The Institutional Review Board (IRB) of Brazil has approved Kintor Pharmaceutical’s clinical trial of Proxalutamide for treating hospitalised Covid-19 patients.
The company noted that the trial was accepted for accelerated review and it has received the Brazilian government’s support in terms of medical resources allocation.
For the trial, patient recruitment is set to begin soon.
The double-blinded, randomised and multi-centre investigational study will enrol around 588 adult patients (294 male and 294 female) within 48 hours of admission to hospital.
It will have two cohorts of men and women and two arms of Proxalutamide and control, respectively.
Participants will randomly receive orally administered Proxalutamide 300mg or placebo once daily (QD) for 14 days.
Apart from this, patients in each arm will be given standard of care as decided by the principal investigator at the site.
From screening to the end of the trial, each patient will be analysed for 28 days.
Treatment efficacy of Proxalutamide arm verus Control arm as assessed by the WHO COVID-19 ordinal scale on day 14, will be the trial’s primary endpoint.
Kintor Pharmaceutical founder, chairman and CEO Dr Tong Youzhi said: “Based on the results that Proxalutamide could alleviate symptoms and has reduced hospitalisation risk of 100% for male Covid-19 outpatients and 90% for female Covid-19 outpatients, respectively, we collaborated with our investigator and quickly initiated the clinical study of Proxalutamide for the treatment of hospitalised Covid-19 male and female patients.
“This clinical trial has received strong support from the Brazilian government and was granted with the accelerated review.
“We are actively initiating MRCT Phase III registrational trials, so as to bring an effective treatment therapy to Covid-19 patients over the world.”
Earlier, Kintor Pharmaceutical reported encouraging results from the investigator initiated clinical trial of Proxalutamide for treating female Covid-19 patients.