NCT04513990

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

Evaluation of a Novel Point-of-Care Diagnostic Test for SARS-CoV-2

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 257 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19 Infection

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of nasopharyngeal, oral, saliva, and nasal samples
OTHER	Questionnaire Administration	Demographic information, sample collection type preferences; clinical outcome information

Timeline

• Start date: 2020-04-09
• Primary completion: 2023-04-30
• Completion: 2023-04-30
• First posted: 2020-08-14
• Last updated: 2021-12-22

Locations

2 sites across 1 country: United States