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

NCT04530500 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2024-05-08

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Applied Biology, Inc.

    collaborator INDUSTRY

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Natasha Mesinkovska, MD, PhD · University of California, Irvine

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-13
Primary Completion
2021-12-01
Completion
2023-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04530500 on ClinicalTrials.gov