Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT04853134
Eligibility 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04853134
Study Brief:
Protocol Section:
NCT04853134