(RTTNews) - Ampio Pharmaceuticals Inc. (AMPE) said that it has begun phase 1 clinical trial of inhaled ampion for COVID-19 patients with respiratory distress.
According to the company, Ampion will be administered to COVID-19 patients by inhalation, allowing the drug to directly target and attenuate inflammation in the lungs, as administered by either a hand-held nebulizer for COVID-19 patients with mild to moderate disease, or by non-invasive ventilation and mechanical ventilation in patients impacted with more severe disease.
The US study will enroll 40 patients, randomized 1 to 1, Ampion in addition to the standard of care versus the standard of care alone.
Each patient in the treatment arm will inhale 8 mL doses of Ampion four times a day for five days. Safety is the primary end-point and various measurements indicative of efficacy are secondary endpoints.
The company noted that dosing of patients will begin at Penrose Hospital in Colorado Springs, Colorado and will expand enrollment to other hospitals in the near future.
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