SpotLight-19 Research & Development Study

Not Applicable

• Conditions: Screening

• Registration Number: NCT05198869
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2021-12-20
• Study Start: 2021-12-29
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-17
• Last Update Submitted: 2022-01-17
• Study First Posted: 2022-01-20
• Last Update Posted: 2022-01-20
• Primary Completion: 2022-04-30
• Study Completion: 2022-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
spectra indicative of COVID-19 infection	immediate upon scan	specific wavelengths of light that correlate with COVID-19 infection

Trial Locations

Locations (2)

COVID-19 CHEO Assessment Centre; 🇨🇦 Ottawa, Ontario, Canada

COVID-19 Assessment Centre for Adults; 🇨🇦 Ottawa, Ontario, Canada