Capturing Infectious COVID-19 Asymptomatic Cases in Singapore

Covid19 Clinical Trial

Official title:

Capturing Infectious COVID-19 Asymptomatic Cases in Singapore

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04812327
• Other study ID #: SGP-21AsymVer-01
• Status: Withdrawn
• Start date: June 2021
• Est. completion date: November 2021

Study information

• Verified date: August 2021
• Source: Becton, Dickinson and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Covid19
• Infection
• SARS CoV-2

Intervention

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

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Becton, Dickinson and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Assay results: Positive percent agreement (PPA); Assay results: Negative percent agreement (NPA)	6 days
Secondary	Assess the performance a commercially available RT-PCR assay compared to viral culture, over multiple test time points	Assay results: Positive percent agreement (PPA); Assay results: Negative percent agreement (NPA)	6 days