Results demonstrate high safety and reduced need for oxygen supplementation in patients with COVID-19 viral pneumonia.
Beyond Air’s LungFit PH is approved for commercial use in the United States exclusively for treating term and near-term neonates with hypoxic respiratory failure.
Image credits: Beyond Air
Beyond Air, Inc released data from a study demonstrating that intermittent high-dose inhaled nitric oxide (iNO) is safe and potentially beneficial for adults hospitalized with COVID-19 viral pneumonia. The study found that intermittent 150-ppm iNO treatment improved recovery times and reduced the need for oxygen support compared with standard care. Specifically, the treatment was well-tolerated and led to shorter oxygen support duration, better oxygen saturation levels, and a trend toward earlier discharge, all without an increase in adverse events.1
In this study, 40 subjects were recruited, of which 35 were included in the analysis (34 with COVID-19). Those receiving 150-ppm iNO (treatment group) had their oxygen support duration reduced by 2.7 days. The treatment group also had a higher rate of achieving oxygen saturation of 93% or higher during hospitalization and showed a trend toward earlier discharge.2
In an exclusive interview with Contagion, Corey Davis, PhD, managing director at LifeSci Advisors and a spokesperson for BeyondAir's investor relations, discussed the improvements in patient outcomes with 150-ppm inhaled nitric oxide compared with standard care, calling it “a significant reduction in the need for oxygen supplementation.”
Study author Talya Wolak, MD, the head of Internal Medicine Department D at Shaare Zedek Medical Center, in Jerusalem, Israel, said in a statement, “We are pleased to publish these promising data showing 150-ppm intermittent inhaled NO administered with the LungFit PRO device is well-tolerated, safe, and beneficial compared to usual care in treating adults hospitalized for viral pneumonia due to COVID-19. Specifically, treatment with high-dose inhaled NO may mitigate viral pneumonia severity and enhance a subject’s recovery by reducing time to reach stable room air saturation and duration of supportive oxygen.”1
This prospective, open-label, multicenter study included subjects aged 18 to 80 years with viral pneumonia. Participants were divided into 2 groups: the control group, which received standard supportive treatment only, and the treatment group, which received standard care plus 150-ppm iNO for 40 minutes, 4 times per day, for up to 7 days.2
Adverse event rates were comparable between groups (56.3% in the control group vs 42.1% in the treatment group), with no treatment-related adverse events reported and only 2 serious adverse events attributed to preexisting conditions.2
Davis explained that “safety assessments were performed by the physicians on-site and reviewed by a safety committee. Nitrogen dioxide and methemoglobin levels were monitored constantly during NO delivery to ensure safety.”
The study faced limitations because of the pandemic, with nearly all subjects having COVID-19 pneumonia instead of the planned 2:1 ratio. This shift occurred because of the impact of COVID-19 and a global decline in other viral infections. Despite this focus, NO inhalation is believed to benefit viral pneumonia by improving oxygenation and reducing inflammation. NO also has known viricidal effects on several viruses causing pneumonia, though this study did not specifically explore those mechanisms.2
Community-acquired pneumonia is a type of pneumonia acquired outside of a hospital or healthcare setting. It is diagnosed based on the presence of pneumonia symptoms, such as cough, fever, and difficulty breathing, combined with radiographic evidence of lung infection. Inappropriate diagnosis of community-acquired pneumonia can occur when patients, particularly the elderly or those with cognitive impairments, receive a pneumonia diagnosis despite lacking sufficient clinical or radiographic criteria.3
Nitric Oxide, a potent molecule naturally produced in the body, is essential for various biological functions. In the airways, it affects the vascular smooth muscle cells around the lung's small arteries. Inhaled NO is used to treat hypoxemia in conditions like adult respiratory distress syndrome, post-cardiac surgery, and persistent pulmonary hypertension in newborns. It also plays a role in the innate immune system, showing antimicrobial properties in vitro against diverse pathogens, including bacteria, viruses, fungi, and parasites, with potential efficacy against multi-drug resistant strains.1
Beyond Air specializes in using NO to treat respiratory illnesses, neurological disorders, and solid tumors. The FDA-approved LungFit PH device is specifically designed for treating neonates with hypoxic respiratory failure. Meanwhile, other LungFit systems are being investigated for their potential in treating severe and chronic lung conditions.1
Davis ended by sharing these findings' potential impacts on future treatments for viral pneumonia and other respiratory illnesses, saying, "High concentration NO should be further studied in a larger, blinded study to confirm these results for viral lung infections. Other studies have shown benefits for patients suffering from chronic, refractory bacterial lung infections.”
