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

Study Overview
=================
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.

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

Conditions
-----------------
Covid19, Androgen Receptor Gene Overexpression

Intervention / Treatment
-----------------
* Genetic: COVID-19 Androgen Sensitivity Test (CoVAST)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm 1<br>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)<br>* 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.<br>|
| Arm 2<br>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)<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
androgen receptor, severity, mortality