Novel Point-of-Care Diagnostic Test for SARS-CoV-2 (COVID-19)
END CoV-2
Evaluation of a Novel Point-of-Care Diagnostic Test for SARS-CoV-2
2 other identifiers
interventional
257
1 country
2
Brief Summary
This study investigates a new diagnostic test in detecting SARS-CoV-2, the virus that causes the disease COVID-19. This may help to improve testing for COVID-19.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2020
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 9, 2020
CompletedFirst Submitted
Initial submission to the registry
June 5, 2020
CompletedFirst Posted
Study publicly available on registry
August 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedDecember 22, 2021
December 1, 2021
3.1 years
June 5, 2020
December 21, 2021
Conditions
Outcome Measures
Primary Outcomes (5)
Sensitivity of diagnostic test
Will use the standard-of-care (real time polymerase chain reaction \[RT-PCR\]) coronavirus disease 19 (COVID-19) test at the MD Anderson Molecular Diagnostic Lab result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as the true result to estimate sensitivity with 95% confidence intervals. Estimates of sensitivity and specificity of the novel point-of-care diagnostic test will be provided separately for the provider-collected nasopharyngeal samples, the self-collected nasal swab, and the self-collected cheek swab.
Up to 1 year
Specificity of diagnostic test
Will use the standard-of-care (RT-PCR) COVID-19 test at the MD Anderson Molecular Diagnostic Lab result for SARS-CoV-2 as the true result to estimate specificity with 95% confidence intervals. Estimates of sensitivity and specificity of the novel point-of-care diagnostic test will be provided separately for the provider-collected nasopharyngeal samples, the self-collected nasal swab, and the self-collected cheek swab.
Up to 1 year
Concordance of the novel point-of-care diagnostic test
Will be estimated with 95% confidence intervals.
Up to 1 year
Positive predictive value (PPV) of the novel point-of-care diagnostic test
Will be estimated with 95% confidence intervals.
Up to 1 year
Negative predictive value (NPV) of the novel point-of-care diagnostic test
Will be estimated with 95% confidence intervals.
Up to 1 year
Secondary Outcomes (2)
Viral load metrics
Up to 1 month
Disease progression
Up to 1 month
Study Arms (1)
Diagnostic (biospecimen collection)
EXPERIMENTALParticipants undergo collection of nasopharyngeal (back of the nose) samples by a medical provider and self-collection of oral, saliva, and nasal samples.
Interventions
Undergo collection of nasopharyngeal, oral, saliva, and nasal samples
Demographic information, sample collection type preferences; clinical outcome information
Eligibility Criteria
You may qualify if:
- Qualifies for SARS-CoV-2 testing at MD Anderson, Lyndon B. Johnson (LBJ) hospital, or affiliated sites (may include MD Anderson and LBJ patients and employees) according to institutional criteria at time of enrollment
- Willing and able to provide informed consent
- Ability to perform protocol-required activities
- Able to speak and read English or Spanish
You may not qualify if:
- Patient or provider decision not to perform SARS-CoV-2 testing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
- William Marsh Rice Universitycollaborator
Study Sites (2)
Lyndon Baines Johnson General Hospital
Houston, Texas, 77026-1967, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathleen M Schmeler
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2020
First Posted
August 14, 2020
Study Start
April 9, 2020
Primary Completion
April 30, 2023
Study Completion
April 30, 2023
Last Updated
December 22, 2021
Record last verified: 2021-12