Novel Point-of-Care Diagnostic Test for SARS-CoV-2 (COVID-19)

COVID-19 Infection Clinical Trial

— END CoV-2  

Official title:

Evaluation of a Novel Point-of-Care Diagnostic Test for SARS-CoV-2

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04513990
• Other study ID #: 2020-0318
• Secondary ID: NCI-2020-0347020
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 9, 2020
• Est. completion date: April 30, 2023

Study information

• Verified date: December 2021
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

PRIMARY OBJECTIVE:

I. To evaluate the clinical performance of a novel point-of-care diagnostic test for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes the disease called coronavirus disease 19 (COVID-19).

SECONDARY OBJECTIVES:

I. To compare the clinical performance of provider-collected nasopharyngeal samples with self-collected nasal swab, cheek swab, and saliva sample using the novel SARS-CoV-2 diagnostic test.

II. To measure viral load and evaluate the role of viral load in COVID-19 severity.

OUTLINE:

Participants undergo collection of nasopharyngeal (back of the nose) samples by a medical provider and self-collection of oral, saliva, and nasal samples.

After completion of study, participants are followed up at 1 month.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 257
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patient or provider decision not to perform SARS-CoV-2 testing

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Infection

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of nasopharyngeal, oral, saliva, and nasal samples

Other:
• Questionnaire Administration
Demographic information, sample collection type preferences; clinical outcome information

Locations

Country	Name	City	State
United States	Lyndon Baines Johnson General Hospital	Houston	Texas
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI), William Marsh Rice University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Concordance of the novel point-of-care diagnostic test	Will be estimated with 95% confidence intervals.	Up to 1 year
Primary	Positive predictive value (PPV) of the novel point-of-care diagnostic test	Will be estimated with 95% confidence intervals.	Up to 1 year
Primary	Negative predictive value (NPV) of the novel point-of-care diagnostic test	Will be estimated with 95% confidence intervals.	Up to 1 year
Secondary	Viral load metrics	Will use descriptive statistics to summarize viral load metrics from the standard-of-care (RT-PCR) SARS-CoV-2 test and from each of the point-of-care tests.	Up to 1 month
Secondary	Disease progression	Will use logistic regression methods to model progression to severe disease (defined as hospitalization) as a function of viral load, age, gender, smoking history, comorbidities, and symptoms for each of these tests.	Up to 1 month

External Links

•   MD Anderson Cancer Center Website