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N/A Completed N=268 Randomized Quadruple-blind Treatment

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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