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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Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04530500
Enrollment
0
Registered
2020-08-28
Start date
2020-08-13
Completion date
2023-12-01
Last updated
2024-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Androgen Receptor Gene Overexpression, Covid19

Keywords

androgen receptor, severity, mortality

Brief 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.

Interventions

GENETICCOVID-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.

Sponsors

Applied Biology, Inc.
CollaboratorINDUSTRY
University of California, Irvine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

* Male over the age of 18 * Laboratory confirmed SARS-CoV-2 infection * Able to give verbal informed consent

Exclusion criteria

* Unable to give informed consent * Diagnosed with an additional respiratory co-infection * XXY males

Design outcomes

Primary

MeasureTime frameDescription
Number of patients deceased28 daysNumber of subjects deceased at or before 28 days

Secondary

MeasureTime frameDescription
Number of patients discharged14 daysNumber of patients discharged at or before 14 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026