COVID-19 Clinical Trial
Official title:
In-vitro Diagnostic Test to Predict COVID-19 Mortality and Disease Severity
NCT number | NCT04368897 |
Other study ID # | AB-IVD-CoV-001 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2020 |
Est. completion date | December 1, 2022 |
Verified date | February 2022 |
Source | Applied Biology, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 1, 2022 |
Est. primary completion date | December 1, 2022 |
Accepts healthy volunteers | |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Male over the age of 18 - First time present at the site - Laboratory confirmed SARS-CoV-2 infection - Able to give informed consent Exclusion Criteria: - Unable to give informed consent - Diagnosed with an additional respiratory co-infection - XXY males |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario Ramon y Cajal | Madrid |
Lead Sponsor | Collaborator |
---|---|
Applied Biology, Inc. | Hospital Universitario Ramon y Cajal |
Spain,
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 20 — View Citation
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 — View Citation
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 — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 1. Severity of Disease | Defined as discharged, hospitalization, admission to intensive care unit [ICU] and death | Day 28 |
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