Capturing Infectious COVID-19 Asymptomatic Cases in Singapore

NCT ID: NCT04812327

Last Updated: 2021-08-11

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2021-11-30

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.

Conditions

Covid19; SARS CoV-2

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Prospective Observational Diagnostic Evaluation

Potential participants will be recruited at study sites where they are admitted/held for COVID-19 isolation. On the first day of isolation (ideally on the day they first test positive for SARS-CoV-2), potential participants will be asked to participate in the study. After consent (Study Day 0), two nasopharyngeal swabs (NP swabs) and one nasal swab will be collected. One NP swab will be tested via viral culture and the other nasal swab will be tested by RT-PCR for SARS-CoV-2. The nasal swab will be tested on the BD Veritor System. Specimen collection and testing will be repeated every 2 days for 6 days (Study Day 2, Day 4, and Day 6) or until the RT-PCR Ct value is \>30, whichever comes first. Participants will be monitored for symptoms of COVID-19 throughout the study.

BD Veritor Plus System for Rapid Detection of SARS CoV-2

Intervention Type: DIAGNOSTIC_TEST

Nasal Sawb for the conduct of the Veritor Antigen Test

rt-PCR

Intervention Type: DIAGNOSTIC_TEST

Nasopharyngeal Swab for the conduct of a rt-PCR

viral culture

Intervention Type: DIAGNOSTIC_TEST

Nasopharyngeal Swab for the conduct of viral culture

Interventions

BD Veritor Plus System for Rapid Detection of SARS CoV-2

Nasal Sawb for the conduct of the Veritor Antigen Test

Intervention Type: DIAGNOSTIC_TEST

rt-PCR

Nasopharyngeal Swab for the conduct of a rt-PCR

Intervention Type: DIAGNOSTIC_TEST

viral culture

Nasopharyngeal Swab for the conduct of viral culture

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Becton, Dickinson and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yen Seow Tan, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Employee

Locations

Changi General Hospital

Singapore, , Singapore

Countries

Singapore

Other Identifiers

SGP-21AsymVer-01

Identifier Type: -

Identifier Source: org_study_id