SpotLight-19 Research & Development Study

Not Applicable

• Conditions: Screening
• Interventions: Device: Spectral scan

• 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

Arm && Interventions

Group	Intervention	Description
Spectral scan (All participants)	Spectral scan	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.

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