Efficacy and Safety of Proxalutamide in Severe or Critically Ill COVID-19 Patients: Study Protocol for an Exploratory Trial
June 2023
in “
BMC Pharmacology and Toxicology
”
Studysummary This study is investigating the efficacy and safety of proxalutamide, an androgen receptor antagonist, in treating severe or critically ill patients with COVID-19, aiming to provide new insights into potential therapeutic options. Results are not reported yet.
Our plain-language summary. Not medical advice or a treatment recommendation. Consult a qualified healthcare professional before changing treatment. Full disclaimer
The document details a study protocol for a trial investigating the efficacy and safety of proxalutamide, an androgen receptor antagonist, in treating severe or critically ill COVID-19 patients. The trial aims to recruit 64 patients in China, with the primary outcome being the 30-day all-cause mortality. Secondary endpoints include 60-day all-cause mortality, rate of clinical deterioration within 30 days, and other clinical and diagnostic measures. The study hypothesizes that proxalutamide could reduce the mortality rate in severe or critically ill COVID-19 patients from 12% to 2%. The trial will also assess safety through vital signs, physical examination, ECG, laboratory examination, chest radiography, CT scans, and adverse events.
