Clinical trial NCT05198869: SpotLight-19 Research & Development Study
Official title: SpotLight-19 Research and Development Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Screening
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: ISBRG Corp
First posted: 2022-01-20
Enrollment: 12500
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: spectra indicative of COVID-19 infection
timeFrame: immediate upon scan
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: COVID-19 CHEO Assessment Centre
state: Ontario
city: Ottawa
country: Canada
facility: COVID-19 Assessment Centre for Adults
state: Ontario
Study officials:
affiliation: ISBRG Corp
name: Rae Lake, MD
role: PRINCIPAL_INVESTIGATOR
References: