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

NCT04530500 — Withdrawn, University of California, Irvine

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

Registry	NCT04530500
Status	Withdrawn - Covid pandemic prohibited us from completing study-related activities.
Study type	Observational
Sponsor	University of California, Irvine (Other); collaborators: Applied Biology, Inc.
Conditions	Covid19, Androgen Receptor Gene Overexpression
Interventions	COVID-19 Androgen Sensitivity Test (CoVAST) (Genetic)
Dates	start 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 in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Arm 1		Genetic: COVID-19 Androgen Sensitivity Test (CoVAST)	Males first tested positive for SARS-CoV-2 at the site (medical center) with CAG length <24 (based on the CoVAST Test)
Arm 2		Genetic: COVID-19 Androgen Sensitivity Test (CoVAST)	Males first tested for SARS-CoV-2 at the site (medical center) with CAG length >=24 (based on the CoVAST Test)

COVID-19 Androgen Sensitivity Test (CoVAST) (Genetic): 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.

+Outcome measures

Primary outcomes

Number of patients deceased [28 days]: Number of subjects deceased at or before 28 days

Secondary outcomes

Number of patients discharged [14 days]: Number of patients discharged at or before 14 days

+Eligibility

Sex: Male, ages: 18 Years to 90 Years, accepts healthy volunteers

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

+Locations (2)

Facility	City	Country	Status
Applied Biology, Inc	Irvine, California	United States
University of California, Irvine - Dermatology Clinical Research	Irvine, California	United States

+Investigators

Natasha Mesinkovska, MD, PhD, Principal investigator, University of California, Irvine