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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04513990.
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.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorKathleen Marie Schmeler