Proxalutamide Treatment for COVID-19 Female Outpatients

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study is intended to explore the possible protective role of anti-androgens in SARS-CoV-2 infection

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Applied Biology, Inc.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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