NCT04368897

Brief Summary

The COVID-19 Androgen Sensitivity Test is a non-invasive In-Vitro Diagnostic device that utilizes Next Generation Sequencing Technology (NGS). The results of the test are used by a physician to assess the risk of developing severe symptoms following COVID-19 infection, The COVID-19 Androgen Sensitivity Test requires a health care professional to collect a DNA sample using an FDA cleared DNA sample collection kit.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

July 19, 2023

Status Verified

February 1, 2022

Enrollment Period

2.6 years

First QC Date

April 27, 2020

Last Update Submit

July 18, 2023

Conditions

SARS-CoV 2COVIDCOVID-19Androgenetic AlopeciaAndrogen Receptor AbnormalAndrogen Deficiency

Outcome Measures

Primary Outcomes (2)

  • Hospital-free days to Day 28 [ Time Frame: 28 days]

    Defined as 28 days minus the number of days from randomization to discharge home. If a patient has not been discharged home prior to day 28 or dies prior to day 28, hospital free days will be zero.

    28 days

  • 1. Severity of Disease

    Defined as discharged, hospitalization, admission to intensive care unit \[ICU\] and death

    Day 28

Study Arms (1)

COVID-19 Male Patients

Males with laboratory confirmed SARS-CoV-2 infection

Diagnostic Test: CAG length <22Diagnostic Test: CAG length >=22

Interventions

CAG length >=22DIAGNOSTIC_TEST

CAG repeat length in exon 1 of AR gene

Also known as: Genetic Test - Long CAG Allele
COVID-19 Male Patients

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsSelf description
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to the hospital due to COVID-19

You may qualify if:

  • Male over the age of 18
  • First time present at the site
  • Laboratory confirmed SARS-CoV-2 infection
  • Able to give informed consent

You may not qualify if:

  • Unable to give informed consent
  • Diagnosed with an additional respiratory co-infection
  • XXY males

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Ramon y Cajal

Madrid, Spain

Location

Related Publications (4)

  • Goren A, McCoy J, Wambier CG, Vano-Galvan S, Shapiro J, Dhurat R, Washenik K, Lotti T. What does androgenetic alopecia have to do with COVID-19? An insight into a potential new therapy. Dermatol Ther. 2020 Jul;33(4):e13365. doi: 10.1111/dth.13365. Epub 2020 Apr 8. No abstract available.

    PMID: 32237190RESULT

  • Wambier CG, Goren A. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is likely to be androgen mediated. J Am Acad Dermatol. 2020 Jul;83(1):308-309. doi: 10.1016/j.jaad.2020.04.032. Epub 2020 Apr 10.

    PMID: 32283245RESULT

  • Goren A, Vano-Galvan S, Wambier CG, McCoy J, Gomez-Zubiaur A, Moreno-Arrones OM, Shapiro J, Sinclair RD, Gold MH, Kovacevic M, Mesinkovska NA, Goldust M, Washenik K. A preliminary observation: Male pattern hair loss among hospitalized COVID-19 patients in Spain - A potential clue to the role of androgens in COVID-19 severity. J Cosmet Dermatol. 2020 Jul;19(7):1545-1547. doi: 10.1111/jocd.13443. Epub 2020 Apr 23.

    PMID: 32301221RESULT

  • McCoy J, Wambier CG, Vano-Galvan S, Shapiro J, Sinclair R, Ramos PM, Washenik K, Andrade M, Herrera S, Goren A. Racial variations in COVID-19 deaths may be due to androgen receptor genetic variants associated with prostate cancer and androgenetic alopecia. Are anti-androgens a potential treatment for COVID-19? J Cosmet Dermatol. 2020 Jul;19(7):1542-1543. doi: 10.1111/jocd.13455. Epub 2020 Jun 14. No abstract available.

    PMID: 32333494RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Saliva DNA sample

MeSH Terms

Conditions

COVID-19Alopecia

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesHypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Sabina Herrera, MD

    Hospital Universitario Ramon y Cajal

    PRINCIPAL INVESTIGATOR

  • Carlos Wambier, MD

    Brown University

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2020

First Posted

April 30, 2020

Study Start

May 1, 2020

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

July 19, 2023

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)