Novel Point-of-Care Diagnostic Test for SARS-CoV-2 (COVID-19)
NCT ID: NCT04513990
Last Updated: 2021-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
257 participants
INTERVENTIONAL
2020-04-09
2023-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
Biospecimen Collection
Undergo collection of nasopharyngeal, oral, saliva, and nasal samples
Questionnaire Administration
Demographic information, sample collection type preferences; clinical outcome information
Interventions
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Biospecimen Collection
Undergo collection of nasopharyngeal, oral, saliva, and nasal samples
Questionnaire Administration
Demographic information, sample collection type preferences; clinical outcome information
Eligibility Criteria
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Inclusion Criteria
* Willing and able to provide informed consent
* Ability to perform protocol-required activities
* Able to speak and read English or Spanish
Exclusion Criteria
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
William Marsh Rice University
OTHER
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Kathleen M Schmeler
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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Lyndon Baines Johnson General Hospital
Houston, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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MD Anderson Cancer Center Website
Other Identifiers
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NCI-2020-03470
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-0318
Identifier Type: OTHER
Identifier Source: secondary_id
2020-0318
Identifier Type: -
Identifier Source: org_study_id