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

NCT ID: NCT04530500

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-13
• Study Completion Date: 2023-12-01

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.

Conditions

Covid19; Androgen Receptor Gene Overexpression

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Arm 1

Males first tested positive for SARS-CoV-2 at the site (medical center) with CAG length \<24 (based on the CoVAST Test)

COVID-19 Androgen Sensitivity Test (CoVAST)

Intervention Type: 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.

Arm 2

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)

Intervention Type: 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.

Interventions

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.

Intervention Type: GENETIC

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Applied Biology, Inc.

INDUSTRY

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Natasha Mesinkovska

Director of Clinical Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Natasha Mesinkovska, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

Applied Biology, Inc

Irvine, California, United States

University of California, Irvine - Dermatology Clinical Research

Irvine, California, United States

Countries

United States

Other Identifiers

20205907

Identifier Type: -

Identifier Source: org_study_id