10-20 seconds. Participants will not feel any sensation from the device, i.e., no heat, no pain, no cold, no vibration or pressure.
  3. Information collected from the medical record regarding participant age, COVID-19 vaccination status, presence of COVID-19 symptoms, and PCR test result.
Device: Spectral scan
Consenting participants will have a SpotLight-19 scan




Primary Outcome Measures :
  1. spectra indicative of COVID-19 infection [ Time Frame: immediate upon scan ]
    specific wavelengths of light that correlate with COVID-19 infection



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Qualifies for COVID-19 testing as per Assessment Site protocol; or
  • Is capable of cooperating with testing
  • Is clinically stable such that the testing protocol may be completed safely

Exclusion Criteria:

  • Extreme fingertip scarring or other physical condition that prevents use of the device

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05198869


Contacts
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Contact: Alison Jennings 6137985555 ext 19717 ajennings@ohri.ca
Contact: Austin MacIntyre amacintyre@isbrgcorp.com

Locations
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Canada, Ontario
COVID-19 CHEO Assessment Centre Not yet recruiting
Ottawa, Ontario, Canada, K1S 5T1
Contact: Nadine Drosdowech         
Principal Investigator: Ken Farion, Dr.         
COVID-19 Assessment Centre for Adults Recruiting
Ottawa, Ontario, Canada, K1S5T1
Contact: Cassie Matthews         
Principal Investigator: Alan Forster, MD         
Sponsors and Collaborators
Ottawa Hospital Research Institute
ISBRG Corp
Investigators
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Principal Investigator: Rae Lake, MD ISBRG Corp
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Responsible Party: Alan Forster, Principal Investigator, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT05198869    
Other Study ID Numbers: 20210902
First Posted: January 20, 2022    Key Record Dates
Last Update Posted: January 20, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No