Recruiting

Observational Study

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT05198869

Conditions

Screening

Eligibility Criteria

Sex: All

Age: 3+

Healthy Volunteers: Accepted

Interventions

Spectral scan

Study Details

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.

Conditions

Screening

Study ID

NCT05198869

Start date

Dec 29, 2021

Status verified date

Jan, 2022

Completion date

Jul 31, 2022

Anticipated

Primary completion date

Apr 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3+

Healthy Volunteers: Accepted

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

Enrollment

12500 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: 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.

Interventions

Spectral scan

Consenting participants will have a SpotLight-19 scan

Primary outcome measure

  • spectra indicative of COVID-19 infection [ Time Frame: immediate upon scan ]

Central Contacts and Locations

Central contacts

Alison Jennings

6137985555ajennings@ohri.ca

Austin MacIntyre

amacintyre@isbrgcorp.com

Locations

COVID-19 Assessment Centre for Adults

Recruiting

Ottawa, Ontario, Canada, K1S5T1

Principal Investigator:

Alan Forster, MD

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Jan 20, 2022

Last verified

Jan, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2022-01-20.