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COVID-19 Rapid Testing for Self-Administration Among an Asymptomatic Sample

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04896710
Recruitment Status : Enrolling by invitation
First Posted : May 21, 2021
Last Update Posted : June 2, 2021
Sponsor:
Collaborators:
Health Canada
Roche Pharma AG
Information provided by (Responsible Party):
Sabrina Wong, PhD, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Covid19 Asymptomatic Shedding Viral Device: SD Biosensor Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 569 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Rapid Testing for Self-Administration Among an Asymptomatic Sample
Actual Study Start Date : May 26, 2021
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Self administration
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
Nasal swab SD biosensor to be self administered




Primary Outcome Measures :
  1. Concordance [ Time Frame: 2 months ]
    Concordance (calculated using Cohen's Kappa) between self administered and health care professional administered SD Biosensor rapid antigen test results.

  2. Ability of rapid antigen test to detect COVID-19 positive [ Time Frame: 3 months ]
    >80% sensitivity and >95% specificity for SD Biosensor rapid antigen test among asymptomatic population


Secondary Outcome Measures :
  1. Acceptability of self administration [ Time Frame: 3 months ]
    Self reported acceptability of self administration will be collected from participants by questionnaire; acceptability will be defined by 4 response categories: very acceptable, acceptable, somewhat acceptable, not at all acceptable.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04896710


Locations
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Canada, British Columbia
Orchard Commons
Vancouver, British Columbia, Canada, V6T2B5
Sponsors and Collaborators
University of British Columbia
Health Canada
Roche Pharma AG
Investigators
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Principal Investigator: Sabrina T Wong, RN, PhD University of British Columbia
Publications:
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Responsible Party: Sabrina Wong, PhD, Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT04896710    
Other Study ID Numbers: 331297
First Posted: May 21, 2021    Key Record Dates
Last Update Posted: June 2, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A de-identified and anonymized dataset can be made available upon request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: August 31, 2022
Access Criteria: send email to: jonathan.beaumier@ubc.ca

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases