Capturing Infectious COVID-19 Asymptomatic Cases in Singapore

Withdrawn

• Conditions: SARS CoV-2; Covid19

• Registration Number: NCT04812327
• Lead Sponsor: Becton, Dickinson and Company

Brief Summary

This study is being conducted to assess the performance of the BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2, used in serial testing, in identification of infectious, asymptomatic individuals. This information may be used to inform development of an effective testing strategy by policy makers.

Detailed Description

This multi-center, prospective, observational, diagnostic evaluation study is designed to assess the performance of the BD Veritor System in the detection of SARS-CoV-2 in asymptomatic individuals compared to viral culture and a commercially available RT-PCR assay over multiple testing time points. The study will enroll a minimum of 150 asymptomatic, adult participants who test positive for SARS-CoV-2 during community/traveler screening procedures.

Study Timeline

• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-19
• Study First Posted: 2021-03-23
• Study Start: 2021-06
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-04
• Last Update Posted: 2021-08-11
• Primary Completion: 2021-09
• Study Completion: 2021-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Male or female ≥21 years of age at the time of informed consent
2. Has a positive screening test for SARS-CoV-2 by RT-PCR
3. Is asymptomatic for COVID-19 on the day of their positive screening test (may have symptoms on the actual day of study enrollment)
4. Is expected to remain at the study site for the full 6-day study period
5. Willing and able to complete all study required procedures
6. Provision of signed and dated informed consent form

Exclusion Criteria

1. History of frequent or difficult to control nosebleeds within the 14 days prior to study participation
2. If, at the discretion of the Investigator, involvement in the study is likely to jeopardize the subject's health or their current or future medical treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the performance of the BD Veritor System for Rapid Detection of SARS-CoV-2 compared viral culture, over multiple collection time points	6 days	* Assay results: Positive percent agreement (PPA); * Assay results: Negative percent agreement (NPA)

Secondary Outcome Measures

Name	Time	Method
Assess the performance of the BD Veritor System for Rapid Detection of SARS-CoV-2 compared to a commercially available RT-PCR asay, over multiple collection time points	6 days	* Assay results: Positive percent agreement (PPA); * Assay results: Negative percent agreement (NPA)
Assess the performance a commercially available RT-PCR assay compared to viral culture, over multiple test time points	6 days	* Assay results: Positive percent agreement (PPA); * Assay results: Negative percent agreement (NPA)

Trial Locations

Locations (1)

Changi General Hospital; 🇸🇬 Singapore, Singapore