Capturing Infectious COVID-19 Asymptomatic Cases in Singapore

• ClinicalTrials.gov Identifier: NCT04812327
• Recruitment Status: Withdrawn
• First Posted: March 23, 2021
• Last Update Posted: August 11, 2021
• Sponsor: Becton, Dickinson and Company
• Information provided by (Responsible Party): Becton, Dickinson and Company

Study Description

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.

Condition or disease	Intervention/treatment
Covid19; SARS CoV-2	Diagnostic Test: BD Veritor Plus System for Rapid Detection of SARS CoV-2; Diagnostic Test: rt-PCR; Diagnostic Test: viral culture

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 Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Capturing Infectious COVID-19 Asymptomatic Cases in Singapore
• Estimated Study Start Date: June 2021
• Estimated Primary Completion Date: September 2021
• Estimated Study Completion Date: November 2021

Groups and Cohorts

Group/Cohort

Intervention/treatment

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.

Diagnostic Test: BD Veritor Plus System for Rapid Detection of SARS CoV-2; Nasal Sawb for the conduct of the Veritor Antigen Test; Diagnostic Test: rt-PCR; Nasopharyngeal Swab for the conduct of a rt-PCR; Diagnostic Test: viral culture; Nasopharyngeal Swab for the conduct of viral culture

Outcome Measures

Primary Outcome Measures :

1. Assess the performance of the BD Veritor System for Rapid Detection of SARS-CoV-2 compared viral culture, over multiple collection time points [ Time Frame: 6 days ]
   • Assay results: Positive percent agreement (PPA)
   • Assay results: Negative percent agreement (NPA)

Secondary Outcome Measures :

1. 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 [ Time Frame: 6 days ]
   • Assay results: Positive percent agreement (PPA)
   • Assay results: Negative percent agreement (NPA)
2. Assess the performance a commercially available RT-PCR assay compared to viral culture, over multiple test time points [ Time Frame: 6 days ]
   • Assay results: Positive percent agreement (PPA)
   • Assay results: Negative percent agreement (NPA)

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Participants will be recruited at study sites from individuals admitted for SARS-CoV-2 isolation. Once enrolled, participants may be transferred to a different care unit, or units, throughout their time in the study depending on their medical needs.

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

Contacts and Locations

Locations

Singapore

Changi General Hospital

Singapore, Singapore

Sponsors and Collaborators

Becton, Dickinson and Company

Investigators

• Principal Investigator: Yen Seow Tan, MD; Hospital Employee

More Information

• Responsible Party: Becton, Dickinson and Company
• ClinicalTrials.gov Identifier: NCT04812327
• Other Study ID Numbers: SGP-21AsymVer-01
• First Posted: March 23, 2021
• Last Update Posted: August 11, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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