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
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Sponsor:
Applied Biology, Inc.
Information provided by (Responsible Party):
Applied Biology, Inc.
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Study Type | Interventional |
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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 |
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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.
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Baseline Characteristics
Arm/Group Title | Usual Care | Proxalutamide + Usual Care | Total | |
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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 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 134 participants | 134 participants | 268 participants | |
Female |
0 0.0%
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0 0.0%
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0 0.0%
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Male |
134 100.0%
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134 100.0%
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268 100.0%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Mixed ethnicity (Brazil) | Number Analyzed | 134 participants | 134 participants | 268 participants |
134 100.0%
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134 100.0%
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268 100.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Brazil | Number Analyzed | 134 participants | 134 participants | 268 participants |
134 | 134 | 268 | ||
Coexisting conditions
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 134 participants | 134 participants | 268 participants | |
20 14.9%
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29 21.6%
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49 18.3%
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[1]
Measure Description: At least one coexisting conditions: Type 2 diabetes, Hypertension, COPD and Obesity
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Director of Clinical Trials |
Organization: | Applied Biology |
Phone: | +1-949-387-4526 |
EMail: | monican@appliedbiology.com |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |