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

Not Applicable

• Conditions: COVID-19 Infection
• Interventions: Procedure: Biospecimen Collection; Other: Questionnaire Administration

• Registration Number: NCT04513990
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Detailed 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.

Study Timeline

• Study Start: 2020-04-09
• Study First Submitted: 2020-06-05
• Study First Submitted QC: 2020-08-13
• Study First Posted: 2020-08-14
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-21
• Last Update Posted: 2021-12-22
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 257

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (biospecimen collection)	Questionnaire Administration	Participants undergo collection of nasopharyngeal (back of the nose) samples by a medical provider and self-collection of oral, saliva, and nasal samples.
Diagnostic (biospecimen collection)	Biospecimen Collection	Participants undergo collection of nasopharyngeal (back of the nose) samples by a medical provider and self-collection of oral, saliva, and nasal samples.

Primary Outcome Measures

Name	Time	Method
Sensitivity of diagnostic test	Up to 1 year	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.
Specificity of diagnostic test	Up to 1 year	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.
Concordance of the novel point-of-care diagnostic test	Up to 1 year	Will be estimated with 95% confidence intervals.
Positive predictive value (PPV) of the novel point-of-care diagnostic test	Up to 1 year	Will be estimated with 95% confidence intervals.
Negative predictive value (NPV) of the novel point-of-care diagnostic test	Up to 1 year	Will be estimated with 95% confidence intervals.

Secondary Outcome Measures

Name	Time	Method
Viral load metrics	Up to 1 month	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.
Disease progression	Up to 1 month	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.

Trial Locations

Locations (2)

Lyndon Baines Johnson General Hospital; 🇺🇸 Houston, Texas, United States

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States