SpotLight-19 Research & Development Study

Screening Clinical Trial

Official title:

SpotLight-19 Research and Development Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05198869
• Other study ID #: 20210902
• Status: Recruiting
• Phase: N/A
• Start date: December 29, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: January 2022
• Source: Ottawa Hospital Research Institute
• Contact: Alison Jennings
• Phone: 6137985555
• Email: ajennings[@]ohri.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12500
• Est. completion date: July 31, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Screening

Intervention

Device:
• Spectral scan
Consenting participants will have a SpotLight-19 scan

Locations

Country	Name	City	State
Canada	COVID-19 Assessment Centre for Adults	Ottawa	Ontario
Canada	COVID-19 CHEO Assessment Centre	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	ISBRG Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	spectra indicative of COVID-19 infection	specific wavelengths of light that correlate with COVID-19 infection	immediate upon scan