Covid19NCT04530500
COVID-19 In-vitro Diagnostic Test and Androgen Receptor Gene Expression
An observational study of Covid19 and Androgen Receptor Gene Overexpression, run by University of California, Irvine at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Covid19, Androgen Receptor Gene Overexpression
- What is being tested?
- COVID-19 Androgen Sensitivity Test (CoVAST)
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Aug 2020to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Males over age 18 who have tested positive for SARS-CoV-2 infection within the University of California, Irvine Health System.
Who may be able to join
- Male over the age of 18
- Laboratory confirmed SARS-CoV-2 infection
- Able to give verbal informed consent
Who cannot join
- Unable to give informed consent
- Diagnosed with an additional respiratory co-infection
- XXY males
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Applied Biology, Inc
Irvine, California, 92614
University of California, Irvine - Dermatology Clinical Research
Irvine, California, 92697
About this study
Official title: In-vitro Diagnostic Test to Predict COVID-19 Mortality and Disease Severity
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
- Being tested
- COVID-19 Androgen Sensitivity Test (CoVAST)
- Keywords
- androgen receptor, severity, mortality
- Medical subject headings
- COVID-19, Bulbo-Spinal Atrophy, X-Linked
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Males first tested positive for SARS-CoV-2 at the site (medical center) with CAG length <24 (based on the CoVAST Test) Receives: 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) Receives: Genetic: COVID-19 Androgen Sensitivity Test (CoVAST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients deceased
Number of subjects deceased at or before 28 days
Measured: 28 days
Secondary outcomes (1)
Number of patients discharged
Number of patients discharged at or before 14 days
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start13 Aug 2020
- Primary completion1 Dec 2021
- Study completion1 Dec 2023
Why it stopped: Covid pandemic prohibited us from completing study-related activities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Applied Biology, Inc.
- Responsible party
- Principal investigator, Natasha Mesinkovska, University of California, Irvine
- Investigators
- Natasha Mesinkovska, MD, PhD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530500
- Sponsor's protocol ID
- 20205907
- Status last verified
- May 2024
- First submitted
- 26 Aug 2020
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-vitro Diagnostic Test to Predict COVID-19 Mortality and Disease Severity
- ClinicalTrials.gov ID
- NCT04530500
- Acronym / sponsor ID
- 20205907
- Conditions
- Covid19, Androgen Receptor Gene Overexpression
- Keywords
- androgen receptor, severity, mortality
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Covid pandemic prohibited us from completing study-related activities.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Applied Biology, Inc.
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 28 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Genetic: 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 | – | Genetic: 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) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Males over age 18 who have tested positive for SARS-CoV-2 infection within the University of California, Irvine Health System.
Key inclusion criteria (3 listed)
- Male over the age of 18
- Laboratory confirmed SARS-CoV-2 infection
- Able to give verbal informed consent
Key exclusion criteria (3 listed)
- Unable to give informed consent
- Diagnosed with an additional respiratory co-infection
- XXY males
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Genetic | Arm 1, Arm 2 |
Primary outcome
Number of patients deceased
Time frame: 28 days
Number of subjects deceased at or before 28 days
1 secondary outcome
Number of patients discharged
Time frame: 14 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natasha Mesinkovska, MD, PhD principal investigator
University of California, Irvine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Androgen Receptor Gene Overexpression, run by University of California, Irvine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients deceased (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.