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

Withdrawn

• Conditions: Covid19; Androgen Receptor Gene Overexpression
• Interventions: Genetic: COVID-19 Androgen Sensitivity Test (CoVAST)

• Registration Number: NCT04530500
• Lead Sponsor: University of California, Irvine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-13
• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-08-28
• Primary Completion: 2021-12-01
• Study Completion: 2023-12-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm 1	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	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)

Primary Outcome Measures

Name	Time	Method
Number of patients deceased	28 days	Number of subjects deceased at or before 28 days

Secondary Outcome Measures

Name	Time	Method
Number of patients discharged	14 days	Number of patients discharged at or before 14 days

Trial Locations

Locations (2)

Applied Biology, Inc; 🇺🇸 Irvine, California, United States

University of California, Irvine - Dermatology Clinical Research; 🇺🇸 Irvine, California, United States