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

NCT04530500 | Withdrawn DMC FDA Device

• 1 other identifier: 20205907
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

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

Keywords

androgen receptor; severity; mortality

Outcome Measures

Primary Outcomes (1)

• Number of patients deceased

  Number of subjects deceased at or before 28 days

  28 days

Secondary Outcomes (1)

• Number of patients discharged

  14 days

Study Arms (2)

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)

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)

Interventions

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.

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Irvine: lead
• Applied Biology, Inc.: collaborator

Study Sites (2)

Applied Biology, Inc

Irvine, California, 92614, United States

Location

University of California, Irvine - Dermatology Clinical Research

Irvine, California, 92697, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples

MeSH Terms

Conditions

COVID-19; Bulbo-Spinal Atrophy, X-Linked

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Muscular Atrophy, Spinal; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Motor Neuron Disease; Neuromuscular Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Natasha Mesinkovska, MD, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: August 28, 2020
• Study Start: August 13, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)