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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 : June 16, 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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Usual Care Proxalutamide + Usual Care
Hide 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.
Arm/Group Title Usual Care Proxalutamide + Usual Care Total
Hide 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
Hide 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
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
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
1.Primary Outcome
Title COVID-19 Hospitalization
Hide Description Percentage of subjects hospitalized due to COVID-19
Time Frame 30 days
Hide Outcome Measure Data
Hide 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
Hide 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%
Time Frame 30 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Usual Care Proxalutamide + Usual Care
Hide 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%)    
Hide 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
Hide 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
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:
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: June 16, 2021