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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Covid19; Androgen Receptor Gene Overexpression
• Intervention / Treatment: Genetic: COVID-19 Androgen Sensitivity Test (CoVAST)

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92614
      • Applied Biology, Inc
    • Irvine, California, United States, 92697
      • University of California, Irvine - Dermatology Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Males over age 18 who have tested positive for SARS-CoV-2 infection within the University of California, Irvine Health System.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients deceased	Number of subjects deceased at or before 28 days	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients discharged	Number of patients discharged at or before 14 days	14 days

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: Applied Biology, Inc.
• Investigators: Principal Investigator: Natasha Mesinkovska, MD, PhD, University of California, Irvine

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2020
• Primary Completion (Anticipated): June 24, 2023
• Study Completion (Anticipated): June 24, 2023

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (Actual): August 28, 2020

Study Record Updates

• Last Update Posted (Actual): December 11, 2020
• Last Update Submitted That Met QC Criteria: December 9, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: mortality; severity; androgen receptor
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens
• Other Study ID Numbers: 2020-5907

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes