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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 90 Years
Eligible Genders
Male
Accepts 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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Arm 1 Males first tested positive for SARS-CoV-2 at the site (medical center) with CAG length <24 (based on the CoVAST Test)
  • 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.
Arm 2 Males first tested for SARS-CoV-2 at the site (medical center) with CAG length >=24 (based on the CoVAST Test)
  • 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.

Recruiting Locations

More Details

NCT ID
NCT04530500
Status
Withdrawn
Sponsor
University of California, Irvine

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.