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

M.D. Anderson Cancer Center

Status: Unknown

Conditions: COVID-19 Infection

Treatments: Procedure: Biospecimen Collection; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04513990

NCI-2020-03470 (Registry Identifier)

2020-0318

Details and patient eligibility

About

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.

Full 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.

Enrollment: 257 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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257 participants in 1 patient group

Diagnostic (biospecimen collection)

Experimental group

Description:

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

Treatment:

Procedure: Biospecimen Collection

Other: Questionnaire Administration