Covid19NCT04812327
Capturing Infectious COVID-19 Asymptomatic Cases in Singapore
An observational study of Covid19 and SARS CoV-2, run by Becton, Dickinson and Company at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Covid19, SARS CoV-2
- What is being tested?
- BD Veritor Plus System for Rapid Detection of SARS CoV-2, rt-PCR and viral culture
- How many people
- 0 participants
- Where
- 1 siteSingapore
- Study dates
- Jun 2021to Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- BD Veritor Plus System for Rapid Detection of SARS CoV-2, rt-PCR, viral culture
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BD Veritor Plus System for Rapid Detection of SARS CoV-2Diagnostic test
Nasal Sawb for the conduct of the Veritor Antigen Test
rt-PCRDiagnostic test
Nasopharyngeal Swab for the conduct of a rt-PCR
viral cultureDiagnostic test
Nasopharyngeal Swab for the conduct of viral culture
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: BD Veritor Plus System for Rapid Detection of SARS CoV-2; Diagnostic Test: rt-PCR; Diagnostic Test: viral culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
- Assay results: Positive percent agreement (PPA)
- Assay results: Negative percent agreement (NPA)
Measured: 6 days
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)
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study startJun 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionNov 2021 (estimated)
Why it stopped: Study was cancelled prior enrollment due to business decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yen Seow Tan, MD, Principal investigator, Hospital Employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812327
- Sponsor's protocol ID
- SGP-21AsymVer-01
- Status last verified
- Aug 2021
- First submitted
- 19 Mar 2021
- Last updated
- 11 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capturing Infectious COVID-19 Asymptomatic Cases in Singapore
- ClinicalTrials.gov ID
- NCT04812327
- Acronym / sponsor ID
- SGP-21AsymVer-01
- Conditions
- Covid19, SARS CoV-2
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study was cancelled prior enrollment due to business decision.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective Observational Diagnostic Evaluation | – | Diagnostic Test: BD Veritor Plus System for Rapid Detection of SARS CoV-2, Diagnostic Test: rt-PCR, Diagnostic Test: viral culturePotential 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BD Veritor Plus System for Rapid Detection of SARS CoV-2Nasal Sawb for the conduct of the Veritor Antigen Test | Diagnostic test | Prospective Observational Diagnostic Evaluation |
| rt-PCRNasopharyngeal Swab for the conduct of a rt-PCR | Diagnostic test | Prospective Observational Diagnostic Evaluation |
| viral cultureNasopharyngeal Swab for the conduct of viral culture | Diagnostic test | Prospective Observational Diagnostic Evaluation |
Primary outcome
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)
2 secondary outcomes
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
Assess the performance a commercially available RT-PCR assay compared to viral culture, over multiple test time points
Time frame: 6 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yen Seow Tan, MD principal investigator
Hospital Employee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and SARS CoV-2, run by Becton, Dickinson and Company at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2021.