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Purpose

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.

Condition

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Diagnostic (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.
  • Procedure: Biospecimen Collection
    Undergo collection of nasopharyngeal, oral, saliva, and nasal samples
  • Other: Questionnaire Administration
    Demographic information, sample collection type preferences; clinical outcome information

Recruiting Locations

More Details

NCT ID
NCT04513990
Status
Unknown status
Sponsor
M.D. Anderson Cancer Center

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.