Bioxytran, Inc. announced the initiation of a clinical trial to treat Mild to Moderate COVID-19 patients. The trial's objective is to provide guidance for a 408 patient Phase III trial. Based on the success of Bioxytran's Phase 2 trial in mild to moderate COVID-19 patients which achieved a 100% response rate by day 7 versus 6% in placebo the Central Drugs Standard Control Organization (CDSCO) in India approved the clinical trial protocol.

The Company is initiating the first stage of its registrational trial which is a dose optimization study that will evaluate 3 different dosage levels against a matching placebo arm in a 5-day trial. The primary endpoints are time weighted average change in SARS-CoV-2 viral load and time to non-detection of viral shedding in outpatient swabs at various time intervals. Inclusion criteria allows for the recruitment of patients at high risk for progression to severe COVID-19 or patients with a Ct value less than 25.

The next stage is large randomized double-blind placebo-controlled Phase 3 study with 408 patients looking to assess a statistically significant increase in responders rate at day 5 over placebo.