NCT04896710

Brief Summary

Point-of-care testing can provide an additional layer of protection to reduce transmission of COVID-19 safely and effectively in the population, and if such tests can be self-administered, barriers to access may be reduced. The investigators will conduct a study among those self-identifying as asymptomatic for COVID-19 to evaluate the reliability and feasibility of self-administration of a point-of-care nasal swab test, determine the sensitivity and specificity of the point-of-care nasal swab test relative to reverse transciptase polymerase chain reaction (RT-PCR) testing, and gather quantitative and qualitative data on the acceptability and self efficacy of self-administration.

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
569

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

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

May 5, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 21, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

May 26, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

June 2, 2021

Status Verified

May 1, 2021

Enrollment Period

3 months

First QC Date

May 5, 2021

Last Update Submit

May 31, 2021

Conditions

Covid19Asymptomatic Shedding Viral

Outcome Measures

Primary Outcomes (2)

  • Concordance

    Concordance (calculated using Cohen's Kappa) between self administered and health care professional administered SD Biosensor rapid antigen test results.

    2 months

  • Ability of rapid antigen test to detect COVID-19 positive

    \>80% sensitivity and \>95% specificity for SD Biosensor rapid antigen test among asymptomatic population

    3 months

Secondary Outcomes (1)

  • Acceptability of self administration

    3 months

Study Arms (1)

Self administration

EXPERIMENTAL

The participant will self administer the SD Biosensor. Their rapid antigen test result will be compared to health care professional administered SD Biosensor

Device: SD Biosensor

Interventions

SD BiosensorDEVICE

Nasal swab SD biosensor to be self administered

Self administration

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female aged 16 years and over
  • Living or working at University of British Columbia
  • Self identified as asymptomatic for COVID-19
  • Participants able to give written informed consent

You may not qualify if:

  • Anyone who is self identified as having COVID-19 symptoms
  • Those diagnosed with COVID-19 in last 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orchard Commons

Vancouver, British Columbia, V6T2B5, Canada

Location

Related Publications (3)

  • Gandhi M, Yokoe DS, Havlir DV. Asymptomatic Transmission, the Achilles' Heel of Current Strategies to Control Covid-19. N Engl J Med. 2020 May 28;382(22):2158-2160. doi: 10.1056/NEJMe2009758. Epub 2020 Apr 24. No abstract available.

    PMID: 32329972BACKGROUND

  • Arons MM, Hatfield KM, Reddy SC, Kimball A, James A, Jacobs JR, Taylor J, Spicer K, Bardossy AC, Oakley LP, Tanwar S, Dyal JW, Harney J, Chisty Z, Bell JM, Methner M, Paul P, Carlson CM, McLaughlin HP, Thornburg N, Tong S, Tamin A, Tao Y, Uehara A, Harcourt J, Clark S, Brostrom-Smith C, Page LC, Kay M, Lewis J, Montgomery P, Stone ND, Clark TA, Honein MA, Duchin JS, Jernigan JA; Public Health-Seattle and King County and CDC COVID-19 Investigation Team. Presymptomatic SARS-CoV-2 Infections and Transmission in a Skilled Nursing Facility. N Engl J Med. 2020 May 28;382(22):2081-2090. doi: 10.1056/NEJMoa2008457. Epub 2020 Apr 24.

    PMID: 32329971BACKGROUND

  • Mina MJ, Parker R, Larremore DB. Rethinking Covid-19 Test Sensitivity - A Strategy for Containment. N Engl J Med. 2020 Nov 26;383(22):e120. doi: 10.1056/NEJMp2025631. Epub 2020 Sep 30. No abstract available.

    PMID: 32997903BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Sabrina T Wong, RN, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 5, 2021

First Posted

May 21, 2021

Study Start

May 26, 2021

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

June 2, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

A de-identified and anonymized dataset can be made available upon request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
August 31, 2022
Access Criteria
send email to: jonathan.beaumier@ubc.ca

Locations

CA(1)