Researchers are administering continuously pulsed inhaled nitric oxide via the Bellerophon INOpulse® delivery system to prevent the progression of respiratory disease in patients with mild to moderate COVID-19-related pneumonia. The targeted treatment is given to patients who require oxygen but before a ventilator is needed to support breathing.
"There's a greater likelihood of death among COVID-19 patients with pneumonia who are placed on a ventilator," said Dr. Sitaramesh Emani, principal investigator, cardiologist at The Ohio State University Wexner Medical Center and associate professor of cardiology at The Ohio State University College of Medicine. "If we can treat patients with inhaled nitric oxide before they become so ill that they require a ventilator, we believe we can improve patient outcomes and reserve ventilators and hospital resources for the sickest patients."
COVID-19 is caused by the SARS-CoV-2 virus, which is approximately 82% identical to the SARS-CoV that caused a global outbreak between 2003 and 2004. Symptoms range from mild upper respiratory tract infection to severe pneumonia and death. End-stage disease is unpredictable with high fatality rates in mechanically ventilated patients as a result of multi-organ failure.
Inhaled nitric oxide is a well-established, safe and effective treatment to dilate arteries in the lungs, improving oxygen in the blood stream. Prior studies of SARS-CoV found inhaled nitric oxide's antiviral properties could suppress how the virus replicates. Based on the genetic similarities between the two coronaviruses, the historical data supports the potential for inhaled nitric oxide to provide meaningful benefit for patients infected with COVID-19.
The INOpulse technology uses high concentration pulses of nitric oxide to provide a precise and constant dose regardless of a patient's breathing pattern. The delivery system is compact and can be worn on a belt or waistband.
"Traditionally, inhaled nitric oxide treatments use bulky canisters that require patients to remain in the hospital during treatment," said Dr. Raymond Benza, co-principal investigator, director of the Division of Cardiovascular Medicine at The Ohio State University Wexner Medical Center and professor of cardiology at The Ohio State University College of Medicine. "As the patients in this trial improve, this novel delivery system will allow them to continue inhaled nitric oxide treatment at home, reducing their time in the hospital and limiting their exposure as they recover."
Patients are admitted to the trial via individual patient expanded access, also known as compassionate use, as approved by the U.S. Food and Drug Administration. They will receive treatment for a minimum of five days and up to two weeks if needed. Patients will be followed for four weeks to assess how they respond to the treatment.
