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

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ClinicalTrials.gov Identifier: NCT04530500
Recruitment Status : Enrolling by invitation
First Posted : August 28, 2020
Last Update Posted : December 11, 2020
Sponsor:
Collaborator:
Applied Biology, Inc.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Covid19 Androgen Receptor Gene Overexpression Genetic: COVID-19 Androgen Sensitivity Test (CoVAST)

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: In-vitro Diagnostic Test to Predict COVID-19 Mortality and Disease Severity
Actual Study Start Date : August 13, 2020
Estimated Primary Completion Date : June 24, 2023
Estimated Study Completion Date : June 24, 2023


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.




Primary Outcome Measures :
  1. Number of patients deceased [ Time Frame: 28 days ]
    Number of subjects deceased at or before 28 days


Secondary Outcome Measures :
  1. Number of patients discharged [ Time Frame: 14 days ]
    Number of patients discharged at or before 14 days


Biospecimen Retention:   Samples With DNA
Saliva samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04530500


Locations
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United States, California
Applied Biology, Inc
Irvine, California, United States, 92614
University of California, Irvine - Dermatology Clinical Research
Irvine, California, United States, 92697
Sponsors and Collaborators
University of California, Irvine
Applied Biology, Inc.
Investigators
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Principal Investigator: Natasha Mesinkovska, MD, PhD University of California, Irvine
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Responsible Party: University of California, Irvine
ClinicalTrials.gov Identifier: NCT04530500    
Other Study ID Numbers: 2020-5907
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: December 11, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University of California, Irvine:
androgen receptor
severity
mortality
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs