Status:
COMPLETED
Anti-Androgen Treatment for COVID-19
Lead Sponsor:
Applied Biology, Inc.
Conditions:
COVID-19
SARS-CoV2
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
This study is intended to explore the possible protective role of anti-androgens in SARS-CoV-2 infection
Detailed Description
During the continuing SARS-CoV-2 (COVID-19) pandemic, several studies have reported a significant difference in the rate of severe cases between adult females and adult males (42% vs 58%).Among childr...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2021
Estimated Enrollment :
268 Patients enrolled
Trial Details
Trial ID
NCT04446429
Start Date
October 21 2020
End Date
January 21 2021
Last Update
December 10 2021
Active Locations (1)
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1
Corpometria Institute
Brasília, Brazil, 70390-150