According to Beyond Air, the company has received permission from the FDA to initiate a clinical study of its LungFit inhaled nitric oxide system for the treatment of COVID-19 patients. The announcement comes almost a month after the company said that it had submitted an investigational device exemption application to the FDA for that purpose. The company said that it has applied for funding for the study from the Biomedical Advance Research and Development Authority (BARDA).
The open-label study is expected to enroll 20 hospitalized adult COVID-19 patients who will receive either 80 ppm NO over 40 minutes, 4 times per day in addition to standard of care or standard of care alone. The study’s primary endpoint of time to clinical deterioration will be measured by time to a need for intervention by non-invasive ventilation, high flow nasal cannula, or intubation. Additional endpoints include length of hospital stay, reduction of viral load, need for supplemental oxygen, and mortality.
Beyond Air Chairman and CEO Steve Lisi said, “We are pleased with the rapid action taken by the FDA to allow this first step in providing high concentration nitric oxide therapy to COVID-19 patients. The Beyond Air team is working tirelessly to initiate this important study, into which we expect to begin enrolling patients within weeks.”
In addition to the US trial, Beyond Air said that it has applied to regulatory agencies in Israel and Canada to conduct similar trials. Instead of 80 ppm of NO, however, those trials would evaluate the use of 150 ppm.
Read the Beyond Air press release.
