N/A
Completed N=268
Anti-Androgen Treatment for COVID-19
Source: ClinicalTrials.gov NCT04446429 ↗Enrolled (actual)
268
Serious AEs
14.2%
Results posted
Feb 2021
Primary outcomePrimary: COVID-19 Hospitalization — 35; 3 Participants
Summary
This study is intended to explore the possible protective role of anti-androgens in SARS-CoV-2 infection
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY COVID-19 Hospitalization |
35; 3 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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) 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
Data sourced from ClinicalTrials.gov (NCT04446429). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.