Clinical trial · Interventional
Anti-Androgen Treatment for COVID-19
NCT04446429CI-TRIAL-00055476completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is intended to explore the possible protective role of anti-androgens in SARS-CoV-2 infection
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Androgenetic Alopecia | — | UNRESOLVED | — |
| Benign Prostatic Hyperplasia | Benign Prostatic Hyperplasia | ONTOLOGY_EXACT | 0.98 |
| COVID-19 | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| SARS-CoV2 | — | UNRESOLVED | — |
| SARS (Severe Acute Respiratory Syndrome) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proxalutamide | Drug | — | UNRESOLVED |
| Standard of Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Usual Care
- description
- Usual care as determined by the PI
- interventionNames
- Other: Standard of Care
- type
- EXPERIMENTAL
- label
- Proxalutamide + Usual Care
- description
- Proxalutamide + Usual care as determined by the PI
- interventionNames
- Drug: Proxalutamide
Primary outcomes (1)
- measure
- COVID-19 Hospitalization
- timeFrame
- 30 days
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male age ≥18 years old 2. Laboratory confirmed positive SARS-CoV-2 rtPCR test within 7 days prior to randomization 3. Clinical status on the COVID-19 8-point Ordinal Scale of 1 or 2 4. Coagulation: INR ≤ 1.5×ULN, and APTT ≤ 1.5×ULN 5. Subject (or legally authorized representative) gives written informed consent prior to any study screening procedures 6. Subject (or legally authorized representative) agree that subject will not participate in another COVID-19 trial while participating in this study Exclusion Criteria: 1. Subject enrolled in a study to investigate a treatment for COVID-19 2. Subject taking an anti-androgen of any type including: androgen depravation therapy, 5-alpha reductase inhibitors, etc… 3. Patients who are allergic to the investigational product or similar drugs (or any excipients); 4. 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 5. 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 6. Subjects with uncontrolled medical conditions that could compromise participation in the study(e.g. uncontrolled hypertension, hypothyroidism, diabetes mellitus) 7. Known diagnosis of human immunodeficiency virus(HIV) , hepatitis C, active hepatitis B, treponema pallidum (testing is not mandatory） 8. Alanine Transaminase (ALT) or Aspartate Transaminase (AST) \> 5 times the upper limit of normal. 9. Estimated glomerular filtration rate (eGFR) \< 30 ml/min 10. Severe kidney disease requiring dialysis 11. Subject unlikely to return for day 15 site visit for reasons other then remission 12. Subject (or legally authorized representative) not willing or unable to provide informed consent
References
Publications (7)
- BACKGROUNDGoren 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
- BACKGROUNDGoren 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
- BACKGROUNDMcCoy 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
- BACKGROUNDWambier 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
- BACKGROUNDWambier 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
- BACKGROUNDMontopoli 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.