Anti-Androgen Treatment for COVID-19

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ClinicalTrials.gov Identifier: NCT04446429

Recruitment Status : Completed

First Posted : June 24, 2020

Results First Posted : February 3, 2021

Last Update Posted : December 10, 2021

Sponsor:

Information provided by (Responsible Party):

Applied Biology, Inc.

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions	COVID-19 SARS-CoV2 Androgenetic Alopecia Prostate Cancer Benign Prostatic Hyperplasia SARS (Severe Acute Respiratory Syndrome)
Interventions	Drug: Proxalutamide Other: Standard of Care
Enrollment	268

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Usual Care	Proxalutamide + Usual Care
Arm/Group Description	Usual care as determined by the PI ...	Proxalutamide + usual care as deter...
Arm/Group Description	Usual care as determined by the PI Usualf Care: Care as determined by the PI	Proxalutamide + usual care as determined by the PI Proxalutamide: 200 mg q.d.
Period Title: Overall Study
Started	134	134
Completed	128 ^[1]	134
Not Completed	6	0
Reason Not Completed
Lost to Follow-up	6	0
[1] In placebo group, 6 patients were lost to follow-up but were included in intention-to-treat analysis.

Baseline Characteristics

Arm/Group Title		Usual Care	Proxalutamide + Usual Care	Total
Arm/Group Description		Usual care as determined by the PI ...	Proxalutamide + usual care as deter...	Total of all reporting groups
Arm/Group Description		Usual care as determined by the PI Usual Care: Care as determined by the PI	Proxalutamide + usual care as determined by the PI Proxalutamide: 200 mg q.d.	Total of all reporting groups
Overall Number of Baseline Participants		134	134	268
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	134 participants	134 participants	268 participants
		45 (10.8)	44.2 (14)	44.5 (7.7)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	134 participants	134 participants	268 participants
	Female	0 0.0%	0 0.0%	0 0.0%
	Male	134 100.0%	134 100.0%	268 100.0%
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants
Mixed ethnicity (Brazil)	Number Analyzed	134 participants	134 participants	268 participants
Mixed ethnicity (Brazil)		134 100.0%	134 100.0%	268 100.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants
Brazil	Number Analyzed	134 participants	134 participants	268 participants
Brazil		134	134	268
Coexisting conditions ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	134 participants	134 participants	268 participants
		20 14.9%	29 21.6%	49 18.3%
		[1] Measure Description: At least one coexisting conditions: Type 2 diabetes, Hypertension, COPD and Obesity

Outcome Measures

1.Primary Outcome


Title	COVID-19 Hospitalization
Description	Percentage of subjects hospitalized due to COVID-19
Description	Percentage of subjects hospitalized due to COVID-19
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

All randomized patients were included. 6 patients from the placebo arm lost to follow-up were assumed to be non-hospitalized (COVID-19 8-point ordinal scale 1) and were included in the intention-to-treat analysis.


Arm/Group Title	Usual Care	Proxalutamide + Usual Care
Arm/Group Description:	Usual care as determined by the PI ...	Proxalutamide + usual care as deter...
Arm/Group Description:	Usual care as determined by the PI Usual Care: Care as determined by the PI	Proxalutamide + usual care as determined by the PI Proxalutamide: 200 mg q.d.
Overall Number of Participants Analyzed	134	134
Measure Type: Count of Participants Unit of Measure: Participants
	35 26.1%	3 2.2%

Adverse Events

Time Frame	30 days
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Usual Care		Proxalutamide + Usual Care
Arm/Group Description	Usual care as determined by the PI ...		Proxalutamide + usual care as deter...
Arm/Group Description	Usual care as determined by the PI Usual Care: Care as determined by the PI		Proxalutamide + usual care as determined by the PI Proxalutamide: 200 mg q.d.
All-Cause Mortality
	Usual Care		Proxalutamide + Usual Care
	Affected / at Risk (%)		Affected / at Risk (%)
Total	2/134 (1.49%)		0/134 (0.00%)
Serious Adverse Events Serious Adverse Events
	Usual Care		Proxalutamide + Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	35/134 (26.12%)		3/134 (2.24%)
Respiratory, thoracic and mediastinal disorders
Death ^† 1	2/134 (1.49%)	2	0/134 (0.00%)	0
Hospitalization ^† 1	35/134 (26.12%)	35	3/134 (2.24%)	3
1 Term from vocabulary, MedDRA (19.0) † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Usual Care		Proxalutamide + Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	78/134 (58.21%)		45/134 (33.58%)
Cardiac disorders
Tachycardia ^† 1	45/134 (33.58%)		6/134 (4.48%)
Gastrointestinal disorders
Diarrhea ^† 1	20/134 (14.93%)		39/134 (29.10%)
Nausea ^† 1	15/134 (11.19%)		21/134 (15.67%)
Abdominal pain or discomfort ^† 1	18/134 (13.43%)		22/134 (16.42%)
Dyspepsia or Heartburn ^† 1	6/134 (4.48%)		23/134 (17.16%)
General disorders
Fatigue ^† 1	71/134 (52.99%)		1/134 (0.75%)
Fever ^† 1	34/134 (25.37%)		2/134 (1.49%)
Disease progression ^† 1	43/134 (32.09%)		4/134 (2.99%)
Musculoskeletal and connective tissue disorders
Back pain ^† 1	36/134 (26.87%)		16/134 (11.94%)
Nervous system disorders
Ageusia ^† 1	23/134 (17.16%)		13/134 (9.70%)
Anosmia ^† 1	26/134 (19.40%)		14/134 (10.45%)
Headache ^† 1	12/134 (8.96%)		1/134 (0.75%)
Respiratory, thoracic and mediastinal disorders
Shortness of breath ^† 1	40/134 (29.85%)		4/134 (2.99%)
1 Term from vocabulary, MedDRA (19.0) † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Director of Clinical Trials
Organization:	Applied Biology
Phone:	+1-949-387-4526
EMail:	monican@appliedbiology.com

Publications:

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.

Goren A, Vaño-Galván 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.

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.

Wambier CG, Goren A, Vaño-Galván 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.

Wambier CG, Vaño-Galván S, McCoy J, Gomez-Zubiaur A, Herrera S, Hermosa-Gelbard Á, Moreno-Arrones OM, Jiménez-Gómez N, González-Cantero A, Fonda-Pascual P, Segurado-Miravalles G, Shapiro J, Pérez-García 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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

McCoy J, Goren A, Cadegiani FA, Vaño-Galván 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.

Layout table for additonal information

Responsible Party:	Applied Biology, Inc.
ClinicalTrials.gov Identifier:	NCT04446429
Other Study ID Numbers:	AB-DRUG-SARS-004
First Submitted:	June 22, 2020
First Posted:	June 24, 2020
Results First Submitted:	January 22, 2021
Results First Posted:	February 3, 2021
Last Update Posted:	December 10, 2021

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