Efficacy and Safety of Proxalutamide in Severe or Critically Ill COVID-19 Patients: Study Protocol for an Exploratory Trial

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.