Status:
WITHDRAWN
Proxalutamide Treatment for COVID-19 Female Outpatients
Lead Sponsor:
Applied Biology, Inc.
Conditions:
Covid19
SARS-CoV Infection
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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
- Female age \>=18 years old
- Laboratory confirmed positive SARS-CoV-2 rtPCR test within 7 days prior to randomization
- Clinical status on the NIAID COVID-19 Ordinal Scale of 1 or 2 (i.e., not requiring hospitalization)
- Coagulation: INR\<=1.5XULN, and APTT\<=1.5XULN
- 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
- Not Pregnant or breastfeeding
Exclusion
- Subject enrolled in a study to investigate a treatment for COVID-19 Page 17 of 40
- 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
- Pregnant or breastfeeding
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04853134
Start Date
November 1 2020
End Date
December 1 2021
Last Update
March 4 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Corpometria Institute
Brasília, Brazil, 70390-150