Kintor Pharmaceutical Limited said that on September 22 the Brazilian Health Regulatory Agency (ANVISA) granted an approval for the phase III clinical trial of proxalutamide to treat hospitalized COVID-19 patients.
It is the third ANVISA-approved pivotal study sponsored by Kintor Pharma for the treatment of COVID-19 patients with proxalutamide.
The phase III trial, dubbed as NCT05009732, is a randomized, double-blind, placebo-controlled, multi-regional clinical study, designed to evaluate the efficacy and safety of proxalutamide in hospitalized COVID-19 patients. The study is expected to enroll 1,030 patients.
The primary endpoint of the trial is the time to sustained recovery evaluated by day 30. The secondary endpoint of the trial is 30-day mortality.
Kintor Pharma said it is now conducting two registered phase III multi-regional clinical trials (MRCT) of proxalutamide for the treatment of COVID-19 outpatients, and one phase III MRCT for COVID-19 inpatients in countries and regions that include the United States, South America (including Brazil), the European Union, and Asia.
Kintor Pharma was granted an emergency use authorization for proxalutamide for the treatment of COVID-19 infection in hospitalized patients in Paraguay.
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