NCT05198869

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

December 29, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

January 20, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

December 20, 2021

Last Update Submit

January 17, 2022

Conditions

Screening

Outcome Measures

Primary Outcomes (1)

  • spectra indicative of COVID-19 infection

    specific wavelengths of light that correlate with COVID-19 infection

    immediate upon scan

Study Arms (1)

Spectral scan (All participants)

OTHER

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.

Device: Spectral scan

Interventions

Spectral scanDEVICE

Consenting participants will have a SpotLight-19 scan

Spectral scan (All participants)

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Extreme fingertip scarring or other physical condition that prevents use of the device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

COVID-19 CHEO Assessment Centre

Ottawa, Ontario, K1S 5T1, Canada

NOT YET RECRUITING

COVID-19 Assessment Centre for Adults

Ottawa, Ontario, K1S5T1, Canada

RECRUITING

Study Officials

  • Rae Lake, MD

    ISBRG Corp

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alison Jennings

CONTACT

6137985555ajennings@ohri.ca

Austin MacIntyre

CONTACT

amacintyre@isbrgcorp.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 20, 2021

First Posted

January 20, 2022

Study Start

December 29, 2021

Primary Completion

April 30, 2022

Study Completion

July 31, 2022

Last Updated

January 20, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)