The open-label trial will enrol 75 patients aged 22 to 75 years
LungFit BRO system to be used in proposed study to treat COVID-19 patients. (Credit: Pixabay/Vektor Kunst)
Biopharmaceutical firm Beyond Air has submitted an investigational device exemption (IDE) to the US Food and Drug Administration (FDA) for use of its LungFit BRO system to treat patients suffering from COVID-19.
The company is involved in the development of the LungFit platform system, a generator and delivery system that produces nitric oxide (NO) from ambient air, eliminating the need for expensive and cumbersome cylinders.
LungFit BRO system is designed for easy transportation
Beyond Air intends to test the LungFit BRO system in a proposed study to treat COVID-19 patients. The system weighs about 20 lbs and is easy to transport.
After securing the FDA approval, the open-label trial will enrol 75 patients aged 22 to 75 years, requiring hospitalisation due to COVID-19. The patients will be randomised 2:1 and treated with 150 ppm NO administered during a period of 40 minutes, 4 times per day, in addition to standard of care (SOC) or SOC alone.
According to Beyond Air, the primary endpoint is time to clinical improvement based on parameters such as fever and oxygen support.
Additional endpoints include fall in viral load, fever resolution, oxygen support, hospital length of stay, requirement of mechanical ventilation, mortality, and various biomarkers.
Beyond Air chairman and CEO Steve Lisi said: “There is a mounting body of evidence that inhaled NO, including NO generated and delivered by our LungFitTM BRO system, is safe and well-tolerated in animals and in human subjects at concentrations of 150 ppm and higher.
“In vitro evidence1 points to inhibition of viral replication in a variety of viruses, including coronaviruses, as well as anti-inflammatory properties of nitric oxide.
“We believe that our LungFitTM BRO system may, given the three completed pilot clinical studies in bronchiolitis, be a significant tool in the battle against this coronavirus that has reached global pandemic status.”