Capturing Infectious COVID-19 Asymptomatic Cases in Singapore

NCT04812327 | Withdrawn

• 1 other identifier: SGP-21AsymVer-01
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; SARS CoV-2

Outcome Measures

Primary Outcomes (1)

• Assess the performance of the BD Veritor System for Rapid Detection of SARS-CoV-2 compared viral culture, over multiple collection time points

  * Assay results: Positive percent agreement (PPA) * Assay results: Negative percent agreement (NPA)

  6 days

Secondary Outcomes (2)

• 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

• Assess the performance a commercially available RT-PCR assay compared to viral culture, over multiple test time points

  6 days

Study Arms (1)

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; Diagnostic Test: rt-PCR; Diagnostic Test: viral culture

Interventions

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

Nasal Sawb for the conduct of the Veritor Antigen Test

Prospective Observational Diagnostic Evaluation

rt-PCR DIAGNOSTIC_TEST

Nasopharyngeal Swab for the conduct of a rt-PCR

Prospective Observational Diagnostic Evaluation

viral culture DIAGNOSTIC_TEST

Nasopharyngeal Swab for the conduct of viral culture

Prospective Observational Diagnostic Evaluation

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• History of frequent or difficult to control nosebleeds within the 14 days prior to study participation
• 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

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

Study Sites (1)

Changi General Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Nucleic Acid Testing

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

COVID-19 Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Yen Seow Tan, MD

  Hospital Employee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 23, 2021
• Study Start: June 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: November 1, 2021
• Last Updated: August 11, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)