NRx Pharmaceuticals and Quantum Leap With Treatment of Severely Ill COVID-19 Patients with ZYESAMIÔ

NRx Pharmaceuticals, Inc. and Quantum Leap Healthcare Collaborative™ have begun treating patients with inhaled ZYESAMIÔ (Aviptadil), in the I-SPY COVID Trial (NCT04488081), a phase 2 adaptive platform trial aimed at improving treatment for severely and critically ill COVID-19 patients.

The I-SPY COVID Trial utilizes Quantum Leap's adaptive platform trial design methodology, which focuses on the efficient assessment of multiple investigational agents simultaneously.

The objective of the trial is to screen a variety of promising agents for the treatment of severely and critically ill COVID-19 patients.  Specifically, the goal is to identify agents that have a high impact on reducing mortality, as well as the need for and duration of mechanical ventilation. 

ZYESAMI™ has demonstrated a statistically significant increase in the likelihood of patients being alive and free of respiratory failure at 60 days when administered by intravenous infusion in a phase 2b/3 clinical trial in posthoc analyses. In the I-SPY COVID Trial, inhaled ZYESAMI will be given to critically ill patients in order to determine whether inhaled administration has the potential to achieve similar results.