Kintor Pharmaceutical Limited (HKEX: 9939), a China-based clinical-stage novel drug developer, has revealed updates on the preliminary analysis of the clinical trial of Proxalutamide intended for the treatment of COVID-19 patients, it was reported on Sunday.
The investigator started trial was conducted by Dr Andy Goren and Dr Flavio Adsuara Cadegiani and indicated promising results in the treatment of COVID-19 female outpatients.
The trial enrolled 168 female patients who were randomised in a 2:1 ratio to receive either Proxalutamide + standard care (Proxalutamide arm) or Placebo + standard care (Control arm). The co-primary endpoints of the clinical trial are the percentage of subjects hospitalised with COVID-19 and the COVID-19 Ordinal Outcome Scale (an 8-point ordinal scale used by the US National Institute of Allergy and Infection Diseases, such as mechanical ventilation usage and death) in 30 days. This data was revealed based on the interim analysis of 60 patients in Proxalutamide arm and 35 patients in the control arm. The percentage of hospitalisation, admission to ICU, mechanical ventilation requirement and death were 1.7% vs 17.1%, 0% vs 8.6%, 0% vs 5.7% and 0%, vs 2.9% in Proxalutamide and placebo arms respectively.
The trial is likely to complete enrolment this month and complete the data collection by March 2021.
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