NCT04530500

COVID-19 In-vitro Diagnostic Test and Androgen Receptor Gene Expression

In-vitro Diagnostic Test to Predict COVID-19 Mortality and Disease Severity

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: Male
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

This research study will evaluate the association of Androgen Receptor (AR) gene expression and COVID-19 disease severity and mortality. The research procedure involves collection of a single saliva sample which will be mailed to the participants by the study team. This saliva will be used in a COVID-19 Androgen Sensitivity Test (CoVAST) which will detect AR gene expression. Eligible participants are males, at least 18 years or older, and have tested positive for COVID-19.

Conditions

• Covid19
• Androgen Receptor Gene Overexpression

Interventions

Type	Name	Description
GENETIC	COVID-19 Androgen Sensitivity Test (CoVAST)	The CoVAST Test is an in-vitro non diagnostic test. The test reports the genetic health risk of male patients in developing severe symptoms following COVID 19 infection. The genetic information provided by this test will help physicians evaluate the association of AR gene polymorphism with disease severity and mortality following COVID-19 infection. The CoVAST Test is indicated for reporting of the following variant associated with the following gene.

Timeline

• Start date: 2020-08-13
• Primary completion: 2021-12-01
• Completion: 2023-12-01
• First posted: 2020-08-28
• Last updated: 2024-05-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study