Anti-Androgen Treatment for COVID-19

NCT04446429 | Completed Results

• 1 other identifier: AB-DRUG-SARS-004
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

Brief Summary

This study is intended to explore the possible protective role of anti-androgens in SARS-CoV-2 infection

Conditions

COVID-19; SARS-CoV2; Androgenetic Alopecia; Prostate Cancer; Benign Prostatic Hyperplasia; SARS (Severe Acute Respiratory Syndrome)

Keywords

Anti-Androgen; Proxalutamide

Outcome Measures

Primary Outcomes (1)

• COVID-19 Hospitalization

  Percentage of subjects hospitalized due to COVID-19

  30 days

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Usual care as determined by the PI

Other: Standard of Care

Proxalutamide + Usual Care

EXPERIMENTAL

Proxalutamide + Usual care as determined by the PI

Drug: Proxalutamide

Interventions

Proxalutamide DRUG

200 mg q.d.

Proxalutamide + Usual Care

Standard of Care OTHER

Standard of care as determined by the PI

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male age ≥18 years old
• Laboratory confirmed positive SARS-CoV-2 rtPCR test within 7 days prior to randomization
• Clinical status on the COVID-19 8-point Ordinal Scale of 1 or 2
• Coagulation: INR ≤ 1.5×ULN, and APTT ≤ 1.5×ULN
• Subject (or legally authorized representative) gives written informed consent prior to any study screening procedures
• Subject (or legally authorized representative) agree that subject will not participate in another COVID-19 trial while participating in this study

You may not qualify if:

• Subject enrolled in a study to investigate a treatment for COVID-19
• Subject taking an anti-androgen of any type including: androgen depravation therapy, 5-alpha reductase inhibitors, etc…
• Patients who are allergic to the investigational product or similar drugs (or any excipients);
• Subjects who have malignant tumors in the past 5 years, with the exception of completed resected basal cell and squamous cell skin cancer and completely resected carcinoma in situ of any type
• Subjects with known serious cardiovascular diseases, congenital long QT syndrome, torsade de pointes, myocardial infarction in the past 6 months, or arterial thrombosis, or unstable angina pectoris, or congestive heart failure which is classified as New York Heart Association (NYHA) class 3 or higher, or left ventricular ejection fraction (LVEF) \< 50%, QTcF \> 450 ms
• Subjects with uncontrolled medical conditions that could compromise participation in the study(e.g. uncontrolled hypertension, hypothyroidism, diabetes mellitus)
• Known diagnosis of human immunodeficiency virus(HIV) , hepatitis C, active hepatitis B, treponema pallidum (testing is not mandatory）
• Alanine Transaminase (ALT) or Aspartate Transaminase (AST) \> 5 times the upper limit of normal.
• Estimated glomerular filtration rate (eGFR) \< 30 ml/min
• Severe kidney disease requiring dialysis
• Subject unlikely to return for day 15 site visit for reasons other then remission
• Subject (or legally authorized representative) not willing or unable to provide informed consent

Sponsors & Collaborators

• Applied Biology, Inc.: lead

Study Sites (1)

Corpometria Institute

Brasília, 70390-150, Brazil

Location

Related Publications (7)

• 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: 32237190 BACKGROUND

• 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: 32301221 BACKGROUND

• 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: 32333494 BACKGROUND

• Wambier CG, Goren A, Vano-Galvan S, Ramos PM, Ossimetha A, Nau G, Herrera S, McCoy J. Androgen sensitivity gateway to COVID-19 disease severity. Drug Dev Res. 2020 Nov;81(7):771-776. doi: 10.1002/ddr.21688. Epub 2020 May 15.

  PMID: 32412125 BACKGROUND

• Wambier CG, Vano-Galvan S, McCoy J, Gomez-Zubiaur A, Herrera S, Hermosa-Gelbard A, Moreno-Arrones OM, Jimenez-Gomez N, Gonzalez-Cantero A, Fonda-Pascual P, Segurado-Miravalles G, Shapiro J, Perez-Garcia B, Goren A. Androgenetic alopecia present in the majority of patients hospitalized with COVID-19: The "Gabrin sign". J Am Acad Dermatol. 2020 Aug;83(2):680-682. doi: 10.1016/j.jaad.2020.05.079. Epub 2020 May 22.

  PMID: 32446821 BACKGROUND

• Montopoli M, Zumerle S, Vettor R, Rugge M, Zorzi M, Catapano CV, Carbone GM, Cavalli A, Pagano F, Ragazzi E, Prayer-Galetti T, Alimonti A. Androgen-deprivation therapies for prostate cancer and risk of infection by SARS-CoV-2: a population-based study (N = 4532). Ann Oncol. 2020 Aug;31(8):1040-1045. doi: 10.1016/j.annonc.2020.04.479. Epub 2020 May 6.

  PMID: 32387456 BACKGROUND

• McCoy J, Goren A, Cadegiani FA, Vano-Galvan S, Kovacevic M, Situm M, Shapiro J, Sinclair R, Tosti A, Stanimirovic A, Fonseca D, Dorner E, Onety DC, Zimerman RA, Wambier CG. Proxalutamide Reduces the Rate of Hospitalization for COVID-19 Male Outpatients: A Randomized Double-Blinded Placebo-Controlled Trial. Front Med (Lausanne). 2021 Jul 19;8:668698. doi: 10.3389/fmed.2021.668698. eCollection 2021.

  PMID: 34350193 DERIVED

MeSH Terms

Conditions

COVID-19; Alopecia; Prostatic Neoplasms; Prostatic Hyperplasia; Severe Acute Respiratory Syndrome

Interventions

proxalutamide; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Applied Biology

monican@appliedbiology.com

+1-949-387-4526

Study Officials

• Flavio A Cadegiani, MD

  Corpometria Institute

  PRINCIPAL INVESTIGATOR

• Andy Goren, MD

  Applied Biology, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is designed as a prospective, interventional, placebo controlled, double-blinded, randomized parallel assignment study.

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 24, 2020
• Study Start: October 21, 2020
• Primary Completion: December 24, 2020
• Study Completion: January 21, 2021
• Last Updated: December 10, 2021
• Results First Posted: February 3, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)